On June 13, 2024 Brenus Pharma, French biotech developing its proprietary discovery platform: "Stimulated-Tumor-Cell" (STC), reported it has presented the study design of "BreAK-CRC" First-in-human of STC-1010, Brenus’ lead candidate, during ASCO (Free ASCO Whitepaper) annual meeting (31st May – 4th June 2024) – Trials in Progress poster session, in Chicago (Press release, Brenus Pharma, JUN 13, 2024, View Source [SID1234644321]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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.