1) Imugene is developing B-cell peptide cancer immunotherapy vaccines targeting the HER-2 receptor, which is the target of Roche's $6.4 billion breast cancer drug Herceptin.
2) Imugene has completed a Phase 1 clinical trial of its lead HER-Vaxx vaccine in HER-2 positive breast cancer patients, and plans to begin a Phase 1b/2 gastric cancer trial in early 2016.
3) HER-Vaxx induces polyclonal antibody responses against HER-2, unlike monoclonal antibodies, and has the potential to provide long-lasting immunity through immune memory activation.
This document is an investor presentation by PharmAust Limited that includes several disclaimers. It states that the presentation does not contain all information required by investors and should not be considered financial, tax, or legal advice. It also disclaims any representations or warranties regarding the accuracy of the information provided. The presentation is provided for investors to conduct their own independent research on the company. It also cautions that forward-looking statements in the presentation are based on assumptions that may not be realized.
Prescient is preparing to commence a Phase 1b/2 clinical trial of PTX-200 in acute myeloid leukemia (AML) at prominent cancer research centers in the United States. PTX-200 is a novel inhibitor of the Akt signaling pathway that has shown promise in overcoming chemotherapy resistance and inducing cancer cell death with fewer toxic side effects than other Akt inhibitors. If successful, the upcoming AML trial could increase interest in Prescient and validate PTX-200 as an improved treatment for this disease with high unmet medical need. Prescient has additional clinical-stage oncology programs in breast cancer, ovarian cancer, and multiple myeloma across its pipeline.
This document summarizes clinical trial results for a medical device called dermaPACE that uses shockwave technology to treat diabetic foot ulcers. Some key points:
- A supplemental clinical trial of dermaPACE enrolled 130 patients and showed a complete wound closure rate of 22.7% for those treated with dermaPACE versus 18.3% for controls at 12 weeks.
- When combining results from the original and supplemental trials (total 336 patients), treatment with dermaPACE resulted in a statistically significant higher complete wound closure rate of 37.8% versus 26.2% for controls at 24 weeks.
- Subgroup analyses found higher wound closure rates with dermaPACE treatment for those
This document discusses Ruthigen, Inc., a drug development company focused on developing RUT58-60, a hypochlorous acid-based drug candidate for invasive use. RUT58-60 aims to improve patient outcomes for invasive procedures by reducing post-surgical infections in a more effective way than current standard of care antibiotics. Published studies on Microcyn, another hypochlorous acid-based product, show promise in reducing infection rates for diabetic foot ulcers and coronary artery bypass graft surgery wounds. If successful, RUT58-60 could help hospitals reduce costs by shortening patient stays and lowering readmission rates for post-surgical infections.
Aridis Pharmaceuticals is a late-stage clinical development company, leading the creation of transformative, first-in-class anti-infectives for life-threatening viral and bacterial respiratory infections. The company’s lead drug candidate for acute pneumonia met all endpoints for its phase 2 clinical trial and the Company is now preparing for a phase 3 study. Its pipeline of novel mechanism antibacterial and antivirals, sprung from its proprietary technology platforms, are designed to combat the growing public health threat of viral pandemics and antimicrobial resistant (AMR) bacteria. Its anti-toxin monoclonal antibody approach is a proven Mechanism of Action and has shown efficacy as a combination therapy in reducing acute pneumonia patients time in ICU as compared to the current standard of care, which is antibiotics. In addition to its phase 3 program, ARDS also has a phase 2 asset for the treatment of Bacteria HAP/VAP LPS 011. It also recently began enrolling for a phase 2 clinical trial for the treatment of Cystic Fibrosis patients with acute pneumonia, a program funded by the Cystic Fibrosis Foundation for $7.5 million. Importantly, ARDS is also preparing to launch a Phase 1/2 clinical trial in the second half of 2021 with its novel inhalation antibody technology for emerging COVID-19 mutated variants. The expansion of COVID virus strain coverage, combined with the product's self-administered, at-home treatment modality, further differentiates the company's AR-712 COVID treatment offering.
PharmAust is a clinical-stage oncology company focused on drug repurposing. Its lead product PPL-1 (Monepantel-MPL) successfully completed Phase I/II trials and is now Phase II ready. MPL has potential as a new class of targeted anti-cancer therapy. PharmAust also has a profitable specialty chemicals business and options for veterinary cancer applications through partnerships. The company is significantly undervalued given its pipeline and clinical progress.
Aptorum Group Limited (NASDAQ: APM) is a pharmaceutical company dedicated to
developing and commercializing novel therapeutics to tackle unmet medical needs.
Aptorum's current drug pipeline includes indications in orphan diseases, infectious
diseases, and metabolic diseases. In 2021, the company plans to bring two candidates to
clinical trials. Aptorum’s Smart-ACT™ platform is designed to bring an average of three
drug candidates for orphan diseases to clinical trials every 12-18 months. The company is
now preparing to launch a dietary supplement for women undergoing menopause and
experiencing related symptoms, including osteoporosis. Targeting a global woman’s health
supplement market that is expected to reach $17 billion in 2025, Aptorum is expected to
generate near-term revenue with significant long-term growth potential.
This document is an investor presentation by PharmAust Limited that includes several disclaimers. It states that the presentation does not contain all information required by investors and should not be considered financial, tax, or legal advice. It also disclaims any representations or warranties regarding the accuracy of the information provided. The presentation is provided for investors to conduct their own independent research on the company. It also cautions that forward-looking statements in the presentation are based on assumptions that may not be realized.
Prescient is preparing to commence a Phase 1b/2 clinical trial of PTX-200 in acute myeloid leukemia (AML) at prominent cancer research centers in the United States. PTX-200 is a novel inhibitor of the Akt signaling pathway that has shown promise in overcoming chemotherapy resistance and inducing cancer cell death with fewer toxic side effects than other Akt inhibitors. If successful, the upcoming AML trial could increase interest in Prescient and validate PTX-200 as an improved treatment for this disease with high unmet medical need. Prescient has additional clinical-stage oncology programs in breast cancer, ovarian cancer, and multiple myeloma across its pipeline.
This document summarizes clinical trial results for a medical device called dermaPACE that uses shockwave technology to treat diabetic foot ulcers. Some key points:
- A supplemental clinical trial of dermaPACE enrolled 130 patients and showed a complete wound closure rate of 22.7% for those treated with dermaPACE versus 18.3% for controls at 12 weeks.
- When combining results from the original and supplemental trials (total 336 patients), treatment with dermaPACE resulted in a statistically significant higher complete wound closure rate of 37.8% versus 26.2% for controls at 24 weeks.
- Subgroup analyses found higher wound closure rates with dermaPACE treatment for those
This document discusses Ruthigen, Inc., a drug development company focused on developing RUT58-60, a hypochlorous acid-based drug candidate for invasive use. RUT58-60 aims to improve patient outcomes for invasive procedures by reducing post-surgical infections in a more effective way than current standard of care antibiotics. Published studies on Microcyn, another hypochlorous acid-based product, show promise in reducing infection rates for diabetic foot ulcers and coronary artery bypass graft surgery wounds. If successful, RUT58-60 could help hospitals reduce costs by shortening patient stays and lowering readmission rates for post-surgical infections.
Aridis Pharmaceuticals is a late-stage clinical development company, leading the creation of transformative, first-in-class anti-infectives for life-threatening viral and bacterial respiratory infections. The company’s lead drug candidate for acute pneumonia met all endpoints for its phase 2 clinical trial and the Company is now preparing for a phase 3 study. Its pipeline of novel mechanism antibacterial and antivirals, sprung from its proprietary technology platforms, are designed to combat the growing public health threat of viral pandemics and antimicrobial resistant (AMR) bacteria. Its anti-toxin monoclonal antibody approach is a proven Mechanism of Action and has shown efficacy as a combination therapy in reducing acute pneumonia patients time in ICU as compared to the current standard of care, which is antibiotics. In addition to its phase 3 program, ARDS also has a phase 2 asset for the treatment of Bacteria HAP/VAP LPS 011. It also recently began enrolling for a phase 2 clinical trial for the treatment of Cystic Fibrosis patients with acute pneumonia, a program funded by the Cystic Fibrosis Foundation for $7.5 million. Importantly, ARDS is also preparing to launch a Phase 1/2 clinical trial in the second half of 2021 with its novel inhalation antibody technology for emerging COVID-19 mutated variants. The expansion of COVID virus strain coverage, combined with the product's self-administered, at-home treatment modality, further differentiates the company's AR-712 COVID treatment offering.
PharmAust is a clinical-stage oncology company focused on drug repurposing. Its lead product PPL-1 (Monepantel-MPL) successfully completed Phase I/II trials and is now Phase II ready. MPL has potential as a new class of targeted anti-cancer therapy. PharmAust also has a profitable specialty chemicals business and options for veterinary cancer applications through partnerships. The company is significantly undervalued given its pipeline and clinical progress.
Aptorum Group Limited (NASDAQ: APM) is a pharmaceutical company dedicated to
developing and commercializing novel therapeutics to tackle unmet medical needs.
Aptorum's current drug pipeline includes indications in orphan diseases, infectious
diseases, and metabolic diseases. In 2021, the company plans to bring two candidates to
clinical trials. Aptorum’s Smart-ACT™ platform is designed to bring an average of three
drug candidates for orphan diseases to clinical trials every 12-18 months. The company is
now preparing to launch a dietary supplement for women undergoing menopause and
experiencing related symptoms, including osteoporosis. Targeting a global woman’s health
supplement market that is expected to reach $17 billion in 2025, Aptorum is expected to
generate near-term revenue with significant long-term growth potential.
Prescient Therapeutics (PTX:ASX) is an ASX-listed biotechnology company focused on improving outcomes for cancer patients by developing personal medicines, using CAR-T and targeted therapy approaches.
Universal CAR-T therapies like OmniCAR have the potential to take personalised cancer treatment to the next level, by combining the cancer-killing capabilities of a T-cell with the control and pharmacology of a drug.
Catasys provides an integrated virtual healthcare program called OnTrak that identifies and treats behavioral health conditions like substance abuse and depression. OnTrak uses predictive analytics to identify high-cost patients with behavioral health issues who rarely seek treatment. Patients enroll in a 52-week virtual treatment program with care coaching support. Studies show OnTrak significantly reduces medical costs and healthcare utilization for enrolled members. Catasys contracts with health plans to provide OnTrak and is paid a monthly fee per enrolled member.
HR Compliance & Insurance Benefit Perspectives: What Employers Should Be Awar...Rea & Associates
Guidelines for employees are constantly changing but it’s important that businesses stay on top of mandates and regulations. What risks should organizations be informed about? Is your organization able to have varied insurance premiums for vaccinated vs. non-vaccinated employees?
