Sernova Biotherapeutics and Seraxis Holdings announced a definitive agreement to combine their technologies and businesses to create a clinical-stage company, BetaNova Biotherapeutics, focused on advancing a differentiated approach to type 1 diabetes (T1D) islet cell replacement.
BetaNova will be a U.S.-based biotech headquartered in Germantown, Maryland, with integrated research laboratories and cGMP manufacturing capabilities. The company’s integrated platform combines stem cell-derived pancreatic islets with in-house scalable cGMP manufacturing, and Sernova’s Cell Pouch Bio-hybrid Organ, a clinically validated implantable and retrievable device proven to support islet cell survival, engraftment and function.
BetaNova’s pipeline will be anchored by its lead allogeneic product candidate, Seraxis’ SR-02, a stem cell-derived pancreatic islet therapy developed to be paired with next-generation, low-toxicity immune suppressants with the goal of eliminating immunosuppression through establishment of tolerance. In addition, BetaNova’s follow-on stem cell-derived pancreatic islet product candidate, Seraxis’ SR-03, incorporates gene edits expected to eliminate immunosuppression through immune-evasion.
The new company has secured $10 million in financing from existing insider shareholders of Sernova and Seraxis, with the round open to additional qualified investors through September 30. The company plans to use the funds to advance manufacturing of its SR-02, launch a phase 1/2 trial in type 1 diabetes in Q1 2027, prepare for a Nasdaq listing and advance SR-03 toward an IND filing in the second half of 2027.
Subscribe to our e-Newsletters
Stay up to date with news, articles and insights relevant to cell and gene therapy development and manufacturing. Plus, get special offers from Cell & Gene Therapy Review delivered right to your inbox!
Sign up now!