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Intensity Therapeutics, Inc. Provides Update on the Phase 2 Presurgical Triple-Negative Breast Cancer INVINCIBLE-4 Study
Preliminary observations of the INVINCIBLE-4 Study to date showed that five (5) out of seven (7) patients (71.4%) who received INT230-6 prior to standard of
About this update from Intensity Therapeutics, Inc.
[{"type":"text","content":"Preliminary observations of the INVINCIBLE-4 Study to date showed that five (5) out of seven (7) patients (71.4%) who received INT230-6 prior to standard of care (\"SOC\") (\"Cohort A\") achieved a pathological complete response (\"pCR\") whereas two (2) out of six (6) (33%) patients in the SOC arm alone (\"Cohort B\") achieved a pCR, with one patient still to be evaluated. Forty-four percent (44%) fewer grade 3 or higher Adverse Events (\"AEs\") were observed in Cohort A compared to Cohort B.A protocol amendment has been submitted to the Swiss Agency for Therapeutic Products (\"Swissmedic\"), Switzerland's regulatory authority, and the Swiss Ethics Committee to resume enrollment.SHELTON, Conn., March 12, 2026 /PRNewswire/ -- Intensity Therapeutics, Inc. (Nasdaq: INTS) (\"Intensity\" or \"the Company\"), a late-stage clinical biotechnology company focused on the discovery and development of proprietary cancer therapies using its non-covalent, drug-conjugation technology that creates drug products designed to kill tumors and increase immune system recognition of cancers, provided an update on the INVINCIBLE-4 Study. In September 2025, enrollment was paused by the Company due to skin irritations observed in Cohort A. In early March 2026, a protocol amendment was submitted to Swissmedic and the Swiss Ethics Committee to resume enrollment using a lower drug volume per tumor volume ratio and a single injection of INT230-6.\n \n \n \n \n \n \n \nThe SOC in the INVINCIBLE-4 Study is the Keynote-522 study regimen, a 6-month presurgical treatment consisting of pembrolizumab every three weeks, then paclitaxel, followed by carboplatin and 4 doxorubicin or epirubicin with cyclophosphamide. The INVINCIBLE-4 Study enrollment criteria is limited to patients with tumors sizes ≥ 1.5 cm, whereas the Keynote-522 study enrolled tumors > 1.0 cm. As a result, patients in the INVINCIBLE-4 Study, on average, have larger tumors than patients in the Keynote-522 study. Patients undergo the Keynote-522 regimen in an attempt to obtain a pCR, which has been shown to significantly reduce the risk of disease recurrence. pCR is an endpoint that the U.S Food and Drug Administration (\"FDA\") and the European Medicines Agency could allow for an accelerated or conditional marketing approval.Overall, fourteen (14) patients have been treated to date in the INVINCIBL...