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 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
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.
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
Medicenna corporate presentation bloom burton final 2018medicenna2016
Medicenna is developing MDNA55, a targeted immunotherapy for the treatment of recurrent glioblastoma and other cancers. Phase 1/2 clinical trials of MDNA55 showed no drug-related serious adverse events and signs of anti-tumor activity. Medicenna is currently enrolling patients in a Phase 2b clinical trial to further evaluate the safety and efficacy of MDNA55 in recurrent glioblastoma. Medicenna is also using its Superkine platform to develop new immunotherapies for cancer and other diseases by engineering interleukins to have improved anti-tumor effects.
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.
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®.
MEDgle is a tech company that addresses healthcare waste and inefficiency by providing a graph-based big health analytics platform. The platform aggregates data from electronic health records, medical literature, and other sources to create a "Graph of Medicine" with over 150 million data points. MEDgle uses this graph to power diagnostic, predictive, and prescriptive analytics through APIs and apps. These analytics can be applied at both the individual and population level to guide care delivery and improve outcomes.
Invitae Corporation is a genetic information company focused on bringing comprehensive genetic testing into mainstream medical practice. Some key points:
- Invitae's market cap is $2.052B with revenue expected to hit $500M by 2020 growing at triple digit rates annually.
- Their goal is to become the "Amazon of genetics" by making genetic testing as easy and affordable as online shopping.
- They offer a variety of genetic testing services including carrier screening, non-invasive prenatal testing, and testing related to miscarriages and IVF.
- Invitae aims to build a global "genome network" to share genetic information and advance healthcare. They have acquired several companies to expand their
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
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.
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
Medicenna corporate presentation bloom burton final 2018medicenna2016
Medicenna is developing MDNA55, a targeted immunotherapy for the treatment of recurrent glioblastoma and other cancers. Phase 1/2 clinical trials of MDNA55 showed no drug-related serious adverse events and signs of anti-tumor activity. Medicenna is currently enrolling patients in a Phase 2b clinical trial to further evaluate the safety and efficacy of MDNA55 in recurrent glioblastoma. Medicenna is also using its Superkine platform to develop new immunotherapies for cancer and other diseases by engineering interleukins to have improved anti-tumor effects.
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.
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®.
MEDgle is a tech company that addresses healthcare waste and inefficiency by providing a graph-based big health analytics platform. The platform aggregates data from electronic health records, medical literature, and other sources to create a "Graph of Medicine" with over 150 million data points. MEDgle uses this graph to power diagnostic, predictive, and prescriptive analytics through APIs and apps. These analytics can be applied at both the individual and population level to guide care delivery and improve outcomes.
Invitae Corporation is a genetic information company focused on bringing comprehensive genetic testing into mainstream medical practice. Some key points:
- Invitae's market cap is $2.052B with revenue expected to hit $500M by 2020 growing at triple digit rates annually.
- Their goal is to become the "Amazon of genetics" by making genetic testing as easy and affordable as online shopping.
- They offer a variety of genetic testing services including carrier screening, non-invasive prenatal testing, and testing related to miscarriages and IVF.
- Invitae aims to build a global "genome network" to share genetic information and advance healthcare. They have acquired several companies to expand their
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.
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.
Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The Company’s portfolio is comprised of drug candidates intended to transform existing treatment and prevention paradigms. Its lead Phase 3 antifungal candidate, rezafungin, will report Phase 3 data at the end of 2021. The potential peak sales opportunity for rezafungin in the US is ~$750M. In addition, the Company is developing Drug-Fc Conjugates (DFCs) targeting viral and oncology diseases from Cidara’s proprietary Cloudbreak® platform.
Posterior Segment Company Showcase - Aura BiosciencesHealthegy
Posterior Segment Company Showcase - Aura Biosciences at OIS@AAO 2016.
Presenter:
Elisabet de los Pinos, CEO
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
This presentation provides an overview of an oncology-focused immunotherapy company. It discusses the company's lead product, NeuVax, which is an immunotherapy targeting HER2-positive breast cancer currently in a Phase 3 clinical trial. The presentation summarizes the clinical development pipeline, mechanism of action involving T-cell activation, positive safety profile established in previous trials, and potential commercial opportunities. It also briefly discusses the company's pipeline of products targeting other cancers, including GALE-301 and GALE-302 which target Folate Binding Protein in ovarian and endometrial cancers.
