Intensity Therapeutics Inc (Nasdaq:INTS), a late-stage clinical biotechnology company, announced on Wednesday that new patients have been administered INT230-6 in the INVINCIBLE-4 Study in Switzerland.

The study analyses INT230-6 given before administration of the standard-of-care neoadjuvant immuno-chemotherapy (SOC) and the SOC alone by using a 2-cohort design. It evaluates the pathological complete response (pCR) rates of the two cohorts relative to a null hypothesis, which is a pCR rate of less than 0.6. The success of each cohort in rejecting the null hypotheses will be evaluated.

INVINCIBLE-4 is a randomised open-label, multicentre study to determine the clinical activity, safety, and tolerability of INT230-6 in patients with early-stage, operable triple-negative breast cancer (TNBC) who undergo SOC treatment and SOC alone. The primary endpoint is pCR in the primary tumour and affected lymph nodes.

In an amended protocol, patients will be randomised to receive a regimen of one dose of INT230-6 followed by SOC, which consists of pembrolizumab, anthracyclines, carboplatin, cyclophosphamide, and paclitaxel, or to SOC alone.

The INVINCIBLE-4 Study has 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 enrolment using a slightly lower drug-to-tumour volume ratio and a single injection of INT230-6. Prior to the pause, 14 patients were treated, seven 7 with the combination and 7 receiving the SOC alone. Patients receiving INT230-6 prior to the SOC reported a favourable trend towards much fewer overall grade 3 or higher adverse events and immune-related adverse events compared to those patients receiving the SOC alone. An additional 47 patients are planned to be enrolled in the study in Switzerland and France.

INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoural injection. INT230-6 was discovered using Intensity's proprietary DfuseRx technology platform.