Medicenna Therapeutics is a clinical-stage immunotherapy company developing therapies targeting the interleukin-4 receptor (IL4R). Their lead candidate, MDNA55, has shown compelling efficacy in recurrent glioblastoma patients in Phase 1 and 2 clinical trials. Medicenna is currently enrolling patients in a Phase 2b clinical trial of MDNA55 for recurrent glioblastoma. In addition to their lead program, Medicenna has a deep pipeline of IL4R-targeting candidates and a platform of interleukin superkines for cancer immunotherapy. The company is well funded with expected cash runway into Q1 2019 and has several near-term value-driving milestones.
This corporate presentation by Medicenna outlines their lead candidate MDNA55 for the treatment of glioblastoma and other IL4R-expressing cancers. MDNA55 is a targeted immunotherapy currently in Phase 2 clinical trials for recurrent glioblastoma. The presentation highlights compelling efficacy data from previous studies of MDNA55 and outlines plans to improve outcomes through second generation convection enhanced delivery. It also discusses Medicenna's pipeline of IL-2 and IL-4 superkines and preclinical programs, as well as upcoming clinical milestones and financial position.
Medicenna is a clinical-stage biotech company developing MDNA55, a targeted immunotherapy for the treatment of glioblastoma and other IL4R-expressing cancers. MDNA55 has shown promising efficacy and safety results in Phase 2 clinical trials for recurrent glioblastoma. Medicenna is currently enrolling patients in a Phase 2b clinical trial evaluating MDNA55 for recurrent glioblastoma and plans to initiate additional clinical trials in brain and other cancers in 2018. The company has a deep pipeline of IL-2 and IL-4 superkines and is well funded through non-dilutive grants and an equity financing to advance its programs over the next two years.
Medicenna corporate presentation renmark fm printablemedicenna2016
This corporate presentation provides an overview of Medicenna Biopharma Corp., a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer. Key points include:
- MDNA55 is Medicenna's lead candidate for treating recurrent glioblastoma and has received orphan drug designation from the FDA and EMA. Phase 1/2 clinical data showed compelling efficacy and safety results.
- Medicenna is currently enrolling patients in a Phase 2b clinical trial of MDNA55 for recurrent glioblastoma and plans to expand into other brain cancer indications.
- The company is developing a pipeline of "superkine" versions of cytokines like IL-2 and IL-4 with potential applications across multiple
Amanda
Email: assistant@scythianbio.com
Phone: 403-777-5177
Website: www.scythianbio.com
Thank you for your time and consideration. We look forward to discussing how we can work together to fulfill our mission of developing the first accepted drug regimen for concussive treatment.
12Private and Confidential
Professor of Neurosurgery at Stanford University;
Inventor of MDNA55
Sam Denmeade, MD
Johns Hopkins University:
Chief Scientific Officer; Expert in Prostate Cancer Therapeutics
David M. Nanus, MD
Memorial Sloan Kettering Cancer Center:
Expert in Immunotherapy for Solid Tumors
David Spetzler, MD, PhD
CSO, Xencor:
Expert in Protein Engineering and Antibody Therapeutics
John Sampson, MD, PhD
Duke University:
Principal Investigator and Expert in Drug Delivery to the Brain
17
This corporate presentation from Target: infinite Hope outlines their lead product candidate MDNA55 for the treatment of cancers with Interleukin-4 Receptor (IL4R) biomarker expression. MDNA55 has shown promising clinical efficacy in recurrent glioblastoma patients in Phase 1/2 trials with an objective response rate of 34%. The presentation highlights the significant market opportunity for MDNA55 in brain cancers, which affect over 133,000 patients annually. Target: infinite Hope is pursuing accelerated approval for MDNA55 in recurrent glioblastoma in 2018 based on its Phase 2b trial and end of Phase 2 meeting with the FDA. The company has a pipeline of next-generation IL4-empowered cytokines and $14.
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.
Jubilant Therapeutics Corporate Deck_Non-Con_May2022.pdfWEI LIN
The document provides an overview of Jubilant Therapeutics, a clinical stage precision therapeutics company developing novel therapies for cancer and autoimmune diseases. Jubilant has a differentiated pipeline including a dual LSD1/HDAC6 inhibitor (JBI-802) in Phase I/II trials for various cancers, as well as preclinical programs targeting PRMT5, PD-L1, and PAD4. The company utilizes a structure-based drug discovery platform called TIBEO to rapidly design and optimize first-in-class and best-in-class small molecule therapies.
