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 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.

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: https://intensitytherapeutics.com/news/publications-papers-and-posters/.

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.

About Intensity Therapeutics' Clinical Studies
INT230-6 is currently being evaluated in patients with various advanced refractory solid tumor cancers as part of Study IT-01 (NCT 03058289). In 2019, the Company signed a clinical collaboration agreement with Merck Sharpe & Dohme (Merck) to evaluate the combination of INT230-6, Intensity's lead product candidate, and KEYTRUDA^® (pembrolizumab), Merck's anti-PD-1 (programmed death receptor-1) therapy in a variety of cancers. In 2020, the Company executed a clinical collaboration agreement with Bristol-Myers Squibb to evaluate the combination INT230-6, with Bristol-Myers Squibb's anti-CTLA-4 antibody, Yervoy^® (ipilimumab), in patients with a variety of cancers. Intensity is managing the individual combination arms separately with each respective partner via a joint development committee. In 2021, the Company executed agreements with the Ottawa Hospital Research Institute (OHRI) and the Ontario Institute for Cancer Research (OICR) to study INT230-6 in a randomized controlled neoadjuvant phase 2 study in women with early stage breast cancer (the INVINCIBLE study) (NCT 04781725). Enrollment is both studies is now complete.

About Intensity Therapeutics
Intensity Therapeutics, Inc. is a clinical-stage biotechnology company pioneering a new immune-based approach to treat solid tumor cancers. Intensity leverages its DfuseRx℠ technology platform to create new, proprietary drug formulations that, following direct injection, rapidly disperse throughout a tumor and diffuse therapeutic agents into cancer cells. Intensity's product candidates have the potential to cause tumor necrosis and induce an adaptive immune response that not only attacks the injected tumor, but also non-injected tumors. In addition to partnerships with Merck and Bristol-Myers Squibb, the Company executed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute's (NCI) Vaccine Branch in 2014. For more information, please visit www.intensitytherapeutics.com and follow the Company on Twitter @IntensityInc.

Forward-Looking Statements
Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These statements include, but are not limited to, statements relating to the expected trading commencement and closing dates. We have based these forward-looking statements on our current expectations and projections about future events, nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, include: the risk that an initial public offering of common stock may not close, as well as other risks described in the section entitled "Risk Factors" in an S-1/A, which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.

YERVOY^® is a trademark of Bristol-Myers Squibb Company

Contact Information

Investor Relations Contact:
Rx Communications Group
Michael Miller
(917)-633-6086
[email protected]

US Media Contact:
KOGS Communication
Edna Kaplan
+1 781 639 1910
[email protected]

SOURCE Intensity Therapeutics, Inc.