On May 3, 2022 Intensity Therapeutics, Inc. ("Intensity"), 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 phase 2 sarcoma data, phase 2 breast cancer data and phase 1/2 solid tumor data from its ongoing cohort studies of lead asset, INT230-6, will be presented in two oral and three poster sessions at the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held live at McCormick Place in Chicago, IL, and online, from June 3-7, 2022 (Press release, Intensity Therapeutics, MAY 3, 2022, View Source [SID1234613447]).

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Abstract Title: INT230-6 monotherapy and in combination with ipilimumab (IPI) across a broad spectrum of refractory soft tissue sarcomas (STS) [Intensity IT-01; BMS#CA184-592].
Presenter/First Author: Matthew Ingham, MD
Session Type/Title: Poster Discussion Session/Sarcoma
Poster Discussion Session Date and Time: Sunday, June 5, 2022, 12:30 PM – 2:00 PM EDT
Location: In-Person & On Demand | S404
Abstract Number: 11515
Poster: 420

Abstract Title: Effect of intratumoral INT230-6 on tumor necrosis and promotion of a systemic immune response: Results from a multicenter phase 1/2 study of solid tumors with and without pembrolizumab (PEM) [Intensity IT-01; Merck KEYNOTE-A10].
Presenter/First Author: Jacob Stephen Thomas, MD
Session Type/Title: Poster Discussion Session/Developmental Therapeutics—Immunotherapy
Poster Discussion Session Date and Time: Sunday, June 5, 2022, 12:30 PM – 2:00 PM EDT
Location: In-Person & Live Stream | Hall D2
Abstract Number: 2520
Poster: 176

Abstract Title: Intratumoral (IT) INT230-6 can cause tumor necrosis In Vivo: Preliminary results of a phase II randomized presurgical window-of-opportunity study in early breast cancers (the INVINCIBLE study).
First Author: Angel Arnaout, MD, FACS
Session Type/Title: Poster Session/Breast Cancer—Local/Regional/Adjuvant
Session Date and Time: Monday, June 6, 2022, 9:00 AM – 11:00 AM EDT
Location: In-Person & On Demand
Abstract Number: 605
Poster: 376

Copies of these materials will also be available on the Intensity Therapeutics website at View Source following completion of the live presentation.

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 that helps disperse the drugs throughout tumors for diffusion into cancer cells. 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.

INT230-6 is currently being evaluated in several phase 2 cohorts (NCT03058289) in patients with various advanced solid tumors as part of Study IT-01. In 2019, the Company signed a clinical collaboration agreement with Merck Sharpe & Dohme (Merck) to evaluate the combination of INT230-6 and KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, in patients with advanced pancreatic, colon, squamous cell and bile duct malignancies. In 2020, the Company executed a clinical collaboration agreement with Bristol-Myers Squibb Company to evaluate the combination of INT230-6 with Bristol-Myers Squibb’s anti-CTLA-4 antibody, Yervoy (ipilimumab), in patients with advanced liver, breast and sarcoma cancers. In 2021, the Company executed agreements with the Ottawa Hospital Research Institute and the Ontario Institute of Cancer Research to study INT230-6 in a randomized controlled neoadjuvant phase 2 study in women with early stage breast cancer (the INVINCIBLE study) (NCT04781725).