This presentation provides an overview of an oncology-focused immunotherapy company. It discusses the company's lead product, NeuVax, which is an immunotherapy targeting HER2-positive breast cancer in both the adjuvant and metastatic settings. Key information includes:
- NeuVax is currently in a Phase 3 clinical trial (PRESENT) in the adjuvant setting for HER2 1+/2+ breast cancer patients. Enrollment is complete for the trial.
- An interim analysis of the PRESENT trial is expected in late Q2 2016 which will evaluate safety and futility based on 70 recurrence events.
- Additional clinical trials are exploring NeuVax in combination with Herceptin and in other HER2-positive cancers like
This presentation provides an overview of an oncology-focused immunotherapy company. It discusses the company's lead product, NeuVax, which is an immunotherapy targeting HER2-positive breast cancer in both the adjuvant and metastatic settings. Key information includes:
- NeuVax is currently in a Phase 3 clinical trial (PRESENT) in the adjuvant setting for HER2 1+/2+ breast cancer patients. Enrollment is complete for the trial.
- An interim analysis of the PRESENT trial is expected in late Q2 2016 which will evaluate safety and futility based on 70 recurrence events.
- Additional clinical trials are exploring NeuVax in combination with Herceptin and in other HER2-positive cancers like
This presentation provides an overview of an oncology-focused immunotherapy company. It discusses the company's lead product, NeuVax, which is an immunotherapy targeting HER2-positive breast cancer in both the adjuvant and metastatic settings. Key information includes:
- NeuVax is currently in a Phase 3 clinical trial (PRESENT) in the adjuvant setting for HER2 1+/2+ breast cancer to prevent disease recurrence.
- Additional trials are planned or ongoing to study NeuVax in combination with Herceptin and in other HER2-positive cancers like gastric cancer.
- NeuVax works by stimulating cytotoxic T-cells to seek out and destroy tumor cells expressing HER2 and has shown a good safety profile
Opexa Therapeutics December 2015 Corporate PresentationOpexaTherapeutics
Opexa Therapeutics presented information on their precision immunotherapy platform and lead programs. Their T-cell immunotherapy Tcelna is in Phase 2b clinical trials for secondary progressive multiple sclerosis. Preclinical studies of OPX-212 showed a reduction of AQP4 reactive T-cells in a murine model of neuromyelitis optica, an orphan disease with no approved therapies. Opexa secured funding to advance OPX-212 into a Phase I/II clinical trial in 2016 pending regulatory approval. Their proprietary ImmPath platform allows for personalized T-cell therapies tailored for individual patient's disease profiles.
Opexa therapeutics corporate presentation september 2016OpexaTherapeutics
Opexa Therapeutics presented information on their precision immunotherapy platform and lead programs. Their lead asset, Tcelna, is in Phase 2b development for secondary progressive multiple sclerosis and top-line data is expected in the next 1-2 months. They are also developing OPX-212 for neuromyelitis optica, an orphan indication with no approved therapies. Opexa has secured an option agreement with Merck Serono for Tcelna in MS and could receive up to $25 million in milestones if Merck exercises their option after seeing Phase 2b data.
Opexa Therapeutics is developing personalized T-cell immunotherapies for autoimmune diseases. Their lead program, Tcelna, is in Phase 2b clinical trials for secondary progressive multiple sclerosis (SPMS). If successful, Tcelna has the potential to address an unmet medical need as there is currently only one approved drug for SPMS that is not suitable for chronic use due to side effects. Opexa has an agreement with Merck Serono to develop Tcelna for MS indications worldwide, excluding Japan. Topline results from the Phase 2b SPMS trial are expected in late 2016.
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.
This presentation provides an overview of Interpace Diagnostics Group (IDXG), a commercial company that provides molecular diagnostic tests and pathology services. Key points:
- IDXG has proprietary molecular diagnostic tests for pancreatic cysts (PancraGEN), thyroid nodules (ThyGenX/ThyraMIR), and Barrett's esophagus (BarreGEN).
