Intensity Therapeutics (NASDAQ: INTS) filed a protocol amendment with Swissmedic and the Swiss Ethics Committee to resume enrollment in its Phase 2 INVINCIBLE‑4 study, which evaluates the intratumoral drug INT230‑6 in early‑stage, operable triple‑negative breast cancer.
The amendment lowers the drug volume per tumor volume ratio and changes the dosing schedule to a single injection of INT230‑6, a modification designed to mitigate the skin irritation that prompted a pause in September 2025. Fourteen patients have already received the revised treatment, and the study is expected to enroll 61 patients in total.
Preliminary data from the first 13 patients show a 71.4% pathological complete response (pCR) rate in the INT230‑6 group (5 of 7 patients) versus a 33% pCR rate in the standard‑of‑care (SOC) group (2 of 6 patients). The company believes the improved safety profile—specifically a 44% reduction in grade 3 or higher adverse events, including immune‑related events—will support accelerated approval based on pCR, a key surrogate endpoint for the FDA.
CEO Lewis Bender said, "Reducing the total number of grade 3 or higher adverse events by 44%, especially immune‑related adverse events, and the potential for a higher pCR rate with INT230‑6 prior to SOC, could be life‑saving for patients. With the amendment now filed with Swissmedic, we look forward to dosing the next patient."
Intensity remains a pre‑commercial biotech company with no revenue and relies on capital raises to fund its clinical programs. The company recently regained compliance with Nasdaq’s minimum bid‑price requirement and completed a 1‑for‑25 reverse split effective February 18 2026, actions that reinforce investor confidence in its ongoing development efforts.
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