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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
One in 8 U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. Following breast cancer surgery in the adjuvant setting, a HER2/neu 3+ patient typically receives Herceptin® in the first year, with the hope that their breast cancer will not recur, and with the odds of recurrence slowly decreasing over the first 5 years after surgery. Herceptin® has been shown to reduce recurrence rates from 25% to 12% in the adjuvant setting. In the neoadjuvant setting, a patient receives treatment before surgery and based on the results of a biopsy at surgery, will receive the same or more potent treatment after surgery. Kadcyla® has been shown to reduce recurrence rates from 22% to 11% in the neoadjuvant setting. Accordingly, we believe that GP2 may be used to address the 50% of recurring patients who do not respond to either Herceptin® or Kadcyla®.
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 is an Australian company focused on developing and commercializing genetic risk assessment tests. The presentation provides an overview of the company's business, including its portfolio of current and upcoming genetic tests, markets and channels to market, and capabilities. Key points include:
- Genetic Technologies aims to offer the most comprehensive suite of genetic risk assessment tests on the market, covering up to 70% of disease risks.
- The company is prioritizing market entry strategies in key regions like Australia, the US, and Asia.
- Tests are marketed through consumer-initiated and medical business-to-business channels.
- An innovative pipeline of new tests for diseases like cancer, heart disease, and diabetes is being
This presentation by Pressure BioSciences discusses their Pressure Cycling Technology platform for biological sample preparation. Some key points:
- PCT uses ultra-high pressure to break up cell walls and extract biomolecules, achieving better results than mechanical methods.
- The market for biological sample preparation is multi-billion dollars. PCT addresses the need for improved sample prep methods.
- Over 275 PCT systems have been installed at over 150 customer sites. There are over 100 publications highlighting PCT's advantages.
- Recent accomplishments include a co-marketing agreement with SCIEX, a leader in analytical technologies, and sales of their new Barocycler 2320EXTREME system.
Reviva Pharmaceuticals Holdings Inc is a clinical development pharmaceutical company. It is developing a portfolio of internally discovered therapies that address unmet medical needs in the areas of central nervous system, cardiovascular, metabolic and inflammatory diseases.
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.
Business and scientific updates presentation given by Dr. Wayne Danter at the Critical Outcome Technologies Inc. 2013 Annual and Special Meeting of Shareholders on December 5, 2013.
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.
Presentation providing an overview of the recent milestones and next steps for getting Critical Outcome's p53-dependent cancer treatment, COTI-2, into clinical trials. This presentation was first given by Dr. Wayne Danter at Critical Outcome Technologies' annual shareholders meeting on October 21, 2014.
Critical Outcome Technologies Inc. is listed on the Toronto Venture Exchange under the trading symbol COT.
The document discusses Critical Outcome Technologies Inc. (COTI), a bioinformatics company that uses its proprietary CHEMSAS platform to accelerate drug discovery and reduce costs. The CHEMSAS platform uses artificial intelligence and computational modeling to simulate the drug discovery process in silico, identifying promising compounds faster and cheaper than traditional wet-lab approaches. COTI has multiple collaborations utilizing the platform and an oncology drug candidate, COTI-2, that shows promise for cancers with p53 mutations and is nearing phase 1 clinical trials. The platform also positions COTI for numerous potential licensing deals and revenue streams from drug development milestones and royalties.
Precision Medicine & Biomarkers Leaders Summit - Boston USA - 7th & 8th MayTony Couch
Global Engage is pleased to announce the 2018 Precision Medicine & Biomarkers Leaders Summit USA taking place on May 7-8th in Boston, MA. The event is part of our highly successful Drug Discovery Series which includes conferences on Biologics, Medicinal Chemistry, NASH, Pharmaceutical R&D IT and the Human Microbiome amongst others. It is also the sister meeting of the European Precision Medicine Summit which has run successfully since 2013.
A global leader in real world health intelligence, Analytica Laser is powered by a renowned scientific team of 140+ senior experts across eight offices. Our consulting, research and data services are employed by the leading biopharma and public health innovators in over 20 countries. Every day, our work directly benefits millions of patients in advancing access to new therapies that are safer, more convenient and more affordable.
Keynote by Michael Berman, Former President at Boston Scientific and Healthcare IT entrepreneur and innvestor, about US digital healthcare investment trends and opportunities for the mHealth Israel meetup community
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.
