Intensity Therapeutics, Inc. announced that eBioMedicine, a Lancet Discovery Science journal, has published the Company's phase 1/2 IT-01 clinical study manuscript for the treatment of metastatic or refractory cancers. The full text article, "Safety and Efficacy of Intratumourally Administered INT230-6 in Adult Patients with Advanced Solid Tumours: Results from an Open-Label Phase 1/2 Dose Escalation Study," can be viewed via Online First 105980 October 29, 2025.Jacob Stephen Thomas, M.D. Assistant Professor of Clinical Medicine at Keck School of Medicine of the University of Southern California (USC) and medical oncologist with USC's Norris Comprehensive Cancer Center, is the first author. Anthony El-Khoueiry, M.D., Associate Director for Clinical Research and Chief of Section of Developmental Therapeutics/Phase I Program at USC Norris, is the senior and corresponding author.

The manuscript includes the following data results: In heavily pretreated patients with advanced disease having over 20 different types of cancer who had progressed following multiple prior lines of therapy, intratumoral INT230-6 achieved: A disease control rate of 75% (48/64 patients) and median overall survival (mOS) of 11.9 months; these results compare favorably in phase 1/2 studies that historically reported an mOS of 4 to 7 months. In a metastatic sarcoma subset population receiving only INT230-6, the median overall survival was 21.3 months. In an exploratory analysis comparing patients receiving INT230-6 at a total dose (in mL) that treated greater than 40% of the patient's total tumour burden ("TTB") compared to those treated with less than 40% of their TTB, the: Disease control rate was 83.3% (40/48) compared to 50% (8/16).

Median overall survival was 18.7 months (95% CI: 11.5?23.5) compared to 3.1 months (95% CI: 1.6?5.9) with a hazard ratio (HR) of 0.17 (95% CI: 0.081?0.342); P<0.0001. Improved survival was consistent across a range of low to high tumor burden and tumor sizes. Approximately 20% of patients in the >40% group had uninjected tumors shrink, abscopal effects.

Fifteen of 64 patients survived for more than 21 months. INT230-6 induced a qualitative decrease in proliferating cancer cells in injected tumors and a qualitative increase in activated T-cells infiltrating the tumor microenvironment. No dose-limiting toxicities were reported among 64 monotherapy patients; seven patients had a grade 3 (10.9%) with no grade 4 or 5 treatment-related adverse events.

Pharmacokinetic results showed that greater than 95% of the active cytotoxic agents remained in the injected tumors.