This corporate presentation by Medicenna outlines their lead candidate MDNA55 for the treatment of glioblastoma and other IL4R-expressing cancers. MDNA55 is a targeted immunotherapy currently in Phase 2 clinical trials for recurrent glioblastoma. The presentation highlights compelling efficacy data from previous studies of MDNA55 and outlines plans to improve outcomes through second generation convection enhanced delivery. It also discusses Medicenna's pipeline of IL-2 and IL-4 superkines and preclinical programs, as well as upcoming clinical milestones and financial position.
Medicenna is a clinical-stage biotech company developing MDNA55, a targeted immunotherapy for the treatment of glioblastoma and other IL4R-expressing cancers. MDNA55 has shown promising efficacy and safety results in Phase 2 clinical trials for recurrent glioblastoma. Medicenna is currently enrolling patients in a Phase 2b clinical trial evaluating MDNA55 for recurrent glioblastoma and plans to initiate additional clinical trials in brain and other cancers in 2018. The company has a deep pipeline of IL-2 and IL-4 superkines and is well funded through non-dilutive grants and an equity financing to advance its programs over the next two years.
Medicenna corporate presentation renmark fm printablemedicenna2016
This corporate presentation provides an overview of Medicenna Biopharma Corp., a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer. Key points include:
- MDNA55 is Medicenna's lead candidate for treating recurrent glioblastoma and has received orphan drug designation from the FDA and EMA. Phase 1/2 clinical data showed compelling efficacy and safety results.
- Medicenna is currently enrolling patients in a Phase 2b clinical trial of MDNA55 for recurrent glioblastoma and plans to expand into other brain cancer indications.
- The company is developing a pipeline of "superkine" versions of cytokines like IL-2 and IL-4 with potential applications across multiple
Amanda
Email: assistant@scythianbio.com
Phone: 403-777-5177
Website: www.scythianbio.com
Thank you for your time and consideration. We look forward to discussing how we can work together to fulfill our mission of developing the first accepted drug regimen for concussive treatment.
12Private and Confidential
Professor of Neurosurgery at Stanford University;
Inventor of MDNA55
Sam Denmeade, MD
Johns Hopkins University:
Chief Scientific Officer; Expert in Prostate Cancer Therapeutics
David M. Nanus, MD
Memorial Sloan Kettering Cancer Center:
Expert in Immunotherapy for Solid Tumors
David Spetzler, MD, PhD
CSO, Xencor:
Expert in Protein Engineering and Antibody Therapeutics
John Sampson, MD, PhD
Duke University:
Principal Investigator and Expert in Drug Delivery to the Brain
17
This corporate presentation from Target: infinite Hope outlines their lead product candidate MDNA55 for the treatment of cancers with Interleukin-4 Receptor (IL4R) biomarker expression. MDNA55 has shown promising clinical efficacy in recurrent glioblastoma patients in Phase 1/2 trials with an objective response rate of 34%. The presentation highlights the significant market opportunity for MDNA55 in brain cancers, which affect over 133,000 patients annually. Target: infinite Hope is pursuing accelerated approval for MDNA55 in recurrent glioblastoma in 2018 based on its Phase 2b trial and end of Phase 2 meeting with the FDA. The company has a pipeline of next-generation IL4-empowered cytokines and $14.
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.
Jubilant Therapeutics Corporate Deck_Non-Con_May2022.pdfWEI LIN
The document provides an overview of Jubilant Therapeutics, a clinical stage precision therapeutics company developing novel therapies for cancer and autoimmune diseases. Jubilant has a differentiated pipeline including a dual LSD1/HDAC6 inhibitor (JBI-802) in Phase I/II trials for various cancers, as well as preclinical programs targeting PRMT5, PD-L1, and PAD4. The company utilizes a structure-based drug discovery platform called TIBEO to rapidly design and optimize first-in-class and best-in-class small molecule therapies.
The document advertises the FORUM 2015 conference on cell and gene therapy taking place from 26-28 January 2015 at the Grand Hyatt Washington DC. It provides details on the expected attendance of over 550 people, 150+ speakers, and prominent participants from major pharmaceutical companies, biotechs, investors, regulators and other organizations. It highlights the conference's role in driving product commercialization and providing unmatched networking and learning opportunities for the cell and gene therapy community.
