Intensity Therapeutics and SAKK to Collaborate on Phase 2 Breast Cancer Trial in Europe for INT230-6

Intensity Therapeutics, Inc., a late-stage clinical biotechnology firm, has announced a Phase 2 clinical trial in collaboration with The Swiss Group for Clinical Cancer Research (SAKK). This trial focuses on early-stage triple-negative breast cancer (TNBC) and involves 54 patients across Switzerland and selected European countries. The study, named INVINCIBLE-4, will compare the effects of Intensity’s investigational drug INT230-6 combined with the standard care regimen (immuno/chemotherapy) against the standard care alone.

SAKK will act as the legal sponsor of the study, overseeing regulatory requirements in Switzerland and the European Union. They will also ensure that all involved investigators and personnel are properly trained. Intensity Therapeutics will be responsible for funding the study and providing the investigational drug and necessary information.

The primary goal of the INVINCIBLE-4 trial is to achieve pathological complete response (pCR) in the primary tumor and affected lymph nodes. The study will also assess the immune landscape of the tumor microenvironment and peripheral blood, MRI changes predictive of pCR, and adverse events using the National Cancer Institute’s criteria.

Lewis H. Bender, Founder, President, and CEO of Intensity Therapeutics, expressed enthusiasm about the partnership with SAKK, noting the significant challenges posed by TNBC due to its aggressiveness and high relapse rates. The goal is to improve pCR rates, which are crucial for event-free survival. Previous studies with INT230-6 showed promising results, including over 95% necrosis in large breast cancer tumors following a single dose, coupled with an immune response. The company aims to increase pCR rates by adding up to two doses of INT230-6 before the standard care regimen, with hopes of accelerated approval by the FDA. The expected data from this study in the second half of 2025 will inform the Phase 3 trial in presurgical TNBC.

INT230-6, the lead investigational product of Intensity Therapeutics, is designed for direct intratumoral injection. It includes two potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule (SHAO), which helps distribute the drugs throughout tumors. This approach not only targets local disease but also prompts systemic anti-tumor effects by releasing neoantigens specific to the patient’s malignancy.

Triple-negative breast cancer, accounting for approximately 11-17% of breast cancers, is characterized by the absence of estrogen, progesterone receptors, and excess HER2 protein. TNBC is generally more aggressive and has fewer treatment options compared to other breast cancer types.

SAKK is an academic research institute that has been conducting cancer treatment trials in Swiss hospitals since 1965. It coordinates clinical operations and collaborates with international groups, especially on rare cancers. SAKK’s mission is to improve existing treatments, test new ones, and set new standards in cancer care.

Intensity Therapeutics focuses on developing treatments that turn “cold” tumors “hot” by enabling its drug product, INT230-6, to saturate the tumor environment. This novel approach has shown promise in eliciting an adaptive immune response and potentially shifting the treatment paradigm for various cancers. The company has completed significant patient enrollment in multiple trials and is planning further studies, including a Phase 3 trial in soft tissue sarcoma and a Phase 2/3 program in presurgical TNBC.

This collaboration and the upcoming INVINCIBLE-4 trial represent a significant step towards advancing cancer treatment, particularly for challenging cases like TNBC.