Somite Therapeutics and OmniaBio Inc. Announce Collaboration on Cell Therapy Program

Somite Therapeutics and OmniaBio Inc. have announced a strategic partnership to advance cell replacement therapy for Duchenne muscular dystrophy (DMD), a severe genetic disorder that leads to progressive muscle degeneration. This collaboration aims to leverage OmniaBio's expertise in induced pluripotent stem cell (iPSC) technology to support the development of Somite's flagship program, SMT-M01.

Somite Therapeutics, a company that utilizes big data and artificial intelligence (AI) to create innovative cell replacement therapies, is excited about the potential of this partnership. Professor Peter Zandstra, a member of Somite's Scientific Advisory Board and Chief Scientific Officer of CCRM, emphasized the long-term benefits of combining cutting-edge technology with scientific expertise to enhance the effectiveness and cost-efficiency of cell therapy products.

DMD has no known cure and is characterized by severe muscle weakness and degeneration. The collaboration with OmniaBio is expected to help Somite develop a therapy that can restore muscle function, slow disease progression, and improve the quality of life for those affected by DMD. Dr. Kristy Brown, Senior Vice President of Translational Development at Somite, highlighted OmniaBio's extensive experience in iPSC technology and their collaborative approach as key factors in advancing their DMD program efficiently.

OmniaBio will be responsible for several crucial tasks in this collaboration, including process optimization, master cell banking, differentiation of pluripotent stem cells into myogenic satellite cells, and the identification of optimal harvest conditions. OmniaBio will also handle the fill and finish of the drug product. Dr. Micha Breakstone, Founder and CEO of Somite Therapeutics, anticipates that SMT-01 will enter phase 1/2 clinical trials within 18-24 months. The data generated during this process will fuel Somite's AlphaStem foundation models, driving further advancements in their therapeutic approach.

Mitchel Sivilotti, President and CEO of OmniaBio Inc., expressed enthusiasm for the collaboration, highlighting the potential of Somite's AI-driven capabilities and their DMD program to significantly improve patient outcomes. OmniaBio's deep expertise in iPSC platform technology and new initiatives in AI are expected to provide valuable insights into manufacturing processes and accelerate the clinical translation of this vital program.

Somite Therapeutics aims to revolutionize stem cell biology by developing AI foundation models to produce human tissue for cell therapies at scale. Their AI platform, AlphaStem, generates massive data that continually improve the platform, enabling faster therapy creation with broader applications. Founded in October 2023, Somite has raised over $10 million to date and is working on promising programs for diseases such as Duchenne muscular dystrophy and metabolic disorders.

OmniaBio Inc., a subsidiary of CCRM, is a global cell and gene therapy CDMO that focuses on manufacturing a disease-free world. With over a decade of expertise in regenerative medicine and advanced therapies, OmniaBio offers comprehensive CDMO services, cutting-edge development, and reliable Good Manufacturing Practices capabilities. Their specialization in immune cell-based therapies, iPSC therapies, and lentiviral vectors positions them to meet the growing global demand for transformative treatments. OmniaBio's new commercial facility, set to open this fall, will further enhance their ability to deliver these vital therapies to patients worldwide.