Join Rea & Associates and Huntington Insurance for a deep dive into best practices for exposures, insurance perspectives, and vaccine mandates and regulations.
This presentation provides an overview of Scythian Biosciences Inc., a pharmaceutical company developing cannabinoid-based drug therapies for traumatic brain injury (TBI). It discusses the large market opportunity for treating TBI, outlines Scythian's solution to develop drugs that inhibit immune response and inflammation following TBI, and presents the company's preclinical and clinical development timelines and leadership team.
Advanced Medical Isotope Corporation is developing RadioGel, a brachytherapy device, to treat cancers in humans and animals. The company plans to generate near-term revenue from veterinary clinics and international licensing. It is working towards FDA approval for human cancer indications like skin cancer. RadioGel consists of radioactive yttrium-90 phosphate particles delivered via a hydrogel vehicle that solidifies in the body. The company expects to begin sales to veterinary clinics in early 2018 and obtain international licensing revenue. It is led by an experienced management team and advises by world-class medical and scientific boards.
Tiziana Life Sciences (NASDAQ: TLSA) Investor Presentation - July 20th 2020RedChip Companies, Inc.
Tiziana Life Sciences (NASDAQ: TLSA) is a dual-listed clinical stage company developing targeted therapeutics to transform treatment of liver diseases, inflammatory diseases, and cancer. Our clinical pipeline includes drug assets for Crohn's, and hepatocellular carcinoma. Tiziana’s two lead drug candidates, Foralumab and Milciclib, uniquely target the root cause of diseases with large unmet needs in multibillion-dollar markets. Tiziana is accelerating development of anti-IL6 receptor monoclonal antibody (mAb) for treatment of COVID-19 lung inflammation. Tiziana is a market leader in the invention of proprietary technology for oral, nasal and inhaled formulation to transform immunotherapies with Monoclonal Antibodies currently administered intravenously. Also, Tiziana has a robust and growing patent portfolio.
NeoStem, Inc. (“NeoStem” or the “Company”), a biopharmaceutical company, is capitalizing on the paradigm shift occurring in medicine by engaging in the development and manufacture of cellular therapies for oncology, immunology, and regenerative medicines in the United States. The Company anticipates that cell therapy will play a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society.
Aridis Pharmaceuticals is a late-stage clinical development company, leading the creation of transformative, first-in-class anti-infectives for life-threatening viral and bacterial respiratory infections. The company’s lead drug candidate for acute pneumonia met the primary endpoint for its phase 2 clinical trial and the Company is now enrolling in a global phase 3 study. Its pipeline of novel mechanism antibacterial and antivirals, sprung from its proprietary discovery technology platforms, are designed to combat the growing public health threat of viral pandemics and antimicrobial resistant (AMR) bacteria. Its anti-toxin monoclonal antibody (mAb) approach is a proven mechanism of action and has shown preliminary trend toward efficacy as an adjunctive therapy in reducing acute pneumonia patients time in ICU as compared to the current standard of care, which is antibiotics. In addition to its phase 3 program, ARDS also has a phase 2 asset for the treatment of Bacteria HAP/VAP LPS 011. The company also has an on-going phase 2 clinical trial for the treatment of Cystic Fibrosis patients, a program funded by the Cystic Fibrosis Foundation for $7.5 million. Importantly, ARDS is also preparing to launch a Phase 1/2 clinical trial in the second half of 2021 with a self-administered broadly neutralizing mAb for emerging COVID-19 mutated variants. The expansion of COVID virus strain coverage, combined with the product's self-administered, at-home treatment modality, further differentiates the company's AR-712 COVID treatment offering.
Virios Therapeutics is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as Fibromyalgia (“FM”). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 (“HSV-1”) have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease (“IBS”), and chronic fatigue syndrome, all of which can be characterized by waxing and waning symptom flare-ups with no obvious etiology. Virios’ lead development candidate (“IMC-1”) is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.
Interpace Diagnostics provides molecular diagnostic tests and pathology services to evaluate cancer risk. The presentation discusses:
1) Interpace's product portfolio including tests that risk-stratify pancreatic cysts, Barrett's esophagus, and thyroid nodules.
2) Clinical evidence and guidelines supporting their tests, and growth in adoption and coverage by payers.
3) Financial highlights including recent funding raises, revenue growth, and progress reducing costs.
4) Drivers for continued growth including expanding sales force and strategic partnerships.
SciSparc is a specialty pharmaceutical company developing unique cannabinoid technologies for treatment of central nervous system disorders. The proprietary compounds capitalize on the biochemistry of receptors that specialize in modulating the central nervous system (CNS) to create therapeutics that mitigate the adverse symptoms associated with CNS disorders.
Immuron Limited is a clinical stage biopharmaceutical company developing oral immunotherapies to treat inflammatory and infectious diseases. It has two lead clinical assets in Phase 2 development for non-alcoholic steatohepatitis (NASH) and Clostridium difficile infection. Immuron's lead candidate, IMM-124E, is being studied in three Phase 2 clinical trials for NASH, alcoholic steatohepatitis, and pediatric non-alcoholic fatty liver disease, with data expected in late 2017 and 2018. IMM-124E works through broad anti-inflammatory effects and has demonstrated a strong anti-fibrotic effect in preclinical models of liver disease.
Opexa Therapeutics is developing personalized T-cell immunotherapies for autoimmune diseases. Their lead candidate, Tcelna, is in Phase 2b clinical trials for secondary progressive multiple sclerosis and has shown signs of stabilizing disease progression in previous trials. Opexa has an option agreement with Merck Serono for the development and commercialization of Tcelna in multiple sclerosis. Recent milestones include completing enrollment in the Tcelna Phase 2b trial for SPMS and receiving a $3 million payment from Merck Serono. Opexa is also developing OPX-212 for neuromyelitis optica and expects to file an IND by the end of 2015.
Liquid biopsy from a simple blood test enabling personalised cancer care | Sh...ANGLE plc
Liquid biopsy from a simple blood test is enabling personalised cancer care. The Parsortix system from ANGLE can harvest cancer cells from blood (liquid biopsy) in a non-invasive and repeatable way. This provides a new approach to obtaining cancer cells for analysis compared to traditional tumour biopsies. Key opinion leaders have evaluated the Parsortix system and found that it captures all types of cancer cells with high purity in an easy to use process, making it well suited for clinical applications in personalised cancer care.
EcoStim is an oilfield services company providing well stimulation services in the US and Argentina. The presentation highlights:
1) EcoStim has secured multiple new contracts in 2017 anchoring a second crew in the US and a long-term contract in Argentina, positioning it for accelerated growth.
2) EcoStim trades at an attractive valuation compared to peers based on enterprise value per hydraulic horsepower.
3) EcoStim utilizes proprietary downhole diagnostic and predictive technologies to more efficiently target completion stages, reducing costs for customers.
Catasys provides a virtual, scalable, and data-driven behavioral health program called OnTrak to help address the high costs of untreated behavioral health conditions like substance abuse, depression, and anxiety. OnTrak uses predictive analytics to identify avoidant patients, engages them in a 52-week outpatient treatment program with care coaching support, and integrates medical and psychosocial care. This approach aims to reduce health plan costs by around 50% while providing full reimbursement. Catasys has signed agreements with several major health insurance companies to provide OnTrak and is seeing growing enrollment.
Tiziana Life Sciences presented an overview of their transformational immunotherapy platform enabling alternative routes of administration. Their proprietary technologies allow for oral, nasal, and inhalation delivery of antibodies, which currently require IV administration. They highlighted clinical progress including trials of their lead asset foralumab administered intranasally for progressive MS and COVID-19. Results demonstrated safety and positive clinical responses. Tiziana is also developing other pipeline assets and expanding their management team and scientific advisory board.
AMBS is a regenerative medicine company developing new treatments for CNS disorders and regenerative medicine. It has several programs and subsidiaries developing treatments for conditions like Parkinson's disease, burns, cancer, and retinal diseases. Its lead programs include Eltoprazine for Parkinson's disease levodopa-induced dyskinesia through its subsidiary Elto Pharma, and recombinant MANF protein for retinal conditions like retinitis pigmentosa through its subsidiary MANF Therapeutics. AMBS is currently trading at very low prices but has achieved much higher values in the past, and it believes further progress in its clinical programs could increase its valuation.
Opexa Therapeutics August 2015 OPXA Corporate PresentationOpexaTherapeutics
Opexa Therapeutics presented information on their precision immunotherapy platform and key programs. Their lead candidate, Tcelna, is in Phase 2b clinical trials for secondary progressive multiple sclerosis and has shown signs of stabilizing disease progression. Tcelna works by reducing myelin reactive T-cells that damage the myelin sheath. Opexa has an option agreement with Merck Serono for the development and commercialization of Tcelna in multiple sclerosis. Additionally, Opexa is developing OPX-212 for neuromyelitis optica, an orphan indication with no approved therapies.
4D CT scanning provides improved target delineation and treatment alignment for lung radiotherapy by accounting for tumor motion throughout the respiratory cycle. Analysis of 4D CT scans from 20 patients at NCCI found that accounting for tumor motion increased planning target volumes by an average of 9.1-42.5% depending on tumor size. Studies have also shown 4D CT can reduce needed planning margins from 2mm down when using bony anatomy for alignment by better visualizing tumor position. NCCI now uses 4D CT along with IMRT and daily CBCT to precisely target tumors and minimize dose to healthy tissues, with the goal of reducing radiation pneumonitis complications.
Tony seruga yolanda seruga business expert. Tony Seruga Yolanda Seruga hates scam and fraud and any kinds of ripoff. Tony Seruga a business i con knows pros and cons and has got very good reviews as he got the best review of internet marketer.In the early years, Tony Seruga started a professional lawn service, employing college kids to do the actual work when he was only 14 years old building revenues to over $12,000 per year by the time he was 17. Tony built his first computer from a kit in 1976 and started his first “online” business in the early 1980s, using AOL and Compuserve.
Tony is a serial entrepreneur, having personally started over 240 businesses and over 600 with business partners. Tony has mentored thousands upon thousands of business owners.
Tony has been an early stage investor and entrepreneur since 1987. Tony has over two decades of experience in the venture capital, technology and entertainment industries in a multitude of investing, operational and engineering roles acting as a key adviser. In addition to his investing efforts, Tony has been active with several non-profit organizations. Tony holds a Juris Doctorate, although he never chose to practice law, opting for buying and selling businesses and investing in those projects he felt had the best chance of success.
Tony was co-owner of half a dozen early search engines including three pay-per-click search engines and was an early angel investor and adviser to four different businesses that went on to become multi-billion dollar companies. As a business adviser, Tony’s past client roster included a number of household names and celebrities.
