Intensity Therapeutics, Inc. announced that data from its ongoing phase 1/2 clinical trial demonstrating the efficacy and tolerability of INT230-6, either as monotherapy or in combination with ipilimumab in patients with relapsed, refractory and metastatic sarcomas, will be presented this afternoon at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago and virtually from June 2-6, 2023. Abstract Title: Intratumoral INT230-6 (Cisplatin, Vinblastine, SHAO) alone or with ipilimumab (IPI) prolonged survival with favorable safety in adults with refractory sarcomas [Intensity IT-01; BMS#CA184-592. Presenter/First Author: Christian F. Meyer, MD, Johns Hopkins SydneyKimmel Cancer Center.

Sarcoma remains a very challenging cancer to treat and has historically proven resistant to checkpoint blockade. Novel approaches are needed for this patient population, and Intensity's data indicate that sarcoma is an attractive target for intratumoral injection. Christian Frederick Meyer, M.D., Ph.D., M.S. Assistant Professor of Oncology at the Sidney Kimmel Cancer Center at Johns Hopkins University is an investigator for Intensity's phase 1/2 clinical trial and the presenter of the data at ASCO.

Dr. Meyer has placed a number of his sarcoma patients into the study. INT230-6 has demonstrated significant survival prolongation and continues to be of great interest to a sarcoma oncologists, such as Dr. Meyer, especially given the data on immune ignition, as sarcoma is considered non-immunogenic and therefore largely unresponsive to immunotherapies. Efficacy in subjects administered INT230-6, with or without ipilimumab, were compared to a synthetic control.

The poster reports the median overall survival (mOS) and disease control rate (DCR equals the cases of stable disease, partial response and complete response divided by number of subjects) per the Response Evaluation Criteria in Solid Tumors (RECIST). Abscopal responses for INT230-6 alone were observed primarily in subjects dosed = 40% of their total tumor burden (TTB). The DCR for the all-treated population (those who received at least one dose of INT230-6) was 93% for monotherapy and 86% for the ipilimumab combination.

For the combination arm, one subject had yet to reach the first timepoint for SD at the time of data cut-off. Study IT-01 was without a randomized control group; however, published clinical phase 1/2 basket trials in sarcoma report mOS ranging from 7.6 to 9.6 months (Jones et. al., Cancer Chemotherapy Pharmacology (2011) 68:423–429; Cassier et.

al., Annals of Oncology 25: 1222–1228, 201; vi. Subbiah et. al., Scientific Reports | 6:35448 2016).

Using the Subbiah study data and the Royal Marsden Hospital scoring system to predict survival for the sarcoma subjects from the IT-01 study, a synthetic Kaplan Meier (KM) control curve was generated. The overall survival of the control, all INT230-6 patients in sarcoma, including those receiving a cumulative dose of greater than 40% of their TTB.