Westport, CT. — October 17, 2018 – Intensity Therapeutics, Inc., a clinical-stage biotechnology company developing proprietary immune cell-activating cancer treatments, today announced  that preliminary data from a Phase 1/2 clinical study of INT230-6 will be presented in poster sessions at the European Society for Medical Oncology (ESMO) 2018 Congress, which is being held October 19-23 in Munich, Germany, and the Society for Immunotherapy of Cancer (SITC) 33rd Annual Meeting, which is being held November 7-11 in Washington, DC.

Details of the posters are below.

ESMO 2018 Congress

Title: Phase 1/2 trial evaluation of intratumoral INT230-6 for the treatment of solid tumors

Abstract Number: 4458

Presentation Number: 1160P

Session: Poster Display Session – Immunotherapy of Cancer

Date/Time: October 20, 2018, 12:30 p.m. CEST

Location: Hall A3; Poster Area Networking Hub, ICM München

Presenter: Anthony El-Khoueiry, MD (University of Southern California, USA)

For more information about the ESMO 2018 Congress, please visit https://www.esmo.org/Conferences/ESMO-2018-Congress/.

 

SITC Annual Meeting

Title: Phase 1/2 evaluation of intratumoral INT230-6 for the treatment of solid tumors

Poster Number: P622

Poster Hall Hours: November 9, 8 a.m.-8 p.m.; November 10, 8 a.m.-8:30 p.m. EST

Poster Presentation Hours: November 10, 12:20-1:50 p.m. and 7-8:30 p.m. EST

Poster Hall Location: Hall E; Walter E. Washington Convention Center

Presenter: Anthony Olszanski, MD, RPh (Fox Chase Cancer Center)

For more information about the SITC Annual Meeting, please visit https://www.sitcancer.org/2018/home.

 

About INT230-6

INT230-6, Intensity’s lead product candidate designed for direct intratumoral injection, is comprised of two proven, potent anti-cancer agents and a penetration enhancer molecule that helps disperse the drugs throughout tumors and diffuse into cancer cells. INT230-6 is being evaluated in a Phase 1/2 clinical study (NCT03058289) in patients with various advanced solid tumors. In preclinical studies, INT230-6 eradicated tumors by a combination of direct tumor kill and 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, INT230-6 has shown strong synergy with checkpoint blockage, including anti-PD-1 and anti-CTLA4 antibodies. INT230-6 was discovered from Intensity’s DfuseRxSM platform.

About the Phase 1/2 Clinical Study

INT230-6 is being evaluated in a Phase 1/2 clinical study in patients with different types of advanced solid tumor malignancies. The study’s primary objective is to assess the safety and tolerability of multiple intratumoral doses of INT230-6. 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 study 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 patients receiving INT230-6. For more information, please visit www.clinicaltrials.gov (NCT03058289).

About Intensity Therapeutics

Intensity Therapeutics, Inc. is a clinical-stage biotechnology company pioneering a new immune-based approach to treat solid tumor cancers. Intensity leverages its DfuseRxSM technology platform to create new drug formulations that, following direct injection, rapidly disperse throughout a tumor and diffuse therapeutic agents into cancer cells. Intensity’s product candidates have the potential to induce an adaptive immune response that not only attacks the injected tumor, but also non-injected tumors and unseen micro-metastases. INT230-6, Intensity’s lead product candidate, is being evaluated in a Phase 1/2 clinical study in patients with various advanced solid tumors. For more information, please visit www.intensitytherapeutics.com and follow us on Twitter @IntensityInc.

Forward Looking Statements

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.

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