Sanofi, in relation to an existing collaboration, has exercised its option to an exclusive license to develop an immunotherapy for the treatment of celiac disease with Selecta Biosciences, a Watertown, Mass.-based clinical stage biotechnology company developing a novel class of targeted antigen-specific immune therapies.

In celiac disease patients, the consumption of gluten-containing food induces harmful immune responses that can lead to abdominal pain and, in most severe cases, intestinal cancer. This new immune tolerance program expands activities within the Sanofi-Selecta collaboration, which already is successfully advancing a novel immunotherapy for a life-threatening food allergy. The products resulting from this collaboration will leverage Selecta's proprietary Synthetic Vaccine Particle (SVP) platform, which has unique capabilities to engineer nanoparticles with the structure and composition to produce immune tolerance by attenuating the overactive response to specific antigens.

"Sanofi and Selecta are working together to push toward the outer barriers of immunotherapy to deliver innovative solutions to patients. This area is constantly evolving, and with partners like Selecta, breakthrough medicines may be within our grasp," said Kurt Stoeckli, vice president and head of Biotherapeutics, R&D at Sanofi.

Selecta is eligible to receive research support and several preclinical, clinical, regulatory and sales milestones totaling up to $300 million for this new program in celiac disease. Additionally, Selecta also is entitled to up to double digit tiered royalties as percentage of product net sales for any commercialized immunotherapy resulting from these efforts with Sanofi.

"We are very pleased that Sanofi and Selecta are now collaborating on three programs for immune tolerance," said Werner Cautreels, Ph.D., Selecta's president and CEO. "Both Sanofi and Selecta recognize the tremendous unmet medical needs in addressing the adverse immune responses leading to allergies and autoimmune diseases."

In November 2012, Selecta had formed a strategic global collaboration to discover highly targeted, antigen-specific immunotherapies for life threatening allergies. Sanofi obtained a first exclusive license to develop an immunotherapy designed to abate acute immune responses against a life threatening food allergen and an option to develop two additional candidate immunotherapies for allergies and celiac disease. With the exercise of this option by Sanofi, Selecta and Sanofi now have two initiatives actively advancing immune tolerance treatments under the terms of the 2012 agreement. In October 2014, Selecta and JDRF announced another collaboration with Sanofi to research novel antigen-specific immunotherapies for type 1 diabetes.