Intensity Therapeutics, Inc., in collaboration with The Swiss Group for Clinical Cancer Research SAKK, announced on May 6, 2025, that the European Medicines Agency (EMA) has authorized the initiation of the INVINCIBLE-4 Study in France. This expansion, in partnership with Unicancer, is expected to significantly increase the enrollment rate for the Phase 2 trial. The study is already recruiting patients in Switzerland and aims to enroll 54 patients with early-stage, operable triple-negative breast cancer (TNBC).
Early observations from patients receiving INT230-6 in the INVINCIBLE-4 study have shown high levels of tumor necrosis from MRI scans and evidence of tumor inflammation after two injections, prior to the initiation of standard-of-care treatment. This early data suggests a promising anti-cancer effect. The primary endpoint of the study is pathological complete response (pCR) in the primary tumor and affected lymph nodes.
Lewis H. Bender, President and CEO of Intensity Therapeutics, stated that the expansion into France, with Unicancer's strong operational capability, is a crucial step. This regulatory approval and geographical expansion are expected to accelerate patient recruitment and advance the development of INT230-6 for TNBC patients.
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