Intensity Therapeutics, Inc. today announced that data from its INVINCIBLE study was presented on June 4, at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago and virtually from June 2-6, 2023.
| INT230-6 Induced T-Cell Receptor Signaling, Macrophage Markers, and IL-18 and B-Cell Receptor Signaling Data Was Presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting on June 4, 2023 WESTPORT, Conn., June 6, 2023 /PRNewswire/ -- Intensity Therapeutics, Inc. (“Intensity”), a clinical-stage biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral (IT) cancer therapies designed to kill tumors and increase immune system recognition of cancers, today announced that data from its INVINCIBLE study was presented on June 4, at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago and virtually from June 2-6, 2023. The INVINCIBLE study is a phase 2, randomized, open label, multi-center study that enrolled 91 women with newly diagnosed operable early-stage intermediate or high-grade T1-T2 invasive breast cancers who were randomly allocated (2:1) prior to resection to IT injections of INT230-6, no treatment or saline sham injection. The study is evaluating clinical and biological effects in patients with early-stage operable breast cancer. The study presented new immune and gene activation related results as well as data demonstrating efficacy and tolerability of INT230-6. Abstract Title: A phase 2 randomized window of opportunity trial evaluating cytotoxic and immunomodulatory effects of intratumoral INT230-6 in early stage breast cancer: The INVINCIBLE Trial. Copies of the presentation materials are available on Intensity’s website on the publications, papers and posters page. “For the majority of breast cancer patients, the typical waiting period of 2-6 weeks from diagnosis to surgery is a very fearful time. Surgeons and patients feel powerless, as there are currently no therapeutic options for the patient prior to the surgery,” said Angel Arnaout, M.D., Scientist and Surgical Oncologist at the Ottawa Hospital, and Professor of Surgery at the University of Ottawa and Co-lead of the Ontario Institute for Cancer Research (OICR) WOO Network. “We have previously reported that the active drug agents comprising INT230-6 cause tumor cell death and high levels of necrosis in multiple breast cancer subtypes including triple negative breast cancer following direct intratumoral injection. The ability, with just one or two doses of this agent, to elicit a rapid and marked cytotoxic and immune induction response within the tumor during the surgical waiting period, all without an increase in postoperative complications, is very novel and highly attractive to patients. For the first time, there is the possibility that patients will have a treatment that can ignite the immune system prior to lumpectomy or mastectomy that may protect the patient from disease recurrence. We look forward to future studies to demonstrate that INT230-6 intratumoral injections can create a positive, long term clinical benefit for patients with breast cancer. As a surgeon, I am excited about how this new drug may shift the way we treat all cancer patients awaiting surgery, in general.” “From Part 2 of our study, we saw an increase in expression levels of dendritic cells, macrophages and CD4 T cells, post treatment, when comparing patients treated with drug with the control group,” said Dr. Melanie Spears, Co-Director of Diagnostic Development, OICR and Co-lead of the WOO Network. “The cell death activates an anti-cancer immune response as evidenced by relative increase in the abundance of CD4 T naïve, B and NK cells, post treatment when comparing treated patients with the control group. Further work is currently in process to determine whether a global immune activation has occurred.” “INT230-6 has novel mechanism of action and is a potential, new weapon in the war on cancer. This drug can cause extensive necrosis with favorable clinical results as a monotherapy in presurgical and metastatic patients with advanced, relapsed and refractory disease,” stated Lewis H. Bender, President and Chief Executive Officer of Intensity. “These new results reported from the INVINCIBLE breast cancer study provide further evidence and support for the potential of our drug in treating local disease prior to surgery. Specifically, the data from Part 2 of the INVINCIBLE study show that INT230-6 elicits both rapid direct tumor killing and immune activating effects. Having completed enrollment, we look forward to concluding the analysis and reporting the full patient study results in the future.” About INT230-6 About the INVINCIBLE Study About Potential INT230-6 Approval Pathways in the Presurgical Setting Data from the INVINCIBLE study has provided an understanding of the effect of INT230-6 on cancer cell proliferation and tumor necrosis. INT230-6 causes increased tumor necrosis with good safety, and the addition of INT230-6 to the existing or a modified neoadjuvant (presurgical) systemic standard-of-care treatment regimen may increase pCR rates in TNBC or HER+ patients. In November of 2020, Intensity Therapeutics met with FDA and discussed the potential use of INT230-6 in the presurgical neoadjuvant breast cancer setting in an accelerated approval program. A new meeting with the FDA is being planned. About Intensity Therapeutics’ Clinical Studies About Intensity Therapeutics Forward-Looking Statements Contact Information Investor Relations Contact: US Media Contact:
SOURCE Intensity Therapeutics, Inc. | ||
Company Codes: NASDAQ-NMS:INTS |
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