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Intensity Therapeutics, Inc. and The Swiss Group for Clinical Cancer Research SAKK Sign a Collaboration Agreement to Conduct a Phase 2 Randomized, Clinical Trial in Early-Stage Breast Cancer in Europe for INT230-6, Intensity's Lead Drug Candidate
SHELTON, Conn., May 10, 2024 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology
About this update from Intensity Therapeutics, Inc.
[{"type":"text","content":"SHELTON, Conn., May 10, 2024 /PRNewswire/ -- Intensity Therapeutics, Inc. (\"Intensity\" or \"the Company\") (Nasdaq: INTS), a late-stage clinical 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, announces that the Company executed a collaboration agreement with The Swiss Group for Clinical Cancer Research SAKK (\"SAKK\") to conduct a Phase 2 randomized, (one to one), controlled trial evaluating clinical and biological effects of intratumoral INT230-6 followed by the standard of care (\"SOC\") immuno/chemotherapy vs. SOC immune/chemotherapy alone in early-stage triple-negative breast cancer (\"TNBC\") in 54 patients in Switzerland and selected countries in Europe (the \"INVINCIBLE-4 Study\"). The INVINCIBLE-4 Study is an open-label randomized two-cohort phase 2 clinical trial.\n\n \n \n \n \n \n \n\n \nSAKK shall undertake the trial as the \"Legal Sponsor\" of the study, with the regulatory agencies in Switzerland and the European Union as described in the study protocol. SAKK will also ensure that all investigators and personnel who participate in the study are informed and trained. Intensity shall fund the study, provide the investigational drug product, and other necessary information to conduct the trial. The primary efficacy endpoint of the INVINCIBLE-4 Study is pathological complete response (pCR) in the primary tumor (ypT0/Tis) and affected lymph nodes (ypN0). Additional key research questions include the immune landscape of the tumor microenvironment and peripheral blood, magnetic resonance imaging (MRI) changes predictive for pCR, and adverse events according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.\n\"We are excited to be working with SAKK on our INVINCIBLE-4 Study in early-stage triple-negative breast cancer,\" said Lewis H. Bender, Founder, President and CEO of Intensity Therapeutics, Inc. \"TNBC poses significant challenges due to its aggressiveness, high relapse rates, and increased mortality especially in patients with large tumors. Achieving pathological complete response (pCR) and clearing positive lymph nodes are crucial prognostic factors for event-free survival. Results from our first INVINCBLE-2 study s...