The program will evaluate the safety and efficacy of Intensity’s lead product INT230-6, an investigational, novel and potent anti-cancer drug designed to directly kill cancer cells through intratumoral injection and improve immune cell recognition of cancer, when dosed in combination with Bristol Myers Squibb’s Cytotoxic T Lymphocyte-Associated Antigen 4 (CTLA-4) immune checkpoint inhibitor Yervoy (ipilimumab). The combination will be evaluated in patients with breast cancer, liver cancer and advanced sarcoma in a series of new cohorts within IT-01, Intensity’s ongoing Phase 1/2 clinical trial. Intensity will sponsor and conduct the clinical trial and Bristol Myers Squibb will supply Yervoy for use in the study.
“We are excited to have entered into this clinical collaboration with Bristol Myers Squibb, a global leader and pioneer in immuno-oncology,” said Lewis H. Bender, President and CEO of Intensity Therapeutics. “This new collaboration builds upon our other partnerships to evaluate the potential of INT230-6 in combination with immunotherapy. A joint publication with the National Cancer Institute last year, showed remarkable synergy with the combination of INT230-6 and CTLA-4 antibodies in nonclinical in vivo models. The ability to combine our drug in the clinic with Yervoy, may benefit patients with cancers that have high unmet medical need. Results from this collaboration could accelerate the timeline for clinical development and approval of our drug.”
Ian. B. Walters, M.D., Intensity’s Chief Medical Officer, added, “We will be able to evaluate the combination of INT230-6 and Yervoy in a variety of difficult-to-treat tumor types. To date, our Phase 1/2 study has produced solid evidence of activity with INT230-6 as a single agent, as well as a favorable safety profile, in patients with a variety of highly refractory, advanced cancers. In our studies we have also shown systemic immune activation and local recruitment of immune cells in treated tumors. The combination cohorts should enable further expansion of the immune response.”
Source: Company Press Release