Intensity Therapeutics Restarts INVINCIBLE-4 TNBC Trial, Reports 2025 Financial Results

Intensity Therapeutics has restarted patient treatment in its randomized, presurgical triple-negative breast cancer Phase 2 clinical trial (INVINCIBLE-4 Study), with new patients administered INT230-6 in Switzerland. The company also reported 2025 year-end financial results, including $11.9 million in cash and cash equivalents as of December 31, 2025, and a cash runway into the second quarter of 2027.

The INVINCIBLE-4 Study is a randomized, open-label, multicenter study analyzing the clinical activity, safety, and tolerability of INT230-6 given before administration of standard-of-care neoadjuvant immuno-chemotherapy (SOC) and SOC alone in patients with early-stage, operable triple-negative breast cancer. The primary endpoint is pathological complete response (pCR) in the primary tumor and affected lymph nodes. In the amended protocol, patients are randomized to receive one dose of INT230-6 followed by SOC, consisting of pembrolizumab, anthracyclines, carboplatin, cyclophosphamide, and paclitaxel, or SOC alone.

The trial reopened following a pause in patient accrual to evaluate skin irritation issues seen in some patients. In March 2026, a protocol amendment was submitted to Swissmedic and the Swiss Ethics Committee to resume enrollment using a slightly lower drug-to-tumor volume ratio and a single injection of INT230-6; full approval was granted on March 26, 2026. Prior to the pause, 14 patients had been treated — seven with the combination and seven with SOC alone. Preliminary observations showed that five of seven patients (71.4%) who received INT230-6 prior to SOC achieved a pCR, compared with two of six (33%) patients in the SOC-alone arm, with one patient still to be evaluated. The company also reported 44% fewer grade 3 or higher adverse events in the INT230-6 cohort compared with the SOC arm. The INVINCIBLE-4 Study is expected to enroll an additional 47 patients in Switzerland and France. The company's Founder, Chairman, and CEO said the new dosing regimen could continue to show favorable overall safety, a meaningful improvement in the percentage of patients who achieve pCR, and ultimately an improved event-free survival.

Intensity also highlighted its peer-reviewed publication in eBioMedicine, a Lancet Discovery Science journal, of the Phase 1/2 IT-01 clinical study of INT230-6 in 64 refractory metastatic cancer patients. The manuscript reported a disease control rate of 75% (48/64 patients) and median overall survival of 11.9 months; in a metastatic sarcoma subset receiving only INT230-6, median overall survival was 21.3 months. In an exploratory analysis, patients treated with INT230-6 covering greater than 40% of total tumor burden had a disease control rate of 83.3% (40/48) versus 50% (8/16) and median overall survival of 18.7 months versus 3.1 months, with a hazard ratio of 0.17 (95% CI: 0.081–0.342). Approximately 20% of patients in the >40% group had uninjected tumors shrink (abscopal effects), and no dose-limiting toxicities were reported among 64 monotherapy patients. More than 200 patients have been enrolled across completed INT230-6 studies, including a Phase 1/2 dose escalation study in metastatic cancers and a randomized Phase 2 study in locally advanced breast cancer.

In soft tissue sarcoma, the company paused new site activations and patient enrollments in the Phase 3 INVINCIBLE-3 study in March 2025 due to funding constraints, after enrolling 21 patients. In April 2026, the company announced it will resume enrollment of the study in a limited number of U.S. sites. The study is designed to evaluate INT230-6 as monotherapy compared with standard-of-care drugs in second- and third-line treatment for specific soft tissue sarcoma subtypes, with overall survival as the primary endpoint. Financially, the company raised over $20 million in gross proceeds in 2025 and held $11.9 million in cash and cash equivalents as of December 31, 2025.