Business
Intensity Therapeutics Reports Second Quarter 2024 Financial Results and Provides Corporate Update
First patient dosed in global randomized, Phase 3 study in metastatic soft tissue sarcomaCollaboration agreement with The Swiss Group for Clinical Cancer
About this update from Intensity Therapeutics, Inc.
[{"type":"text","content":"First patient dosed in global randomized, Phase 3 study in metastatic soft tissue sarcomaCollaboration agreement with The Swiss Group for Clinical Cancer Research SAKK (\"SAKK\") to conduct a Phase 2 randomized, study in early-stage breast cancer in EuropeCash and investments of $6.3 million expected to fund operations into the first quarter of 2025SHELTON, Conn., Aug. 8, 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 second quarter 2024 financial results and provides a corporate update.\n\n \n \n \n \n \n \n\n \nCorporate Update\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, Intensity's lead drug candidate, as a monotherapy compared to the standard of care (\"SOC\") drugs in second- and third-line treatment for certain soft tissue sarcoma subtypes. The Company plans to enroll 333 patients with an endpoint of overall survival and has screened and qualified over 50 sites for the INVINCIBLE-3 Study. Contract negotiations are in process to approve and activate these sites, which is estimated to take up to six months per site.In May 2024, the Company executed a collaboration agreement with SAKK to conduct a Phase 2 randomized, controlled study (the \"INVINCIBLE-4 Study\") evaluating clinical and biological effects of INT230-6 followed by SOC vs. SOC alone in early-stage triple-negative breast cancer. The Company plans to enroll 54 to 60 patients in Europe. The INVINCIBLE-4 Study endpoint is the change in the pathological complete response rate for the combination compared to the SOC alone. The Company expects that the data from INVINCIBLE-4 Study will provide data to size a follow-on Phase 3 study. The Company is in the process of screening and qualifying sites for the INVINCIBLE-4 Study, and plans to initiate the study in the third quarter of 2024.In May 2024, the Company appointed Thomas Dubin, J.D., MPH, to the Intensity board of directors, increasing the size of the board to five members. Mr. Dubin has extensive pharmaceutical business deve...