Intensity Therapeutics and SAKK Dose First Patient in Phase 2 Triple Negative Breast Cancer Trial

Intensity Therapeutics, Inc., a biotechnology firm specializing in the development of novel immune-based cancer therapies, has initiated the INVINCIBLE-4 Study in collaboration with the Swiss Group for Clinical Cancer Research (SAKK). This Phase 2 clinical trial aims to evaluate the efficacy and safety of Intensity’s lead drug candidate, INT230-6, when combined with standard-of-care (SOC) treatment versus SOC alone in patients with localized triple-negative breast cancer (TNBC).

The INVINCIBLE-4 Study follows a 2-cohort design, with the primary endpoint being the change in pathological complete response (pCR) rates. pCR is assessed in the primary tumor and affected lymph nodes. The trial will enroll approximately 54 patients in Switzerland and France, aiming to determine the clinical activity, safety, and tolerability of INT230-6 in early-stage, operable TNBC patients. Participants will be randomized to receive either two doses of INT230-6 followed by SOC, which includes pembrolizumab, anthracyclines, carboplatin, cyclophosphamide, and paclitaxel, or SOC alone.

The study's initiation is based on encouraging data from Intensity’s INVINCIBLE-2 Study, which demonstrated that INT230-6 alone could kill tumors effectively and activate systemic immune responses. Dr. Andreas Mueller, Past-President of the Breast Cancer Group at the National Swiss Association for Clinical Cancer Research, highlighted the potential of INT230-6 to address the unmet need in treating aggressive TNBC by causing tumor cell necrosis and eliciting an anti-cancer immune response.

Dr. Ursina Zuerer-Haerdi, Lead Physician at the Cantonal Hospital in Winterthur, emphasized the importance of increasing pCR rates with this novel intratumoral agent, which could significantly impact treatment outcomes. INT230-6, according to Dr. Markus Joerger of the Cantonal Hospital St. Gallen, combines cisplatin and vinblastine with a penetration enhancer molecule (SHAO), resulting in immunogenic cell death within the tumor and systemic immunostimulatory effects without systemic chemotoxicity.

INT230-6 works by dispersing potent cytotoxic drugs throughout the tumor, leading to effective local disease control and systemic anti-tumor effects. These effects are achieved without the immunosuppression commonly associated with systemic chemotherapy.

TNBC is a particularly aggressive form of breast cancer, lacking receptors for estrogen, progesterone, and HER2. Consequently, fewer targeted treatments are available, and standard treatment often involves a combination of chemotherapy and immunotherapy. Despite this, pCR rates remain suboptimal, particularly in larger tumors, and the treatment regimen can be highly toxic.

SAKK, which has been conducting cancer treatment trials in Swiss hospitals since 1965, collaborates with international groups to investigate new treatments and set new standards. Intensity Therapeutics, through its proprietary DfuseRx℠ technology platform, has developed INT230-6 to directly target tumors and stimulate an immune response, aiming to transform the treatment landscape for patients with various cancers, including TNBC.

Founder and CEO of Intensity Therapeutics, Lewis H. Bender, expressed optimism about the potential of INT230-6 to improve pCR rates and event-free survival for TNBC patients, marking a significant milestone in their European clinical efforts. The results from the INVINCIBLE-4 Study are anticipated to provide critical data for future large-scale trials aimed at improving outcomes for early-stage TNBC patients.