Y-Biologics CI. /Courtesy of Y-Biologics

Y-Biologics said on the 7th that it signed a contract manufacturing and development (CDMO) deal with China's WuXi Biologics to develop new drugs using its next-generation triple-target immuno-oncology platform, "Multi-AbKine."

Multi-AbKine is a platform that Y-Biologics is developing with the goal of creating a next-generation immuno-oncology therapy to replace Merck's immunotherapy Keytruda. It is a bispecific antibody–cytokine fusion that combines the PD-L1 protein, which disguises cancer cells as normal cells, and a bispecific antibody that blocks two targets simultaneously, with a cytokine that activates immune cells.

Y-Biologics is currently developing three pipelines in parallel based on the Multi-AbKine platform. Among them, "AR170" is being prepared for submission of an investigational new drug (IND) application for global clinical trials, including in the United States, in the first half of 2027, and "AR166" in the second half of 2027.

The company selected WuXi Biologics as its CDMO partner in light of the chemistry, manufacturing and controls (CMC) development and mass-production capabilities required for multi-antibody drugs with complex structures such as bispecific and trispecific antibodies. The contract covers overall CMC development for AR170 and the provision of data needed for U.S. IND submission. For AR166, the two sides agreed to develop a research cell bank (RCB) for future mass production.

Y-Biologics has established its own screening and evaluation system to modify and select the signaling molecule (IL-2) that activates immune cells to fit the characteristics of each pipeline. The company said it is securing various variant candidates depending on how IL-2 binds to immune cell receptors and is swiftly identifying optimal candidates by assessing not only efficacy but also scalability for mass production. This approach can be applied not only to IL-2 but also to other cytokines.

Y-Biologics plans to present three posters related to Multi-AbKine at the American Association for Cancer Research 2026 (AACR 2026), to be held in mid-April in San Diego. The presentations will disclose preclinical results on changes in antitumor immune cell activation after administration of AR170 and AR166, as well as efficacy and safety in animal models, along with data on cytokine variants obtained through in-house screening.

A company official said, "This CDMO contract with WuXi Biologics means we have completed the selection of final candidates for each Multi-AbKine pipeline and entered the stage of full-fledged preparation for global clinical trials, including in the United States," adding, "AR170 and AR166 showed superior efficacy and safety compared with competing drugs, and we confirmed meaningful antitumor effects even in animal models that exhibit resistance to PD-1 inhibitors."

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