The document summarizes an upcoming conference on patient-centered clinical trials taking place October 19-20, 2015 in Philadelphia. It will feature over 30 industry experts and leaders from pharmaceutical companies such as Johnson & Johnson, Pfizer, AstraZeneca, and Google. The goal of the conference is to discuss how to better involve patients in the design and conduct of clinical trials to improve recruitment, retention, and trial success by putting the patient voice at the core. It will provide a forum for stakeholders from industry, patient advocacy groups, and regulators to collaborate on developing a framework for patient engagement in clinical trials.
This presentation introduces Scythian Biosciences Inc., which aims to develop cannabinoid and non-cannabinoid drug therapies. Scythian plans to focus on treating traumatic brain injury by inhibiting inflammation and the immune response. The presentation outlines Scythian's leadership, research partners, clinical trial timeline and goals, and competitive landscape. It also notes Scythian's plans to partner with Canadian medical marijuana companies and the large market potential for traumatic brain injury treatments.
Scythian Biosciences Inc. is developing cannabinoid-based drug therapies for traumatic brain injury. Their solution aims to inhibit the immune response and inflammation caused by TBI. Their 2017 timeline includes pre-clinical studies testing CBD and HU211 compounds on rat TBI models. Their clinical timeline involves collecting data from a mild TBI patient registry. Their leadership team, research partners, and advisory board have extensive experience in drug development, neurotrauma, and concussions.
- IDXG provides molecular diagnostic tests for cancer risk assessment and prognosis.
- Recent accomplishments include new product launches, reimbursement from Aetna for ThyraMir, and achieving approval in New York State.
- The presentation provides financial information, with revenue growing but losses continuing from investments in sales, R&D and administrative expenses.
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 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.
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.
AV Therapeutics is developing new cancer therapeutics including Capridine, a patented drug that has shown specific activity against prostate cancer in preclinical studies. Capridine addresses an unmet need as it has limited side effects and bone toxicity compared to existing treatments. AV Therapeutics plans to submit an IND application to begin Phase I/II clinical trials for Capridine based on its promising preclinical results showing potency against prostate cancer cells and taxane resistant cell lines with no toxicity to bone marrow cells. The company has a strong management team and scientific advisory board from top institutions to advance its pipeline of safer and more effective cancer treatments.
Blue Horizon International AG was formed in 2017 to commercialize stem cell technology and regenerative medicine. It operates clinics in Slovakia, Jamaica, and China where it has successfully treated over 600 patients for conditions like spinal cord injury, cerebral palsy, and stroke. The company projects rapid revenue growth from $851k in 2020 to over $310 million in 2024 as it expands globally based on the large and growing market opportunity for stem cell therapies in areas like stroke and Alzheimer's disease that affect millions worldwide.
The DESTINY-Breast04 trial is a Phase III randomized trial evaluating Enhertu compared to chemotherapy for previously treated HER2-low metastatic breast cancer. The trial randomized over 550 patients 2:1 to receive either Enhertu or one of several standard chemotherapy options. The primary endpoint is progression-free survival in the hormone receptor positive subgroup. Key secondary endpoints include overall survival in both the hormone receptor positive and total patient populations. Baseline characteristics were well balanced between the two arms. Results from this trial could establish Enhertu as a new treatment option for HER2-low breast cancer.
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.
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.
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.
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.
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.
This document provides an agenda for the "2nd Biosimilars & Biobetters USA" conference happening on November 16-17, 2015 in Iselin, New Jersey. The conference will focus on the evolving regulatory landscape and commercialization of biosimilars, and will include presentations and panels on topics such as the FDA approval process, the European experience with biosimilars, and determining interchangeability. It lists speakers from companies such as Sandoz, Merck Serono, Dr. Reddy's Laboratories, and the FDA. Workshops on November 18th will focus on regulatory updates and the development and commercial needs for biosimilars globally.
biOasis Technologies, Inc. (BTI:TSXV & BIOAF:OTCQX) Presentation - May 2014graemedick
This document presents a corporate presentation for Bioasis Technologies Inc. It discusses the company's patented Transcend technology which allows drugs to cross the blood-brain barrier and potentially treat diseases of the brain and central nervous system. The presentation notes the blood-brain barrier poses a challenge for drug delivery to the brain but that Transcend is a leading technology in this area. It outlines Bioasis' drug development programs and potential for collaborations to develop new therapeutic entities using Transcend.
