Revolutionizing Cancer Treatment: Brenus Pharma Unveils STC-1010 at ASCO 2024, Targets Advanced Colorectal Cancer

Building on STC-1010's comprehensive preclinical testing across various models including in vivo, in ovo, and ex vivo, the BreAK-CRC study will commence at 9 early phase oncology centers across the EU and US. These centers feature leading investigators specializing in immunotherapy..

François Ghiringhelli (M.D,PhD) Director of early clinical unit CLIPP2 and BreAK-CRC study coordinator, Centre Georges-François Leclerc, University of Burgundy, Dijon, France said that “Cancer vaccines continue to show promising clinical results in solid tumors. STC-1010, is a new immunotherapeutic approach based on cancer vaccine mechanism of action for colorectal cancer patients. In that, “BreAK-CRC” Study is eagerly expected. CRC is still challenging as current immunotherapies were found only active in dMMR/MSI-H “hot” CRC. For the pMMR/MSS population, representing 95% of patients with CRC, there is an important medical need for drugs likely to heat up “cold” tumors and have a real impact for the patient.”

The BreAK-CRC trial protocol underwent a pre-submission meeting with the French National Health Authority. The process of submitting the Clinical Trial Application (CTA) through the European Union's clinical trial information system is currently in progress. This Phase I/IIA clinical trial aims to assess the safety and effectiveness of STC-1010 in patients suffering from unresectable advanced or metastatic colorectal cancer, which is the second leading cause of cancer-related deaths globally.

Phase I of the study will investigate how well two different doses of STC-1010, when used with low-dose immunostimulants and standard chemotherapy (SoC), are tolerated by patients. Phase IIA will then enroll patients to study the effectiveness of this treatment, with a specific focus on the rate of non-progression at 12 months. Exploratory analysis will also look into the immune response and changes in ctDNA over time.

Brenus Pharma developed a pioneering discovery platform, Stimulated-Tumour-Cell (STC), leading the way of a new generation of active immunotherapies against cancer. STC Platform mimics patients' relapsing conditions in vitro to educate the patient’s immune system against tumor evolution and mechanisms of relapse. The STCs will educate the immune system to 200+ specific targets of interest, validated by multi-omics analysis and patient biopsies databases.