First patient dosed in randomized, Phase 2 study in presurgical triple negative breast cancer SHELTON, Conn. , Nov. 13, 2024 /PRNewswire/ -- Intensity Therapeutics, Inc.
("Intensity" or "the Company") (Nasdaq: INTS ), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, announces third quarter 2024 financial results and provides a corporate update. Corporate Update INVINCIBLE-3 Study : a Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in second and third line treatment for certain soft tissue sarcoma subtypes. The INVINCIBLE-3 Study is expected to enroll 333 patients and initiate sites in eight countries.
The primary endpoint in the INVINCIBLE-3 Study is overall survival. July 2024 : the first patients were dosed in the U.S.
in the INVINCIBLE-3 Study. July 2024 : authorization received from Health Canada to initiate the INVINCIBLE-3 Study in Canada . September 2024 : authorization received from The European Medicines Agency to initiate the INVINCIBLE-3 Study in Europe .
October 2024 : authorization received from Australia's Therapeutic Goods Administration to initiate INVINCIBLE-3 Study in Australia . INVINCIBLE-4 Study : a Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before admini.
