Calgary, Alberta–(November 1, 2022) – Marvel Biosciences Corp. (TSXV: MRVL) and its wholly owned subsidiary, Marvel Biotechnology Inc. (collectively the “Company“ or “Marvel“), announces it has successfully completed a large-scale engineering run of its novel solid amorphous dispersion (SAD) formulation of MB-204 by Zhejiang Ausun Pharmaceutical Co., Ltd. (“Ausun”). The engineering run material will be utilized to support the ongoing toxicology studies of MB-204 being conducted by Pharmaron Inc.
The engineering run is a key step forward to manufacturing the Company’s lead product at a large scale for FDA Phase I human trials. An engineering run is a trial run of a small batch sample demonstrating the manufacturing process and resolving any potential issues before entering formal cGMP documentation and activities.
The Company previously reported a highly significant increase in drug exposures in pre-clinical testing using the SAD formulation. This formulation involves coating MB-204 in a special FDA approved sugar-like polymer (similar to starch for example). This novel formulation could potentially reduce the amount of drug needed for human dosing, thereby improving the economics for Marvel.
“We are very pleased with our manufacturing partner Ausun for achieving another manufacturing milestone,” said Rod Matheson, Chief Executive Officer. “The company is advancing effectively to the clinic, and we look forward to updating the market with news on our toxicology studies shortly.”
MB-204 is a fluorinated derivative of the U.S. FDA approved adenosine A2a receptor antagonist, Istradefylline. Both Istradefylline and MB-204 are highly active derivatives of caffeine, the most widely consumed psychoactive drug in the world. Caffeine consumption has been associated with a reduced risk for developing Parkinson’s disease, Alzheimer’s disease and improving concentration.
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
Marvel Biosciences Corp.
J. Roderick (Rod) Matheson, Chief Executive Officer or
Dr. Mark Williams, President and Chief Science Officer
Tel: 403 770 2469