On April 15, 2020 Intensity Therapeutics reported that it has entered into a clinical trial collaboration agreement with Bristol Myers Squibb Company (NYSE: BMY) (Press release, Portage Biotech, APR 15, 2020, View Source [SID1234556354]). 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.
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"We are pleased to share that Intensity has now partnered with Merck (previously announced on June 25th 2019) and BMS, the two leaders in the cancer immunotherapy space" said Ian B. Walters, MD, CEO of Portage and Chief Medical Officer of Intensity. Recently (March 14, 2020) Intensity also announced favorable safety from the first cohort of the Keynote A10 study (pembrolizumab/anti-PD1 plus Intensity’s INT230-6). Intensity is launching into seven phase 2 programs evaluating high unmet medical need tumors types such as colorectal, pancreatic, squamous cell, bile duct, sarcoma, liver and breast cancers.
The full release can be found at: View Source
About INT230-6
INT230-6, Intensity’s lead proprietary product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRxSM technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and 3 vinblastine, and a penetration enhancer molecule that helps disperse the drugs throughout tumors for diffusion into cancer cells. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor killing, releasing tumor antigens and recruitment of immune cells to the tumor. Results generated by the National Cancer Institute (NCI) showed treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responses in animals with long-term, protection from multiple re-challenges of the initial cancer and resistance to other cancers. The NCI and Intensity’s collaborative research, published in July 2019 in the Journal OncoImmunogy, showed strong synergy when INT230-6 was combined with anti-PD-1 and anti-CTLA-4 antibodies. INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289) in patients with various advanced solid tumors. There have been no dose limiting adverse events observed in patients to date, even when dosing into deep tumors in the lung and liver. Several patients demonstrated tumor shrinkage, symptomatic improvement, and evidence of cancer cell death and immune cell activation on tumor biopsy