And while Tony enjoyed speaking at business and marketing events all over the world, his real passion is to empower entrepreneurs and business owners to create massive success. Tony loves to help people to understand specifically what it takes to build a successful business. He has a very successful background in venture capital, investing and marketing. He has spent two decades working with start-ups to major global brands increasing sales, productivity and overall success and is an innovator with a remarkable ability to determine and dictate success strategies that enable companies to seize global market opportunities.
For everyone that either wishes to start their own business, currently owns a business or would like to capitalize the entrepreneurial dream, Tony’s message will enlighten them with knowledge and actionable principles to turn that passion into success. Tony has an extensive background in starting businesses, commercial real estate development and building companies around the world. Over the past two decades, he has specialized in helping companies launch, grow and create exponential valuation in the marketplace.
For more info about Tony Seruga visit http://tonyserugatonyserugatonyseruga.blogspot.com/
Prescient Therapeutics (PTX:ASX) is an ASX-listed biotechnology company focused on improving outcomes for cancer patients by developing personal medicines, using CAR-T and targeted therapy approaches.
Universal CAR-T therapies like OmniCAR have the potential to take personalised cancer treatment to the next level, by combining the cancer-killing capabilities of a T-cell with the control and pharmacology of a drug.
Catasys provides an integrated virtual healthcare program called OnTrak that identifies and treats behavioral health conditions like substance abuse and depression. OnTrak uses predictive analytics to identify high-cost patients with behavioral health issues who rarely seek treatment. Patients enroll in a 52-week virtual treatment program with care coaching support. Studies show OnTrak significantly reduces medical costs and healthcare utilization for enrolled members. Catasys contracts with health plans to provide OnTrak and is paid a monthly fee per enrolled member.
HR Compliance & Insurance Benefit Perspectives: What Employers Should Be Awar...Rea & Associates
Guidelines for employees are constantly changing but it’s important that businesses stay on top of mandates and regulations. What risks should organizations be informed about? Is your organization able to have varied insurance premiums for vaccinated vs. non-vaccinated employees?
Join Rea & Associates and Huntington Insurance for a deep dive into best practices for exposures, insurance perspectives, and vaccine mandates and regulations.
This presentation provides an overview of Scythian Biosciences Inc., a pharmaceutical company developing cannabinoid-based drug therapies for traumatic brain injury (TBI). It discusses the large market opportunity for treating TBI, outlines Scythian's solution to develop drugs that inhibit immune response and inflammation following TBI, and presents the company's preclinical and clinical development timelines and leadership team.
Advanced Medical Isotope Corporation is developing RadioGel, a brachytherapy device, to treat cancers in humans and animals. The company plans to generate near-term revenue from veterinary clinics and international licensing. It is working towards FDA approval for human cancer indications like skin cancer. RadioGel consists of radioactive yttrium-90 phosphate particles delivered via a hydrogel vehicle that solidifies in the body. The company expects to begin sales to veterinary clinics in early 2018 and obtain international licensing revenue. It is led by an experienced management team and advises by world-class medical and scientific boards.
Tiziana Life Sciences (NASDAQ: TLSA) Investor Presentation - July 20th 2020RedChip Companies, Inc.
Tiziana Life Sciences (NASDAQ: TLSA) is a dual-listed clinical stage company developing targeted therapeutics to transform treatment of liver diseases, inflammatory diseases, and cancer. Our clinical pipeline includes drug assets for Crohn's, and hepatocellular carcinoma. Tiziana’s two lead drug candidates, Foralumab and Milciclib, uniquely target the root cause of diseases with large unmet needs in multibillion-dollar markets. Tiziana is accelerating development of anti-IL6 receptor monoclonal antibody (mAb) for treatment of COVID-19 lung inflammation. Tiziana is a market leader in the invention of proprietary technology for oral, nasal and inhaled formulation to transform immunotherapies with Monoclonal Antibodies currently administered intravenously. Also, Tiziana has a robust and growing patent portfolio.
NeoStem, Inc. (“NeoStem” or the “Company”), a biopharmaceutical company, is capitalizing on the paradigm shift occurring in medicine by engaging in the development and manufacture of cellular therapies for oncology, immunology, and regenerative medicines in the United States. The Company anticipates that cell therapy will play a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society.
Aridis Pharmaceuticals is a late-stage clinical development company, leading the creation of transformative, first-in-class anti-infectives for life-threatening viral and bacterial respiratory infections. The company’s lead drug candidate for acute pneumonia met the primary endpoint for its phase 2 clinical trial and the Company is now enrolling in a global phase 3 study. Its pipeline of novel mechanism antibacterial and antivirals, sprung from its proprietary discovery technology platforms, are designed to combat the growing public health threat of viral pandemics and antimicrobial resistant (AMR) bacteria. Its anti-toxin monoclonal antibody (mAb) approach is a proven mechanism of action and has shown preliminary trend toward efficacy as an adjunctive therapy in reducing acute pneumonia patients time in ICU as compared to the current standard of care, which is antibiotics. In addition to its phase 3 program, ARDS also has a phase 2 asset for the treatment of Bacteria HAP/VAP LPS 011. The company also has an on-going phase 2 clinical trial for the treatment of Cystic Fibrosis patients, a program funded by the Cystic Fibrosis Foundation for $7.5 million. Importantly, ARDS is also preparing to launch a Phase 1/2 clinical trial in the second half of 2021 with a self-administered broadly neutralizing mAb for emerging COVID-19 mutated variants. The expansion of COVID virus strain coverage, combined with the product's self-administered, at-home treatment modality, further differentiates the company's AR-712 COVID treatment offering.
Virios Therapeutics is a clinical-stage biotechnology company focused on advancing novel, dual mechanism antiviral therapies to treat conditions associated with virally triggered or maintained immune responses, such as Fibromyalgia (“FM”). Immune responses related to the activation of tissue resident Herpes Simplex Virus-1 (“HSV-1”) have been postulated as a potential root cause triggering and/or sustaining chronic illnesses such as FM, irritable bowel disease (“IBS”), and chronic fatigue syndrome, all of which can be characterized by waxing and waning symptom flare-ups with no obvious etiology. Virios’ lead development candidate (“IMC-1”) is a novel, proprietary, fixed dose combination of famciclovir and celecoxib designed to synergistically suppress HSV-1 replication, with the end goal of reducing virally promoted disease symptoms.
Interpace Diagnostics provides molecular diagnostic tests and pathology services to evaluate cancer risk. The presentation discusses:
1) Interpace's product portfolio including tests that risk-stratify pancreatic cysts, Barrett's esophagus, and thyroid nodules.
2) Clinical evidence and guidelines supporting their tests, and growth in adoption and coverage by payers.
3) Financial highlights including recent funding raises, revenue growth, and progress reducing costs.
4) Drivers for continued growth including expanding sales force and strategic partnerships.
SciSparc is a specialty pharmaceutical company developing unique cannabinoid technologies for treatment of central nervous system disorders. The proprietary compounds capitalize on the biochemistry of receptors that specialize in modulating the central nervous system (CNS) to create therapeutics that mitigate the adverse symptoms associated with CNS disorders.
Immuron Limited is a clinical stage biopharmaceutical company developing oral immunotherapies to treat inflammatory and infectious diseases. It has two lead clinical assets in Phase 2 development for non-alcoholic steatohepatitis (NASH) and Clostridium difficile infection. Immuron's lead candidate, IMM-124E, is being studied in three Phase 2 clinical trials for NASH, alcoholic steatohepatitis, and pediatric non-alcoholic fatty liver disease, with data expected in late 2017 and 2018. IMM-124E works through broad anti-inflammatory effects and has demonstrated a strong anti-fibrotic effect in preclinical models of liver disease.
Opexa Therapeutics is developing personalized T-cell immunotherapies for autoimmune diseases. Their lead candidate, Tcelna, is in Phase 2b clinical trials for secondary progressive multiple sclerosis and has shown signs of stabilizing disease progression in previous trials. Opexa has an option agreement with Merck Serono for the development and commercialization of Tcelna in multiple sclerosis. Recent milestones include completing enrollment in the Tcelna Phase 2b trial for SPMS and receiving a $3 million payment from Merck Serono. Opexa is also developing OPX-212 for neuromyelitis optica and expects to file an IND by the end of 2015.
Liquid biopsy from a simple blood test enabling personalised cancer care | Sh...ANGLE plc
Liquid biopsy from a simple blood test is enabling personalised cancer care. The Parsortix system from ANGLE can harvest cancer cells from blood (liquid biopsy) in a non-invasive and repeatable way. This provides a new approach to obtaining cancer cells for analysis compared to traditional tumour biopsies. Key opinion leaders have evaluated the Parsortix system and found that it captures all types of cancer cells with high purity in an easy to use process, making it well suited for clinical applications in personalised cancer care.
EcoStim is an oilfield services company providing well stimulation services in the US and Argentina. The presentation highlights:
1) EcoStim has secured multiple new contracts in 2017 anchoring a second crew in the US and a long-term contract in Argentina, positioning it for accelerated growth.
2) EcoStim trades at an attractive valuation compared to peers based on enterprise value per hydraulic horsepower.
3) EcoStim utilizes proprietary downhole diagnostic and predictive technologies to more efficiently target completion stages, reducing costs for customers.
Catasys provides a virtual, scalable, and data-driven behavioral health program called OnTrak to help address the high costs of untreated behavioral health conditions like substance abuse, depression, and anxiety. OnTrak uses predictive analytics to identify avoidant patients, engages them in a 52-week outpatient treatment program with care coaching support, and integrates medical and psychosocial care. This approach aims to reduce health plan costs by around 50% while providing full reimbursement. Catasys has signed agreements with several major health insurance companies to provide OnTrak and is seeing growing enrollment.
Tiziana Life Sciences presented an overview of their transformational immunotherapy platform enabling alternative routes of administration. Their proprietary technologies allow for oral, nasal, and inhalation delivery of antibodies, which currently require IV administration. They highlighted clinical progress including trials of their lead asset foralumab administered intranasally for progressive MS and COVID-19. Results demonstrated safety and positive clinical responses. Tiziana is also developing other pipeline assets and expanding their management team and scientific advisory board.
AMBS is a regenerative medicine company developing new treatments for CNS disorders and regenerative medicine. It has several programs and subsidiaries developing treatments for conditions like Parkinson's disease, burns, cancer, and retinal diseases. Its lead programs include Eltoprazine for Parkinson's disease levodopa-induced dyskinesia through its subsidiary Elto Pharma, and recombinant MANF protein for retinal conditions like retinitis pigmentosa through its subsidiary MANF Therapeutics. AMBS is currently trading at very low prices but has achieved much higher values in the past, and it believes further progress in its clinical programs could increase its valuation.
