On October 31, 2019 Intensity Therapeutics, Inc., a clinical-stage biotechnology company developing proprietary technology and products to kill tumors and increase immune system recognition of solid cancers, reported that the first patient has been dosed with a combination of INT230-6, the Company’s lead investigational product, and Keytruda (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy (Press release, Intensity Therapeutics, OCT 31, 2019, View Source [SID1234550127]). The combination is being studied in a series of cohorts within IT-01, Intensity’s ongoing Phase 1/2 international clinical study (NCT03058289).
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The first part of the combination cohort of IT-01 expects to enroll approximately six patients with different types of advanced solid tumors in order to test safety of the combination. The second part will evaluate the safety and efficacy of the combination in several Phase 2 cohorts of patients with different types of cancer, including cancers that are not immunogenic.
"Bringing INT230-6 into human testing in combination with Keytruda is a major milestone for Intensity Therapeutics," commented Lewis H. Bender, President and Chief Executive Officer of Intensity Therapeutics. "Our preclinical and clinical data to date have already demonstrated good safety for INT230-6 as a single agent, with evidence of patient benefit and immune activation in highly refractory cancer patients. We believe the immune activation potential of INT230-6 can be increased when combined with Keytruda, and are excited to have initiated human testing of the combination."
"Our Phase 1/2 study will continue to accrue patients with multiple tumor types in the INT230-6 monotherapy portion while concurrently exploring this combination," said Ian B. Walters, MD, Chief Medical Officer of Intensity Therapeutics. "We are optimistic that our trial design enables us to quickly evaluate safety and efficacy. Tumor types of interest in the Phase 2 cohorts include pancreatic, cholangiocarcinoma, and non and microsatellite unstable colorectal cancer, which are all difficult to treat and historically nonresponsive to a PD1/PDL1 antibody alone. Physicians desperately need improved treatments for these patients and evidence of tumor response in any one of these patient populations would be validation of our approach of releasing tumor antigens derived from the patient’s own tumors to enable an immune attack on the cancer, an effect that can be amplified by blocking a checkpoint signal."
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.
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 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 responder animals with long-term, durable protection from multiple re-challenges of the initial cancer and resistance to other cancers. The NCI and Intensity collaborative research, published in July 2019, showed that there was also 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.