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, have announced a cell therapy development and manufacturing collaboration for producing SMT-M01, Somite’s flagship program for Duchenne muscular dystrophy (DMD), a rare, severe genetic disorder characterized by progressive muscle degeneration and weakness.
  
The new collaboration leverages OmniaBio’s 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, which has no known cure.
 
“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.”