Servier has gained an option to develop and commercialize Iltoo Pharma’s autoimmune disease candidate ILT-100 (low-dose interleukin-2) next year following results of an ongoing Phase II trial, the companies said today.
The companies have signed an exclusive license option agreement that could generate up to €208 million ($233 million)-plus for Iltoo. The agreement gives Servier an exclusive option to develop ILT-100 in autoimmune diseases worldwide except for the U.S. and Japan, where Iltoo would retain those rights.
The option will be triggered next year upon release of Phase II results for ILT-100 in moderate-to-severe systemic lupus erythematosus (SLE). SLE will be the first target indication for ILT-100 development should Servier conclude that the results are promising enough to exercise the option, the companies said.
Servier has agreed to pay Iltoo €8 million ($9 million) upfront in return for granting the option, unspecified payments comprising another upfront payment upon exercise of the option, €200 million ($224 million) in payments tied to achieving development and sales milestones, plus royalties on future sales.
“This partnership with Servier represents a major source of operational support for Iltoo Pharma and provides further evidence of the potential for our novel therapeutic approach,” Iltoo CEO Jérémie Mariau said in a statement. “It opens up fresh prospects for our Company and our products, especially in the United States and Japan, with the acceleration of the development and market launch of ILT-101.”
Paris-based Iltoo seeks to commercialize research by its co-founder, David Klatzmann, M.D., Ph.D., and his team of researchers from Paris Public Hospital Authority (AP-HP) and Sorbonne Universités, showing that low-dose IL-2 represented a promising therapy for multiple autoimmune diseases by increases the number of regulatory T cells that control autoimmune response, restoring the balance between them and effector T cells.
That approach, Iltoo reasons, can overcome immune system dysregulation through administration of a natural therapeutic protein, without the side effects seen in the conventional immunosuppressive approach.