This document appears to be a press release announcement from Intensity Therapeutics, a biotechnology company. The main points of the announcement are:
- New Clinical Trial Initiated: Intensity Therapeutics has initiated a new clinical trial, INVINCIBLE-4 (NCT06358573), which is part of a Phase 2/3 program evaluating INT2306, a novel engineered chemistry that enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment. The trial focuses on patients with presurgical triple-negative breast cancer.
- Primary Endpoint: Pathological Complete Response (pCR) is the primary endpoint for this clinical trial.
- Development Objectives: The goal of INT2306 is to create a new approach to cancer cell death that shifts the treatment paradigm and turns many deadly cancers into chronic diseases, even for malignancies that do not respond to conventional immunotherapy.
- Safety and Efficacy Profile: The INVINCIBLE-2 Study (NCT04781725) has demonstrated the ability of INT2306 to kill tumors and elicit an adaptive immune response within days of injection.
The document also includes a warning about forward-looking statements, cautioning investors and readers not to place undue reliance on these statements, which reflect management's current estimates, projections, expectations, and beliefs.