- Clinical studies show PancraGEN more accurately determines cancer risk of pancreatic cysts compared to current guidelines. ThyGenX/ThyraMIR combination testing can accurately rule in or rule out thyroid cancer risk.
- The tests have significant market opportunities and address unmet clinical needs to avoid unnecessary surgeries and
This presentation provides an overview of Interpace Diagnostics Group (IDXG), a commercial company that provides molecular diagnostic tests and pathology services for cancer evaluation. IDXG operates two CLIA-certified labs and has four proprietary molecular diagnostic tests for pancreatic cysts and thyroid nodules that assess cancer risk. The tests have high margins and barriers to entry due to reimbursement and complexity. Recent accomplishments include raising funds, improving financials, expanding insurance coverage and launching international distribution. The molecular diagnostic market is large and growing due to advantages over drug development. IDXG's tests establish new standards in cancer risk assessment for pancreatic cysts and thyroid nodules compared to current guidelines.
Spark Therapeutics is developing gene therapies for genetic disorders including SPK-RPE65 for retinal diseases. SPK-RPE65 achieved highly statistically significant results in a pivotal Phase 3 trial, demonstrating long-lasting benefits on vision tests over 3 years. If approved, it could be the first gene therapy approved in the US for a genetic disease. Spark is applying its validated AAV gene therapy platform to expand its pipeline to additional retinal diseases and indications.
Opexa Therapeutics is developing personalized T-cell immunotherapies for autoimmune diseases. Their lead candidate, Tcelna, is in Phase 2b clinical trials for secondary progressive multiple sclerosis and has shown signs of stabilizing disease progression in previous trials. Opexa has an option agreement with Merck Serono for the development and commercialization of Tcelna in multiple sclerosis. Recent milestones include completing enrollment in the Tcelna Phase 2b trial for SPMS and receiving a $3 million payment from Merck Serono. Opexa is also developing OPX-212 for neuromyelitis optica and expects to file an IND by the end of 2015.
This document provides an overview of AV Therapeutics' lead drug candidate Capridine-β for treating prostate cancer. Capridine-β has been tested by the NCI and shows promise as a treatment throughout multiple stages of prostate cancer with limited side effects compared to existing drugs. It is selectively toxic to prostate cancer cells and can render hormone-independent cancer cells sensitive again. In animal studies, Capridine-β inhibited both hormone-responsive and non-responsive prostate cancer tumors. The experienced management team, led by Drs. Mittelman and Tiwari who have a 20-year partnership in cancer research, is advancing Capridine-β to address the significant unmet need for effective and tolerable prostate
AV Therapeutics is developing Capridine-β, a novel chemotherapy for prostate cancer patients throughout multiple stages and clinical states of treatment. Capridine-β has advantages over existing therapies such as limited side effects, activity against hormone dependent and independent prostate cancer, and effectiveness against taxane resistant prostate cancer. AV Therapeutics is preparing to commence Phase I and II clinical trials of Capridine-β after completing preclinical studies and formulation development. The company is seeking $3 million to fund the planned clinical trials and further development opportunities for Capridine-β and a peptide vaccine to treat prostate cancer.
Greenwich LifeSciences (the “Company”) is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2/neu (human epidermal growth factor receptor 2) protein, a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or “over-expressor”) levels.
- 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.
ZKsync airdrop of 3.6 billion ZK tokens is scheduled by ZKsync for next week.pdfSOFTTECHHUB
The world of blockchain and decentralized technologies is about to witness a groundbreaking event. ZKsync, the pioneering Ethereum Layer 2 network, has announced the highly anticipated airdrop of its native token, ZK. This move marks a significant milestone in the protocol's journey, empowering the community to take the reins and shape the future of this revolutionary ecosystem.
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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.
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.
Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The Company’s portfolio is comprised of drug candidates intended to transform existing treatment and prevention paradigms. Its lead Phase 3 antifungal candidate, rezafungin, will report Phase 3 data at the end of 2021. The potential peak sales opportunity for rezafungin in the US is ~$750M. In addition, the Company is developing Drug-Fc Conjugates (DFCs) targeting viral and oncology diseases from Cidara’s proprietary Cloudbreak® platform.
