The engineering run will provide the Company with a batch of its lead drug candidate MB-204 that can be used in good laboratory practise (“GLP”) toxicology studies, which are scheduled to begin in Q4 2021.
Calgary, Alberta--(Newsfile Corp. - October 15, 2021) - Marvel Biosciences Corp. (TSXV: MRVL) and its wholly owned subsidiary, Marvel Biotechnology Inc. (collectively the “Company” or “Marvel”), is pleased to announce that as a result of successful process development of the active pharmaceutical ingredient (“API”) of its lead drug MB-204, the Company has now entered an important milestone of engineering and subsequent current good manufacturing practices (“cGMP”) run of its multi-kilogram batches of MB-204 in partnership with Zhejiang Ausun Pharmaceutical Co., Ltd. (“Ausun”).
The engineering run will provide the Company with a batch of its lead drug candidate MB-204 that can be used in good laboratory practise (“GLP”) toxicology studies, which are scheduled to begin in Q4 2021. Ausun will also be providing the Company with a cGMP batch of MB-204 that ensures identity, quality and purity in preparation of entering Phase I clinical studies in 2022 following the completion of the Company’s toxicology studies.
“To date we have shown in a number of pre-clinical studies the level of efficacy and safety MB-204 can deliver,” said Rod Matheson, Chief executive Officer of Marvel. “With the partnership we have in place with Ausun, we have now entered a key and very important stage in the development of MB-204 to drive this asset into clinical studies. These milestones are 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 and ADHD. 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 upcoming Company milestones for its lead compound asset MB-204 include:
- Completion of 2 kg of engineering run material in Q4 2021;
- Initiation of IND-enabling toxicology studies in Q4 2021;
- Completion of 2 kg of cGMP API in Q1 2022;
- Completion of GLP toxicology expected Q2 2022; and
- Initiation of Phase 1 with potential efficacy endpoints in Q3 2022.
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.
Contact Information
Investor Relations:
Virtus Advisory Group
Tel: 416-644-5081
Email: info@virtusadvisory.com
Marvel Biosciences Corp.
Roderick (Rod) Matheson, Chief Executive Officer or
Dr. Mark Williams, President and Chief Science Officer
Tel: 403 770 2469
Email: info@marvelbiotechnology.com
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All information contained in this news release with respect to the Company and its subsidiary, (collectively, the “Parties”) were supplied by Marvel, respectively, for inclusion herein and each parties’ directors and officers have relied on each other for any information concerning such Party.
This news release may contain forward-looking statements and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release, including, without limitation, statements regarding the future plans and objectives of the Company are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the expectations of the Company and include other risks detailed from time to time in the filings made by the Company under securities regulations.
The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. As a result, the Company cannot guarantee that the above events on the terms will occur and within the time disclosed herein or at all. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by Canadian securities law.
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