[Edaily Reporter SONG YOUNG-DOO ] SyntekaBio,Inc.(226330), an AI-based new drug development company, announced that it has secured antibody biobetter candidates with higher solubility than blockbuster antibody drugs, including Keytruda (pembrolizumab), by utilizing its proprietary antibody design platform, 'Ab-ARS®.' This proof-of-concept (PoC) study confirmed that AI can be used to improve solubility while maintaining the antigen-binding affinity of existing antibodies.

The study was conducted on 10 blockbuster antibodies targeting specific antigens that are currently on the market. SyntekaBio,Inc. redesigned existing antibodies by applying a framework (FR) with high solubility (150–200 mg/mL) and, based on analyses from its proprietary AI platform, identified candidates predicted to have solubility at least 5 to 20 times higher than that of the existing antibodies. This approach is designed to achieve the level of solubility required for the development of high-concentration subcutaneous (SC) formulations.

This study was conducted in collaboration with Cyren Therapeutics, a company specializing in antibody discovery. The company secured a total of six biobetter candidates across four of the ten target antigens, all of which demonstrated antigen-binding performance equal to or better than that of the existing antibodies. In particular, the PD-1 and PD-L1-targeting antibodies exhibited binding affinities 2.8 and 2.3 times higher, respectively, than their counterparts, while the CTLA-4 and HER3-targeting antibodies maintained binding affinities equivalent to those of the existing antibodies.

Through this study, the company confirmed that the antibodies can maintain their inherent binding affinity and function even after framework optimization, and plans to verify the solubility improvement effects through follow-up research. Once solubility is also demonstrated, the company intends to expand the platform’s application scope to include the development of high-concentration subcutaneous (SC) formulations and next-generation antibody therapeutics, such as antibody-drug conjugates (ADCs).

SyntekaBio,Inc. explained, “Currently commercialized antibody drugs often rely on buffer optimization to transition to subcutaneous (SC) formulations,” adding, “Design technology that increases the solubility of the antibody itself will serve as a new approach to lower the technical barriers to developing high-concentration formulations.”

A SyntekaBio,Inc. official said, “This study is a proof-of-concept (PoC) demonstrating that AI-driven antibody property optimization technology can be applied to a variety of antibodies,” adding, “We will continue to advance our AI-based antibody design technology to strengthen our competitiveness in the development of biobetters and next-generation antibody therapeutics.”