Posterior Segment Company Showcase - Aura BiosciencesHealthegy
Posterior Segment Company Showcase - Aura Biosciences at OIS@AAO 2016.
Presenter:
Elisabet de los Pinos, CEO
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
This presentation provides an overview of an oncology-focused immunotherapy company. It discusses the company's lead product, NeuVax, which is an immunotherapy targeting HER2-positive breast cancer currently in a Phase 3 clinical trial. The presentation summarizes the clinical development pipeline, mechanism of action involving T-cell activation, positive safety profile established in previous trials, and potential commercial opportunities. It also briefly discusses the company's pipeline of products targeting other cancers, including GALE-301 and GALE-302 which target Folate Binding Protein in ovarian and endometrial cancers.
This presentation provides an overview of an oncology-focused immunotherapy company. It discusses the company's lead product, NeuVax, which is an immunotherapy targeting HER2-positive breast cancer in both the adjuvant and metastatic settings. Key information includes:
- NeuVax is currently in a Phase 3 clinical trial (PRESENT) in the adjuvant setting for HER2 1+/2+ breast cancer patients. Enrollment is complete for the trial.
- An interim analysis of the PRESENT trial is expected in late Q2 2016 which will evaluate safety and futility based on 70 recurrence events.
- Additional clinical trials are exploring NeuVax in combination with Herceptin and in other HER2-positive cancers like
This presentation provides an overview of an oncology-focused immunotherapy company. It discusses the company's lead product, NeuVax, which is an immunotherapy targeting HER2-positive breast cancer in both the adjuvant and metastatic settings. Key information includes:
- NeuVax is currently in a Phase 3 clinical trial (PRESENT) in the adjuvant setting for HER2 1+/2+ breast cancer patients. Enrollment is complete for the trial.
- An interim analysis of the PRESENT trial is expected in late Q2 2016 which will evaluate safety and futility based on 70 recurrence events.
- Additional clinical trials are exploring NeuVax in combination with Herceptin and in other HER2-positive cancers like
This presentation provides an overview of an oncology-focused immunotherapy company. It discusses the company's lead product, NeuVax, which is an immunotherapy targeting HER2-positive breast cancer in both the adjuvant and metastatic settings. Key information includes:
- NeuVax is currently in a Phase 3 clinical trial (PRESENT) in the adjuvant setting for HER2 1+/2+ breast cancer to prevent disease recurrence.
- Additional trials are planned or ongoing to study NeuVax in combination with Herceptin and in other HER2-positive cancers like gastric cancer.
- NeuVax works by stimulating cytotoxic T-cells to seek out and destroy tumor cells expressing HER2 and has shown a good safety profile
Opexa Therapeutics December 2015 Corporate PresentationOpexaTherapeutics
Opexa Therapeutics presented information on their precision immunotherapy platform and lead programs. Their T-cell immunotherapy Tcelna is in Phase 2b clinical trials for secondary progressive multiple sclerosis. Preclinical studies of OPX-212 showed a reduction of AQP4 reactive T-cells in a murine model of neuromyelitis optica, an orphan disease with no approved therapies. Opexa secured funding to advance OPX-212 into a Phase I/II clinical trial in 2016 pending regulatory approval. Their proprietary ImmPath platform allows for personalized T-cell therapies tailored for individual patient's disease profiles.
Opexa therapeutics corporate presentation september 2016OpexaTherapeutics
Opexa Therapeutics presented information on their precision immunotherapy platform and lead programs. Their lead asset, Tcelna, is in Phase 2b development for secondary progressive multiple sclerosis and top-line data is expected in the next 1-2 months. They are also developing OPX-212 for neuromyelitis optica, an orphan indication with no approved therapies. Opexa has secured an option agreement with Merck Serono for Tcelna in MS and could receive up to $25 million in milestones if Merck exercises their option after seeing Phase 2b data.
