GenScript ProBio Congratulates Selecxine's IND Clearance from MFDS

07 December 2022 | Wednesday | News

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."

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