Intensity Therapeutics and SAKK Ink Pact To Conduct Phase 2 Trial

Intensity Therapeutics, Inc., a biotechnology firm, declares that the organization executed an alliance with The Swiss Group for Clinical Cancer Research (SAKK) to lead a stage 2 randomized (coordinated), controlled preliminary assessing clinical and natural impacts of intratumoral INT230-6 kept by the standard of care (SOC) immuno/chemotherapy versus SOC safe/chemotherapy alone in beginning phase triple-negative breast cancer (TNBC) in 54 patients in Switzerland and chose nations in Europe.

SAKK will attempt the preliminary as the "Legal Sponsor" of the review, with the administrative organizations in Switzerland and the European Union as depicted in the review convention. SAKK will likewise guarantee that all specialists and personnel who engage in the review are educated and prepared. Intensity shall finance the review, provide the investigational drug item, and provide other vital data to lead the clinical trial.

"We are excited to be working with SAKK on our INVINCIBLE-4 study in early-stage triple-negative breast cancer," said Lewis H. Bender, founder, president and CEO of Intensity Therapeutics, Inc. "TNBC poses significant challenges due to its aggressiveness, high relapse rates, and increased mortality especially in patients with large tumours. Achieving pathological complete response (pCR) and clearing positive lymph nodes are crucial prognostic factors for event-free survival. Results from our first INVINCBLE-2 study showed that INT230-6 could cause greater than 95% necrosis in large breast cancer tumours following a single dose with the induction of an immune response. By adding up to 2 doses of our unique drug before the standard of care, we hope to increase the rate of patients' pCR, which is an FDA-approved endpoint for accelerated approval. The pCR data from this study, which we expect in the second half of 2025, should provide the information needed to size our phase 3 trial in presurgical TNBC."