Intensity Therapeutics Updates Breast Cancer Trial, Files To Resume Enrollment Following Study Pause

Core Insights - Intensity Therapeutics Inc. provided an update on the INVINCIBLE-4 Study, a Phase 2 study analyzing the clinical activity, safety, and tolerability of INT230-6 in early-stage, operable triple-negative breast cancer patients [1] Enrollment and Preliminary Data - A total of 14 patients have been treated so far, with an expected total enrollment of 61 patients [2] - Preliminary results indicate that 5 out of 7 patients (71.4%) receiving INT230-6 before standard of care (SOC) achieved a pathological complete response (pCR), compared to 2 out of 6 patients (33%) in the SOC arm alone [2] Safety Observations - Safety data for patients receiving INT230-6 plus SOC remain favorable compared to SOC alone [3] Enrollment Status - Enrollment was paused in September 2025 due to skin irritations observed in the INT230-6 group before SOC [4] - A protocol amendment was submitted in March 2026 to resume enrollment with a lower drug volume per tumor volume ratio and a single injection of INT230-6 [4] Management Commentary - The company highlighted a 44% reduction in the total number of grade 3 or higher adverse events, particularly immune-related adverse events, and the potential for a higher pCR rate with INT230-6 prior to SOC [5] Stock Activity - Intensity Therapeutics announced a 1-for-25 reverse stock split to increase the per-share trading price and comply with Nasdaq listing requirements [6] - The company's shares were down 6.70% at $7.50 at the time of publication [8] Market Performance - The Benzinga Edge scorecard indicates that the company's momentum is weak, with a score of 6.98, suggesting underperformance compared to the broader market [7]