Intensity Therapeutics, Inc. (INTS) reported encouraging early results from its Phase 2 INVINCIBLE-4 presurgical study in triple-negative breast cancer (TNBC), with patients receiving INT230-6 before standard therapy showing notably higher complete tumor-response rates than those on standard care alone.
Preliminary data show that 71.4% of patients who received INT230-6 prior to standard immunochemotherapy achieved a pathological complete response (pCR)- meaning no detectable cancer at surgery-compared with 33% in the standard-of-care arm, with one patient still awaiting evaluation. The company also reported 44% fewer severe (grade 3 or higher) adverse events in the INT230-6 group, suggesting a potential safety advantage.
Enrollment in the study had been paused in late 2025 due to skin-related reactions, but Intensity has now submitted a protocol amendment to Swiss medic and the Swiss Ethics Committee to resume dosing using a lower drug-volume ratio and a single injection approach.
INVINCIBLE-4 is evaluating INT230-6-an intratumoral therapy designed to saturate tumors with potent anti-cancer agents-alongside the Keynote-522 regimen, the current presurgical standard for TNBC. Achieving pCR is considered a meaningful predictor of long-term outcomes and is recognized by regulators, including the FDA, as a potential basis for accelerated approval in high-risk breast cancer.
The study's primary endpoint is pathological complete response (pCR), an FDA-recognized accelerated-approval measure in early-stage breast cancer.
To date, 14 patients have been treated across both study arms, with total enrolment expected to reach up to 61 patients. Intensity plans to present more detailed data from Cohort A at an upcoming oncology conference.
CEO Lewis Bender said the early findings are "promising," highlighting both the higher response rates and the reduction in severe immune-related side effects when INT230-6 is added to standard therapy. He noted that TNBC remains one of the most aggressive breast-cancer subtypes, making improvements in safety and tumor clearance particularly meaningful.
INTS has traded between $4.62 and $62.50 over the past year. The stock closed Wednesday's trading session at $7.91, up 2.46%. In pre-market trading, the stock rose further to $8.20, up 3.67%.
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