On December 8, 2022 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, reported 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 (Press release, Intensity Therapeutics, DEC 8, 2022, View Source [SID1234624973]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The 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).
INT230-6 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.
"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 subtypes. The ability to use 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 desirable. Patient feedback and acceptance of this new approach has been quite positive. We are excited about how this new approach may fundamentally change the treatment for pre-surgical cancer patients. We look forward to completing our INVINCIBLE study data analysis and new studies to demonstrate that this new agent can make a long-term, positive impact in patients with breast cancer."
"The cell death activates an anti-cancer immune response as we see a relative increase in the abundance of CD4 T naïve, B and NK cells, post treatment when comparing drug treated with control samples within the tumor," said Dr. Melanie Spears, Co-Director, Diagnostic Development for OICR and Co-lead of the WOO Network. "This effect could be systemic and further work is in process to determine whether a global immune activation has occurred."
"The demonstration of 100% tumor necrosis in a tumor on a single dose of INT230-6 is unique," said Lewis H. Bender, President, and Chief Executive Officer of Intensity Therapeutics. "These new results from the INVINCIBLE study, coupled with our previously reported data in metastatic patients, provide further evidence and support for the potential of INT230-6 to treat several different and highly prevalent cancer types from before surgery to late stage disease. We look forward to reporting the full data set from the INVINCIBLE study and further development of our pioneering new medicine."
Spotlight Poster Discussion Presentation
Submission ID: 1310100
Poster ID: PD11-02
Poster Title: A Phase II Randomized Window of Opportunity Trial Evaluating Cytotoxic and Immunomodulatory effects of Intratumoral INT230-6 in Early Stage Breast Cancer: the INVINCIBLE Trial
Session Date: Thursday, December 8, 2022
Time: 7:00 AM – 8:15 AM CST
First Author: Angel Arnaout M.D., FACS
Each Spotlight Poster Discussion Session will consist of two to three sub-topic groups of posters, with an independent clinical oncology expert as a discussant for each group, to speak about the posters, followed by questions addressed to the discussant and the poster presenter, Dr. Arnaout.
The presentation will be accessible on the "Publications, Papers and Posters" page of Intensity’s website at: View Source
About INT230-6
INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is composed of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor resulting in a favorable safety profile. In addition to local disease control, direct killing of the tumor by INT230-6 releases a bolus of neoantigens specific to the patient’s malignancy, leading to engagement of the immune system and systemic anti-tumor effects. Importantly, these effects are mediated without the immunosuppression of concomitant systemic chemotherapy.