Asymchem, a leading global contract development and manufacturing service provider, and AUM Biosciences (AUM), a global clinical stage biotech company, focused on discovering, acquiring and developing next generation targeted oncology therapeutics, jointly announced the completion of their first GMP production campaign of AUM601.
Earlier this year, Asymchem and AUM Biosciences announced the two companies would collaborate on process development and clinical and commercial production of AUM 601, a highly selective oral small molecule inhibitor of the tropomyosin receptor kinase (TRK) for treating rare cancers.
The partnership resulted in 10 kg GMP bulk drug substance of AUM 601, which will be used to supply Phase II clinical trials. AUM 601 has shown potent in vitro and in vivo anti-tumor activities against tumors harboring NTRK fusion.
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“Through our collaboration with Asymchem, we were able to develop a more robust manufacturing process for AUM 601 by utilizing affordable and safe reagents that enabled us to improve yield and quality. The promising data further justifies the advancement of AUM601 into Phase II clinical trials,” said Vishal Doshi CEO, AUM Biosciences. “Asymchem surpassed our expectations and incorporated innovative ideas and development into the process, allowing us to further our work in transforming the oncology therapeutics market, and addressing unmet needs of patients.”
The successful outcome of this collaboration is a testament to both Asymchem’s and AUM’s commitment to quality and excellence in drug development. “With Asymchem’s world-class CDMO service and AUM’s cutting-edge cancer research, together, we are poised to make a significant difference in the lives of cancer patients worldwide,” added Elut Hsu, President of Asymchem, Inc.
Founded in 1999, Asymchem is a leading global integrated Contract Development and Manufacturing Organization (CDMO) providing innovative drug R&D and manufacturing. Asymchem is supported by 7000 employees based in PR China, the US, and the EU. Our mission is to drive efficiency through continuous technological advances for smarter, greener and more cost-effective manufacturing to support pharmaceutical clinical research and commercialization, backed by a proven track record of successful agency and industry inspections.