Intensity Therapeutics Updates on INVINCIBLE-4 Study Progress
Intensity Therapeutics provided an update on the INVINCIBLE-4 Study. In September 2025, enrollment was paused by the company due to skin irritations observed in Cohort A. In early March 2026, a protocol amendment was submitted to Swissmedic and the Swiss Ethics Committee to resume enrollment using a lower drug volume per tumor volume ratio and a single injection of INT230-6. Preliminary observations of the INVINCIBLE-4 Study to date showed that five out of seven patients who received INT230-6 prior to standard of care achieved a pathological complete response whereas two out of six patients in the SOC arm alone achieved a pCR, with one patient still to be evaluated. Forty-four percent fewer grade 3 or higher Adverse Events were observed in Cohort A compared to Cohort B. A protocol amendment has been submitted to the Swiss Agency for Therapeutic Products, Switzerland's regulatory authority, and the Swiss Ethics Committee to resume enrollment. Lewis Bender, Founder, President & CEO, said, "The pCR data observations to date in the INVINCIBLE-4 study are promising, though preliminary and early. We are also pleased to see fewer total grade 3 or higher adverse events and fewer adverse events associated with checkpoint inhibitors when our drug is combined with immunochemotherapy in Cohort A than seen in Cohort B. The safety observed to date is consistent with our prior results using our drug with immunotherapy in mice and humans, which have been presented at oncology conferences or published in peer-reviewed journals."
