Regeneron Pharmaceuticals, Inc. and Sonoma BioTherapeutics Inc. entered a collaboration to apply their scientific and clinical expertise and respective technology platforms to the discovery, development and commercialization of novel regulatory T cell (Treg) therapies for autoimmune diseases.

The collaboration leverages Regeneron’s VelociSuite technologies for the discovery and characterization of fully human antibodies and T cell receptors (TCRs) with Sonoma Biotherapeutics’ pioneering approach to developing and manufacturing gene modified Treg cell therapies.  

Under the agreement, Sonoma Biotherapeutics will receive $75 million upfront, which includes a $30 million equity investment in Sonoma by Regeneron. Sonoma is also eligible to receive a $45 million development milestone payment. Regeneron and Sonoma will jointly research and develop Treg cell therapies for ulcerative colitis, Crohn’s disease and two other undisclosed indications, with a Regeneron option for a fifth indication.

The parties will co-fund research and development for all potential products and share any future commercial expenses and profits. Regeneron will have the option to lead late-stage development and commercialization on all products globally, with Sonoma retaining rights to co-promote all such products in the U.S. Sonoma will also retain full ownership of its lead cell therapy candidate, SBT-77-7101, and other programs in development.

“We are thrilled to collaborate with Regeneron with the goal of developing best-in-class Treg therapies for ulcerative colitis, Crohn’s, and other diseases,” said Jeff Bluestone, co-founder and CEO of Sonoma Biotherapeutics. “Regeneron has a track record of seeking out pioneers in their fields and forging successful partnerships. This collaboration will combine Regeneron’s proven technology and clinical expertise with Sonoma Bio’s proprietary Tregplatform and Treg research enterprise to develop therapies that restore balance to the immune system and potentially cure disease.”

George Yancopoulos, co-founder, president and chief scientific officer of Regeneron said: “Regeneron’s investigational pipeline includes a diverse range of cutting-edge scientific approaches, and we are pleased to expand this toolkit further through a partnership with Sonoma to explore the potential of engineered Treg cell therapies with enhanced functionality and the ability to target specific tissues. Both Regeneron and Sonoma have strong foundations in basic scientific research, and by bringing together our complementary expertise, we hope to harness the power of Tregs to make further progress in the treatment of autoimmune and inflammatory diseases.”