Opexa Therapeutics August 2015 OPXA Corporate PresentationOpexaTherapeutics
Opexa Therapeutics presented information on their precision immunotherapy platform and key programs. Their lead candidate, Tcelna, is in Phase 2b clinical trials for secondary progressive multiple sclerosis and has shown signs of stabilizing disease progression. Tcelna works by reducing myelin reactive T-cells that damage the myelin sheath. Opexa has an option agreement with Merck Serono for the development and commercialization of Tcelna in multiple sclerosis. Additionally, Opexa is developing OPX-212 for neuromyelitis optica, an orphan indication with no approved therapies.
4D CT scanning provides improved target delineation and treatment alignment for lung radiotherapy by accounting for tumor motion throughout the respiratory cycle. Analysis of 4D CT scans from 20 patients at NCCI found that accounting for tumor motion increased planning target volumes by an average of 9.1-42.5% depending on tumor size. Studies have also shown 4D CT can reduce needed planning margins from 2mm down when using bony anatomy for alignment by better visualizing tumor position. NCCI now uses 4D CT along with IMRT and daily CBCT to precisely target tumors and minimize dose to healthy tissues, with the goal of reducing radiation pneumonitis complications.
Tony seruga yolanda seruga business expert. Tony Seruga Yolanda Seruga hates scam and fraud and any kinds of ripoff. Tony Seruga a business i con knows pros and cons and has got very good reviews as he got the best review of internet marketer.In the early years, Tony Seruga started a professional lawn service, employing college kids to do the actual work when he was only 14 years old building revenues to over $12,000 per year by the time he was 17. Tony built his first computer from a kit in 1976 and started his first “online” business in the early 1980s, using AOL and Compuserve.
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Tony has been an early stage investor and entrepreneur since 1987. Tony has over two decades of experience in the venture capital, technology and entertainment industries in a multitude of investing, operational and engineering roles acting as a key adviser. In addition to his investing efforts, Tony has been active with several non-profit organizations. Tony holds a Juris Doctorate, although he never chose to practice law, opting for buying and selling businesses and investing in those projects he felt had the best chance of success.
Tony was co-owner of half a dozen early search engines including three pay-per-click search engines and was an early angel investor and adviser to four different businesses that went on to become multi-billion dollar companies. As a business adviser, Tony’s past client roster included a number of household names and celebrities.
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The document discusses combined chemoradiotherapy for non-small cell lung cancer (NSCLC). It describes the evolution of radiotherapy techniques from older 2D techniques to modern 3D conformal radiation and IMRT. Studies show combined chemoradiotherapy improves survival over radiotherapy alone or sequential chemotherapy and radiotherapy by reducing locoregional recurrence rates. However, concurrent chemoradiotherapy is associated with increased toxicity risks which must be balanced against survival benefits.
This document discusses radiotherapy techniques for early breast cancer, including:
1) Modern techniques like IMRT and 4D radiotherapy allow for better treatment planning and delivery while avoiding nearby organs.
2) Several randomized clinical trials found that a shorter, hypofractionated course of radiotherapy was not inferior to standard radiotherapy in terms of local recurrence or toxicity.
3) Partial breast irradiation techniques are being studied as a way to further reduce treatment volumes and time for selected low-risk patients.
Oncology Immunotherapy - Nivolumab and other PD-1/PD-L1 Targeted Agents (061213)Will Roettger
This is a short briefing on the oncology immunotherapy PD-1/PD-L1 targeted agents currently under development. In this briefing we look at the competitive landscape, PD-1/PD-L1 product profiles, positioning, strategy, as well as a development timeline and SWOT on the BMS PD-1 blocker nivolumab. Updates to this briefing will come as newer information is discovered.
1. The document discusses the standard treatment for locally advanced cervical cancer, which is concurrent chemoradiotherapy with cisplatin. Several randomized trials from the 1990s showed improved survival with this approach compared to radiotherapy alone.
2. Meta-analyses of these trials demonstrated a 6-8% absolute improvement in survival at 5 years with the addition of chemotherapy to radiotherapy. Cisplatin is the recognized cytotoxic drug used most commonly.
3. The study described in the document investigated the use of ifosfamide and cisplatin with concurrent chemoradiotherapy and consolidation chemotherapy as a potentially improved treatment approach for locally advanced cervical cancer.
The document discusses key concepts in radiobiology relevant for radiotherapy. It defines important treatment volumes including the gross tumour volume (GTV), clinical target volume (CTV), planning target volume (PTV), treated volume (TV), irradiated volume (IV), and organs at risk (OARs). It also describes biological factors that influence radiation effects on tissues, known as the "5 Rs": repair, repopulation, reoxygenation, redistribution, and radiosensitivity. Fractionated radiotherapy takes advantage of these factors to maximize tumor cell kill while minimizing damage to normal tissues.
Technical Advances in radiotherapy for Lung (and liver) Cancerspa718
This document summarizes recent technical advances in radiotherapy for lung and liver cancer, including: 4DCT imaging to account for tumor motion; motion management techniques like gating and breath-holding; intensity modulated radiation therapy (IMRT) and volumetric modulated arc therapy (VMAT) to improve dose conformity; image-guided radiation therapy (IGRT) to reduce margins and enable adaptations; and proton therapy which may further reduce normal tissue dose due to its physical properties, though proton techniques are still evolving to address motion and anatomical changes. The document outlines the benefits and challenges of each technique through examples and studies.
Respiratory gating with intensity-modulated radiation therapy (IMRT) allows for higher doses to be delivered to the tumor target while reducing side effects to normal tissues. It works by synchronizing beam delivery to specific phases of the respiratory cycle using external markers or internal fiducials implanted in or near the tumor. This leads to smaller planning target volumes and sharper dose gradients compared to conventional radiation therapy that does not account for tumor motion. Respiratory gating requires consistent breathing patterns from patients and continuous monitoring during treatment. It is effective for tumors in organs that move significantly during respiration like lung, liver and pancreas.
This presentation is part of MIU CE Pharmacy Program and is designed primarily for pharmacists with the following learning objectives:
1- Explain the mechanisms of action behind immune response to cancer and the application of immunotherapy in cancer treatment
2- Distinguish new and emerging immunotherapy classes and individual agents efficacy, safety to therapy in cancer treatment
3-Strategies to counsel and assist patients to overcome barriers to therapy, including Treatment side effects to improve adherence to therapy
Tracxn Research — Immuno-Oncology Landscape, September 2016Tracxn
In 2015/16, five startups in this space — Stemcentrx, Gritstone Oncology, Hengrui Therapeutics, and Zai Lab secured big ticket funding rounds of $100 million and above.
4D radiotherapy aims to account for tumor motion during radiation therapy by acquiring CT images over multiple phases of the breathing cycle (4D CT imaging) and using this information for treatment planning and delivery. It allows for more accurate targeting of tumors in organs affected by respiratory motion like the lungs. While 4D radiotherapy provides advantages over existing motion management techniques, there are still technological challenges and limitations like complexity, treatment time, and residual motion. Future work includes addressing these issues and further integrating 4D techniques with other advances in radiation oncology.
Immunotherapy is a type of cancer treatment that uses components of the immune system to fight cancer. There are several types of immunotherapy including passive immunotherapy using monoclonal antibodies that target tumor antigens, active immunotherapies using cytokines, cancer vaccines, and cell-based therapies. Monoclonal antibodies can directly kill cancer cells, block proteins that help cancer grow, or be linked to chemotherapy drugs. Cancer vaccines work by boosting the immune system against tumor antigens. Adoptive immunotherapy transfers modified immune cells to the body to attack cancer. Immunotherapy has shown success in treating various cancer types and continues to be improved and developed further.
The immunotherapy of cancer: past, present & the next frontierThe ScientifiK
The immunotherapy of cancer has progressed through several phases from past to present:
1) Early attempts focused on vaccines and cytokines with limited success and understanding.
2) Anti-CTLA4 therapy showed the first durable responses in metastatic melanoma.
3) Anti-PD-1 therapy was found to be superior to anti-CTLA4, with better responses and tolerability. This established that overcoming immunosuppression is key.
4) Combination strategies are now the focus, exploring combinations of immunotherapies or with targeted/chemotherapies to extend responses. Biomarkers like PD-L1 are being used to identify patients most likely to benefit from anti-PD-1
Amgen Cowen and Company 37th Annual Health Care Conference PresentationThe ScientifiK
This document summarizes an oral presentation given by David Meline, Executive Vice President and Chief Financial Officer of Amgen, at the Cowen and Company 37th Annual Health Care Conference on March 8, 2017. The presentation discusses Amgen's strong financial and operational execution in 2016, advancement of its innovative pipeline including positive cardiovascular outcomes data for Repatha, and growth opportunities across therapeutic areas like oncology, neuroscience, and bone health. It also reviews Amgen's biosimilars portfolio and strategy to invest in external innovation and deliver significant returns to shareholders through dividends and share repurchases.
Radiotherapy For Non Small Cell Lung Cancerfondas vakalis
- The document discusses treatment options for non-small cell lung cancer (NSCLC), including surgery, radiotherapy, chemotherapy, and combinations.
- For early stage NSCLC (stages I-II), surgery is the standard treatment but radiotherapy is an alternative for medically inoperable patients. Adjuvant chemotherapy may improve outcomes for stage II.
- For locally advanced NSCLC (stage III), combined modality treatment is usually recommended, with concurrent chemoradiotherapy being superior to sequential treatment for stage IIIB.
Cancer is a significant health problem in Egypt due to large population increases and exposure to risk factors. However, the true magnitude of the problem is not accurately known because cancer data has historically been limited to hospital-based registries. A national population-based cancer registry is needed to establish national estimates of cancer incidence and accurately assess the scale of the issue in Egypt.
The document discusses GSK's oncology R&D strategy of maximizing survival through transformational medicines and combinations. It focuses on immuno-oncology, epigenetics, cell and gene therapy. The pipeline includes BCMA and NY-ESO-1 CAR T-cell therapies, OX40 and ICOS agonist antibodies, a TLR4 agonist, and a BET inhibitor showing early efficacy in NUT midline carcinoma. GSK's strategy involves diversifying across modalities, pursuing combination therapies, and building partnerships to sustain a long-term leadership position in oncology.
Tiziana Life Sciences is a dual-listed clinical stage biotechnology company focused on the discovery and development of novel molecules to treat human disease in oncology and immunology. Tiziana’s two lead drug candidates, Foralumab and Milciclib, uniquely target the root cause of diseases with large unmet needs in multibillion-dollar markets. Tiziana is accelerating development of anti-IL6 receptor monoclonal antibody (mAb) for treatment of COVID-19 lung inflammation. Foralumab is the only fully human anti-CD3 monoclonal antibody in clinical development in the world. This Phase 2 compound has potential application in a wide range of autoimmune and inflammatory diseases, such as nonalcoholic steatohepatitis (NASH), ulcerative colitis, multiple sclerosis, type-1 diabetes (T1D), Crohn's disease, psoriasis and rheumatoid arthritis, where modulation of a T-cell response is desirable. Tiziana is a market leader in the invention of proprietary technology for oral, nasal and inhaled formulation to transform immunotherapies with Monoclonal Antibodies currently administered intravenously. Also, Tiziana has a robust and growing patent portfolio.
