Business
Intensity Therapeutics' Reports Up to 100% Tumor Necrosis After One Dose of Lead Asset, INT230-6 in Phase 2 INVINCIBLE Neoadjuvant Breast Cancer Study at the San Antonio Breast Cancer Symposium (SABCS)
Study accepted for a Spotlight Session Poster Presentation WESTPORT, Conn., Dec. 8, 2022 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity"), a
About this update from Intensity Therapeutics, Inc.
[{"type":"text","content":"Study accepted for a Spotlight Session Poster Presentation\nWESTPORT, Conn., Dec. 8, 2022 /PRNewswire/ -- Intensity Therapeutics, Inc. (\"Intensity\"), a clinical-stage biotechnology company focused on the discovery and development of proprietary, first-in-class immune-based cancer therapies designed to kill tumors and increase immune system recognition of cancers, today presented new data from the INVINCIBLE study in a live Spotlight Session Poster Presentation at the San Antonio Breast Cancer Symposium (SABCS) Annual Meeting being held at the Henry B. Gonzalez Convention Center, San Antonio, TX, from December 6-10, 2022.\nThe INVINCIBLE study (NCT 04781725), a phase 2, randomized study that enrolled 91 women with newly diagnosed, operable early-stage intermediate or high-grade T1-T2 invasive breast cancers 2 to 5 weeks prior to surgery (lumpectomy or mastectomy). Drug dose was set by the diameter of the tumor. Subjects were randomly allocated (2:1) prior to resection to 1 to 3 IT injections of INT230-6 versus no treatment (part 1 n=29) or saline sham injection (part 2 n=58). \nINT230-6 demonstrated the ability to cause up to 100% necrosis of presurgical breast cancer tumors in the window period from diagnosis to surgery. Pathway enrichment analysis demonstrated changes in T cell activation, lymphocyte activation and inflammatory response. Analysis is ongoing for part 2 of the clinical trial for changes in Ki67 and other parameters. Adverse events were mostly grade 1 with expected pain at the breast injection site; there were very few systemic adverse effects.\n\"A diagnosis of breast cancer is a traumatic experience for a patient. There is a waiting period prior to surgery that can last for several weeks, which is a stressful time. For the majority of surgical candidates, there are currently no therapeutic options during the waiting period. Surgeons and patients can feel powerless,\" said Angel Arnaout, M.D., Scientist and Surgical Oncologist at the Ottawa Hospital, Professor of Surgery at the University of Ottawa and Co-lead of the Ontario Institute for Cancer Research (OICR) Window-of-Opportunity (WOO) Network. \"INT230-6 a new drug approach where the drug is directly injected into the tumor. The technology uses a dispersion enhancer that can cause high levels of tumor cell death and necrosis in multiple breast cancer subtyp...