Business
Intensity Therapeutics Provides Business Update Highlighting Key Achievements with Lead Drug Candidate INT230-6
The US FDA, Health Canada, European Medicines Authority, and the Australian Therapeutic Goods Administration authorized the Company's global, randomized Phase
About this update from Intensity Therapeutics, Inc.
[{"type":"text","content":"The US FDA, Health Canada, European Medicines Authority, and the Australian Therapeutic Goods Administration authorized the Company's global, randomized Phase 3 study (INVINCIBLE-3) in Metastatic Soft Tissue SarcomaTwenty-three sites are currently contracted in the INVINCIBLE 3 study, and several sites have treated patientsSeven Swiss sites are activated in the Phase 2 (INVINCIBLE-4) study for early-stage, operable Triple Negative Breast Cancer (\"TNBC\"), and several patients have been treatedSHELTON, Conn., Jan. 10, 2025 /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, today announces a business update highlighting key achievements with its lead drug candidate INT230-6. \n\n \n \n \n \n \n \n\n \nBusiness Development\nDiscussions with multiple companies regarding potential strategic collaborations and licenses in various territories for INT230-6 initiated in 2024. While term sheets may be negotiated, there is no assurance that any ongoing discussions, negotiations, or due diligence processes will result in definitive agreements, partnerships, collaborations, or relationships.\nSarcoma INVINCIBLE-3\nIn July 2024, the Company initiated and dosed its first patient in a Phase 3 open-label, randomized study (the \"INVINCIBLE-3 Study\") testing INT230-6 as a monotherapy compared to the standard of care (\"SOC\") drugs in second-and third-line treatment for certain soft tissue sarcoma subtypes. This study has been authorized by the US FDA, Health Canada, the European Medicines Authority, and Australia's Therapeutics Goods Administration. The trial is enrolling and being conducted in eight countries: the US, Australia, Canada, France, Germany, Italy, Poland, and Spain. Up to 62 sarcoma-focused hospitals and other centers are expected to participate from these countries.\nIn November 2024, the Company presented INT230-6 Phase 1/2 data in a late-breaking session at the 2024 Annual Connective Tissue Oncology Society Meeting (CTOS). These data showed a median overall survival (\"mOS\") of 21.3 months versus a synthetic control of 6.7 months, an increase in T-cell activati...