Parsortix non-invasive cancer diagnostics | 3 September 2014ANGLE plc
ANGLE presented on their Parsortix system for non-invasive cancer diagnostics. The Parsortix system captures circulating tumor cells (CTCs) from blood, which can then be analyzed to personalize cancer treatment. Key opinion leaders have validated that Parsortix captures CTCs at high levels with low contamination. ANGLE aims to obtain FDA approval and roll out the system commercially to support personalized cancer care through molecular analysis of CTCs.
Precision Medicine & Biomarkers Leaders Summit - Boston USA - 7th & 8th MayTony Couch
Tracks focus on R&D strategies, Biomarker development, Immuno-oncology, CDx development, AI and Big data analysis and approaches – Attending this Summit will provide you with the opportunity to mix and interact with experts working in all facets of Precision Medicine through the individual, panel and roundtable discussions on offer.
This feasibility analysis examines developing a nucleic acid detection probe for fungal infections. It discusses the unmet need for rapid and accurate diagnosis of fungal sepsis in immunocompromised patients. Currently, diagnosis can take 2-4 days via blood culture and has low sensitivity. The proposed invention is a DNA-based probe that can detect fungal infections in 4-10 hours with higher sensitivity. The analysis covers the intellectual property landscape, potential licensees in biotech and diagnostics, licensing terms, and financial projections. It estimates the US market size as $900 million annually and projects revenues of $198 million within 5 years of licensing. However, the single patent expires in 2017. The recommendation is to donate the intellectual property to research
A presentation of Genentech strategic growth options vis-a-vis the current economic and structural challenges the biotech industry is facing.
Team project, December 2008.
Game Changers Cancer Immunotherapies: Checkpoint InhibitorsiData Insights
This document provides an overview and analysis of checkpoint inhibitors for cancer immunotherapy. It discusses the PD-1/PD-L1 and CTLA-4 pathways that are targeted by these drugs. Case studies are presented on the checkpoint inhibitor drugs Opdivo, Keytruda, and Yervoy, examining their development timelines, clinical trial profiles, pricing, regulation, and life cycle management. The report also analyzes the efficacy and safety of these drugs in melanoma treatment and provides insights on the global melanoma market and market potential of Opdivo and Keytruda.
RATIONAL COMBINATION IMMUNOTHERAPY: The best of ASCO16 clinical dataPaul D. Rennert
Presented at the Immuno-Oncology Summit August 31, 2016. Studies from ASCO16 on immune checkpoint combinations, immune checkpoints with other therapies, immune checkpoints and CAR T, and other studies that enrich our understanding of immuno-oncology as a broad-based discipline for cancer therapy.
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.
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.
One in 8 U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. Following breast cancer surgery in the adjuvant setting, a HER2/neu 3+ patient typically receives Herceptin® in the first year, with the hope that their breast cancer will not recur, and with the odds of recurrence slowly decreasing over the first 5 years after surgery. Herceptin® has been shown to reduce recurrence rates from 25% to 12% in the adjuvant setting. In the neoadjuvant setting, a patient receives treatment before surgery and based on the results of a biopsy at surgery, will receive the same or more potent treatment after surgery. Kadcyla® has been shown to reduce recurrence rates from 22% to 11% in the neoadjuvant setting. Accordingly, we believe that GP2 may be used to address the 50% of recurring patients who do not respond to either Herceptin® or Kadcyla®.
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 is an Australian company focused on developing and commercializing genetic risk assessment tests. The presentation provides an overview of the company's business, including its portfolio of current and upcoming genetic tests, markets and channels to market, and capabilities. Key points include:
- Genetic Technologies aims to offer the most comprehensive suite of genetic risk assessment tests on the market, covering up to 70% of disease risks.
- The company is prioritizing market entry strategies in key regions like Australia, the US, and Asia.
- Tests are marketed through consumer-initiated and medical business-to-business channels.
- An innovative pipeline of new tests for diseases like cancer, heart disease, and diabetes is being
This presentation by Pressure BioSciences discusses their Pressure Cycling Technology platform for biological sample preparation. Some key points:
- PCT uses ultra-high pressure to break up cell walls and extract biomolecules, achieving better results than mechanical methods.
- The market for biological sample preparation is multi-billion dollars. PCT addresses the need for improved sample prep methods.
