On November 2, 2023 Intensity Therapeutics, Inc. (Nasdaq: INTS), a clinical-stage biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported 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 (Press release, Intensity Therapeutics, NOV 2, 2023, View Source [SID1234636830]). The poster will be displayed for the duration of the Annual Meeting.

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Abstract Title: INTRATUMORAL INT230-6 (CISPLATIN, VINBLASTINE, SHAO) ALONE OR WITH IPILIMUMAB PROLONGED SURVIVAL WITH FAVORABLE SAFETY AND IMMUNE ACTIVATION IN ADULTS WITH REFRACTORY SARCOMAS (NCT 03058289)
Presenter: Christian F. Meyer, M.D., Ph.D., M.S., Johns Hopkins Sydney Kimmel Cancer Center
Abstract Number: 1574238

Copies of the presentation materials are available on Intensity’s website on the publications, papers and posters page.

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.

"The data presented at CTOS highlights the true potential of INT230-6 as both a monotherapy or in combination with ipilimumab. INT230-6 showed an extensive increase in overall survival in metastatic patients over expected results for the heavily pretreated and diverse sarcoma population with an increase of nearly 15 months compared to a synthetic control. Approval of INT230-6, a locally delivered therapy, could be a paradigm-changing treatment for metastatic cancers," said Lewis H. Bender, President and Chief Executive Officer of Intensity. "INT230-6 can fully saturate a tumor with cytotoxic agents to begin apoptosis and cause necrosis when delivered intratumorally, resulting in immune activation consisting of dendritic and T-cell influx to the tumor all while maintaining a favorable safety profile. We have begun the preparations for a Phase 3 study of INT230-6 as a monotherapy and look forward to providing updates on the trial in the future."

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.

Efficacy Data:

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.
Safety Data:

Data 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.
About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is composed of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor resulting in a favorable safety profile. In addition to local disease control, direct killing of the tumor by INT230-6 releases a bolus of neoantigens specific to the patient’s malignancy, leading to engagement of the immune system and systemic anti-tumor effects. Importantly, these effects are mediated without the immunosuppression of concomitant systemic chemotherapy.