- 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.
The document advertises the FORUM 2015 conference on cell and gene therapy taking place from 26-28 January 2015 at the Grand Hyatt Washington DC. It provides details on the expected attendance of over 550 people, 150+ speakers, and prominent participants from major pharmaceutical companies, biotechs, investors, regulators and other organizations. It highlights the conference's role in driving product commercialization and providing unmatched networking and learning opportunities for the cell and gene therapy community.
The document summarizes an upcoming conference on patient-centered clinical trials taking place October 19-20, 2015 in Philadelphia. It will feature over 30 industry experts and leaders from pharmaceutical companies such as Johnson & Johnson, Pfizer, AstraZeneca, and Google. The goal of the conference is to discuss how to better involve patients in the design and conduct of clinical trials to improve recruitment, retention, and trial success by putting the patient voice at the core. It will provide a forum for stakeholders from industry, patient advocacy groups, and regulators to collaborate on developing a framework for patient engagement in clinical trials.
This presentation introduces Scythian Biosciences Inc., which aims to develop cannabinoid and non-cannabinoid drug therapies. Scythian plans to focus on treating traumatic brain injury by inhibiting inflammation and the immune response. The presentation outlines Scythian's leadership, research partners, clinical trial timeline and goals, and competitive landscape. It also notes Scythian's plans to partner with Canadian medical marijuana companies and the large market potential for traumatic brain injury treatments.
Scythian Biosciences Inc. is developing cannabinoid-based drug therapies for traumatic brain injury. Their solution aims to inhibit the immune response and inflammation caused by TBI. Their 2017 timeline includes pre-clinical studies testing CBD and HU211 compounds on rat TBI models. Their clinical timeline involves collecting data from a mild TBI patient registry. Their leadership team, research partners, and advisory board have extensive experience in drug development, neurotrauma, and concussions.
- IDXG provides molecular diagnostic tests for cancer risk assessment and prognosis.
- Recent accomplishments include new product launches, reimbursement from Aetna for ThyraMir, and achieving approval in New York State.
- The presentation provides financial information, with revenue growing but losses continuing from investments in sales, R&D and administrative expenses.
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 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.
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.
AV Therapeutics is developing new cancer therapeutics including Capridine, a patented drug that has shown specific activity against prostate cancer in preclinical studies. Capridine addresses an unmet need as it has limited side effects and bone toxicity compared to existing treatments. AV Therapeutics plans to submit an IND application to begin Phase I/II clinical trials for Capridine based on its promising preclinical results showing potency against prostate cancer cells and taxane resistant cell lines with no toxicity to bone marrow cells. The company has a strong management team and scientific advisory board from top institutions to advance its pipeline of safer and more effective cancer treatments.
Blue Horizon International AG was formed in 2017 to commercialize stem cell technology and regenerative medicine. It operates clinics in Slovakia, Jamaica, and China where it has successfully treated over 600 patients for conditions like spinal cord injury, cerebral palsy, and stroke. The company projects rapid revenue growth from $851k in 2020 to over $310 million in 2024 as it expands globally based on the large and growing market opportunity for stem cell therapies in areas like stroke and Alzheimer's disease that affect millions worldwide.
The DESTINY-Breast04 trial is a Phase III randomized trial evaluating Enhertu compared to chemotherapy for previously treated HER2-low metastatic breast cancer. The trial randomized over 550 patients 2:1 to receive either Enhertu or one of several standard chemotherapy options. The primary endpoint is progression-free survival in the hormone receptor positive subgroup. Key secondary endpoints include overall survival in both the hormone receptor positive and total patient populations. Baseline characteristics were well balanced between the two arms. Results from this trial could establish Enhertu as a new treatment option for HER2-low breast cancer.
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.
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.
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.
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.
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.
This document provides an agenda for the "2nd Biosimilars & Biobetters USA" conference happening on November 16-17, 2015 in Iselin, New Jersey. The conference will focus on the evolving regulatory landscape and commercialization of biosimilars, and will include presentations and panels on topics such as the FDA approval process, the European experience with biosimilars, and determining interchangeability. It lists speakers from companies such as Sandoz, Merck Serono, Dr. Reddy's Laboratories, and the FDA. Workshops on November 18th will focus on regulatory updates and the development and commercial needs for biosimilars globally.
biOasis Technologies, Inc. (BTI:TSXV & BIOAF:OTCQX) Presentation - May 2014graemedick
This document presents a corporate presentation for Bioasis Technologies Inc. It discusses the company's patented Transcend technology which allows drugs to cross the blood-brain barrier and potentially treat diseases of the brain and central nervous system. The presentation notes the blood-brain barrier poses a challenge for drug delivery to the brain but that Transcend is a leading technology in this area. It outlines Bioasis' drug development programs and potential for collaborations to develop new therapeutic entities using Transcend.
