On the 16th of December, 2021, in Beijing and San Francisco, Cothera Bioscience, the parent company of Percans Oncology, announced that it had successfully completed the first administration for the first patient in the Phase 1/2 clinical trial of CTB-02 for the treatment of pan-KRAS/BRAF mutant colorectal cancer in Australia.
CTB-02 is a first-in-class targeted combination therapy discovered by the i-CR® technology platform that has been independently developed by Cothera Bioscience and clinically verified for the treatment of KRAS/BRAF mutant colorectal cancer. CTB-02 has demonstrated strong inhibitory activity against KRAS/BRAF mutant colorectal cancer in multiple animal models, especially those based on patient transplanted tumor PDX. Colorectal cancer (CRC) is a common malignant tumor disease. According to the statistics, there were nearly two million new cases and one million deaths from this disease worldwide in 2020, among which there were about 560,000 new cases and 290,000 deaths in China. The incidence of colorectal cancer has been significantly increasing in China. KRAS mutation is the most important genetic variation in colorectal cancer, and has been detected in 40% of patients with metastatic colorectal cancer (mCRC). KRAS mutations may lead to sustained activation of the RAS-RAF-MEK pathway, resulting in tumor resistance to EGFR monoclonal antibodies. In CRC, KRAS mutations are significantly associated with resistance to EGFR-targeted drugs such as cetuximab. BRAF is a component of the RAS-RAF-MEK signaling pathway. About 10% of mCRC patients have BRAF activation mutations that are mutually exclusive with KRAS mutations. BRAF mutations, mostly the V600E subtype, have been demonstrated to be associated with a poor overall prognosis in studies.
"This is the first clinical trial of CTB-02," said Dr. Chun Jiang, cofounder of Cothera Bioscience and the executive vice president leading product development. “KRAS mutant colorectal cancer currently has no approved targeted therapies and there is a huge unmet clinical need. CTB-02 has presented an effect not only on KRAS G12C mutant colorectal cancer, but also on other KRAS mutations in cells as well as CDX and PDX animal experiments. We are fully committed to advancing this clinical trial and expect CTB-02 to lead to a breakthrough in the treatment of patients with KRAS/BRAF mutant colorectal cancer."