Opexa Therapeutics is developing personalized T-cell immunotherapies for autoimmune diseases. Their lead program, Tcelna, is in Phase 2b clinical trials for secondary progressive multiple sclerosis (SPMS). If successful, Tcelna has the potential to address an unmet medical need as there is currently only one approved drug for SPMS that is not suitable for chronic use due to side effects. Opexa has an agreement with Merck Serono to develop Tcelna for MS indications worldwide, excluding Japan. Topline results from the Phase 2b SPMS trial are expected in late 2016.
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.
This presentation provides an overview of Interpace Diagnostics Group (IDXG), a commercial company that provides molecular diagnostic tests and pathology services. Key points:
- IDXG has proprietary molecular diagnostic tests for pancreatic cysts (PancraGEN), thyroid nodules (ThyGenX/ThyraMIR), and Barrett's esophagus (BarreGEN).
- Clinical studies show PancraGEN more accurately determines cancer risk of pancreatic cysts compared to current guidelines. ThyGenX/ThyraMIR combination testing can accurately rule in or rule out thyroid cancer risk.
- The tests have significant market opportunities and address unmet clinical needs to avoid unnecessary surgeries and
This presentation provides an overview of Interpace Diagnostics Group (IDXG), a commercial company that provides molecular diagnostic tests and pathology services for cancer evaluation. IDXG operates two CLIA-certified labs and has four proprietary molecular diagnostic tests for pancreatic cysts and thyroid nodules that assess cancer risk. The tests have high margins and barriers to entry due to reimbursement and complexity. Recent accomplishments include raising funds, improving financials, expanding insurance coverage and launching international distribution. The molecular diagnostic market is large and growing due to advantages over drug development. IDXG's tests establish new standards in cancer risk assessment for pancreatic cysts and thyroid nodules compared to current guidelines.
Spark Therapeutics is developing gene therapies for genetic disorders including SPK-RPE65 for retinal diseases. SPK-RPE65 achieved highly statistically significant results in a pivotal Phase 3 trial, demonstrating long-lasting benefits on vision tests over 3 years. If approved, it could be the first gene therapy approved in the US for a genetic disease. Spark is applying its validated AAV gene therapy platform to expand its pipeline to additional retinal diseases and indications.
Opexa Therapeutics is developing personalized T-cell immunotherapies for autoimmune diseases. Their lead candidate, Tcelna, is in Phase 2b clinical trials for secondary progressive multiple sclerosis and has shown signs of stabilizing disease progression in previous trials. Opexa has an option agreement with Merck Serono for the development and commercialization of Tcelna in multiple sclerosis. Recent milestones include completing enrollment in the Tcelna Phase 2b trial for SPMS and receiving a $3 million payment from Merck Serono. Opexa is also developing OPX-212 for neuromyelitis optica and expects to file an IND by the end of 2015.
This document provides an overview of AV Therapeutics' lead drug candidate Capridine-β for treating prostate cancer. Capridine-β has been tested by the NCI and shows promise as a treatment throughout multiple stages of prostate cancer with limited side effects compared to existing drugs. It is selectively toxic to prostate cancer cells and can render hormone-independent cancer cells sensitive again. In animal studies, Capridine-β inhibited both hormone-responsive and non-responsive prostate cancer tumors. The experienced management team, led by Drs. Mittelman and Tiwari who have a 20-year partnership in cancer research, is advancing Capridine-β to address the significant unmet need for effective and tolerable prostate
AV Therapeutics is developing Capridine-β, a novel chemotherapy for prostate cancer patients throughout multiple stages and clinical states of treatment. Capridine-β has advantages over existing therapies such as limited side effects, activity against hormone dependent and independent prostate cancer, and effectiveness against taxane resistant prostate cancer. AV Therapeutics is preparing to commence Phase I and II clinical trials of Capridine-β after completing preclinical studies and formulation development. The company is seeking $3 million to fund the planned clinical trials and further development opportunities for Capridine-β and a peptide vaccine to treat prostate cancer.
Greenwich LifeSciences (the “Company”) is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2/neu (human epidermal growth factor receptor 2) protein, a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or “over-expressor”) levels.
- 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.