- 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.
Similar to Medicenna corporate presentation renmark printable (20)
UnityNet World Environment Day Abraham Project 2024 Press ReleaseLHelferty
June 12, 2024 UnityNet International (#UNI) World Environment Day Abraham Project 2024 Press Release from Markham / Mississauga, Ontario in the, Greater Tkaronto Bioregion, Canada in the North American Great Lakes Watersheds of North America (Turtle Island).
Cleades Robinson, a respected leader in Philadelphia's police force, is known for his diplomatic and tactful approach, fostering a strong community rapport.
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The E-Way Bill revolutionizes logistics by digitizing the documentation of goods transport, ensuring transparency, tax compliance, and streamlined processes. This mandatory, electronic system reduces delays, enhances accountability, and combats tax evasion, benefiting businesses and authorities alike. Embrace the E-Way Bill for efficient, reliable transportation operations.
Methanex is the world's largest producer and supplier of methanol. We create value through our leadership in the global production, marketing and delivery of methanol to customers. View our latest Investor Presentation for more details.
2. One Target. Infinite Hope™…
TSX: MDNA
Certain statements in this presentation are “forward-looking statements. Any statements that express or involve discussions
with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions or future events or
performance (often, but not always using words or phrases such as “expect”, “seek”, “endeavour”, “anticipate”, “plan”,
“estimate”, “believe”, “intend”, or stating that certain actions, events or results may, could, would, might or will occur or be
taken, or achieved) are not statements of historical fact and may be “forward-looking statements”.
Forward-looking statements are based on expectations, estimates and projections at the time the statements are made that
involve a number of risks and uncertainties which would cause actual results or events to differ materially from those
presently anticipated. Forward-looking statements are based on expectations, estimates and projections at the time the
statements are made and involve significant known and unknown risks, uncertainties and assumptions. A number of
factors could cause actual results, performance or achievements to be materially different from any future results,
performance or achievements that may be expressed or implied by such forward-looking statements. These include, but are
not limited to, the risk factors discussed in the public filings made by Medicenna with the applicable securities commissions
in Canada, including the Annual Information Form dated June 15, 2017. Should one or more of these risks or uncertainties
materialize, or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance
or achievements could vary materially from those expressed or implied by the forward-looking statements contained in this
document. These factors should be considered carefully and prospective investors should not place undue reliance on
these forward-looking statements.
Although the forward-looking statements contained in this document are based upon what Medicenna currently believes to
be reasonable assumptions, Medicenna cannot assure prospective investors that actual results, performance or
achievements will be consistent with these forward-looking statements. Except as required by law, Medicenna does not
have any obligation to advise any person if it becomes aware of any inaccuracy in or omission from any forward-looking
statement, nor does it intend, or assume any obligation, to update or revise these forward-looking statements to reflect new
events or circumstances.
2
Forward Looking Statements
3. One Target. Infinite Hope™…
MDNA55 (lead): Compelling, Phase 1
and 2 clinical data (N=66) for recurrent
glioblastoma (rGBM)
Publicly listed (TSX: MDNA), clinical-stage,
immuno-oncology company developing
novel therapies targeting the Type 2
Interleukin-4 Receptor (IL4R)
MDNA55 has Orphan Drug (FDA, EMA) &
Fast Track Designations (FDA)
Currently enrolling in a Phase 2b recurrent
GBM trial at 9 centers in the U.S.
Exciting pre-clinical IL-2, IL-4 and
IL-13 Superkine platform
Technology platform protected by
13 patent families
Well funded with $14M US non-dilutive
grant and $14M CAD Private Placement
Well established cGMP compliant
commercial scale manufacturing process
Seasoned management, advisors and
directors
Corporate Highlights
3
4. One Target. Infinite Hope™…
Seasoned Management & Experienced Board
4
Management Team
Fahar Merchant, PhD
Chairman, President & CEO
Former CEO Sophiris Bio
(TSX); Former Director,
President & CTO at KS
Biomedix (LSE); Founder,
President & CEO of Avicenna
Medica and IntelliGene
Expressions
Jay Stoudemire, PhD
Chief Scientific Officer
Former VP Preclinical
Development, Regulatory, and
QA at Mirna Therapeutics,
previously at Genentech,
Ascenta, Chugai-Roche, Cytel,
Genetics Institute, and Xoma
Nina Merchant, MESc.
