On May 10, 2024 Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), 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 that the Company executed a collaboration agreement with The Swiss Group for Clinical Cancer Research SAKK ("SAKK") to conduct a Phase 2 randomized, (one to one), controlled trial evaluating clinical and biological effects of intratumoral INT230-6 followed by the standard of care ("SOC") immuno/chemotherapy vs. SOC immune/chemotherapy alone in early-stage triple-negative breast cancer ("TNBC") in 54 patients in Switzerland and selected countries in Europe (the "INVINCIBLE-4 Study") (Press release, Intensity Therapeutics, MAY 10, 2024, View Source [SID1234643093]). The INVINCIBLE-4 Study is an open-label randomized two-cohort phase 2 clinical trial.
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SAKK shall undertake the trial as the "Legal Sponsor" of the study, with the regulatory agencies in Switzerland and the European Union as described in the study protocol. SAKK will also ensure that all investigators and personnel who participate in the study are informed and trained. Intensity shall fund the study, provide the investigational drug product, and other necessary information to conduct the trial. The primary efficacy endpoint of the INVINCIBLE-4 Study is pathological complete response (pCR) in the primary tumor (ypT0/Tis) and affected lymph nodes (ypN0). Additional key research questions include the immune landscape of the tumor microenvironment and peripheral blood, magnetic resonance imaging (MRI) changes predictive for pCR, and adverse events according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
"We are excited to be working with SAKK on our INVINCIBLE-4 Study in early-stage triple-negative breast cancer," said Lewis H. Bender, Founder, President and CEO of Intensity Therapeutics, Inc. "TNBC poses significant challenges due to its aggressiveness, high relapse rates, and increased mortality especially in patients with large tumors. Achieving pathological complete response (pCR) and clearing positive lymph nodes are crucial prognostic factors for event-free survival. Results from our first INVINCBLE-2 study showed that INT230-6 could cause greater than 95% necrosis in large breast cancer tumors following a single dose with the induction of an immune response. By adding up to 2 doses of our unique drug before the standard of care, we hope to increase the rate of patients’ pCR, which is an FDA-approved endpoint for accelerated approval. The pCR data from this study, which we expect in the second half of 2025, should provide the information needed to size our Phase 3 trial in presurgical TNBC."
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 immunosuppression that so often occurs with systemic chemotherapy.
About Triple Negative Breast Cancer
Approximately 11-17% of breast cancers test negative for estrogen receptors (ER), progesterone receptors (PR), and excess human epidermal growth factor receptor 2 (HER2) protein, qualifying them as triple negative. TNBC is considered to be more aggressive and has a poorer prognosis than other types of breast cancer, mainly because there are fewer available targeted medicines. Most patients with local TNBC typically receive immune/chemotherapy before surgery.