Regeneron and Sonoma Biotherapeutics partner on autoimmune disease therapies

Regeneron and Sonoma Biotherapeutics have announced a partnership to identify and develop regulatory T cell (Treg) therapies for autoimmune diseases.

Treg cells work by surveying the body for unwanted immune attacks and rebalancing the immune system. They have been shown to potentially possess multiple therapeutic effects within a single medicine, helping overcome the multifaceted nature of autoimmune and inflammatory diseases.

Emerging research also shows that enhanced Treg cells work directly at the site of inflammation and have the potential to create a durable response.

The collaboration will see the partners combine Regeneron’s VelociSuite technologies with Sonoma’ approach to developing and manufacturing gene-modified Treg cell therapies.

Under the terms of the agreement, Sonoma will receive $75m in the form of cash and a $30m equity investment, and will also be eligible to receive a $45m development milestone payment.

The companies will initially work on the research and development of up to four therapies, including potential treatments for ulcerative colitis, Crohn’s disease and two undisclosed indications, with a Regeneron option for a fifth therapy.

The partners will equally fund research and development for all potential products and split any future commercial expenses and profits. Regeneron will then have the option to take the lead of late-stage development and commercialisation on all products globally, with Sonoma retaining rights to co-promote all products in the US.

George Yancopoulos, co-founder, president and chief scientific officer of Regeneron, said: “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.”

Jeff Bluestone, co-founder and chief executive officer of Sonoma, said: “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.”

The announcement comes just days after Regeneron and partner Sanofi’s Dupixent (dupilumab) was approved by the European Commission to treat severe atopic dermatitis in children aged six months to five years who are candidates for systemic therapy.

The approval, which follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use earlier this year, makes Dupixent the first and only targeted medicine in the EU for this patient population.