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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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2. One Target. Infinite Hope™
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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™
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1 Million cancer patients annually
diagnosed with tumors with the Interleukin-
4 Receptor (IL4R)
MDNA55: Compelling, Phase 1 and 2
clinical data (N=66) for recurrent
glioblastoma (rGBM), the most common
and uniformly fatal form of brain cancer
MDNA55 has Orphan Drug (FDA, EMA) &
Fast Track Designations (FDA)
Currently enrolling in a Phase 2b recurrent
GBM trial at 10 centers in the U.S. and
Europe
Exciting pre-clinical IL-2, IL-4 and
IL-13 Superkine platform
Technology platform protected by
13 patent families
Lead program funded with $14M US non-
dilutive grant and $14M CAD Private
Placement
cGMP compliant commercial scale
manufacturing process established
Seasoned management, advisors and
directors
Corporate Highlights
Publicly listed (TSX: MDNA, OTCQX: MDNAF), clinical-stage,
Immunotherapy company
3
4. One Target. Infinite Hope™
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Treatment Pathway for Glioblastoma (GBM)
4
Surgery
(85-90%)
GBM Diagnosis
Radiotherapy
+ Chemotherapy
Relapse
Chemotherapy
GBM is uniformly fatal; virtually all tumors will recur (rGBM)
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)
INOPERABLE rGBM
75%
Surgery Add’l Chemotherapy
or Experimental Therapies
25%
OPERABLE rGBM
5. One Target. Infinite Hope™
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MDNA55
Targeted Dual-Action Immunotherapeutic
5
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)
Ø Potently toxic to tumor cells with a wide therapeutic window
Ø Bypass the Blood Brain Barrier through localized Convection Enhanced Delivery (CED)
Ø Simultaneously purges the Tumor Microenvironment (TME) and un-blinds the immune
system to cancer cells
Ø Proven payload efficacy– identical to Medimmune’s anti-CD22 immunotoxin,
Moxetumomab Pasudotox, currently in PhIII trial for Hairy Cell Leukemia
6. One Target. Infinite Hope™
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Mechanism of Action of MDNA55
6
MDNA55
NUCLEUS
Efficient intracellular
delivery of Toxin
Payload
ADP Ribosylation
Endocytosis
Inhibits Protein
Synthesis - Apoptosis
7. One Target. Infinite Hope™
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Compelling Efficacy in Non-Resected rGBM
(n=25)
7
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
8. One Target. Infinite Hope™
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MDNA55 Survival Results Consistent
with Immunotherapy Benefits
8
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)
9. One Target. Infinite Hope™
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2nd Generation Infusion
Will Improve Outcomes
9
Images courtesy of John Sampson, Duke University
Ø Inaccurate
catheter placement
Ø Drug leakage
due to backflow
Ø Inadequate
tumor coverage
1st Generation CED: Past Studies
Ø Image-guided
catheter placement
Ø New catheters
prevent backflow
Ø 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
Sampson et al, Congress for Neurosurgery, Oct 9-11, 2017
10. One Target. Infinite Hope™
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US Sites Participating in the Study
10
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)
11. One Target. Infinite Hope™
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MDNA55 Brain Cancer Market Opportunity
11
Tumor Type Annual Incidence Projected Market
Recurrent Glioblastoma
(rGBM)
33,300 $650M
Metastatic Brain Cancer 91,500 $1.30B
Pediatric Glioma 3,800 $50M
TOTAL 133,500 $2.0B
12. One Target. Infinite Hope™
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Future Indications: 1 Million IL4R Cancers Annually
12
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
14. One Target. Infinite Hope™
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Deep Early Stage Pipeline
14
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
15. One Target. Infinite Hope™
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MDNA109 Synergizes With Anti-PD-1
