CDMO collaboration propels cell replacement therapy targeting Duchenne muscular dystrophy forward, with consequences for the role of AI in cell therapy.
September 9, 2024 (BOSTON, MA and HAMILTON, Ontario) – Somite Therapeutics, a tech-bio company harnessing big data and AI to pioneer novel cell replacement therapies, and OmniaBio Inc., a technology-driven cell and gene therapy CDMO founded by CCRM, today announced a cell therapy development and manufacturing collaboration for producing SMT-M01, Somite’s flagship program for Duchenne muscular dystrophy (DMD).
“I am excited about the long-term potential of this collaboration, which extends beyond this initial program,” said Prof. Peter Zandstra, a Scientific Advisory Board member of Somite and Chief Scientific Officer of CCRM. “Somite’s innovative use of AI to drive the discovery and optimization of cell therapy manufacturing presents our field with exciting opportunities to enhance the effectiveness and cost-efficiency of cell therapy products. This collaboration exemplifies how combining cutting-edge technology with deep scientific expertise can accelerate the development of transformative therapies.”
DMD is a rare, severe genetic disorder characterized by progressive muscle degeneration and weakness and has no known cure. The new collaboration leverages OmniaBio’s extensive induced pluripotent stem cell (iPSC) experience to support Somite’s development of a cell replacement therapy that aims to restore muscle function, slow disease progression, and improve quality of life for individuals living with DMD.
“Working with OmniaBio allows us to leverage their unparalleled experience in iPSC technology and ensures that we can advance our DMD program efficiently and effectively,” said Dr. Kristy Brown, SVP of Translational Development at Somite Therapeutics. “OmniaBio’s collaborative approach and proven track record in process development and regulatory compliance provides us with confidence that we have found the ideal partner to bring our innovative therapies to patients in need.”
Through the collaboration, OmniaBio will conduct process optimization, master cell banking, differentiation of the pluripotent stem cells to the myogenic satellite cells, identification of harvest conditions and fill finish of the drug product.
“We anticipate SMT-01 will enter phase 1/2 in 18-24 months, and this collaboration is a great step forward,” said Dr. Micha Breakstone, Founder and CEO of Somite Therapeutics. “As the cells are produced, the data we’ll be generating will allow us to fuel our AlphaStem foundation models, driving further advancements in our therapeutic approach. We are extremely excited about the future and the potential this collaboration holds for transforming both patient outcomes and stem cell biology at large.”
“Somite’s flagship DMD program and AI-driven capabilities have the potential to significantly improve the lives of patients worldwide,” said Mitchel Sivilotti, President and CEO of OmniaBio Inc. “We are thrilled to provide our deep iPSC platform expertise, combined with our new initiatives in AI, to deliver meaningful manufacturing process insights and analytical advancements, along with GMP manufacturing expertise to accelerate clinical translation for this vital program.”
About Somite
Somite.ai is a venture-backed company aiming to become the OpenAI of stem cell biology, developing AI foundation models to produce human tissue for cell therapies at scale for diseases such as diabetes, obesity, and muscular dystrophies. Somite’s AI platform, AlphaStem, fuels a virtuous cycle: It enables new cell therapies, generating massive data that further improve the platform, empowering even faster therapy creation with broader applications. Incorporated in Oct. 2023, Somite.ai has raised over $10m to date.
Somite Management Team:
- Micha Breakstone, PhD: CEO and Co-founder – Repeat AI entrepreneur (Chorus.ai acq. for $575m)
- Jonathan Rosenfeld, PhD: CTO and Co-founder – Head of the Fundamental AI group at MIT FutureTech
- Carl Morris, PhD: Chief Scientific Officer
- Kristy Brown, PhD: SVP Translational Development
- Olivier Pourquie, PhD: Professor of Genetics and Pathology, Harvard Medical School and Brigham and Women’s Hospital
- Allon Klein, PhD: Professor of Systems Biology at Harvard Medical School
- Cliff Tabin, PhD: Chair of the Department of Genetics at Harvard Medical School
- Jay Shendure, MD, PhD: HHMI Investigator and Professor of Genome Sciences at University of Washington
OmniaBio Inc. is a technology-focused, global cell and gene therapy CDMO with a vision to manufacture a disease-free world. As a subsidiary of CCRM, OmniaBio harnesses over a decade of expertise in regenerative medicine and advanced therapies. Offering comprehensive and tailored CDMO services, cutting-edge development and reliable Good Manufacturing Practices capabilities, OmniaBio specializes in immune cell-based therapies, induced pluripotent stem cell therapies and lentiviral vectors, driving advancements in the field and bringing maturity to cell and gene therapy. With existing clinical manufacturing capabilities and a commercial facility opening this fall, OmniaBio is poised to meet the surging global manufacturing demand, enabling access to transformative treatments for patients around the world. Please visit us at www.omniabio.com to learn more.
For further information, please contact:
Media Relations
Somite Therapeutics
media-relations@somite.ai