Tiziana Life Sciences (NASDAQ: TLSA) is a dual-listed clinical stage company developing targeted therapeutics to transform treatment of liver diseases, inflammatory diseases, and cancer. Our clinical pipeline includes drug assets for Crohn's, and hepatocellular carcinoma. Tiziana’s two lead drug candidates, Foralumab and Milciclib, uniquely target the root cause of diseases with large unmet needs in multibillion-dollar markets. Tiziana is accelerating development of anti-IL6 receptor monoclonal antibody (mAb) for treatment of COVID-19 lung inflammation. Tiziana is a market leader in the invention of proprietary technology for oral, nasal and inhaled formulation to transform immunotherapies with Monoclonal Antibodies currently administered intravenously. Also, Tiziana has a robust and growing patent portfolio.
Hoth Therapeutics Inc is a development-stage biopharmaceutical company. It is focused on targeted therapeutics for patients suffering from conditions such as atopic dermatitis, also known as eczema, chronic wounds, psoriasis, asthma, and acne. The company owns the BioLexa Platform which combines an FDA-approved zinc chelator with one or more approved antibiotics in a topical dosage form to address unchecked eczema flare-ups.
Tiziana Life Sciences (NASDAQ: TLSA) is a dual-listed clinical stage company developing targeted therapeutics to transform treatment of liver diseases, inflammatory diseases, and cancer. Our clinical pipeline includes drug assets for Crohn's, and hepatocellular carcinoma. Tiziana’s two lead drug candidates, Foralumab and Milciclib, uniquely target the root cause of diseases with large unmet needs in multibillion-dollar markets. Tiziana is accelerating development of anti-IL6 receptor monoclonal antibody (mAb) for treatment of COVID-19 lung inflammation. Tiziana is a market leader in the invention of proprietary technology for oral, nasal and inhaled formulation to transform immunotherapies with Monoclonal Antibodies currently administered intravenously. Also, Tiziana has a robust and growing patent portfolio.
This document provides an overview of Tiziana Life Sciences and its innovative platform technologies for oral, nasal, and inhalation administration of monoclonal antibodies. Some key points:
- Tiziana is developing oral and nasal formulations of the fully human anti-CD3 monoclonal antibody Foralumab for conditions like Crohn's disease and progressive multiple sclerosis.
- They are also developing an inhalable formulation of an anti-IL-6 receptor monoclonal antibody for treatment of COVID-19 patients, allowing direct delivery to the lungs.
- The company's technologies aim to transform antibody delivery from intravenous to more patient-friendly oral, nasal, and inhalation routes.
This corporate presentation outlines Aura Biosciences' novel targeted therapy approach using viral-like particles to treat cancer. Their lead product, AU-011, is being developed for the treatment of ocular melanoma, an orphan disease with no approved therapies. Preclinical data shows AU-011 effectively targets and kills tumor cells through a unique mechanism of action. Aura plans to initiate clinical trials in Q1-2/2016 to obtain proof of concept data and accelerate approval. If approved, AU-011 could be the first FDA-approved treatment for the primary tumor in ocular melanoma patients.
- PTX has a deep clinical pipeline with 3 ongoing or planned clinical trials, including Phase Ib/II trials of PTX-200 in breast cancer and ovarian cancer, and a planned Phase Ib trial of PTX-100 in AML.
- PTX-200 and PTX-100 are novel cancer drugs targeting the Akt and Ras pathways that have potential to overcome chemotherapy resistance.
- The clinical trials are being conducted at prestigious cancer centers in the US including Moffitt Cancer Center and Albert Einstein College of Medicine.
Inovio Pharmaceuticals, Inc. Corporate Presentation December 2013Company Spotlight
This document summarizes information presented by Dr. J. Joseph Kim, President and CEO of Inovio Pharmaceuticals, Inc. It discusses Inovio's DNA immunotherapy technology, clinical programs, partnerships, leadership, and upcoming value drivers. Key points include:
- Inovio is developing DNA-based immunotherapies delivered using electroporation for cancers and infectious diseases.
- Their lead program, VGX-3100 for HPV-related cancers, has shown strong T-cell responses and is in Phase II trials with efficacy data expected in mid-2014.
- Inovio has partnerships with Roche for prostate cancer and hepatitis B therapies and external funding to support several clinical programs.
Mimotopes greatly increases Imugene's pipeline and B-cell peptide cancer immunotherapy franchise. HER-Vaxx is re-entering the clinic targeting the same receptor as Roche's $8 billion breast cancer drugs with a robust intellectual property portfolio. The company has compelling science, commercially validated targets, leadership and numerous upcoming milestones that could drive valuation over the next 12-24 months.
Aptorum Group Limited (NASDAQ: APM) is a pharmaceutical company dedicated to developing and commercializing novel therapeutics to tackle unmet medical needs. Aptorum's current drug pipeline includes indications in orphan diseases, infectious diseases, and metabolic diseases. The Company launched two new clinical trials in 2021. Aptorum’s Smart-ACT™ platform is designed to bring an average of three drug candidates for orphan diseases to clinical trials every 12-18 months. The Company is now preparing to launch a dietary supplement for women undergoing menopause and experiencing related symptoms, including osteoporosis. Targeting a global woman’s health supplement market that is expected to reach $17 billion in 2025, Aptorum is expected to generate near-term revenue with significant long-term growth potential.
Aptorum Group Limited (NASDAQ: APM) is a pharmaceutical company dedicated to developing and commercializing novel therapeutics to tackle unmet medical needs. Aptorum's current drug pipeline includes indications in orphan diseases, infectious diseases, and metabolic diseases. The Company launched two new clinical trials in 2021. Aptorum’s Smart-ACT™ platform is designed to bring an average of three drug candidates for orphan diseases to clinical trials every 12-18 months. The Company is now preparing to launch a dietary supplement for women undergoing menopause and experiencing related symptoms, including osteoporosis. Targeting a global woman’s health supplement market that is expected to reach $17 billion in 2025, Aptorum is expected to generate near-term revenue with significant long-term growth potential.
Imugene is developing B-cell peptide vaccines called mimotopes that induce a patient's own B-cells to produce antibodies targeting specific cancer antigens. Their lead candidate, HER-Vaxx, is a mimotope therapy for HER2-positive cancers that is designed to mimic the Herceptin antibody. A completed Phase 1 trial in breast cancer demonstrated HER-Vaxx was safe and induced anti-HER-2 antibodies and immune responses. Imugene is now conducting a Phase 1b/2 trial of HER-Vaxx in combination with chemotherapy in HER2-positive gastric cancer patients with results expected in 2018. The document provides an overview of Imugene's novel mimotope platform and its
Tiziana Life Sciences provides an update on their clinical pipeline, including completing a study of nasally administered Foralumab in COVID-19 patients that showed positive responses, initiating several phase 2 trials with Foralumab and Milciclib, and executing an agreement with Precision Biosciences to use Foralumab to improve CAR-T cell therapy outcomes for cancer treatment. The company is developing oral and intranasal formulations of antibodies to enable local tissue delivery and reduce costs and side effects compared to IV administration. Milciclib is advancing in clinical trials as a potential treatment for cancers like hepatocellular carcinoma and KRAS-mutated
Genetic Technologies Limited (ASX: GTG; Nasdaq: GENE), a diversified molecular diagnostics company. GTG offers cancer predictive testing and assessment tools to help physicians proactively manage patient health. The Company’s lead products GeneType for Breast Cancer and GeneType for Colorectal Cancer are clinically validated risk assessment tests and are first in class. Genetic Technologies is developing a pipeline of risk assessment products. Learn more at GENETechinfo.com.
Genetic Technologies Limited is a diversified molecular diagnostics
company developing tools for the prediction and assessment of cancer
risk to help physicians proactively manage patient health. The
Company’s lead products, ‘GeneType for Breast Cancer’ and
‘GeneType for Colorectal Cancer’, are clinically validated risk
assessment tests that are first in their class. The Company’s
development pipeline includes new tests for COVID-19, Type 2
diabetes, cardiovascular disease, prostate cancer, and melanoma.
Listed on the ASX in 2000 and NASDAQ in 2005, Genetic
Technologies has been a leader in the development and
commercialization of genetic risk assessment technology for 20 years.
Immuron is presenting an overview of their company and investment opportunities. They have a unique oral immunotherapy platform targeting the microbiome and inflammation with potential in various indications. Their lead program is in NASH (non-alcoholic steatohepatitis), where their drug IMM-124E has shown in preclinical and clinical trials to reduce liver inflammation and fibrosis by binding to LPS (bacterial endotoxin) and promoting regulatory T-cells. Phase 2 trials in NASH are ongoing with results expected in late 2016 to early 2017. Immuron is also developing a vaccine for C. difficile and generates revenues from their traveler's diarrhea drug Travelan. They highlight the significant commercial potential of NASH which is estimated
Immuron Ltd is an Australian biopharmaceutical company focused on immunotherapy using dairy-derived antibody products for humans. Immuron has a unique and versatile technology platform that is capable of generating a wide range of products, all with a high safety profile. The versatility of Immuron’s platform technology enables the development of medicines that target a large range of medical needs, including infectious diseases, immune mediated disorders, and cancers. The versatility is also a function of the dairy origin of Immuron’s antibodies, which enables Immuon to commercialize its platform derived products through a range of regulatory pathways, including prescription (Rx), medical foods, over-the-counter (OTC) medicines, and dietary supplements. The Company has received clearance from the FDA to commence a Phase IIb clinical trial for its NASH product (IMM-124E), a potential blockbuster, in less than three years from commencing its NASH R&D program. Additionally, Immuron has one marketed product (Travelan, for the prevention of travelers’ diarrhea) and a pipeline of products at various stages of clinical and earlier development.
Slide deck used by Dr. Wayne Danter, President and CEO of Critical Outcome Technologies, at the Equities.com Small-Cap Stars investor conference in New York City on June 10, 2015.
Based in Ann Arbor, Michigan, Zomedica is a veterinary health company creating diagnostic and therapeutic products for horses, dogs, and cats by focusing on the unmet needs of clinical veterinarians. With modest cash burn and a strong balance sheet, including $142.4 million cash and cash equivalents as of June 30, 2023, Zomedica is well-positioned to fund both organic growth and acquisitions.
Docola has developed a healthcare communication platform that utilizes asynchronous telehealth to deliver patient education and support. Their proprietary platform currently has over 55,000 patient users and over 1,100 clinician users. Docola seeks to raise up to $500,000 through a convertible note to fund working capital, research and development, and costs associated with an upcoming IPO.