- Over 275 PCT systems have been installed at over 150 customer sites. There are over 100 publications highlighting PCT's advantages.
- Recent accomplishments include a co-marketing agreement with SCIEX, a leader in analytical technologies, and sales of their new Barocycler 2320EXTREME system.
Reviva Pharmaceuticals Holdings Inc is a clinical development pharmaceutical company. It is developing a portfolio of internally discovered therapies that address unmet medical needs in the areas of central nervous system, cardiovascular, metabolic and inflammatory diseases.
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.
Business and scientific updates presentation given by Dr. Wayne Danter at the Critical Outcome Technologies Inc. 2013 Annual and Special Meeting of Shareholders on December 5, 2013.
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.
Presentation providing an overview of the recent milestones and next steps for getting Critical Outcome's p53-dependent cancer treatment, COTI-2, into clinical trials. This presentation was first given by Dr. Wayne Danter at Critical Outcome Technologies' annual shareholders meeting on October 21, 2014.
Critical Outcome Technologies Inc. is listed on the Toronto Venture Exchange under the trading symbol COT.
The document discusses Critical Outcome Technologies Inc. (COTI), a bioinformatics company that uses its proprietary CHEMSAS platform to accelerate drug discovery and reduce costs. The CHEMSAS platform uses artificial intelligence and computational modeling to simulate the drug discovery process in silico, identifying promising compounds faster and cheaper than traditional wet-lab approaches. COTI has multiple collaborations utilizing the platform and an oncology drug candidate, COTI-2, that shows promise for cancers with p53 mutations and is nearing phase 1 clinical trials. The platform also positions COTI for numerous potential licensing deals and revenue streams from drug development milestones and royalties.
Precision Medicine & Biomarkers Leaders Summit - Boston USA - 7th & 8th MayTony Couch
Global Engage is pleased to announce the 2018 Precision Medicine & Biomarkers Leaders Summit USA taking place on May 7-8th in Boston, MA. The event is part of our highly successful Drug Discovery Series which includes conferences on Biologics, Medicinal Chemistry, NASH, Pharmaceutical R&D IT and the Human Microbiome amongst others. It is also the sister meeting of the European Precision Medicine Summit which has run successfully since 2013.
A global leader in real world health intelligence, Analytica Laser is powered by a renowned scientific team of 140+ senior experts across eight offices. Our consulting, research and data services are employed by the leading biopharma and public health innovators in over 20 countries. Every day, our work directly benefits millions of patients in advancing access to new therapies that are safer, more convenient and more affordable.
Keynote by Michael Berman, Former President at Boston Scientific and Healthcare IT entrepreneur and innvestor, about US digital healthcare investment trends and opportunities for the mHealth Israel meetup community
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.
Parsortix non-invasive cancer diagnostics | 3 September 2014ANGLE plc
ANGLE presented on their Parsortix system for non-invasive cancer diagnostics. The Parsortix system captures circulating tumor cells (CTCs) from blood, which can then be analyzed to personalize cancer treatment. Key opinion leaders have validated that Parsortix captures CTCs at high levels with low contamination. ANGLE aims to obtain FDA approval and roll out the system commercially to support personalized cancer care through molecular analysis of CTCs.
Precision Medicine & Biomarkers Leaders Summit - Boston USA - 7th & 8th MayTony Couch
Tracks focus on R&D strategies, Biomarker development, Immuno-oncology, CDx development, AI and Big data analysis and approaches – Attending this Summit will provide you with the opportunity to mix and interact with experts working in all facets of Precision Medicine through the individual, panel and roundtable discussions on offer.
This feasibility analysis examines developing a nucleic acid detection probe for fungal infections. It discusses the unmet need for rapid and accurate diagnosis of fungal sepsis in immunocompromised patients. Currently, diagnosis can take 2-4 days via blood culture and has low sensitivity. The proposed invention is a DNA-based probe that can detect fungal infections in 4-10 hours with higher sensitivity. The analysis covers the intellectual property landscape, potential licensees in biotech and diagnostics, licensing terms, and financial projections. It estimates the US market size as $900 million annually and projects revenues of $198 million within 5 years of licensing. However, the single patent expires in 2017. The recommendation is to donate the intellectual property to research
A presentation of Genentech strategic growth options vis-a-vis the current economic and structural challenges the biotech industry is facing.
Team project, December 2008.
