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May 14, 2013

RuiYi, CMC Collaborate to Speed mAb Development

  • CMC Biologics will use its CHEF1® high-productivity expression plasmid to accelerate development of a cell line for RuiYi’s monoclonal antibody RYI-008, under a collaboration whose value was not disclosed.

    RYI-008 is highly selective to IL-6, a cytokine widely implicated in inflammation and cancer. RuiYi is developing RYI-008 under a global commercialization license from Belgian-owned arGEN-X, which discovered the monoclonal antibody and previously named it ARGX-109. It was the first of five preclinical stage human antibody candidates developed by arGEN-X using its SIMPLE Antibody™ platform since beginning operations in 2009.

    Under an agreement announced in October, RuiYi agreed to take over development of the molecule in return for an undisclosed up-front payment to arGEN-X consisting of cash and equity. arGEN-X is also eligible for additional undisclosed amount of payments tied to achievement of clinical, regulatory, and commercialization milestones, as well as royalties based on worldwide net sales of therapeutic products.

    "RYI-008 is an antibody with unprecedented potency and remarkable half-life, creating a significant opportunity to be a best-in-class product in the rapidly evolving field of IL-6 biology." said Mark Sawicki, Ph.D., global vp, business development of CMC Biologics. "This agreement underscores our strategic focus on biologics development in emerging markets."

    CMC Biologics is a CMO that specializes in custom services for scale up, as well as cGMP manufacture of protein-based therapeutics for preclinical, clinical trials, and in-market production. CHEF1, approved for commercial production, is designed to produce high levels of recombinant protein quickly.

    Headquartered in La Jolla, CA, RuiYi—which changed its name in October from Anaphore—carries out drug discovery in China at the Zhangjiang Hi-Tech Park in Pudong, Shanghai, using its own intramembranous Conformation Antigen Presenting (iCAP) system. Anaphore acquired the original RuiYi in March 2012.

    In addition to RYI-008, RuiYi’s pipeline includes two internally-developed monoclonal antibodies that target G protein coupled receptors (GPCRs). 

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