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Intensity Therapeutics, Inc. and The Swiss Group for Clinical Cancer Research SAKK Announce the First Patient Dosed in the Randomized, Presurgical Triple Negative Breast Cancer Phase 2 Clinical Trial (INVINCIBLE-4 / SAKK 66/22)
Testing the efficacy and safety of Intensity's lead drug candidate, INT230-6, when combined with Standard-of-Care versus Standard-of-Care alone
The endpoint is the change in pathological complete response rates
SHELTON, Conn. and BERN, Switzerland, Oct. 31, 2024 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumorally injected cancer therapies intended to kill tumors directly 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, are collaborating in the INVINCIBLE-4 Study, a Phase 2 trial to treat patients with localized triple-negative breast cancer ("TNBC"), and announce that the first patient has been dosed in the study. The trial (NCT06358573) analyzes INT230-6 given before administration of the standard-of-care neoadjuvant immuno-chemotherapy ("SOC") and the SOC alone by using a 2-cohort design. The study evaluates the pathological complete response ("pCR") rates of the two cohorts relative to a null hypothesis, which is a pCR rate of ≤ 0.6. The success of each cohort in rejecting the null hypotheses will be evaluated.
The Phase 2 study is expected to enroll approximately 54 patients in Switzerland and France. The 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 TNBC who undergo SOC treatment and SOC alone. The primary endpoint is 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, or to the SOC alone. 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.
The endpoint is the change in pathological complete response rates
SHELTON, Conn. and BERN, Switzerland, Oct. 31, 2024 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumorally injected cancer therapies intended to kill tumors directly 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, are collaborating in the INVINCIBLE-4 Study, a Phase 2 trial to treat patients with localized triple-negative breast cancer ("TNBC"), and announce that the first patient has been dosed in the study. The trial (NCT06358573) analyzes INT230-6 given before administration of the standard-of-care neoadjuvant immuno-chemotherapy ("SOC") and the SOC alone by using a 2-cohort design. The study evaluates the pathological complete response ("pCR") rates of the two cohorts relative to a null hypothesis, which is a pCR rate of ≤ 0.6. The success of each cohort in rejecting the null hypotheses will be evaluated.
The Phase 2 study is expected to enroll approximately 54 patients in Switzerland and France. The 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 TNBC who undergo SOC treatment and SOC alone. The primary endpoint is 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, or to the SOC alone. 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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