Intensity Therapeutics (INTS) and The Swiss Group for Clinical Cancer Research SAKK, a decentralized academic research institute that has been conducting clinical trials of cancer treatments in all major Swiss hospitals since 1965, are collaborating in the INVINCIBLE-4 Study, a Phase 2 trial to treat patients with localized triple-negative breast cancer, or TNBC, and announce that the first patient has been dosed in the study. The trial analyzes INT230-6 given before administration of the standard-of-care – SOC – neoadjuvant immuno-chemotherapy and the SOC alone by using a 2-cohort design. The study evaluates the pathological complete response rates of the two cohorts relative to a null hypothesis. The primary endpoint is pCR in the primary tumor and affected lymph nodes. The INVINCIBLE-4 Study initiation follows data reported from the Company’s INVINCIBLE-2 Study, where INT230-6 given alone showed tumor-killing properties at levels greater than 95% on a single intratumoral dose with systemic immune activation.
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