ILDR2 (formerly CGEN-15001T) is a novel immune checkpoint target discovered by Compugen. Studies testing the immune function of ILDR2 demonstrated inhibitory effects on T cells consistent with it being an immune checkpoint ligand. ILDR2 appears to have a unique mechanism of action relative to other immune checkpoints currently being targeted in clinical testing. ILDR2 is expressed in lymph nodes, suggesting that BAY 1905254 exerts its effects on immune cell priming rather than on directly enhancing immune cell killing effects in the tumor microenvironment.
In August 2013, Compugen signed a research and discovery collaboration and license agreement with Bayer for the development and commercialization of antibody-based therapeutics for cancer immunotherapy against ILDR2. After achieving all preclinical stage milestones, this program was transferred to Bayer for further development.
In April 2018, Bayer disclosed BAY 1905254 a human/mouse cross-reactive antibody blocking the immunosuppressive activity of ILDR2. BAY 1905254 has exhibited anti-tumor activity as a monotherapy in various mouse models and was also shown to have additive anti-tumor effects in combination with other cancer therapy approaches, indicating the possibility for multiple combination uses in cancer immunotherapy.
To date, Compugen received from Bayer over $30 million in upfront and preclinical milestone payments. It is entitled to over $250 million in potential milestone payments and mid-to-high single digit royalties on global net sales.
BAY 1905254 is currently being evaluated in a Phase 1 study in patients with advanced solid tumors. The study, sponsored and conducted by Bayer, is an open-label, dose escalation study designed to evaluate the safety and tolerability of BAY 1905254. The study is evaluating BAY1905452 as monotherapy and in combination with Keytruda, with expansion cohorts in bladder, gastric, cervical and head & neck cancers (monotherapy or combination). The Phase 1 study is currently enrolling patients in the United States. For additional information on the Phase 1 study click here.