On June 11, 2025 Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or the "Company"), 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, reported first few patients receiving INT230-6 achieved high levels of necrosis after 8 days in the Phase 2, INVINCIBLE-4 study, before they initiated the standard-of-care regimen (Press release, Intensity Therapeutics, JUN 11, 2025, View Source [SID1234653822]).
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The INVINCIBLE-4 Study is a randomized, open-label, multicenter study to determine the clinical activity, safety, and tolerability of INT230-6 in patients with early-stage, operable triple-negative breast cancer ("TNBC") who undergo standard of care neoadjuvant immunochemotherapy ("SOC") treatment and SOC alone. The primary endpoint is pathological complete response ("pCR"), i.e., the absence of live cancer in the primary tumor and affected lymph nodes. Patients are being randomized one-to-one to receive either a regimen of two doses of INT230-6 followed by SOC, which consists of pembrolizumab, anthracyclines, carboplatin, cyclophosphamide, and paclitaxel (i.e., the Keynote-522 regimen), or SOC alone. The study is recruiting patients in Switzerland and France and is expected to enroll 54 patients.
"We are encouraged to see high levels of tumor necrosis from the MRI scans and evidence of tumor inflammation after two INT230-6 injections and before initiation of the SOC in our first patients," said Ursina Zürrer, M.D. Chief Physician for Genetic Counseling, Department of Medical Oncology and Hematology Cantonal Hospital Winterthur, Switzerland, and the Coordinating Investigator for the INVINCIBLE-4 Study. "We are encouraged that these patients achieved such a good response to INT230-6 prior to their beginning the Standard immune-chemo regimen and look forward to continuing enrollment in the study."
"We are excited to see that INT230-6 is achieving meaningful levels of necrosis in patients with evidence of immune activation. TNBC Patients who have no live cancer in their tumor or nodes at the time of surgery have a significantly improved event-free survival advantage compared to those who do not have a pathological complete response. TNBC patients risk their lives to achieve a pCR, and about forty percent fail to achieve the desired result. We look forward to seeing the pathological complete response data being generated by our partners at SAKK and Unicancer," said Lewis H. Bender, President and CEO of Intensity.
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 comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell 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 and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.
About Triple Negative Breast Cancer in the Presurgical Setting
Women with aggressive forms of breast cancer, such as TNBC, are often counseled to undergo pre-surgical (neoadjuvant) systemic therapy in advance to reduce the risk of the disease returning. Having a pathological complete response, meaning the absence of live cancer at the time of surgery, has been shown to result in a lower risk of recurrence. Approximately 11-17% of breast cancers test negative for estrogen receptors (ER), progesterone receptors (PR), and overexpression of human epidermal growth factor receptor 2 (HER2) protein, qualifying them as triple negative. There are approximately 56,000 new cases of TNBC in the US and 420,000 Worldwide diagnosed each year, the majority of which are local to the breast. TNBC is considered to be more aggressive and has a poorer prognosis than other types of breast cancer, because there are fewer available targeted medicines. Most patients with local TNBC typically receive immune/chemotherapy before surgery. Since the publication of Keynote-522, the standard neoadjuvant treatment for TNBC includes systemic chemotherapy (anthracyclines, cyclophosphamide, paclitaxel, carboplatin) and the anti-PD-1 monoclonal antibody pembrolizumab. pCR rates are 65%, with rates generally lower in the larger-sized tumors or with lymph node metastasis. The toxicity of the Keynote-522 regimen is high, with 80% of patients experiencing grade 3 or higher treatment-related AEs, including treatment-related adverse events that lead to death in 0.5% of patients.