- INNO Holdings is presenting an IPO investor presentation for an initial public offering on the NASDAQ Capital Market.
- The company manufactures prefabricated steel building components and systems using proprietary technology to reduce construction costs and environmental impact.
- INNO Holdings has four initial product lines - metal studs, prefabricated housing units, modular apartment buildings, and a mobile factory system. It aims to disrupt the construction industry through standardized, sustainable construction methods.
Everything Blockchain builds platforms of trust for the modern enterprise and is on a mission to ensure every organization has access to the tools and platforms that enable them to manage, store, and protect data without the cost and complexity that holds them back today. The Company’s patented advances in engineering deliver the essential elements needed for real-world business use: speed, security, and efficiency. Everything Blockchain’s current business lines include: EB Advise, Build DB and EB Control.
ASP Isotope is an isotope enrichment company utilizing technology developed in South Africa over the past 20 years to enrich isotopes of elements or molecules with low atomic masses. Many of these elements are unsuitable for enrichment using traditional methods such as centrifuges. The Company’s initial focus is on producing and commercializing highly enriched isotopes for the healthcare and technology industries.
MDNA Life Sciences is a pioneer in the science of mitochondrial DNA. It’s our mission to create an extensive portfolio of proprietary tests that dramatically improve diagnosis, treatment, prognosis and monitoring. Putting an end to the unnecessary surgical procedures, pain and uncertainty that affect patients across the world.
Digital Ally, Inc. is a diversified holding company with operations in video solution technology, human and animal health protection products, healthcare revenue cycle management, ticket brokering and marketing, and event production. The Company pursues an acquisition strategy that targets organizations with positive earnings, strong growth potential, innovation, and operational synergies. To maximize long-term shareholder value, Digital Ally intends to spin-off its ticketing and entertainment business lines into a separate public company in 2023. The spin-off will create two optimized, tech-driven public companies with strong growth opportunities and operating metrics.
Lantern Pharma is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) platform, RADR®, leverages over 25 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of therapies including eleven cancer indications and an antibody-drug conjugate (ADC) program. On average, our newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials in 2-3 years and at approximately $1.0-2.0 million per program.
Sharps Technology is a medical device and pharmaceutical packaging company specializing in the development and manufacturing of innovative drug delivery systems. The Company’s product lines focus on low waste and ultra-low waste syringe technologies that incorporate both passive and active safety features. These features protect front line healthcare workers from life-threatening needle stick injuries and protect the public from needle re-use. Sharps Technology has extensive expertise in specialized prefilled syringe systems and is on track to launch this new product line in Q4 2023. The Company has a manufacturing facility in Hungary and has partnered with Nephron Pharmaceuticals to expand its manufacturing capacity in the US.
Aditxt is a biotech company developing immune monitoring and immune modulation platforms. Its AditxtScore platform can provide comprehensive immune profiles to monitor responses to pathogens, vaccines, drugs and transplants. Its Adimune platform aims to modulate the immune system to treat conditions like psoriasis, type 1 diabetes, and increase skin allograft survival. The company is working to develop, operate and commercialize these platforms. It currently generates revenue from immune monitoring tests and expects revenue from licensing deals for immune modulation programs as they advance in clinical trials towards commercialization.
1847 Holdings LLC, a publicly traded diversified acquisition holding company, was founded by Ellery W. Roberts, a former partner of Parallel Investment Partners, Saunders Karp & Megrue and Principal of Lazard Freres Strategic Realty Investors. EFSH's investment thesis is that capital market inefficiencies have left the founders and/or stakeholders of many small business enterprises and lower-middle market businesses with limited exit options, despite the intrinsic value of their business. Given this dynamic, EFSH can consistently acquire "solid" businesses for reasonable multiples of cash flow and then deploy resources to strengthen the infrastructure and systems to improve operations. These improvements may lead to a sale or IPO of an operating subsidiary at considerably higher valuations than the purchase price (as successfully demonstrated with the mid-2020 IPO of 1847 Goedeker on the NYSE American) and/or alternatively, an operating subsidiary may be held in perpetuity and contribute to EFSH's ability to pay regular and special dividends to shareholders.
Sharps Technology is a medical device and pharmaceutical packaging company specializing in the development and manufacturing of innovative drug delivery systems. The Company’s product lines focus on low waste and ultra-low waste syringe technologies that incorporate both passive and active safety features. These features protect front line healthcare workers from life-threatening needle stick injuries and protect the public from needle re-use. Sharps Technology has extensive expertise in specialized prefilled syringe systems and is on track to launch this new product line in Q4 2023. The Company has a manufacturing facility in Hungary and has partnered with Nephron Pharmaceuticals to expand its manufacturing capacity in the US.
SPI Energy is a global renewable energy company and provider of solar storage and electric vehicle (EV) solutions that was founded in 2006 in Roseville, California and is headquartered in McClellan Park, California. The Company has three core divisions: SolarJuice which has solar wholesale distribution, as well as residential solar and roofing installation and solar module manufacturing (Solar4America & SEM Wafertech), SPI Solar and Orange Power which operates a commercial & utility solar division, and the EdisonFuture/Phoenix Motor EV division. SolarJuice is the leader in renewable energy system solutions for residential and small commercial markets and has extensive operations in the Asia Pacific and North America markets. The SPI Solar commercial & utility solar division provides a full spectrum of EPC services to third party project developers, and develops, owns and operates solar projects that sell electricity to the grid in multiple regions, including the U.S., U.K., and Europe. Phoenix Motor is a leader in medium-duty commercial electric vehicles, and is developing EV charger solutions, electric pickup trucks, electric forklifts, and other EV products. SPI maintains global operations in North America, Australia, Asia and Europe and is also targeting strategic investment opportunities in fast growing green energy industries such as battery storage, charging stations, and other EVs which leverage the Company's expertise and substantial solar cash flow.
BullFrog AI is a technology enabled drug development company using machine learning to usher in a new era of precision medicine. Through its collaborations with leading research institutions, including Johns Hopkins University and J. Craig Venter Institute, BullFrog AI is at the forefront of AI-driven drug development. Using its proprietary bfLEAP™ artificial intelligence platform, BullFrog AI aims to enable the successful development of pharmaceuticals and biologics by predicting which patients will respond to therapies in development. BullFrog AI is deploying bfLEAP™ for use at several critical stages of development with the intention of streamlining data analytics in therapeutics development, decreasing the overall development costs by decreasing failure rates for new therapeutics, and impacting the lives of countless patients that may have otherwise not received the therapies they need.
BullFrog AI is a technology enabled drug development company using machine learning to usher in a new era of precision medicine. Through its collaborations with leading research institutions, including Johns Hopkins University and J. Craig Venter Institute, BullFrog AI is at the forefront of AI-driven drug development. Using its proprietary bfLEAP™ artificial intelligence platform, BullFrog AI aims to enable the successful development of pharmaceuticals and biologics by predicting which patients will respond to therapies in development. BullFrog AI is deploying bfLEAP™ for use at several critical stages of development with the intention of streamlining data analytics in therapeutics development, decreasing the overall development costs by decreasing failure rates for new therapeutics, and impacting the lives of countless patients that may have otherwise not received the therapies they need.
BioVie is a clinical-stage company developing what it believes will be transformative therapies to overcome unmet medical needs in neurodegeneration and liver disease. The Company is developing NE3107 for Alzheimer’s (AD) and Parkinson’s (PD) and BIV201 for refractory ascites and HRS-AKI.
Lantern Pharma is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) platform, RADR®, leverages over 25 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of therapies including eleven cancer indications and an antibody-drug conjugate (ADC) program. On average, our newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials in 2-3 years and at approximately $1.0-2.0 million per program.
Genetic Technologies is a diversified molecular diagnostics company. A global leader in genomics-based tests in health, wellness and serious disease through its geneType and EasyDNA brands. GENE offers cancer predictive testing and assessment tools to help physicians to improve health outcomes for people around the world. The Company has a proprietary risk stratification platform that has been developed over the past decade and integrates clinical and genetic risk to deliver actionable outcomes to physicians and individuals. Leading the world in risk prediction in oncology, cardiovascular and metabolic diseases, Genetic Technologies continues to develop risk assessment products.
Splash Beverage Group, an innovator in the beverage industry, owns a growing portfolio of alcoholic and non-alcoholic beverage brands including Copa di Vino wines by the glass, SALT naturally flavored tequilas, Pulpoloco Sangria, and TapouT performance hydration and recovery drinks and TapouT Cognitive Energy Drink. Splash’s strategy is to rapidly develop early-stage brands already in its portfolio as well as acquire and then accelerate brands that have high visibility or are innovators in their categories. Led by a management team that has built and managed some of the top brands in the beverage industry and led sales from product launch into the billions, Splash is rapidly expanding its brand portfolio and global distribution.
Splash Beverage Group, an innovator in the beverage industry, owns a growing portfolio of alcoholic and non-alcoholic beverage brands including Copa di Vino wines by the glass, SALT naturally flavored tequilas, Pulpoloco Sangria, and TapouT performance hydration and recovery drinks and TapouT Cognitive Energy Drink. Splash’s strategy is to rapidly develop early-stage brands already in its portfolio as well as acquire and then accelerate brands that have high visibility or are innovators in their categories. Led by a management team that has built and managed some of the top brands in the beverage industry and led sales from product launch into the billions, Splash is rapidly expanding its brand portfolio and global distribution.
Cover Story - China's Investment Leader - Dr. Alyce SUmsthrill
In World Expo 2010 Shanghai – the most visited Expo in the World History
https://www.britannica.com/event/Expo-Shanghai-2010
China’s official organizer of the Expo, CCPIT (China Council for the Promotion of International Trade https://en.ccpit.org/) has chosen Dr. Alyce Su as the Cover Person with Cover Story, in the Expo’s official magazine distributed throughout the Expo, showcasing China’s New Generation of Leaders to the World.
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Presentation by Herman Kienhuis (Curiosity VC) on Investing in AI for ABS Alu...Herman Kienhuis
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2. 2
Disclaimer
This presentation is confidential and has been provided to the recipient for information purposes only, and no representation or warranty,
express or implied, is made as to the completeness or accuracy of the information contained herein. This presentation does not constitute an
offer to purchase securities in Imugene Limited (the “Company”) or an offer to sell, or a solicitation of an offer to buy any securities in the
Company. This presentation neither constitutes nor includes a prospectus to offer securities. Further, this presentation does not constitute
an offer by the Company to enter into any transaction with any person or a solicitation of an offer to enter into any transaction with the
Company in any manner. This presentation is being made only to qualified institutional buyers and institutions that are accredited investors,
as those terms are defined under the U.S. federal securities laws and regulations, pursuant to Section 105(c) of the Jump Start Our Business
Startups Act of 2012, for the sole purpose of determining whether such persons might have an interest in a contemplated securities
offering. This presentation may not contain all the details and information necessary for you to make a decision or evaluation. Neither this
presentation nor any of its contents may be used for any other purpose without the prior written consent of the Company. This presentation
is not being distributed through mass communication media or addressed to the general public, or to any person other than the immediate
audience that is receiving this presentation in person on the date hereof. This presentation must not be distributed, published, reproduced or
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of the presentation or any of the terms, conditions, or other facts with respect thereto. No recipient is permitted to utilize this presentation
to make an offer, or to solicit any offer, to enter into any transaction whatsoever with or on behalf of the Company.