Game Changers Cancer Immunotherapies: Checkpoint InhibitorsiData Insights
This document provides an overview and analysis of checkpoint inhibitors for cancer immunotherapy. It discusses the PD-1/PD-L1 and CTLA-4 pathways that are targeted by these drugs. Case studies are presented on the checkpoint inhibitor drugs Opdivo, Keytruda, and Yervoy, examining their development timelines, clinical trial profiles, pricing, regulation, and life cycle management. The report also analyzes the efficacy and safety of these drugs in melanoma treatment and provides insights on the global melanoma market and market potential of Opdivo and Keytruda.
RATIONAL COMBINATION IMMUNOTHERAPY: The best of ASCO16 clinical dataPaul D. Rennert
Presented at the Immuno-Oncology Summit August 31, 2016. Studies from ASCO16 on immune checkpoint combinations, immune checkpoints with other therapies, immune checkpoints and CAR T, and other studies that enrich our understanding of immuno-oncology as a broad-based discipline for cancer therapy.
T cells have the potential to eliminate cancer cells but tumors can evade detection by the immune system and suppress T cell activity. The document discusses how T cells can be genetically engineered for cancer therapy by modifying them with genes that encode receptors recognizing cancer antigens or genes that enable resistance to immunosuppression and extended survival of the T cells within tumors. This genetic engineering has the goal of generating self-propagating T cells that can effectively target and destroy cancer cells.
In 3 sentences:
Envigo is a global contract research organization dedicated to helping customers advance human and animal health. They provide contract research services and research models across 5 continents, employing over 3,800 people at 52 locations. The presentation discussed key considerations for the non-clinical safety evaluation of drugs targeting immune checkpoints, including challenges assessing immunotoxicity and predicting autoimmune risks in animal models.
VGX-3100, Inovio's immunotherapy for HPV-associated cervical dysplasia, achieved statistically significant efficacy in a Phase II clinical trial. The treatment generated antigen-specific CD8+ killer T cells in vivo that regressed high-grade cervical dysplasia to low grade or normal in 49.5% of patients, compared to 30.6% for the control. This first-ever result validates Inovio's DNA-based immunotherapy platform and positions VGX-3100 for Phase III development as a potential non-surgical treatment for cervical dysplasia.
Immunotherapy: Novel Immunomodulatory TargetsPaul D. Rennert
An approach to discovering new immunotherapy targets for oncology is introduced and examples presented. New programs from biotech and pharma are discussed.
This document summarizes a presentation by Dr. George Poste on the next era of immuno-oncology. It discusses cancer as a complex adaptive system and the challenges of tumor heterogeneity and resistance. It outlines passive immunotherapies like antibodies and cell therapies, as well as active immunotherapies like checkpoint inhibitors and vaccines. Combination immunotherapies aim to overcome limitations of single agents. Challenges include toxicity, biomarkers, and the complex interactions between the immune system and tumor microenvironment. Next generation immunotherapies seek better responses, durability, tolerability through new targets and combination approaches.
The document summarizes recent developments in cancer immunotherapy, focusing on immune checkpoint blockade and the potential role of mesenchymal stem cells. It notes that between 2011-2016, the FDA approved several immune checkpoint inhibitors (targeting PD-1, PD-L1, CTLA-4) for various cancer types including melanoma, lung cancer, kidney cancer, and Hodgkin's lymphoma. While these drugs have shown success, many patients still do not respond. The document discusses using engineered mesenchymal stem cells to deliver immunotherapeutic agents directly to tumors, with the goal of overcoming adaptive immune resistance in the tumor microenvironment and improving response rates to immunotherapy.
n overview of current immunotherapy therapies used to treat cancer. Also provides MOA of various medications, and updates on SITC guidelines for metastatice melanoma.
immunology chapter 9 : activation of T lymphocytesprincesa_mera
1. T lymphocyte activation involves recognition of antigen peptides presented by MHC molecules on antigen presenting cells. This provides an initial activation signal that is enhanced by costimulatory molecules like B7 and CD28.
2. Upon activation, naive T cells proliferate extensively through clonal expansion, increasing the number of antigen-specific T cells by 100,000-fold. They also differentiate into effector T cell subsets.
3. The main effector T cell subsets are TH1 and TH2 cells, distinguished by their cytokine production. TH1 cells produce IFNγ and activate macrophages, while TH2 cells produce IL-4 and stimulate antibody class switching and eosinophil responses.
