Marvel Biosciences Provides Updates On The Status Of Its MB-204 Manufacturing Efforts And Defines Next Steps

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Calgary, Alberta – (Newsfile Corp. – October 15, 2021) – Marvel Biosciences Corp. (TSXV: MRVL) and its wholly owned subsidiary, Marvel Biotechnology Inc. (collectively the Society Where wonder“), is pleased to announce that following the successful development of the Active Pharmaceutical Ingredient (” API “) process of its flagship drug MB-204, the Company has now entered an important milestone in the engineering and current Good Manufacturing Practices (“cGMP”) of its multi-kilogram batches of MB-204 in partnership with Zhejiang Ausun Pharmaceutical Co., Ltd. (“Ausun”).

The engineering cycle will provide the Company with a batch of its drug candidate MB-204 which can be used in Good Laboratory Practice (“GLP”) toxicology studies, which are expected to begin in the fourth quarter of 2021. Ausun will also supply the Company with a cGMP batch of MB-204 which guarantees identity, quality and purity for entry into phase I clinical studies in 2022 after the completion of the Company’s toxicological studies.

“To date, we have shown in a number of preclinical studies the level of efficacy and safety that MB-204 can offer,” said Rod Matheson, CEO of Marvel. “With the partnership that we have set up with Ausun, we have now entered a key and very important stage in the development of MB-204 to lead this asset in clinical studies. These steps are essential to advance our discussions with potential business partners to ensure the best outcome for our shareholders. ”

Marvel’s main active ingredient, MB-204 (“MB-204”), is under development for neurological disorders such as depression and anxiety, Alzheimer’s disease and ADHD. Marvel’s compound is a new patented fluorinated derivative of Istradefylline (Nourianz®), a Parkinson’s disease drug approved by the US-FDA. Istradefylline and MB-204 are both highly active derivatives of caffeine, which act as antagonists of the A2a adenosine receptor (“A2aR”). Caffeine is the most consumed psychoactive drug in the world and has been linked to a reduced risk of developing Parkinson’s disease, Alzheimer’s disease and improved concentration.

The Company’s next milestones for its main compound asset MB-204 include:

  • Completion of 2 kg of engineering equipment in Q4 2021;
  • Launch of toxicological studies allowing IND in the fourth quarter of 2021;
  • Completion of 2 kg of API cGMP in the first quarter of 2022;
  • Completion of GLP toxicology expected in Q2 2022; and
  • Start of phase 1 with potential efficacy criteria in the third quarter of 2022.

About Marvel Biosciences Corp.

Marvel Biosciences Corp., and its wholly owned subsidiary, Marvel Biotechnology Inc., is a Calgary-based preclinical pharmaceutical development biotechnology company that uses a “drug redevelopment” approach to drug development. Historically, when a new class of drugs is developed, it is optimized for a particular target, but generally approved only for a specific disease. Often a new disease is identified which involves the same target, however, while awaiting the remaining patent life, the initially approved drug may not have sufficient time to be commercially viable and developed for the new disease indication. Marvel is developing new synthetic chemical derivatives of the original drug approved for the new indication for the disease. Patent protection is sought as the new potential asset is developed by the Company. The Company believes that the business model entails considerably less risk, cost and time to develop its assets compared to traditional biotech companies.

Marvel Biotechnology Inc. has currently developed several new chemical entities, using synthetic chemical derivatives of known and unpatented drugs, which inhibit the A2a adenosine receptor with application to neurological diseases (depression and anxiety, Alzheimer’s, ADHD) and non-neurological disease conditions of cancer and non-alcoholic steatohepatitis. Marvel is also exploring other undisclosed targets to expand its portfolio of assets.

Contact details

Investor Relations:
Virtus Advisory Group
Phone. : 416-644-5081

Email: [email protected]

Marvel Biosciences Corp.
Roderick (Rod) Matheson, Chief Executive Officer or
Dr Mark Williams, President and Scientific Director
Phone. : 403 770 2469

Email: [email protected]

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this press release.

All information in this press release relating to the Company and its subsidiary (collectively, the “Parties”) has been provided by Marvel, respectively, for inclusion herein and the directors and officers of each party have relied on each other. on the others for any information concerning a particular Party.

This press release may contain forward-looking statements and other statements that are not historical facts. Forward-looking statements are often identified by words such as “will”, “may”, “should”, “anticipate”, “expect” and similar expressions. All statements other than statements of historical fact included in this press 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 that actual results and future events could differ materially from those anticipated in such statements. Important factors which could cause actual results to differ materially from the Company’s expectations and include other risks detailed from time to time in documents filed by the Company under securities regulations.

The reader is cautioned that the 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 expected, due to many known and unknown risks, uncertainties and other factors, many of which are beyond the control of the Company. Accordingly, the Company cannot guarantee that the above events will occur on the terms and within the timeframe disclosed herein or not at all. The reader is cautioned not to place undue reliance on forward-looking information. This information, although considered reasonable by management at the time of its preparation, may prove to be incorrect and actual results may differ materially from those anticipated. The forward-looking statements contained in this press release are expressly qualified by this cautionary statement. The forward-looking statements contained in this press release are made as of the date of this press release and the Company will publicly update or revise all forward-looking statements included as expressly required by Canadian securities laws.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/99747


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