Intensity Therapeutics, Inc. is a clinical stage biotechnology company passionately committed to applying scientific leadership in the field of localized cancer reduction leading to anticancer immune activation. Our new approach involves the direct injection into tumors of a unique product created from our DfuseRx℠ discovery platform. Our platform creates patented anti-cancer product candidates comprising active anti-cancer agents and amphiphilic molecules. Amphiphilic molecules have two distinct components: one part is soluble in water and the other is soluble in fat or oils. When an amphiphilic compound is mixed with therapeutic agents, such as chemotherapies, the agents also become soluble in both fat and water.
Our lead product candidate, INT230-6, consists of two proven anticancer cytotoxic agents, cisplatin and vinblastine, mixed with the amphiphilic molecule (SHAO) — all in one vial. In 2017, we initiated a Phase 1/2 dose escalation study in the United States under an investigational new drug application ("IND") authorized by the United States Food & Drug Administration (the "FDA") and in Canada following receipt of a no objection letter from Health Canada. The study, IT-01, is exploring the safety and efficacy of INT230-6 in patients with refractory or metastatic cancers. We completed the Phase 1 dose escalation portion of this study, in which INT230-6 showed excellent safety with only limited cases of low grade of side effects, such as injection site pain, fatigue and brief nausea. We are currently conducting the Phase 2 portion of the trial, which consists of several different expansion cohorts. Four of the cohorts combine our product candidate with partner Merck's Keytruda® (pembrolizumab) and 3 arms combine our drug with partner Bristol-Myers Squibb's drug Yervoy® (ipilimumab). We are also evaluating INT230-6 in a Phase 2 study (the INVINCIBLE study) in Canada as a treatment prior to surgery in early stage breast cancer. We are planning two phase 3 programs for 2022, one to treat metastatic soft tissue sarcoma and the other to treat metastatic triple negative breast cancer.