Safoni, ImmuNext to Team Up to Develop INX-021 Antibody for Autoimmune Disorders

Sanofi will work with ImmuNext to develop INX-021, a CD40L monoclonal antibody designed to suppress overactive cell signals associated with autoimmune disorders, including lupus and multiple sclerosis.

Under the agreement, Sanofi will have an exclusive license to further develop and commercialize INX-021, a synthetic antibody from ImmuNext that is now in preclinical testing. The companies will collaborate on clinical trials of INX-021 in autoimmune disorders.

INX-021 acts against the CD40L protein that is found in immune-system T-cells and elsewhere when inflammation occurs.

The CD40L that is present in specific activated T-cells interacts with the CD40 protein present in antigen-presenting cells to trigger a T-cell immune response. INX-021 blocks the CD40L-CD40 interaction, preventing the heightened T-cell response associated with autoimmune disorders.

Blocking the interaction with an anti-CD40L monoclonal antibody (mAb) has proven effective in animal models of lupus and other autoimmune disorders. In these models, mAb prevented disease from developing and inhibited disease that was already present.

INX-021 evolved from research by ImmuNext scientific founder Randolph Noelle, a professor of microbiology and immunology at Dartmouth College’s Medical School.

The agreement provides ImmuNext with milestone payments of up to $500 million. ImmuNext may also receive tiered royalties reaching the double digits on product sales.

“The immunoregulatory 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.”

“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 Sanofi’s immunology and inflammation research division and the company’s North America chief scientific officer.