Intensity Therapeutics Resumes Phase 2 Breast Cancer Trial in Switzerland

The company secured approval from Swissmedic and the Swiss Ethics Committee to restart the study using a modified protocol. This update implements a single-injection approach with a reduced drug-to-tumor volume ratio, a change designed to mitigate the adverse skin reactions observed during earlier stages of the trial. Before the pause, 14 patients had been treated, and preliminary data suggested that those receiving INT230-6 experienced fewer high-grade adverse events compared to those undergoing standard-of-care treatment alone.

Markus Joerger, coordinating investigator of the trial, noted that the drug’s mechanism—inducing necrosis to trigger an immune response—addresses a critical gap in treating aggressive breast cancer subtypes. With the trial now active again, Intensity Therapeutics plans to enroll 47 additional participants across sites in Switzerland and France. The study’s primary endpoint remains the pathological complete response rate, a metric that serves as a key indicator of treatment efficacy in the presurgical setting.