Chief Development Officer
Former SVP Development at
Sophiris Bio; Formerly VP
Development at KS Biomedix
(LSE); Previously at Avicenna
Medica, IntelliGene, Pharmacia
and Sanofi Pasteur
Elizabeth Williams, CPA,CA
Chief Financial Officer
Former VP Finance & Admin
and interim CFO at Aptose
(TSX and Nasdaq); Previously
with Ernst & Young
Martin Bexon, MD
Head of Clinical Development
Former Medical Director at
CSL Behring; Medical Director
at Hoffman La Roche (UK and
Switzerland)
Patrick Ward, MBA
Chief Operating Officer
Former COO of Aviara
Pharma; President/COO at
Ocusoft, Executive Director at
Encysive Pharma
Shafique Fidai, PhD
Head of Corp Development
Former VP of Business
Development at Sophiris Bio;
Formerly with Xenon Pharma,
Chromos
Board of Directors
Fahar Merchant, PhD
Chairman, President & CEO
Albert Beraldo, CPA, CA
Independent Director
Founder, President and CEO of
Alveda Pharmaceuticals until its
acquisition by Teligent, Inc.
(NASDAQ: TLGT); Former
President and CEO of Bioniche
(TSX).
William W. Li, M.D.
Independent Director
CEO, President and Co-
Founder of the Angiogenesis
Foundation. Executive
strategic consultant to pharma
in drug development and
advised leaders at major
investment banks. Director of
Leap Therapeutics (NASDAQ)
Chandra Panchal, PhD
Independent Director
Founder, Chairman and CEO of
Axcelon; Former Co-Founder,
President, and CEO of Procyon
Biopharma Inc (TSX); Former
Senior Executive VP of
Business Development at
Ambrilia Biopharma Inc. (TSX).
Andrew Strong, JD
Independent Director
Partner at Pillsbury Winthrop
Shaw Pittman - leading the Life
Sciences Team in Houston,
TX. Formerly CEO of Kalon
Biotherapeutics. Director of
Ashford Hospitality Prime
(NYSE)
Nina Merchant, M.E.Sc
Director, Chief Development
Officer
5. One Target. Infinite Hope™…
World Class Advisors and Collaborators
5
Clinical & Scientific Advisors
John Sampson, MD, PhD,
MBA
Duke University
Principal Investigator and
Expert in Drug Delivery to the
Brain
Sam Denmeade, MD
John Hopkins University
Professor of Oncology:
Targeted therapies for cancer
Nicholas Butowski, MD
University of California San
Francisco
Principal Investigator; Novel
therapies for brain cancer
Guido Kroemer, MD, PhD
University of Paris
Chair: SAB and Expert in
Cancer Immunotherapy
Ralph Smalling, MSc
Regulatory Advisor
Former VP Regulatory Affairs
at Amgen; Filed 40 INDs; 5
NDAs
Collaborators & Inventors
Michael Rosenblum, PhD
MD Anderson Cancer Center
Head, Immunopharmacology
and Targeted Therapy
Collaborator: MDNA57
Raj Puri, MD
USFDA
Director at CBER
Inventor of MDNA55
Aaron Ring, MD, PhD
Yale University
Asst. Prof Immunobiology &
Cancer Biology
Co-Inventor of IL-2
Superkines
Chris Garcia, PhD
Stanford University
Co-Inventor of IL-2, IL-4 and
IL-13 Superkines
Haya Loberboum Galski,
PhD
Hebrew University of
Jerusalem
Inventor of Fully Human
Payloads)
6. One Target. Infinite Hope™…
Treatment Pathway for Glioblastoma (GBM)
6
Surgery
(85-90%)
GB Diagnosis
Radiotherapy
+ Chemotherapy
Relapse
Chemotherapy
GB is uniformly fatal; virtually all tumors will recur (rGB)
55% of GBM Chemo-Resistant*
* Expression of the DNA repair protein O6-methylguanine-DNA
methyltransferase (MGMT) is responsible for resistance to alkylating
agents used in GBM treatment.
