Intensity Therapeutics, Inc. Restarts Patient Treatment in the Randomized, Presurgical Triple Negative Breast Cancer Phase 2 Clinical Trial (INVINCIBLE-4 Study)

About this update from Intensity Therapeutics, Inc.

First patients dosed in Switzerland SHELTON, Conn., July 15, 2026 /PRNewswire/ -- Intensity Therapeutics, Inc . ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, today announces that new patients have been administered INT230-6 in the INVINCIBLE-4 Study in Switzerland. 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 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 triple-negative breast cancer ("TNBC") who undergo SOC treatment and SOC alone. The primary endpoint is pCR in the primary tumor and affected lymph nodes. In the amended protocol, patients will be randomized to receive a regimen of one dose of INT230-6 followed by SOC, which consists of pembrolizumab, anthracyclines, carboplatin, cyclophosphamide, and paclitaxel, or to SOC alone. The INVINCIBLE-4 Study reopens following a pause in patient accrual to evaluate skin irritation issues seen in some patients. In March 2026, a protocol amendment was submitted to Swissmedic and the Swiss Ethics Committee to resume enrollment using a slightly lower drug-to-tumor volume ratio and a single injection of INT230-6. Prior to the pause, fourteen (14) patients were treated, seven (7) with the combination and (7) received the SOC alone. Patients receiving INT230-6 prior to the SOC reported a favorable trend towards much fewer overall grade 3 or higher adverse events and immune-related adverse events compared to those patients receiving the SOC alone. The INVINCIBLE-4 Study is expected to enroll an additional 47 patients in Switzerland and France. "Many TNBC patients undergoing SOC treatment alone fail to achieve a pathological complete response at the time of surgery, especially in larger tumor sizes. Early data indicates that INT230-6 has the potential to fill this unmet need for aggressive subtypes, such as TNBC, through its anti-cancer mechanisms of action that cause tumor cell necrosis and ignite an anti-cancer immune-based response," said Markus Joerger, MD-PhD from the Department of Medical Oncology and Hematology at Health Ostschweiz, Professor of Medicine at the University of Basel, Co-Chair of the SCI's Project Group for Developmental Therapeutics and coordinating investigator of the trial. "The ability for INT230-6 to induce necrosis and activate immune effects before a patient's surgery with reduction in toxicity would be a major advance for the treatment of breast cancer and potentially many other cancers."

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