ASCO 2024: Brenus Pharma's STC-1010 Cancer Vaccine Phase I/IIA Trial for mCRC

Brenus Pharma, a French biotechnology company, has showcased its pioneering work on a novel cancer immunotherapy approach at the ASCO annual meeting held from May 31 to June 4, 2024, in Chicago. The company's leading candidate, STC-1010, was the focus of a study design presentation for the "BreAK-CRC" trial, a first-in-human clinical study targeting colorectal cancer.

STC-1010 is the product of Brenus Pharma's proprietary Stimulated-Tumor-Cell (STC) platform. This innovative platform is designed to educate the patient’s immune system to recognize and fight cancer cells by simulating the tumor's environment in vitro. The mechanism involves exposing the immune system to over 200 specific targets associated with tumor evolution and relapse, as validated by advanced multi-omics analyses and patient biopsy databases.

The "BreAK-CRC" study is particularly significant given the current therapeutic landscape for colorectal cancer (CRC). Existing immunotherapies have shown efficacy primarily in a small subset of CRC patients with dMMR/MSI-H “hot” tumors. However, a substantial majority of CRC patients (approximately 95%) have pMMR/MSS “cold” tumors, which are less responsive to these treatments. François Ghiringhelli, M.D., Ph.D., Director of the early clinical unit CLIPP2 and coordinator of the BreAK-CRC study at the Centre Georges-François Leclerc, emphasized the urgent need for treatments that can effectively target these “cold” tumors and provide substantial benefits for a broader patient population.

The clinical trial protocol for BreAK-CRC has undergone a pre-submission review with the French National Health Authority, and the process for submitting the Clinical Trial Application (CTA) to the European Union's clinical trial information system is currently underway. The Phase I/IIA clinical trial is designed to assess both the safety and efficacy of STC-1010 in patients with unresectable advanced or metastatic colorectal cancer, which remains the second leading cause of cancer-related mortality worldwide.

The trial will be conducted in two phases. Phase I will focus on evaluating the tolerability of two different dose levels of STC-1010, which will be administered in combination with low-dose immunostimulants and standard chemotherapy (SoC). Phase IIA will further investigate the efficacy of the treatment by enrolling additional patients and measuring outcomes such as the 12-month non-progression rate. Additionally, exploratory analyses will examine the immune response and the dynamics of circulating tumor DNA (ctDNA) to gain deeper insights into the treatment's impact.

Brenus Pharma's innovative STC platform represents a new generation of active immunotherapies against cancer, poised to address significant unmet medical needs. By simulating the conditions of tumor relapse in vitro, the STC platform aims to educate the patient’s immune system effectively, offering hope for more effective cancer treatments.

In summary, Brenus Pharma's presentation at the ASCO annual meeting marks a significant milestone in the development of STC-1010. The BreAK-CRC study holds promise for advancing the treatment of colorectal cancer, particularly for patients with "cold" tumors who currently have limited therapeutic options. As the trial progresses, the oncology community eagerly anticipates the potential breakthroughs that this novel immunotherapeutic approach may bring.