INT230-6 - (INVINCIBLE-4)

July 15, 2026: Intensity Therapeutics, Inc. (NASDAQ: INTS) announced that new patients have been dosed with INT230-6 in Switzerland in the Phase 2 randomized, open-label, multicenter INVINCIBLE-4 study (NCT06358573) in early-stage, operable triple-negative breast cancer (TNBC). The trial compares INT230-6 given presurgically before standard-of-care (SOC) neoadjuvant immuno-chemotherapy versus SOC alone, with pathological complete response (pCR) in primary tumor and affected lymph nodes as the primary endpoint; each cohort is assessed versus a null hypothesis pCR rate of ≤0.6.

The study reopened after a pause in accrual to evaluate skin irritation seen in some patients. A protocol amendment was submitted in March 2026 to Swissmedic and the Swiss Ethics Committee to resume enrollment using a slightly lower drug-to-tumor volume ratio and a single INT230-6 injection. Before the pause, 14 patients were treated (7 combination; 7 SOC alone); the company reports a favorable trend toward fewer grade ≥3 adverse events and fewer immune-related adverse events in the INT230-6+SOC cohort versus SOC alone.

INVINCIBLE-4 is expected to enroll an additional 47 patients in Switzerland and France.