Certain statements contained in this presentation, including, without limitation, statements containing the words “believes,” “plans,”
“expects,” “anticipates,” and words of similar import, constitute “forward-looking statements.” Such forward-looking statements involve
known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the Company
to be materially different from any future results, performance or achievements expressed or implied by such forward-looking
statements. Such factors include, among others, the following: the risk that our clinical trials will be delayed and not completed on a timely
basis; the risk that the results from the clinical trials are not as favorable as we anticipate; the risk that our clinical trials will be more costly
than anticipated; and the risk that applicable regulatory authorities may ask for additional data, information or studies to be completed or
provided prior to their approval of our products. Given these uncertainties, undue reliance should not be placed on such forward-looking
statements. The Company disclaims any obligation to update any such factors or to publicly announce the results of any revisions to any of
the forward-looking statements contained herein to reflect future events or developments except as required by law.
This presentation may not contain all the details and information necessary for you to make a decision or evaluation. Neither this
presentation nor any of its contents may be used for any other purpose without the prior written consent of the Company.
3. 3
• Experienced management & board – Board & management own
13%
• B-cell peptide cancer immunotherapy that induces antibody
responses + major new initiative into mimotopes
• Targeting same receptor as Roche's $6.4bn breast cancer drug
Herceptin
• Anti- HER-2 antibody responses, T helper cytokines, T reg cells
suppressed, therapy safe
• IP with exclusivity until 2030, granted in all major jurisdictions.
Further patent life extensions under way
• Numerous milestone announcements & valuation inflection
points over next 12-24 months
Investment Highlights
Leadership
Compelling Science
Commercially
Validated Target
Phase 1 Completed
Robust IP
News Flow
4. 4
Company Overview
• Phase 1 trial completed in patients with HER-2+/++ breast cancer
• Phase 1b/2 gastric cancer trial to begin early 2016
• Technology originates from Medical University of Vienna, one of Europe’s leading
cancer institutes
• Technology identified in 2012 by Axel Hoos and referred to Paul Hopper
• Manufacturing, clinical and regulatory initiatives began in 2013
• Public listing on ASX in December 2013 via reverse merger into listed shell, Imugene
Ltd - Axel Hoos joins the Board – his only Board worldwide
• 2014 – manufacturing, clinical & regulatory development continues
• 2015 – Leslie Chong (ex Genentech) appointed COO
• $9M raised to date
Developing B-cell based immunotherapy vaccines plus major new initiative into
mimotopes
5. 5
Imugene is an immunotherapy company developing
B-cell based vaccines in the most promising area of
oncology today – IMMUNO-ONCOLOGY
IMU is in the Most Promising Area of Oncology
Today
6. 6
Leslie Chong – Chief Operating Officer
• Appointment as COO in August 2015
• Previously Senior Clinical Program Lead at Genentech, Inc., in San Francisco
Paul Hopper – Executive Chairman
• International & ASX biotech capital markets experience particularly in immuno-oncology & vaccines
• Head of Life Sciences Desk & Australia Desk at Los Angeles-based investment bank, Cappello Group
• Director Prescient Therapeutics, Chairman Viralytics, former Director pSivida, Somnomed & Fibrocell Science
Dr Axel Hoos – Non-Executive Director
• Currently Vice President Oncology R&D at GlaxoSmithKline
• Previously Clinical Lead on Ipilumimab at Bristol-Myers Squibb
• Co-Director of the think-tank Cancer Immunotherapy Consortium; Imugene is his only Board seat worldwide
Dr Nick Ede – Head of Manufacturing
• Former CTO Consegna, CEO Adistem Ltd, CEO Mimotopes P/L, COO EQiTX Ltd (ZingoTX & VacTX)
• VP Chemistry Chiron (now Novartis), Research Fellow CRC Vaccine Technology
Leadership –
Extensive Drug Development Experience
Prof Ursula Wiedermann – Chief Scientific Officer
• Co-inventor of technology
• Prof of Vaccinology at Medical University of Vienna
7. 7
7
Generation 2
MPDL3280A
Pembrolizumab
(checkpoint modulator)
(Cell Therapy)
2010 2011 2012 20152013 2014 2016 2017
Sipuleucel-T
Ipilimumab /
CTLA-4
Generation 3
CAR-T
Generation 1
MEDI 4736
2018 2019
Approved
Under Investigation
Multiple
Therapies
under
Development
(
Blinotumumab
AMGEN
Nivolumab
Immuno-Oncology State of Play
Generation 1 and 2
predicted to generate
sales of $36bn by
2025*
2020 2021 2022
*Citigroup research note
8. 8
Next Wave Opportunities
Cancer Vaccines
T-Cell Immunity
Cytokines
Cellular Therapies
T-cell Checkpoint Modulators
Innate
ImmunityB-Cell
Immunity
Adaptive Immunity
Oncolytic Viruses
NK Cells
Checkpoint Modulators
-
Adjuvants
“Connector” Bi-specific Abs -
Approved Therapies
Dual-specific Abs
Small Molecules
9. 9
Why B-Cell Peptide Vaccines?
• Anti-tumor activity of antibodies induced by B-cell epitopes
• Patient produces their own antibodies against the target
• Polyclonal responses (superior to treatment with monoclonal antibodies)
• No HLA restriction! (advantage over T-cell peptide vaccines)
• Induction of T-cell responses and cytokine production via effective carrier system
• Broader activation of humoral and cellular immune response
• Potential cross-presentation to CD8 T-cells
• Immune memory and potential use of booster vaccinations
c.
• Anti-tumor activity of antibodies induced by B cell epitopes.
• Patient produces their own antibodies against the target.
• Polyclonal responses (superior to treatment with mAbs).
• No HLA restriction! (advantage over T cell responses).
• Induction of T cell responses and cytokine production via effective carrier system.
• Multi-epitope approach means broad antigen recognition.
• Identification via computer aided algorithms or mimotope technology.
• High chemical stability
• Easy construction and manufacturing
• No oncogenic potential
• Immunogenic – break of tumour tolerance
Long-Lasting Immunity
B-Cell Vaccines Offer
10. 10* $USD Source: Roche H1 Report http://www.roche.com/hy15e.pdf p12
Binding site of
Binding site of
Tumor cell
HER-Vaxx Attacks the Same Cancer Receptor the
World’s Largest Cancer Franchise
HER-2
Receptor
P4
P6
P7
HER-Vaxx: x3
polyclonal
responses
Franchise sales annualising at
nearly $8bn growing 13%*
P4
P6
P7
HER–Vaxx:
3 peptides
Monoclonal
response
11. 11
HER-Vaxx Key Differentiation
• B-cell vaccines are an open frontier for immunotherapy, unlike T cell
vaccines which have been exhaustively researched
• HER-Vaxx is a universal vaccine & can be used for all patient types
irrespective of their “HLA haplotypes”, an issue which impacts T cell
vaccines
• HER-Vaxx generates polyclonal responses that may be superior to
treatment with a monoclonal antibody like Herceptin
• Toxicity of HER-Vaxx is negligible
• HER-Vaxx induces IFNγ production that can influence the tumour micro
environment and suppresses T Reg cells which are enhanced in cancer
patients & which assist tumor evasion mechanisms – thereby the efficacy of
the HER-Vaxx might be enhanced
• Potential as an adjuvant therapy i.e., post surgery
• HER-Vaxx is active immunisation and induces immunological memory –
Herceptin is passive immunisation, and its effectiveness depends upon
frequent applications
12. 12
• n=10
• All metastatic breast
cancer patients
• HER-2 +/++
• Life expectancy >
4 months
• Conducted at Medical
University of Vienna
❶ Safety and
Tolerability
❷ Immunogenicity:
antibodies/humoral
and cellular
responses
Clinical EndpointsDesign
Clinical Status:
Phase 1 Breast Trial Completed
13. 13
• Patients developed anti-HER-2 antibodies
• Induction of cytokines (Th1 biased; IFNγ)
• Induction of memory T & B cells post vaccination
• Reduction in T reg cells post vaccination,
indicating strong vaccine response
• Antibodies induced displayed potent anti-tumor
activity
• Results were even more promising given
patients were in the end stage of disease and
not the primary target group
Clinical Status:
Phase 1 Breast Trial Completed
Wiedermann et al.,
Breast Cancer Res Treat
(2010)119:673 - 683
Results
14. 14
Phase 1b/2 Trial Design
Gastric Cancer
• Open label
• US IND
• 15 patients, x3 groups of
5 patients
• Combination with chemo
• Endpoints:
– RP2D (Recommended Phase 2
Dose) of HER-Vaxx
– Safety: any HER-Vaxx toxicity
– Immunogenicity (anti-HER-2
antibody titers)
– Test booster schedule
(q 4 weeks or 8 weeks)
• Open label
• Randomised
• ~68 patients in Asia (2 arms
by 34)
• Combination with chemo
• Efficacy, safety & immune
response
• Endpoints:
– Overall survival
– Progression-free survival
• Secondary endpoint:
– Immune response
Phase 1b lead-in Phase 2 Trial
Combined Phase 1b/2 clinical trial under IND
15. 15
Advanced
Adenocarcin
oma of the
Stomach
n=68
SOC: Cisplatin + 5FU or
Capcitabine
No crossover treatment
interim PFS analysis
Continuous Immune response monitoring
** under delayed treatment effect on PFS at month 3
** OBF for error spending
Phase 1b/2 Trial Design
Gastric Cancer
R
A
N
D
O
M
I
Z
E
1:1
Her-Vaxx + Cisplatin + 5FU or
Capcitabine
Treat
until
PD
Follow for
OS
Cohort 2
Cohort 3
Cohort 1 5
5
5
RP2D
Design Phase 1b/2
IND Submission Q1, 2016
Final Protocol Q1, 2016
N Phase 1b =15; Phase II = 68
# Sites 18-20
Enrollment Duration 36 months: Phase 1b=12 months; Phase 2 = 24 months
FPI Q2, 2016
End Points PFS, OS and Immune response
Vendors IRF, Central Lab
Phase 1b Phase 2
16. 16
Novel Mimotope Technology Platform
• Developing mimotope immuno-oncology platform against cutting edge
immuno-oncology targets, in partnership with Medical University of Vienna
• Mimotopes are peptide antigens which mirror the structure of an epitope and
which are designed to induce a specific and potent antibody response to an
identified oncology target
• Mimotopes to be part of the next wave of the immuno-oncology revolution
• Potential tool for selecting novel vaccine candidates against a variety of
tumours
• Greatly extends the company’s oncology franchise and pipeline.
