INT230-6 - (INVINCIBLE-4)

July 1, 2026: Intensity Therapeutics, Inc. (NASDAQ: INTS) provided a mid-year pipeline and business update focused on its lead intratumoral investigational therapy INT230-6.

Presurgical triple-negative breast cancer (INVINCIBLE-4, Phase 2/3 strategy): The company reiterated preliminary observations from a small sample comparing INT230-6 given prior to standard-of-care (SOC) immunochemotherapy vs SOC alone. Previously reported results included pathological complete response in 5/7 patients in the INT230-6 arm vs 2/6 evaluable in the SOC arm (one SOC patient pending evaluation), and 44% fewer grade ≥3 adverse events in the INT230-6 cohort. A protocol amendment was submitted to Swissmedic and the Swiss Ethics Committee; approval to resume enrollment was granted March 26, 2026. Enrollment is planned to restart in Q3 2026 in Switzerland and France.

Soft tissue sarcoma (INVINCIBLE-3, Phase 3): After pausing new site activations/enrollment in March 2025 due to funding constraints, Intensity announced in April 2026 it will resume enrollment at a limited number of U.S. sites. The trial compares INT230-6 monotherapy vs SOC in 2L/3L sarcoma subtypes, with overall survival as the primary endpoint.

Other catalysts: The company cited >200 patients enrolled across completed INT230-6 studies and a peer-reviewed eBioMedicine publication; it plans additional peer-reviewed data publications from two completed studies in 2H 2026. It also reported >20 partnering discussions at the 2026 BIO International Convention and disclosed a $60M ATM established in March 2026.