Under the terms of the agreement, ImmuNext will give Sanofi an exclusive, worldwide license to develop and commercialize INX-021, a CD40L monoclonal antibody that is in preclinical development. The companies also will collaborate to support clinical trials.
Monoclonal antibodies can be used as therapies to trigger natural immune system functions to fight disease. The antibody INX-021 suppresses the activity of a cellular pathway that is overactive in many autoimmune diseases.
CD40L, or CD40 ligand, is a protein that is mainly expressed on activated T-cells, which are immune cells known to be involved in autoimmune diseases. It is a member of the tumor necrosis factor (TNF) superfamily of molecules that plays a role in systemic inflammation.
“The immune-regulatory molecule, CD40L, is critical to the progression of a wide spectrum of autoimmune diseases,” Randolph Noelle, PhD, co-founder and chief scientific officer of ImmuNext, said in a press release. “Antibodies that block the function of CD40L have proven in pre-clinical models of autoimmunity to be amongst the most effective agents in treating disease. The development of anti-CD40L for the treatment of autoimmune diseases offers a unique opportunity to silence disease progression and offer long-term remission.”
Under the agreement, ImmuNext could receive as much as $500 million in milestone payments, and the company will be eligible to receive tiered royalties on sales.
“Sanofi is committed to expanding our pipeline of specialty care products in multiple sclerosis, where we have established a strong foundation, and immunology, where we are poised to launch new treatments this year for atopic dermatitis and rheumatoid arthritis,” said Frank Nestle, global head of the immunology and inflammation research therapeutic area and North America chief scientific officer at Sanofi. “We are excited to collaborate with Dr. Noelle and the team at ImmuNext on this promising endeavor.”
In October, ImmuNext entered a commercial arrangement with Selexis to develop its anti-CD40 ligand antibody, with the intent to bring it to testing as an MS treatment.