Marvel Biosciences Achieves CGMP Milestone and Begins IND-Enabling Pre-Clinical Toxicology Testing of Lead Compound
Calgary, Alberta--(Newsfile Corp. - December 8, 2021) - Marvel Biosciences Corp. (TSXV: MRVL) and its wholly owned subsidiary, Marvel Biotechnology Inc. (collectively the "Company" or "Marvel"), is pleased to announce that it has initiated its pre-clinical investigational new drug ("IND") enabling toxicology studies for its lead compound MB-204 with Pharmaron, Inc. ("Pharmaron"), with its principal office in Louisville, Kentucky.
Pharmaron, one of the world's largest contract research organizations, has begun testing of MB-204, initiating the maximum tolerated dosing studies, which is expected to be completed in Q1 2022. In addition, the four-week good lab practice ("GLP") studies, which allows the study of the lead compound over a longer exposure time is also scheduled to complete in Q3 2022.
"This is another important milestone for Marvel as we transition in a short period of time from a pre-clinical company to a clinical company," stated Dr. Mark Williams, President and Chief Science Officer. "Our goal has been to move from lead identification to dosing in humans in less than two years, and we are on track to deliver on that vision."
Rod Matheson, Chief Executive Officer, further added, "To date we have shown in a number of pre-clinical studies the level of efficacy and safety MB-204 can deliver with the partnership with Ausun. As we move to the next phase of our pre-clinical development with Pharmaron, we have now entered a key and very important stage in the development of MB-204 to drive this asset into clinical studies. This new milestone is key in further advancing our discussions with potential commercial partners to ensure the best outcome for our shareholders."
Marvel's lead compound asset MB-204 ("MB-204") is being developed for neurological conditions such as depression and anxiety, Alzheimer's, ADHD and NASH. Marvel's compound is a novel patented fluorinated derivative of the US-FDA approved Parkinson's disease drug Istradefylline (Nourianz®). Both Istradefylline and MB-204 are highly active derivatives of caffeine, which act as antagonists of the adenosine A2a receptor ("A2aR"). Caffeine is the most widely consumed psychoactive drug in the world and has been associated with a reduced risk for developing Parkinson's disease, Alzheimer's disease and improving concentration.
The Company's milestones for its lead compound asset MB-204 include:
- Completion of 2 kg of engineering run material in Q4 2021, now completed;
- Initiation of IND-enabling toxicology studies in Q4 2021, now initiated;
- Completion of 2 kg of cGMP API in Q1 2022;
- Completion of GLP toxicology expected Q3 2022; and
- Initiation of Phase 1 with potential efficacy endpoints in Q4 2022.
About Pharmaron, Inc.
Pharmaron, Inc., a public company listed on the Hong Kong and Shenzhen Stock exchanges (Stock Code: 3759.HK/300759.SZ), is a premier research and development service provider for the life sciences industry. Pharmaron was founded in 2004 and has invested in its people and facilities, and established a broad spectrum of research, development and manufacturing service capabilities throughout the entire drug discovery, preclinical and clinical development process across multiple therapeutic modalities, including small molecules, biologics and CGT products. The Company reports over 14,000 employees, it has operations in China, the U.S., and the U.K., and has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China.
About Marvel Biosciences Corp.
Marvel Biosciences Corp., and its wholly owned subsidiary, Marvel Biotechnology Inc., is a Calgary-based pre-clinical stage pharmaceutical development biotechnology company that utilizes a "drug redevelopment" approach to drug development. Historically, when a new class of drug is developed, it is optimized for a particular target, but typically only approved for a specific disease. Often, a new disease is identified which involves the same target, however, pending the remaining patent life, the originally approved drug may not have sufficient time left for it to be commercially viable to be developed for the new disease indication. Marvel develops new synthetic chemical derivatives of the original approved drug for the new disease indication. Patent protection is sought as the new potential asset is developed by the Company. The Company believes the business model results in significantly less risk, cost and time to develop its assets compared to traditional biotechnology companies.
Marvel Biotechnology Inc. has currently developed several new chemical entities, using synthetic chemical derivatives of known, off-patent drugs, that inhibit the A2a adenosine receptor with application to neurological diseases (depression & anxiety, Alzheimer's, ADHD), and the non-neurological conditions of cancer and non-alcoholic steatohepatitis. Marvel is also exploring additional undisclosed targets to expand its asset pipeline.
Virtus Advisory Group J.
Marvel Biosciences Corp.
Roderick (Rod) Matheson, Chief Executive Officer or
Dr. Mark Williams, President and Chief Science Officer
Tel: 403 770 2469
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