Servier and ILTOO Pharma have joined forces with an exclusive license agreement for the development and commercialization of the investigational drug ILT-101 (low-dose interleukin-2) to target systemic lupus erythematosus (SLE) and other autoimmune diseases.
The companies expect that results of the ongoing Phase 2 clinical trial (NCT02955615) in patients with moderate to severe SLE, which are expected by 2018, will support and trigger the license option, leading to additional trials for the drug candidate.
Under the agreement, ILTOO Pharma will retain exclusive rights on ILT-101 in the United States and Japan, and Servier can decide to develop and commercialize the drug in other countries.
“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,” Jérémie Mariau, CEO of ILTOO Pharma, said in a press release.
“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,” Mariau added.
ILTOO Pharma will receive 8 million euros ($8.97 million dollars) from Servier, with subsequent annual payments when the option is exercised. ILTOO will also receive development and sales milestones equal to 200 million euros ($224.24 million dollars), plus royalty payments on future sales.
Autoimmune diseases are characterized by an imbalance in immune T-cell subsets. When the numbers of regulatory T-cells decrease, the body is not able to protect itself from being attacked by its own cells.
Researchers from the AP-HP hospital authority and Sorbonne Universities in France were the first to discover that low doses of a protein called IL-2 (interleukin-2) could stimulate regulatory T-cells. Because of its different mechanism of action, low dose IL-2 therapy (ILT-101) has therapeutic potential without the adverse effects commonly found in immunosuppressive drugs.
Low-dose IL-2 has been explored as a potential tool to overcome the immune system imbalance seen in autoimmune diseases.
“The approach taken by ILTOO Pharma’s team persuaded us of ILT-101’s potential to treat highly debilitating diseases, for which no effective treatment exists today,” said Patricia Belissa-Mathiot, head of Servier’s research and development department for immune-inflammatory diseases. “Our original corporate structure of governance by a nonprofit foundation enables us to invest in innovative projects in our areas of expertise for the benefit of patients.”