Intensity Therapeutics(US:INTS) Prnewswire·2025-10-30 11:30Core Insights - Intensity Therapeutics, Inc. announced the publication of its phase 1/2 IT-01 clinical study manuscript for the treatment of metastatic or refractory cancers, demonstrating promising efficacy and safety of its investigational product INT230-6 [1][4][5] Study Results - The phase 1/2 trial showed a disease control rate of 75% (48 out of 64 patients) and a median overall survival (mOS) of 11.9 months, which is significantly better than historical mOS of 4 to 7 months for similar patient populations [4][5] - In a subset of metastatic sarcoma patients treated with INT230-6, the mOS was reported at 21.3 months [4] - An exploratory analysis indicated that patients receiving INT230-6 at doses treating more than 40% of their tumor burden had an 83.3% disease control rate and an mOS of 18.7 months, compared to 50% and 3.1 months for those treated with less than 40% [4] Mechanism of Action - INT230-6 utilizes a diffusion process for local treatment, directly injected into tumors, leading to tumor cell death and systemic immune activation [4][6] - The treatment resulted in a qualitative decrease in proliferating cancer cells and an increase in activated T-cells within the tumor microenvironment [4][5] Safety Profile - The trial reported no dose-limiting toxicities among the 64 patients, with only 10.9% experiencing grade 3 adverse events and no grade 4 or 5 treatment-related adverse events [4][5] - Pharmacokinetic data showed over 95% of active cytotoxic agents remained localized within the injected tumors, indicating a favorable safety profile [5] Future Directions - The company plans to initiate randomized controlled studies, including a Phase 3 trial in sarcoma, to further evaluate the efficacy of INT230-6 [5][10]