Intensity Therapeutics, Inc. announced that safety, tolerability and efficacy data from IT-01, the company's ongoing Phase 1/2 clinical trial of INT230-6, either as a monotherapy or in combination with ipilimumab in patients with relapsed, refractory and metastatic sarcomas, was presented at the Connective Tissue Oncology Society 2023 Annual Meeting being held in Dublin, Ireland from November 1-4, 2023. The poster will be displayed for the duration of the Annual Meeting. Christian Frederick Meyer, M.D., Ph.D., M.S., is an Assistant Professor of Oncology at the Sidney Kimmel Cancer Center at Johns Hopkins University.

Dr. Meyer is an investigator for Intensity's Phase 1/2 clinical trial of INT230-6 and the presenter of the data at CTOS. Dr. Meyer has placed a number of his sarcoma patients into the study due to the demonstrated significant survival prolongation effects of INT230-6. IT-01, now complete, was an open-label Phase 1/2 study of INT230-6 in adults with locally advanced, unresectable or metastatic solid tumors, including sarcoma. INT230-6 dose was determined by a target injected tumor's diameter or volume and administered intratumorally once every two weeks for up to 5 doses with regular maintenance treatment either alone or in combination with ipilimumab at 3 mg/kg every three weeks for 4 doses.

The primary endpoint was safety and approximately 90% of subjects had low grade adverse events. When compared to synthetic controls, INT230-6 alone extended survival in refractory soft tissue sarcoma subjects by approximately 14.9 months. Dosing higher amounts of INT230-6 relative to a patient's presenting total tumor burden showed increased survival when compared to the synthetic control.

An INT230-6 dose relative to the presenting tumor burden of = 40% further improved overall survival and the addition of ipilimumab may improve survival further. Median overall survival of INT230-6 was ~14.9 months longer than a synthetic control that was developed to predict survival of the enrolled sarcoma population. Median survival of synthetic control was about 6.8 months.

The INT230-6 Disease Control Rate was 93% in subjects who received at least one dose of INT230-6 as monotherapy. to date indicate that INT230-6 has a favorable safety profile and is well tolerated. The majority of treatment-emergent adverse events (TEAEs) were grade 1 or 2 primarily localized pain, fatigue, and nausea.

Two monotherapy and one combination subject experienced a grade 3 adverse event (AE) There were no reported grade 4 or 5 AEs.