Intensity Therapeutics, Inc. to Present Two Posters at the 2025 San Antonio Breast Cancer Symposium

Core Insights - Intensity Therapeutics, Inc. is presenting two posters at the San Antonio Breast Cancer Symposium, focusing on its investigational drug INT230-6 for treating Triple Negative Breast Cancer (TNBC) [1][2] Study Observations - The INVINCIBLE-4 study, initiated in 2024, has treated 14 patients, with 7 in each cohort, showing favorable safety data [3][6] - Cohort A (INT230-6 plus standard of care) exhibited 50% fewer grade 3 or higher adverse events compared to Cohort B (standard of care alone) [5][6] - Specific adverse events included 9 grade 3 or higher events in Cohort A versus 20 in Cohort B [6] Clinical Trial Details - The ongoing Phase II randomized clinical trial is evaluating INT230-6's safety and efficacy in early-stage TNBC patients [5][11] - A potential Phase 3 study design may include INT230-6 with standard of care, with and without the anthracycline doxorubicin, aiming for improved safety and efficacy [8][9] Drug Mechanism and Composition - INT230-6 is designed for direct intratumoral injection, combining cisplatin and vinblastine sulfate with a diffusion enhancer to improve drug delivery within tumors [13] - The drug aims to elicit an immune response while minimizing systemic toxicity, a common issue with traditional chemotherapy [13][14] Market Context - TNBC represents a significant challenge in breast cancer treatment, with approximately 56,000 new cases diagnosed annually in the U.S. and 420,000 worldwide [11] - Current standard treatments often involve high toxicity, with 80% of patients experiencing severe adverse events [11] Regulatory Pathway - The FDA's Accelerated Approval Program may facilitate INT230-6's approval based on pathological complete response (pCR) as a surrogate endpoint [12] - If successful, this could lead to a safer treatment regimen for TNBC patients, potentially avoiding the use of highly toxic agents like doxorubicin [11][12]