MDNA55 Treatment
(Direct infusion into tumor - CED)
NON-OPERABLE rGBM
75%
Surgery Add’l Chemotherapy
or Experimental Therapies
25%
OPERABLE rGBM
7. One Target. Infinite Hope™…
Potently toxic to tumor cells with a wide therapeutic window
Simultaneously purges the Tumor Microenvironment (TME) and un-blinds the
immune system to cancer cells
Proven payload efficacy– identical to Medimmune’s anti-CD22 immunotoxin,
Moxetumomab Pasudotox, currently in PhIII trial for Hairy Cell Leukemia1
MDNA55
Targeted Dual-Action Immunotherapeutic
7
A Powerful Molecular Trojan Horse
Tumor Targeting Domain
Circularly Permuted
Interleukin-4 (cpIL-4)
Tumor Killing “Cytotoxic” Domain
Catalytic domain of Pseudomonas
Exotoxin A (PE)
8. One Target. Infinite Hope™…
Mechanism of Action of MDNA55
8
MDNA55
NUCLEUS
Efficient intracellular
delivery of Toxin
Payload
ADP Ribosylation
Endocytosis
Inhibits Protein
Synthesis - Apoptosis
9. One Target. Infinite Hope™…
MDNA55 Brain Cancer Market Opportunity
9
Tumor Type Annual Incidence Projected Market
Recurrent Glioblastoma
(rGB)
33,300 $650M
Metastatic Brain Cancer 91,500 $1.30B
Pediatric Glioma 3,800 $50M
TOTAL 133,500 $2.0B
10. One Target. Infinite Hope™…
55% of GBMs are chemo-resistant 1
Immunosuppressive tumor
microenvironment (TME) comprises
40% of GBM tumor mass 2
Blood Brain Barrier (BBB) blocks
transport of therapeutic to tumor
High doses are required due to
BBB causing systemic toxicities
Current Therapies Do Not Address
Key Challenges
10
Therapeutic Challenges Rationale for MDNA55
1. Hegi ME (2005). N Engl J Med;352(10):997-1003.
2. Kennedy B, et al (2013). J Oncol. Vo; 2013: 486912.
3. Shimamura, et al.(2007.Cancer Res;67:9903-9912.
4. Kohanbash et al (2013).Cancer Res.;73(21):6413-23
MDNA55 targets resistant tumors3
IL4R over-expressed in GBM and its
TME (Myeloid Derived Suppressor
Cells) but not in normal brain4
Delivery by direct injection (CED) of
MDNA55 by-passes the BBB
Precision delivery achieves high
doses without systemic exposure
11. One Target. Infinite Hope™…
Compelling Efficacy in Non-Resected rGBM
(n=25)
11
Pre-treatment 9 months Pre-treatment Week 26
Complete Response
(CR): 5/25
Partial Response
(PR): 9/25
High Objective Response Rate
Kawakami, et al (2003)
Interleukin-4-Pseudomonas exotoxin chimeric fusion
protein
for malignant glioma therapy
Journal of Neuro-Oncology Vol 65 p 15-25
12. One Target. Infinite Hope™…
MDNA55 Survival Results Consistent
with Immunotherapy Benefits
12
MDNA55 Overall Survival in
Non-Resectable (Phase 1 - Blue) and
Resectable (Phase 2 - Red) rGBM
100
PercentSurvival
Non-Resectable Recurrent GBM:
Survival of Responders vs Non Responders
0 300 600 900 1200 1500
0
Days
Responders (CR +PR): MS =
379 days (n=14)
Non-Responders (SD +PD) MS
= 98 days (n=11)
SD –Stable disease
PD –Progressive disease
Investigators Brochure (page 82)
50
Log-Rank test p-value is 0.9430 (N=57)
13. One Target. Infinite Hope™…
2nd Generation Infusion
Will Improve Outcomes
13
Images courtesy of John Sampson, Duke University
Inaccurate
catheter placement
Drug leakage
due to backflow
Inadequate
tumor coverage
1st Generation CED: Past Studies
Image-guided
catheter placement
New catheters
prevent backflow
Real-time monitoring
ensures tumor coverage
2nd Generation CED: Future Studies
Real-Time Monitoring
of Drug Distribution
Saito and Tominaga (2012), Neurol Med Chir (Tokyo) 52, 531
14. One Target. Infinite Hope™…
US Sites Participating in the Study
