SYN004, an Anti-Colorectal Cancer Antibody Drug Received IND Approval from CFDA
China National Food and Drug Administration (CFDA) has approved IND application of SYN004, an anti-colorectal Cancer Antibody for a Clinical Phase I study.
SYN004, a monoclonal antibody biological drug for the treatment of patients with K-ras mutation-negative (wild-type), EGFR-expressing metastatic colorectal cancer (mCRC), targets cancer cell EGFR, therefore, to inhibit or kill cancer cells. SYN004 and Erbitux (Cetuximab) listed by Merck Pharmaceutical (Merck KGaA) share similar characteristics in many studies of physicochemical properties and biological activities. In animal disease model, both SYN004 and Erbitux have shown a significant inhibition on tumor growth. Toxicology study in non-human primate did not show any toxicity, and SYN004’s pharmacokinetic properties are similar with Erbitux.
Founded in December 2013, Synermore Biologics Co. Ltd. has established a large number of the state-of-the-art technologies and platforms necessary for the development and production of therapeutic monoclonal antibodies, focusing on innovative biologics and high commercial potential biosimilars. The company is committed to providing effective medicines for the unmet medical need therefore contributing to human health and the economic development of Great China.
SYN004 is a monoclonal antibody biological drug for the treatment of epidermal growth factor receptor expressing (EGFR expressing) and KRAS wild-type metastatic colorectal cancer, targeting EGFR on cancer cells to inhibit or kill cancer cells. SYN004 and Merck Pharmaceutical (Merck KGaA) listed products Erbitux (Cetuximab) show similar characteristics in many physicochemical properties and biological activities. Animal disease model also showed that both SYN004 and Erbitux have significant inhibition of tumor growth and similar pharmacokinetic properties, toxicology study in non-human primate did not observe any toxicity, and SYN004’s pharmacokinetic properties are similar with Erbitux.
Erbitux® has been approved by FDA in US for use in combination with FOLFIRI (irinotecan, 5-fluorouracil, and leucovorin) for first-line treatment of patients with K-ras mutation-negative (wild-type), EGFR-expressing metastatic colorectal cancer (mCRC). In combination with radiotherapy, it has also been approved for locally advanced oropharyngeal cancer, hypopharyngeal cancer and laryngeal cancer. In another combination with platinum-based therapy plus 5-florouracil (5-FU), it has been approved for the first-line treatment of patients with recurrent locoregional disease and/or metastatic squamous cell carcinoma of the head and neck. However, as the original biological drugs are known to be expensive, SYN004, through completion of clinical trials and the successful market approval, will provide patients the similar biological therapeutic drug in the future.
It is expected to benefit many patients with lower medical expense, and reduce the burden of health insurance. Synermore has possessed the key technology of SYN004. In January 9, 2015, FDA has approved IND application of SYN004 clinical phase I study, and currently the study in the United States is in intensive preparation. It is expected that all participants will be enrolled and admitted, and the treatment will be completed by the end of 2017. Synermore has also obtained IND approval from CFDA. Synermore planned to produce and sell this biologics medicine in China in the future. According to Merck's big pharma report, Erbitux global sales have reached about $200 million in 2016. The market is huge, and SYN004 is expected to create considerable revenue for the company.