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Intensity Therapeutics Receives Orphan Drug Designation for the three key ingredients in INT230-6 for the Treatment of Soft Tissue Sarcoma
WESTPORT, Conn., Sept. 7, 2023 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or the "Company") (Nasdaq: INTS), a clinical-stage biotechnology
About this update from Intensity Therapeutics, Inc.
[{"type":"text","content":"WESTPORT, Conn., Sept. 7, 2023 /PRNewswire/ -- Intensity Therapeutics, Inc. (\"Intensity\" or the \"Company\") (Nasdaq: INTS), a clinical-stage biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, today announced that the US Food and Drug Administration's Office of Orphan Products Development has granted orphan-drug designation for the treatment of soft tissue sarcoma (STS) to the three active moieties comprising INT230-6, cisplatin, vinblastine sulfate, and the diffusion enhancer SHAO-FA (8-((2-hydroxybenzoyl) amino)octanoate). INT230-6 is the Company's lead product candidate.\n\n \n \n \n \n \n \n\n \n\"The designation of cisplatin, vinblastine and our diffusion enhancer, SHAO for orphan status for STS is quite important,\" said Lewis H. Bender President and CEO. \"The Orphan Drug Designation qualifies us for incentives including tax credits for qualified clinical trials, exemption from user fees and potentially seven years of marketing exclusivity for products containing these three key components should the Company gain approval of INT230-6 for treatment of STS.\" \nAn FDA condition to obtain orphan drug designation was for the Company to provide a scientific rationale in its application with sufficient data to establish a medically plausible basis for expecting the drug to be effective in STS. The Company submitted clinical data including immune activation results in sarcoma patients.\nAt ASCO in June 2023 Assistant Professor of Oncology at the Sidney Kimmel Cancer Center at Johns Hopkins University Christian Frederick Meyer, M.D., Ph.D., M.S., an investigator involved in Intensity's Phase 1/2 clinical study, reported that compared to synthetic controls, median overall survival using INT230-6 alone in refractory soft tissue sarcoma subjects was prolonged by nearly 450 days with favorable safety over what would have been expected for the patient population. Data also reported at ASCO showed that INT230-6 when delivered locally led to a systemic immune response in several sarcoma subtypes that are considered to be non-immunogenic cancers. Intensity is planning a phase 3 registration study in STS.\nAbout Soft Tissue SarcomaSoft tissue sarcoma is a broad term for cancers that star...