T CELL ACTIVATION AND IT'S TERMINATIONpremvarma064
T cell activation requires two signals: 1) recognition of antigens displayed on antigen-presenting cells by T cell receptors and 2) co-stimulatory signals through molecules like CD28. This leads T cells to proliferate, differentiate into effector and memory cells, and perform effector functions. Proper activation requires interaction between T cells and antigen-presenting cells in lymphoid tissues, where costimulatory molecules are highly expressed. Dysregulation of T cell activation can lead to autoimmunity or susceptibility to infection.
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) 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.
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 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.
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.
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
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.
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.
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 potential in preclinical and clinical studies to reduce liver inflammation and fibrosis through its anti-LPS and regulatory T-cell promoting properties. They are also developing a vaccine against C. difficile and have an approved traveler's diarrhea drug called Travelan that is generating revenues. Immuron believes they are significantly undervalued given their pipeline, which includes programs targeting large markets like NASH estimated at $35-40 billion by
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.
This particular slides consist of- what is hypotension,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is the summary of hypotension:
Hypotension, or low blood pressure, is when the pressure of blood circulating in the body is lower than normal or expected. It's only a problem if it negatively impacts the body and causes symptoms. Normal blood pressure is usually between 90/60 mmHg and 120/80 mmHg, but pressures below 90/60 are generally considered hypotensive.
Get Covid Testing at Fit to Fly PCR TestNX Healthcare
A Fit-to-Fly PCR Test is a crucial service for travelers needing to meet the entry requirements of various countries or airlines. This test involves a polymerase chain reaction (PCR) test for COVID-19, which is considered the gold standard for detecting active infections. At our travel clinic in Leeds, we offer fast and reliable Fit to Fly PCR testing, providing you with an official certificate verifying your negative COVID-19 status. Our process is designed for convenience and accuracy, with quick turnaround times to ensure you receive your results and certificate in time for your departure. Trust our professional and experienced medical team to help you travel safely and compliantly, giving you peace of mind for your journey.
The best massage spa Ajman is Chandrima Spa Ajman, which was founded in 2023 and is exclusively for men 24 hours a day. As of right now, our parent firm has been providing massage services to over 50,000+ clients in Ajman for the past 10 years. It has about 8+ branches. This demonstrates that Chandrima Spa Ajman is among the most reasonably priced spas in Ajman and the ideal place to unwind and rejuvenate. We provide a wide range of Spa massage treatments, including Indian, Pakistani, Kerala, Malayali, and body-to-body massages. Numerous massage techniques are available, including deep tissue, Swedish, Thai, Russian, and hot stone massages. Our massage therapists produce genuinely unique treatments that generate a revitalized sense of inner serenely by fusing modern techniques, the cleanest natural substances, and traditional holistic therapists.
At Apollo Hospital, Lucknow, U.P., we provide specialized care for children experiencing dehydration and other symptoms. We also offer NICU & PICU Ambulance Facility Services. Consult our expert today for the best pediatric emergency care.
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Name: Apollo Hospital
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Phone: 08429021957
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Let's Talk About It: Breast Cancer (What is Mindset and Does it Really Matter?)bkling
Your mindset is the way you make sense of the world around you. This lens influences the way you think, the way you feel, and how you might behave in certain situations. Let's talk about mindset myths that can get us into trouble and ways to cultivate a mindset to support your cancer survivorship in authentic ways. Let’s Talk About It!
R3 Stem Cell Therapy: A New Hope for Women with Ovarian FailureR3 Stem Cell
Discover the groundbreaking advancements in stem cell therapy by R3 Stem Cell, offering new hope for women with ovarian failure. This innovative treatment aims to restore ovarian function, improve fertility, and enhance overall well-being, revolutionizing reproductive health for women worldwide.
Letter to MREC - application to conduct studyAzreen Aj
Application to conduct study on research title 'Awareness and knowledge of oral cancer and precancer among dental outpatient in Klinik Pergigian Merlimau, Melaka'
About this webinar: This talk will introduce what cancer rehabilitation is, where it fits into the cancer trajectory, and who can benefit from it. In addition, the current landscape of cancer rehabilitation in Canada will be discussed and the need for advocacy to increase access to this essential component of cancer care.
