The Nasdaq-listed biotech said amended INVINCIBLE-4 enrollment has resumed in Switzerland after a pause to assess skin irritation, with the trial expected to add 47 patients across Switzerland and France.
Intensity Therapeutics said new patients in Switzerland have been dosed with INT230-6 in the Phase 2 INVINCIBLE-4 study, restarting enrollment after a pause to review skin irritation seen in some patients. The randomized, open-label, multicenter trial is testing INT230-6 before standard neoadjuvant immuno-chemotherapy against standard of care alone in early-stage, operable triple-negative breast cancer (TNBC), with pathological complete response, or pCR (no detectable cancer after treatment), in the primary tumor and affected lymph nodes as the primary endpoint. The company said a March 2026 protocol amendment submitted to Swissmedic (Swiss drug regulator) and the Swiss Ethics Committee lowered the drug-to-tumor volume ratio slightly and shifted to a single INT230-6 injection. Before the pause, 14 patients had been treated, with seven receiving the combination and seven receiving standard of care alone. Intensity said patients given INT230-6 before standard treatment showed a favorable trend toward fewer overall grade 3 or higher adverse events and fewer immune-related adverse events than those on standard treatment alone. The study is expected to enroll 47 additional patients in Switzerland and France.