• Four mimotopes to be complete by May 2016 (targets currently confidential)
Imugene’s novel mimotope technology platform enables us to
reverse engineer any antibody and produce a peptide mimic of the
antibody’s target (epitope)
17. 17
News Flow & Milestones
US FDA IND allowed 1H 2016
Appoint Principal Investigator 1H 2016
Announce preclinical toxicology results (WIL) 2H 2015
Announce preclinical immunologic results (Charles River) 1H 2016
Recruit and run lead in Phase 1b trial 1H 2016
Recruit and run randomized controlled Phase 2 trial 2H 2017
Report Phase 1b trial results late 1H 2017
Report Phase 2 results 2H 2019
Her-Vaxx GMP clinical batch complete 2H 2015
Report on dose escalation progress and status of Ph1b 2H 2016
Report Progress and dose selection on Phase 1b 1H 2017
Her-Vaxx
18. 18
• Experienced management & board – Board & management own
13%
• B-cell peptide cancer immunotherapy that induces antibody
responses + major new initiative into mimotopes
• Targeting same receptor as Roche's $6.4bn breast cancer drug
Herceptin
• Anti- HER-2 antibody responses, T helper cytokines, T reg cells
suppressed, therapy safe
• IP with exclusivity until 2030, granted in all major jurisdictions.
Further patent life extensions under way
• Numerous milestone announcements & valuation inflection
points over next 12-24 months
Investment Highlights
Leadership
Compelling Science
Commercially
Validated Target
Phase 1 Completed
Robust IP
News Flow
20. 20
Capital Structure
Options on issue (as at 2015)
No of options Exercise
Price
Expiry
IMUAK 50,000,000 $0.020 31-Dec-15
IMUAL 2,500,000 $0.025 14-July-19
IMUAM 4,500,000 $0.010 10-Nov-17
Total Options on
Issue
57,000,0002
ASX:IMU
`
Market Cap (Sept 2015) $17.0M (AUD)1
Ordinary Shares 1,329,912,516B
12 month price range $0.01 - $0.02
Avg daily volume 1.4M shares (June-Sept, 2015)
Public Equity Invested to
date
$9.00M
Cash & Equivalents $4.96M (includes Sept 3.0M raise)
No. of Shares %
Capital
Webinvest Pty Ltd (Otto Buttula) 77,000,000 5.79
Paul Hopper 69,796,875 5.25
JK Nominees Pty Ltd 40,000,000 3.01
Oaktone Nominees Pty Ltd 29,625,000 2.23
Cabletime Pty Ltd 29,527,778 2.22
Top 5 Holders as at 2015
NOTE: 1 inc September 2015 Capital Raise.
Board and Management Ownership
Otto Buttula 77,000,000 Shares
Paul Hopper 69,000,000 Shares
Axel Hoos 25,000,000
7,000,000
Options
Shares
Leslie Chong 25,000,000
2,000,000
Options
Shares
Charlie Walker 25,000,000 Shares
Nick Ede 4,500,000
8,000,000
Options
Shares
21. 21
Administration & readout schedule
Phase I – Study Design
Patient inclusion criteria
• Metastatic breast cancer
• HER2 +, ++
• ER/PgR pos.
Life expectance > 4 mo
Primary endpoint
• Safety & Tolerability
Secondary endpoint
• Immunogenicity
– Specific antibodies
– Cellular responses
PEV06 clinical Phase 1 study
Blood drawVaccination with 10μg
of each peptide antigen
D0 D28 D56 D84
Wiedermann U et al, Breast Cancer Res Treat. 2010
22. 22
Phase 1 – Patient Characteristics
Patients aged 55+ and up to 84 years
Patient ID Age Metas. disease since Prior chemotherapy Current antihormonal therapy
1 55 Oct. 2006 no Anastrozol
2 66 May 2004 yes (1 adj) Fulvestrant
3 84 Mar. 1999 no Anastrozol
4 79 Sept. 2003 no Anastrozol
5 67 Apr. 2004 no Fulvestrant
6 69 Sept. 2004 no Anastrozol
7 60 Aug. 2002 yes (3 met) Fulvestrant
8 76 Apr. 1999 no Fulvestrant
9 63 Jun. 2006 yes (1 met) Exemestan
10 70 Apr. 2008 No Anastrozol
Wiedermann U et al, Breast Cancer Res Treat. 2010
23. 23monitored by DMSB
Phase I – Safety and Tolerability
Few grade 1 local reactions; none systemic
Patient ID Local vaccination reaction grade Systemic grade 3/4 toxicity
1 1 no
2 0 no
3 0 no
4 1 no
5 1 no
6 0 no
7 0 no
8 0 no
9 1 no
10 0 no
Wiedermann U et al, Breast Cancer Res Treat. 2010
24. 24
Phase I – Secondary Endpoint:
Immunologic Responses
• 8/10 developed significant anti-peptide antibody levels
• In all but one the antibodies were also directed against Her-2/neu
• The majority also showed a 4-fold increase in influenza titers (HHT)16c.
29
Phase I - Secondary Endpoint:
Immunologic Responses
kappa IgG lambda IgG
0
1
2
3
Her-2/neuabtiterincrease
pre-post-pre-post-pre-post-
0
10
20
30
40
50
60
70
80
P4 P6 P7
peptideabtiter
pre- post-
0
100
200
300
400
500
600
700
800
IFN-ggggpg/ml
pre- post-
0
100
200
300
400
500
600
700
800
TNF-aaaapg/ml
pre- post-
0
20
40
60
80
100
120
140
IL-2pg/ml
P<0.05
185 kDa
1 2 3 4
Cellular responses show Th1 profile
• 8/10 developed significant anti-peptide antibody levels
• In all but one the antibodies were also directed against Her-2/neu
• The majority also showed a 4-fold increase in influenza titers (HHT)16
c.
29
Immunologic Responses
kappa IgG lambda IgG
0
1
2
3
Her-2/neuabtiterincrease
pre-post-pre-post-pre-post-
0
10
20
30
40
50
60
70
80
P4 P6 P7
peptideabtiter
pre- post-
0
100
200
300
400
500
600
700
800
IFN-ggggpg/ml
pre- post-
0
100
200
300
400
500
600
700
800
TNF-aaaapg/ml
pre- post-
0
20
40
60
80
100
120
140
IL-2pg/ml
P<0.05
185 kDa
1 2 3 4
Cellular responses show Th1 profile
• 8/10 developed significant anti-peptide antibody levels
• In all but one the antibodies were also directed against Her-2/neu
• The majority also showed a 4-fold increase in influenza titers (HHT)16
25. 25
Phase I – Regulatory T Cells:
Cancer Patients vs. Healthy Controls
• Significantly higher number
of CD4+Foxp3+ regulatory T
cells in tumour patients than
healthy controls
• Vaccination significantly
reduced T reg cells in both
groups
Wiedermann U et al, Breast Cancer Res Treat. 2010
26. 26
Phase 1 HER-Vaxx breast cancer vaccine
– key developments
• Strong immunogenicity in 8/10
patients in Phase I study with
10 μg of peptide antigen
• Good correlation with cellular
responses (cytokines)
• Safe and well tolerated, in
particular no cardiotoxicity
• Protective efficacy of peptides
demonstrated in preclinical
tumor model in mice showing
delay of onset and reduced
tumor growth
Pat. # Peptide-
specific ab
P4, P6, P7
HER2-
specific
ab
Infl.
HIT
IL-2, IFNγ,
TNF
T reg
1 ↑ ↑ ↑ ↑ - - - - ↓
2 ↑ ↑ ↑ ↑ ↑ ↑ ↑ ↑ ↓
3 ↑ ↑ ↑ ↑ (+/-) - ↑ - - ↓
4 ↑ ↑ ↑ ↑ ↑ - ↑ ↑ ↓
5 ↑ ↑ ↑ ↑ ↑ ↑ ↑ ↑ ↓
6 - - - - - ↓ ↓ ↓ ↓
7 ↑ ↑ ↑ ↑ ↑ - - - ↓
8 ↑ ↑ ↑ ↑ (+/-) ↑ ↑ ↑ - ↑
9 ↑ +/- +/- ↑ ↑ ↑ ↑ ↑ ↓
10 - - - - - +/- ↓ +/- ↓
HER-Vaxx breast cancer vaccine – Phase I trial 10 μg group
Antibody and cellular responses in human
Excellent immunogenicity even at low dose
and in patients aged up to 84 years
Wiedermann U et al, Breast Cancer Res Treat. 2010
27. 27
Tumor Growth Inhibition in vivo
• Prolonged time to disease
progression
• Immunization of c-neu
transgenic mice (recognized
HER2 cancer model) with
tetanus toxoid-conjugated
peptides P4, P6 and P7
• Vaccinated animals show
significant delay in tumor onset
and reduced growth kinetics
• Co-administration of IL-12
further improves the vaccine
performance
Wagner S, Wiedermann U et al Breast Cancer Res Treat. 2007 Nov;106(1):29-38
Days after randomization
Preclinical study with tetanus toxoid–conjugated peptide antigens
Cumulativeproportiontumor-free
No treatment
TT carrier alone
Vaccine
Vaccine + IL-12
IL-12 alone
27
d 170 d 235d 65
Time to disease progression
28. 28
Rat cardiomyocytes
No toxicity, in particular no cardiotoxicity
• Repeat dose toxicity study with
TT-conjugated peptides in mice
• Repeat dose toxicity study with
HER-Vaxx in rats
• Local tolerability & immuno-
genicity study with HER-Vaxx in
rabbits
• In vitro toxicity study with
purified serum from immunized
animals on rat cardiomyocytes
In vitro toxicity study on rat cardiomyocytes
29. 29
Forward looking statement
Any forward looking statements in this presentation have been prepared on the basis of a
number of assumptions which may prove incorrect and the current intentions, plans,
expectations and beliefs about future events are subject to risks, uncertainties and other
factors, many of which are outside Imugene Limited’s control. Important factors that could
cause actual results to differ materially from any assumptions or expectations expressed or
implied in this brochure include known and unknown risks. As actual results may differ
materially to any assumptions made in this brochure, you are urged to view any forward looking
statements contained in this brochure with caution. This presentation should not be relied on as
a recommendation or forecast by Imugene Limited, and should not be construed as either an
offer to sell or a solicitation of an offer to buy or sell shares in any jurisdiction.
Leslie Chong
Chief Operating Officer
Imugene Limited
m: +61 458 040 433
Leslie.Chong@imugene.com
w: imugene.com
ASX: IMU