Healthy Eating Habits:
Understanding Nutrition Labels: Teaches how to read and interpret food labels, focusing on serving sizes, calorie intake, and nutrients to limit or include.
Tips for Healthy Eating: Offers practical advice such as incorporating a variety of foods, practicing moderation, staying hydrated, and eating mindfully.
Benefits of Regular Exercise:
Physical Benefits: Discusses how exercise aids in weight management, muscle and bone health, cardiovascular health, and flexibility.
Mental Benefits: Explains the psychological advantages, including stress reduction, improved mood, and better sleep.
Tips for Staying Active:
Encourages consistency, variety in exercises, setting realistic goals, and finding enjoyable activities to maintain motivation.
Maintaining a Balanced Lifestyle:
Integrating Nutrition and Exercise: Suggests meal planning and incorporating physical activity into daily routines.
Monitoring Progress: Recommends tracking food intake and exercise, regular health check-ups, and provides tips for achieving balance, such as getting sufficient sleep, managing stress, and staying socially active.
COPD Treatment in Ghatkopar,Mumbai. Dr Kumar DoshiDr Kumar Doshi
Are you or a loved one affected by Chronic Obstructive Pulmonary Disease (COPD)? Discover comprehensive and advanced treatment options with Dr. Kumar Doshi, a preeminent COPD specialist based in Ghatkopar, Mumbai.
Dr. Kumar Doshi is dedicated to delivering the highest standard of care for COPD patients. Whether you are seeking a diagnosis, a second opinion, or exploring new treatment avenues, this presentation will guide you through the exceptional services available at his practice in Ghatkopar, Mumbai.
Chandrima Spa Ajman is one of the leading Massage Center in Ajman, which is open 24 hours exclusively for men. Being one of the most affordable Spa in Ajman, we offer Body to Body massage, Kerala Massage, Malayali Massage, Indian Massage, Pakistani Massage Russian massage, Thai massage, Swedish massage, Hot Stone Massage, Deep Tissue Massage, and many more. Indulge in the ultimate massage experience and book your appointment today. We are confident that you will leave our Massage spa feeling refreshed, rejuvenated, and ready to take on the world.
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TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - ...rightmanforbloodline
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
TEST BANK FOR Health Assessment in Nursing 7th Edition by Weber Chapters 1 - 34.
DECODING THE RISKS - ALCOHOL, TOBACCO & DRUGS.pdfDr Rachana Gujar
Introduction: Substance use education is crucial due to its prevalence and societal impact.
Alcohol Use: Immediate and long-term risks include impaired judgment, health issues, and social consequences.
Tobacco Use: Immediate effects include increased heart rate, while long-term risks encompass cancer and heart disease.
Drug Use: Risks vary depending on the drug type, including health and psychological implications.
Prevention Strategies: Education, healthy coping mechanisms, community support, and policies are vital in preventing substance use.
Harm Reduction Strategies: Safe use practices, medication-assisted treatment, and naloxone availability aim to reduce harm.
Seeking Help for Addiction: Recognizing signs, available treatments, support systems, and resources are essential for recovery.
Personal Stories: Real stories of recovery emphasize hope and resilience.
Interactive Q&A: Engage the audience and encourage discussion.
Conclusion: Recap key points and emphasize the importance of awareness, prevention, and seeking help.
Resources: Provide contact information and links for further support.
MYASTHENIA GRAVIS POWER POINT PRESENTATIONblessyjannu21
Myasthenia gravis is a neurological disease. It affects the grave muscles in our body. Myasthenia gravis affects how the nerves communicate with the muscles. Drooping eyelids and/or double vision are often the first noticeable sign. It is involving the muscles controlling the eyes movement, facial expression, chewing and swallowing. It also effects the muscles neck and lip movement and respiration.
It is a neuromuscular disease characterized by abnormal weakness of voluntary muscles that improved with rest and the administration of anti-cholinesterase drugs.
The person may find difficult to stand, lift objects and speak or swallow. Medications and surgery can help the patient to relieve the symptoms of this lifelong illness.
As Mumbai's premier kidney transplant and donation center, L H Hiranandani Hospital Powai is not just a medical facility; it's a beacon of hope where cutting-edge science meets compassionate care, transforming lives and redefining the standards of kidney health in India.
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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
disclosed (in whole or in part) by recipients to any other person. By attendance at the presentation each recipient agrees to keep the
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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.
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• 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