14
OSU (Columbus, OH)
Cleveland Clinic (Cleveland,
OH)
Weill Cornell +
MSKCC
(New York, NY)
Duke
(Durham, NC)
UT Southwestern (Dallas, TX)
UT San Antonio (San Antonio,
TX)
UCSF
(San Francisco, CA)
JWCI
(Santa Monica, CA)
Marcus
Neuroscience
Institute
(Boca Raton, FL)
15. One Target. Infinite Hope™…
Future Indications: 1 Million IL4R Cancers Annually
15
B-Cell CLL
78%
Bladder
73%
Head and Neck
60%
Pancreatic
60%
Anaplastic Thyroid
91%
67%
Hodgkins
Lymphoma
>2000 Patient BiopsiesAnalyzed Consistently Show IL4R Over-Expression
NSCLC
79%
Biliary Tract
56%
Breast
82%
Mesothelioma
96%
89% 75%
Colorectal
Ovarian
16. One Target. Infinite Hope™…
Deep Early Stage Pipeline
16
Candidate
Targets Validated by Multiple Big Pharma Transactions
Potential
Indications
Deal Size
Target and
Mechanism
Recent Transactions
MDNA413
MDNA109
MDNA209
IL4/13 Dual
Super-
Antagonist
IL2 Super-
Agonist
IL2 Super-
Antagonist
Solid Tumors,
Respiratory,
Fibrotic and
Atopic Diseases
Autoimmune
Diseases
Cancer
Immunotherapy
$2 Billion
with $60M
Upfront
$775M with
$300M
Upfront
Undisclosed
Undisclosed
$400M with
$150M
Upfront
17. One Target. Infinite Hope™…
MDNA109 Synergizes With Anti-PD-1
Immunotherapy
17
Combination Therapy Produces Robust Responses
MDNA109 and anti-PD-1 produce limited efficacy alone
Combination treatment sufficient to cure most mice without increased toxicities
19. One Target. Infinite Hope™…
Multiple Near Term Value Inflection Milestones
19
Milestone Estimated Timing
Commenced Enrollment in Phase 2b rGBM Trial
First Patient In - Phase 2b rGBM Trial
Commence Phase 2 Trial in other types of Brain Cancer Q4/2017
Complete Enrollment in Phase 2b rGBM Trial Q4/2017
Report rGBM Phase 2b Interim Top-Line Results Q1/2018
End of Phase 2 Meeting with FDA Q2/2018
Commence IND Enabling Studies with MDNA109 Q2/2018
Pursue Accelerated Approval for rGBM Q4/2018
Report Interim Top-Line Results from P2 Brain Cancer Trial Q3/2018
Commence IND Enabling Studies with MDNA57 Q4/2018
Pursue Accelerated Approval for rGBM in 2018
20. One Target. Infinite Hope™…
Financial Snapshot
20
TSX: MDNA
Cash balance at June 30, 2017: CDN$12 million
Available to be drawn under CPRIT grant: US$6.5 million
Expected cash burn: CDN$1 million per month
Cash available to fund operations until Q1 2019
Number
Issued and Outstanding 24,344,048
Fully Diluted* 29,024,096
* Fully diluted includes 3,294,105 warrants with a $2.00 exercise price
and 1,382,143 stock options with a weighted average exercise price of $2.03
21. One Target. Infinite Hope™…
Medicenna Public Company Comparables
21
(1) Medicenna market cap estimate based on current basic shares O/S and current share price. Enterprise value estimate based on net debt as of Jun. 30, 2017
Source: FactSet & Company filings
22. One Target. Infinite Hope™…
22
Medicenna Corporate Highlights
1
Focused on ONE
TARGET: the IL4R
20
Number of Cancers
Known to Over-
Express the IL4R
1 Million
Annual Incidence of IL4R
Positive Cancers
40
Number of Patents
Filed or Issued
250,000
Annual Incidence of
Glioblastoma and
Metastatic Brain Cancer
∞HOPE
10,000
Brain Tumor Patients
that can be treated with
1 Gram of MDNA55
30+ million
Non-Dilutive Grant and Equity
(funding in Cdn$)
2 Billion
Potential Market of
MDNA55 Market for Brain
Cancer ($US)
23. One Target. Infinite Hope™…
Thank You.
Fahar Merchant, PhD
Chairman, President & CEO
fmerchant@medicenna.com
www.medicenna.com
23