SillaJen_신라젠 has signed a cooperative research and development agreement with the U.S. National Cancer Institute (NCI) to develop colorectal cancer treatments in the United States.

The deal will start clinical trials that target 35 patients with metastatic microsomal stabilized (MSS) colorectal cancer who did not fully recover after a tumor excision. The agreement signals the first for a Korean company to partner with a U.S. government agency in immuno-oncology.

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The phase 1 and 2 trials will compare PexaVec-Durvalumab combination therapy with PexaVec-Durvalumab-Tremelimumab combination to prove the drugs’ safety and efficacy. Pexa-Vec will be administered four times intravenously according to the clinical trial protocol developed by the two sides.

Under the agreement, NCI will shoulder the entire trial costs and be the dominant lead with NCI’s leading researcher Dr. Tim F. Greten. Greten is an expert in gastrointestinal oncology and immunocytochemistry.

At the same time, the U.S. government institution will provide SillaJen with expert consulting services while providing the Korean company access to U.S. government-owned research facilities and intellectual property rights.

SillaJen will provide Pexa-Vec for NCI with AstraZeneca supplying Durvalumab (PD-L1 inhibitor) and Tremelimumab (CTLA-4 inhibitor).

"Dr. Greten’s expertise regarding the interactions between tumors and the immune system as well as the technical competence of the U.S. National Cancer Institute will help SillaJen become a global representative in the anti-cancer drug market,” said SillaJen CEO Moon Moon Eun-sang_문은상.

The Ministry of Science, ICT and Future Planning and the Ministry of Health and Welfare are funding Pexa-Vec development under the government’s global advanced biopharmaceutical technology development project.