Intensity Therapeutics, Inc., a leading biotechnology company, has embarked on a pivotal collaboration with The Swiss Group for Clinical Cancer Research (SAKK) to launch a Phase 2 clinical trial, dubbed the INVINCIBLE-4 Study. This trial aims to explore the effectiveness of the innovative cancer treatment INT230-6 in early-stage triple-negative breast cancer (TNBC). The study will be conducted across Switzerland and selected European countries, marking a significant stride in cancer research.

INVINCIBLE-4 Study Details

The INVINCIBLE-4 Study is set as a randomized, open-label, two-cohort clinical trial that will compare the results of intratumoral INT230-6 followed by standard of care (SOC) immuno/chemotherapy against SOC immuno/chemotherapy alone. The primary goal is to assess the pathological complete response (pCR) in both the primary tumor and affected lymph nodes. This trial will enroll 54 patients, offering new insights into the treatment of this aggressive cancer form.

Commitment from Intensity and SAKK

SAKK will act as the “Legal Sponsor” of the study, ensuring compliance with regulatory standards in Switzerland and the European Union. Intensity Therapeutics will fund the study and provide the investigational drug. Lewis H. Bender, Founder, President, and CEO of Intensity Therapeutics, expressed enthusiasm about the collaboration, noting the challenges posed by TNBC and the promising results of earlier studies which showed significant tumor necrosis and immune response post-treatment with INT230-6.

Potential Impact and Clinical Advances

INT230-6, developed using Intensity’s proprietary DfuseRx℠ technology, is designed for direct intratumoral injection. This approach allows for localized treatment of tumors with a high concentration of cytotoxic agents, potentially reducing systemic side effects and enhancing immune system engagement. The study’s outcomes could revolutionize the presurgical treatment landscape for TNBC, providing critical data to inform future Phase 3 trials.

This collaborative effort between Intensity Therapeutics and SAKK could significantly impact the future treatment of TNBC, a cancer type known for its poor prognosis and limited treatment options. By focusing on a localized treatment approach, INT230-6 holds the promise of improving survival rates and reducing side effects, offering a new beacon of hope for patients.

  clinical trials in cancer, Intensity Therapeutics, intratumoral cancer therapy, INVINCIBLE-4 Study, TNBC treatment