Intensity Therapeutics & SAKK Collaborate on Phase 2 Trial for INT230-6 in Early-Stage Breast Cancer

SHELTON, Conn., May 10, 2024 – Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a biotechnology firm in the late stages of clinical development, has announced a new collaboration with The Swiss Group for Clinical Cancer Research SAKK ("SAKK"). This partnership aims to conduct a Phase 2 randomized, controlled trial to evaluate the combined effects of Intensity's intratumoral cancer drug INT230-6 and standard-of-care immuno/chemotherapy against standard immuno/chemotherapy alone in treating early-stage triple-negative breast cancer (TNBC). The trial will involve 54 patients across Switzerland and selected European countries and is named the "INVINCIBLE-4 Study."

SAKK will serve as the "Legal Sponsor" of the study, ensuring compliance with regulatory requirements in Switzerland and the European Union, as outlined in the study protocol. SAKK will also be responsible for informing and training all participants involved in the trial. Intensity Therapeutics will finance the study and supply the investigational drug and necessary resources. The primary goal of the INVINCIBLE-4 Study is to achieve a pathological complete response (pCR) in both the primary tumor and affected lymph nodes. Additional research objectives include analyzing the immune landscape of the tumor microenvironment and peripheral blood, predicting pCR through MRI changes, and monitoring adverse events as per NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Lewis H. Bender, Founder, President, and CEO of Intensity Therapeutics, expressed enthusiasm about the collaboration. He highlighted the significant challenges TNBC presents due to its aggressiveness and high relapse rates. Bender noted that achieving pathological complete response is critical for event-free survival in TNBC patients. He referred to previous successful results from the INVINCIBLE-2 study, where a single dose of INT230-6 resulted in over 95% necrosis in large breast cancer tumors and induced an immune response. By incorporating up to two doses of INT230-6 before standard treatment, Bender hopes to increase the pCR rate, which is an FDA-approved endpoint for accelerated approval. Results from the study are expected in the second half of 2025 and will guide the sizing of a Phase 3 trial in presurgical TNBC.

INT230-6, the leading investigational product from Intensity, is designed for direct intratumoral injection. Developed using the company's DfuseRx℠ technology platform, the drug consists of two potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule (SHAO). This combination helps disperse the cytotoxic agents throughout the tumor, ensuring sustained presence and localized disease control. This method releases neoantigens specific to the patient’s cancer, engaging the immune system without the immunosuppressive effects typical of systemic chemotherapy.

Triple-negative breast cancer (TNBC) constitutes approximately 11-17% of breast cancer cases, marked by the absence of estrogen receptors (ER), progesterone receptors (PR), and excess HER2 protein. TNBC is more aggressive and has a poorer prognosis compared to other breast cancer types due to limited targeted treatment options. Typically, patients with localized TNBC undergo immune/chemotherapy before surgery.

The Swiss Group for Clinical Cancer Research (SAKK) is an esteemed academic research institution that has been conducting cancer treatment trials in major Swiss hospitals since 1965. SAKK coordinates a large network of research groups and collaborates with international partners, particularly on rare cancers. Its mission includes improving existing cancer treatments, exploring new therapies, and establishing new treatment standards. SAKK’s activities are funded by federal subsidies and support from organizations like the Swiss Cancer League and the Swiss Cancer Research Foundation.

Intensity Therapeutics is a late-stage clinical biotech company that employs engineered chemistry to enhance tumor treatment. Its product, INT230-6, has shown promise in killing tumors and eliciting immune responses, potentially transforming deadly cancers into manageable chronic diseases. The company has completed a Phase 1/2 dose escalation trial and a Phase 2 trial in breast cancer, with plans for a Phase 3 trial in soft tissue sarcoma and further studies in TNBC.