Intensity Therapeutics, Inc. and The Swiss Group for Clinical Cancer Research SAKK Receive European Medicines Agency Authorization to Initiate Phase 2 INVINCIBLE-4 (SAKK/66/22) Study for INT230-6 in the Treatment of Presurgical Triple-Negative Breast ...

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[{"type":"text","content":"Intensity Therapeutics, Inc. and The Swiss Group for Clinical Cancer Research SAKK Receive European Medicines Agency Authorization to Initiate Phase 2 INVINCIBLE-4 (SAKK/66/22) Study for INT230-6 in the Treatment of Presurgical Triple-Negative Breast Cancer in France \n \n\nINVINCIBLE-4 (SAKK/66/22) Study continues to recruit patients in eight sites in Switzerland\nSHELTON, Conn. and BERN, Switzerland, May 6, 2025 /PRNewswire/ -- Intensity Therapeutics, Inc. (Nasdaq: INTS), (\"Intensity\" or \"the Company\") 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, and The Swiss Group for Clinical Cancer Research SAKK (\"SAKK\"), a decentralized academic research institute that has been conducting clinical trials of cancer treatments in all major Swiss hospitals since 1965, announced that the European Medicines Agency (\"EMA\") has authorized the initiation of the INVINCIBLE-4 (SAKK 66/22) (\"INVINCIBLE-4 Study\") (NCT06358573) in France in collaboration with Unicancer.\n\n \n \n \n \n \n \n\n \nThe INVINCIBLE-4 Study is a randomized open-label, multicenter study to determine the clinical activity, safety, and tolerability of INT230-6 in patients with early-stage, operable triple-negative breast cancer (\"TNBC\") who undergo standard of care neoadjuvant immunochemotherapy (\"SOC\") treatment and SOC alone. The primary endpoint is pathological complete response (\"pCR\") in the primary tumor and affected lymph nodes. Patients will be randomized one-to-one to receive a regimen of either two doses of INT230-6 followed by SOC, which consists of pembrolizumab, anthracyclines, carboplatin, cyclophosphamide, and paclitaxel (i.e., the Keynote-522 regimen), or the SOC alone. The study is already recruiting patients in Switzerland and is expected to enroll 54 patients.\n\"We are encouraged to see high levels of tumor necrosis from the MRI scans and evidence of tumor inflammation after two INT230-6 injections and prior to initiation of the SOC in our first patients,\" said Ursina Zürrer, M.D. Chief Physician for Genetic Counseling, Department of Medical Oncology and Hematology Cantonal Hospital Winterthur, Switzerland, and the Coordinating Investigator for the INVINCIBLE-4 St...

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