Intensity Therapeutics pauses new patient enrollment in INVINCIBLE-4 trial

Intensity Therapeutics (INTS) provided an update on the INVINCIBLE-4 trial. A pathological complete response has been observed in the first patient evaluated in Cohort A, where each patient receives two doses of INT230-6 eight days apart, followed by the SOC. To date, there has been favorable safety in cohort A. However, some patients in Cohort A experienced localized skin irritation near the tumor. As a result, new patient enrollment has been paused to evaluate the data collected and to implement necessary adjustments prior to reopening accrual. “While efficacy of INT230-6 is quite promising, and we are excited by the early radiological and pathological results, an essential aspect of any treatment for breast cancer patients is to have a good cosmetic result post-surgery,” said Ursina Zurrer, M.D. Chief Physician for Genetic Counseling, Department of Medical Oncology and Hematology, Cantonal Hospital Winterthur, Switzerland, and the Coordinating Investigator for the INVINCIBLE-4 Study. “We believe that the INT230-6 has the potential to make a positive impact on patients with triple-negative breast cancer from a safety and efficacy perspective. We expect to reinitiate the enrollment with a modified INT230-6 dosing regimen as soon as possible. The pause was a decision made with Intensity and not a directive from any regulatory agency.” “As was seen in our prior studies, tumor scans indicate high levels of drug absorption and significant tumor necrosis with evidence of immune activation before the initiation of the standard of care therapy, and we are excited that the first patient evaluated who received our drug had a pCR,” said Lewis H. Bender, Intensity’s President and CEO. “We plan to complete a data evaluation to determine the cause of the skin irritation and implement changes needed to eliminate or reduce the issue. Our objective is to reinitiate enrollment and complete the study as soon as possible. Intensity’s ultimate goal is to provide patients with a new product that offers presurgical triple-negative breast cancer patients improved safety and a greater likelihood of having a pathological complete response, while also providing a good appearance post-surgery.”