Brenus Pharma, French biotech developing its proprietary discovery platform: "Stimulated-Tumor-Cell" (STC), has presented the study design of "BreAK-CRC" First-in-human of STC-1010, Brenus' lead candidate, during ASCO annual meeting (31st May 4th June 2024) Trials in Progress poster session, in Chicago.
Poster here. Benoit You et al. Journal of Clinical Oncology 42, TPS3635-TPS3635(2024). DOI:10.1200/JCO.2024.42.16_suppl.TPS3635
Authors information's: here.
Based on STC-1010' robust preclinical package in vivo, in ovo, ex vivo, BreAK-CRC study will be launched in 9 oncology early phase centers (EU, US) with expert investigators in immunotherapy:
"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." 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.
BreAK-CRC trial protocol has been reviewed in pre-submission meeting with the French National Health Authority. The submission of the CTA through the clinical trial information system of the European union is ongoing.
The Phase I/IIA clinical trial, aims to evaluate the safety and efficacy of STC-1010 in patients with unresectable advanced or metastatic colorectal cancer, 2nd cause of cancer mortality worldwide.
The Phase I will assess the tolerability of two dose levels of STC-1010, combined with low-dose immunostimulants and standard of care chemotherapy (SoC). The Phase IIA will enroll patients to further evaluate the treatment's efficacy, particularly focusing on 12-month non-progression rate.
Exploratory analysis will evaluate the immune response and the ctDNA dynamic.
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About Brenus Pharma:
Brenus Pharma developing a pioneering discovery platform, Stimulated-Tumor-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.
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