“The abstract being presented at ASCO 2018 highlights the progress of our clinical program and the potential of INT230-6 as a medicine for multiple cancer types,” said Lewis H. Bender, President and CEO of Intensity Therapeutics, Inc. “We are pleased to describe our current clinical study evaluating INT230-6 at this prestigious meeting, which to date has had no dose limiting toxicities following treatments to fourteen patients having nine different solid tumor types.”
Details of the trials-in-progress abstract accepted for presentation at the 2018 ASCO Annual Meeting are below.
Abstract TPS2609: Phase 1/2 trial evaluating intratumoral administration of INT230-6 alone and in combination with an anti-PD1 antibody for advanced malignancies.
Presenter: Yada Kanjanapan, MBBS
Session: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics
Clinical Trial Registry Number: NCT03058289
Date/Time: June 4, 2018, 8:00 AM-11:30 AM
Location: Hall A; Poster Board Number: 428b
INT230-6 is a novel, anti-cancer drug for direct intratumoral injection. The product contains potent anti-cancer agents that disperse throughout tumors and diffuse into cancer cells. INT230-6 was identified from Intensity’s DfuseRxSM platform and is being evaluated in a clinical trial; IT 01. In preclinical studies INT230-6 administration eradicated tumors by a combination of direct tumor kill coupled with recruitment of dendritic cells to the tumor micro-environment that induced anti-cancer T-cell activation. Treatment with INT230-6 in in vivo models of severe cancer resulted in substantial improvement in overall survival compared to standard therapies. Further, INT230-6 provided complete responder animals with long-term, durable protection from multiple re-inoculations of the initial cancer and resistance to other cancers. In mouse models the drug has shown strong synergy with checkpoint blockage including anti-PD-1 and anti-CTLA4 antibodies.
About Study IT-01
IT-01 is entitled A Phase 1/2 Safety Study of Intratumorally Administered INT230-6 in Adult Subjects with Advanced Refractory Cancers. The trial aims to enroll approximately 60 patients with different types advanced solid tumor malignancies in a multicycle dosing regimen. The study is currently recruiting in the U.S. and Canada with plans to open additional sites in multiple countries. The study’s primary objective is to assess the safety and tolerability of multiple intratumoral doses of INT230-6 with or without an anti-PD-1 or other checkpoint blockade antibodies. Secondary assessments are the measurement of injected and bystander tumor responses, and determination of the systemic pharmacokinetic profile of multiple doses of INT230-6’s drug substances after single and then multiple intratumoral injections. Exploratory analysis will characterize patient outcome, as well as evaluate various tumor and anti-tumor immune response biomarkers that may correlate with response. The trial includes several adaptive components that will allow for adjustments in patient groups, dosing schedule and dose volumes administered. Data will be used to assess the progression free and overall survival in subjects receiving INT230-6. Further information can be found at www.clinicaltrials.gov (NCT#03058289).
About Intensity Therapeutics, Inc.
Intensity Therapeutics, Inc. is a clinical-stage biotechnology company whose mission is to greatly extend the lives of patients with cancer. Intensity Therapeutics is pioneering a new immune-based approach to treat cancer. The Company uses its DfuseRxSM platform technology to create new drug formulations that following direct injection rapidly disperse throughout a tumor and diffuse therapeutic agents into cancer cells. Drug products created using the technology are capable of attenuating (killing) a tumor in a manner that allows for the adaptive immune system to recognize the cancer and attack distal tumors and micrometastases. Further information can be found at www.intensitytherapeutics.com.
This press release contains forward-looking statements regarding Intensity Therapeutics’ plans, future operations and objectives. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual performance or achievements to be materially different from those currently anticipated. These forward-looking statements include, among other things, statements about the initiation and timing of future clinical trials.