Clinical TrialMay 7, 2026, 04:08 PM
Intensity Therapeutics Resumes Phase 3 Trial; Phase 2 Shows 71% pCR
AI Summary
Intensity Therapeutics provided updates on its clinical programs, including the resumption of its Phase 3 INVINCIBLE-3 study for soft tissue sarcoma in limited U.S. sites after a pause due to funding. The company also reported preliminary positive data from its Phase 2 INVINCIBLE-4 study for triple-negative breast cancer, showing a 71% pCR rate in one cohort compared to 33% for standard of care, and a 44% reduction in Grade 3 adverse events. Enrollment for INVINCIBLE-4 has also resumed, targeting completion by the end of 2027.
Key Highlights
- Intensity Therapeutics resumed enrollment in its INVINCIBLE-3 (Phase 3) study for soft tissue sarcoma in April 2026 in limited U.S. sites.
- The INVINCIBLE-3 trial had enrolled 21 patients before pausing in March 2025 due to funding constraints.
- Preliminary data from the INVINCIBLE-4 (Phase 2) study for triple-negative breast cancer showed a 71% pathological complete response (pCR) in Cohort A.
- This compares to a 33% pCR rate in patients receiving standard of care alone in the INVINCIBLE-4 study.
- The INVINCIBLE-4 study also reported a 44% reduction in Grade 3 adverse events in Cohort A.
- Enrollment for the INVINCIBLE-4 study, paused in September 2025 for dosing revision, resumed in March 2026, targeting completion by end of 2027.
- The INVINCIBLE-2 (Phase 2) study for early-stage breast cancer enrolled 91 subjects, with the database locked in November 2023.
- FDA agreed on a chemical manufacture and control (CMC) plan for Phase 3 and product registration for INT230-6 in Q4 2023.