WATERTOWN, Mass.—Clinical-stage biotechnology company Selecta Biosciences Inc. has announced that Sanofi, its collaboration partner, has exercised its option to an exclusive license to develop an immunotherapy for celiac disease.
The companies established an exclusive strategic global collaboration in November 2012 for the discovery of highly targeted, antigen-specific immunotherapies for life-threatening allergies. The agreement granted Sanofi a first exclusive license to develop an immunotherapy designed to mitigate acute immune responses against a life-threatening food allergen and an option to develop two additional candidate immunotherapies for allergies and celiac disease.
Per the terms of the collaboration, Selecta is eligible to receive research support and preclinical, clinical, regulatory and sales milestones totaling up to $300 million for this program in celiac disease. Selecta is also eligible to receive up to double-digit tiered royalties as percentage of net sales for any commercialized immunotherapy that results from this initiative.
"We are very pleased that Sanofi and Selecta are now collaborating on three programs for immune tolerance," Dr. Werner Cautreels, president and CEO of Selecta, noted in a statement. "Both Sanofi and Selecta recognize the tremendous unmet medical needs in addressing the adverse immune responses leading to allergies and autoimmune diseases."
Celiac disease is a chronic inflammatory disorder of the small bowel that results from the consumption and intolerance of gluten. Approximately 1 percent of the population in the United States and Europe suffer from this condition, which has a variety of symptoms including abdominal pain, weight loss, diarrhea and hypoproteinemia. At present, maintaining a gluten-free diet is the only treatment option for celiac patients, but in addition to being extremely restrictive with low compliance, it is ineffective in about 30 percent of patients. Selecta's SVP platform could adjust the body's response specifically to gluten without interfering with or interrupting other immune system functions.
"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, Research & Development at Sanofi.
In other partnering news for Selecta, the company announced an ongoing research collaboration with Généthon, a French leader in gene therapies for rare diseases, aimed at enabling repeat dosing for gene therapies. Per the terms of the proposed collaboration, the companies will leverage Selecta's Synthetic Vaccine Particle (SVP) platform in their efforts to eliminate the neutralizing antibodies and other undesired immune responses to the viral vector used in gene therapy. It is thought that Selecta's SVP platform and Généthon's expertise in developing gene therapy vectors combined could allow for repeat, systemic dosing of gene therapy vectors. Selecta and Généthon intend to co-develop and co-own these next-generation gene therapies.
Though no financial details were disclosed, it was noted that the companies' initial focus will be on gene therapies under development for muscular dystrophies and pediatric liver metabolic diseases that employ adeno-associated virus vectors, the gene transfer platform of choice for many in-vivo therapies.
