News & Activities » GenScript ProBio Congratulates Selecxine’s IND Clearance from MFDS

GenScript ProBio Congratulates Selecxine’s IND Clearance from MFDS

Recently, Selecxine, a partner of GenScript ProBio, announced MFDS clearance of its phase I/II clinical trial application for innovative antibody drug program (SLC-3010) . GenScript ProBio extended congratulations on this. Since December 2019, GenScript ProBio has joined the strategic collaboration with Selecxine for the development of an innovative antibody with the responsibility on the CMC development and IND filing. This is the second IND clearance of this team followed by their earlier approval from the US FDA in July 2022. This product, SLC-3010, is an antibody-cytokine conjugate that has been developed based on Selecxine’s proprietary non-covalent conjugation technology, which enables multiple modes of immune responses against tumor, termed as the “Triple Action”.

As the SLC-3010 required the non-covalent conjugation of the antibodies and the cytokines for its unique modes of actions, customizations were mandated in the upstream and downstream process and the conjugation process, not only to optimize the production, but also to elicit the drug activity. GenScript ProBio had successfully developed a process that enabled the mild conjugation conditions, excellent productivity, and high purity. In addition, GenScript ProBio further developed multiple customized assays to support the quality control and drug release.

Junyoung Lee, the CEO of Selecxine said, "We are very pleased that this project was successfully approved by from the MFDS. It is the second approval following the US FDA, which it is a crucial milestone for Selecxine. We are highly impressed by the GenScript ProBio’s one-stop CDMO platform, and we want to collaborate closely to aim for the global clinical development.”

Dr. Brian Min, CEO of GenScript ProBio said, "We congratulate Selecxine on MFDS clearance of its IND application, and we are honored to be part of this novel project. These IND clearances demonstrated our expertise in biopharmaceutical development and prove that our R&D capability and speed have reached the international level. We wish that this clinical study moves forward for the benefit of cancer patients as soon as possible."

About Selecxine

Selecxine is a South Korean biotech that specializes in developing therapeutical antibodies. Founded in December 2018, Selecxine is now in clinical trial with its lead asset and keep developing follow-up pipelines with their in-house antibody development technology. Based on understanding of cancer immunology and structural biology, Selecxine focuses on bifunctional cytokines or receptors and develops antibodies that can maneuver the biological activities towards the desired direction. Their lead asset, SLC-3010 is a non-covalent conjugate of IL-2 and anti-hIL-2 antibody (TCB2), which can preferentially stimulate immune cells related with the anti-cancer activities rather than the immune suppression. Such specificity was achieved based on their unique antibody development platform, SelectopeTM, which can evaluate and select the antibody clones that bind to the epitope of interest.

About GenScript ProBio

GenScript ProBio, a subsidiary of GenScript Biotech Corporation, offers end-to-end CDMO services from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in CGT, vaccine, biologics discovery and antibody protein drug, aiming to accelerate drug development for customers. GenScript ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 40 IND approvals since October 2017.

Toward the mission of “Innovation through Collaboration”, GenScript ProBio is committed to helping customers shorten the timeline for the development of biological drugs from discovery to commercialization, significantly lowering R&D costs and shaping a healthier future.