Immunotherapy
15
Combination Therapy Produces Robust Responses
Ø MDNA109 and anti-PD-1 produce limited efficacy alone
Ø Combination treatment sufficient to cure most mice without increased toxicities
16. One Target. Infinite Hope™
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Multiple Near Term Value Inflection Milestones
16
Milestone Estimated Timing
Commenced Enrollment in Phase 2b rGBM Trial ü
First Patient In - Phase 2b rGBM Trial ü
Commence Phase 2a Trial in other types of Brain Cancer H1/2018
Complete Enrollment in Phase 2b rGBM Trial H1/2018
Report rGBM Phase 2b Interim Top-Line Results H2/2018
End of Phase 2 Meeting with FDA H2/2018
Commence IND Enabling Studies with MDNA109 H2/2018
Pursue Accelerated Approval for rGBM H1/2019
Report Interim Top-Line Results from P2 Brain Cancer Trial H1/2019
Pursue Accelerated Approval for rGBM in 2019
17. One Target. Infinite Hope™
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Financial Snapshot
17
TSX: MDNA OTCQX:MDNAF
Ø Cash balance at Sept 30, 2017: CDN$9.5 million
Ø Available to be drawn under CPRIT grant: US$6.5 million
Ø Expected cash burn: CDN$1 million per month
Ø Lead program fully funded
Number
Issued and Outstanding 24,344,048
Fully Diluted* 29,595,296
* Fully diluted includes 3,294,105 warrants with a CND$2.00 exercise price
and 1,957,143 stock options with a weighted average exercise price of CDN$2.00
18. One Target. Infinite Hope™
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Seasoned Management & Experienced Board
18
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
Martin Bexon, MD
Head of Clinical Development
Former Medical Director at
CSL Behring; Medical
Director at Hoffman La Roche
(UK and Switzerland)
Shafique Fidai, PhD
Head of Corp Development
Former VP of Business
Development at Sophiris Bio;
Formerly with Xenon Pharma,
Chromos
Elizabeth Williams, CPA,CA
Chief Financial Officer
Former VP Finance & Admin
and interim CFO at Aptose
(TSX and Nasdaq);
Previously with Ernst &
Young
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
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 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
19. One Target. Infinite Hope™
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World Class Advisors and Collaborators
19
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
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)
20. One Target. Infinite Hope™
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Medicenna Public Company Comparables
20
(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 Sept. 30, 2017
Source: FactSet & Company filings
All amounts in USD, unless noted otherwise
Company (Listing/Symbol) Price
(25-Jan-2018)
Market
Cap (MM)
Enterprise
Value (MM)
Lead Indication (Stage)
ZIOPHARM Oncology, Inc.
(NASDAQ:ZIOP)
US$4.72 $670.7 $725.3 Recurrent Glioblastoma (pre-Ph III)
Stemline Therapeutics, Inc.
(NASDAQ:STML)
US$15.60 $452.0 $386.4 Recurrent Glioblastoma (post-Ph II)
Kadmon Holdings, Inc.
(NYSE:KDMN)
US$5.10 $401.1 $400.4 Recurrent Glioblastoma (Ph II)
Agenus Inc.
(NASDAQ:AGEN)
US$3.75 $382.4 $424.2 Newly Diagnosed Glioblastoma (Ph II)
Newlink Genetics Corporation
(NASDAQ:NLNK)
US$8.64 $320.3 $206.0 Malignant Brain Tumors (Ph II)
Tocagen Inc.
(NASDAQ:TOCA)
US$14.39 $285.1 $186.8 Recurrent High Grade Glioma (Ph III)
Vascular Biogenics Ltd.
(NASDAQ:VBLT)
US$7.15 $193.9 $165.7 Recurrent Glioblastoma (Ph III)
Diffusion Pharmaceuticals Inc.
(NASDAQ:DFFN)
US$0.71 $10.4 ($0.3) Newly Diagnosed Glioblastoma (pre-Ph III)
Average $339.5 $311.8
Median $351.4 $296.2
Medicenna Therapeutics1
(TSX:MDNA)
C$2.59 $51.3
(C$63.1M)
$43.5 Recurrent Glioblastoma (Ph II)
21. One Target. Infinite Hope™
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21
Medicenna Corporate Highlights
1
Focused on ONE
TARGET: the IL4R
20
Number of Cancers
Known to Over-
Express the IL4R
1 Million
Annual Incidence of IL4R
Positive Cancers
40
Number of Patents
Filed or Issued
250,000
Annual Incidence of
Glioblastoma and
Metastatic Brain Cancer
∞HOPE
5,000
Brain Tumor Patients
that can be treated with
1 Gram of MDNA55
30+ Million
Non-Dilutive Grant and Equity
(funding in Cdn$)
2 Billion
Potential Market of
MDNA55 Market for Brain
Cancer ($US)