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Laekna announces first IND clearance by U.S. FDA for internally-discovered LAE102


Shanghai, China and New Jersey, U.S., May 20, 2023 — Laekna, a clinical-stage biotechnology company dedicated to bringing novel therapies to cancer and liver fibrosis patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of LAE102 antibody to initiate clinical development. This is Laekna’s first internally-discovered drug candidate to obtain IND clearance, reflecting the company’s strength in internal discovery.


LAE102 is a potent and selective monoclonal antibody against a novel target that has regulatory effects on tumor growth, immune activation, muscle regeneration, and hematopoietic development. The drug candidate is now cleared for a phase I/II study targeting solid tumors, with the indication of Non-Small Cell Lung Cancer(NSCLC).


Dr. Justin Gu, Chief Scientific Officer of Laekna, said, "We are very proud that one of our internally discovered drug candidates has been cleared for clinical trials in the U.S. LAE102 represents a journey from ‘zero to one’ and a potential first-in-class innovative drug. Laekna's internal discovery focuses on identifying innovative biological therapies and small molecule drugs for patients with cancer or liver diseases, and we are advancing ten programs at various pre-clinical stages."


Dr. Chris Lu, Chief Executive Officer of Laekna, said, "Leveraging our know-how and R&D approach, Laekna has implemented a ‘Tri-Pillar’ product development model at the beginning of our establishment: internal discovery, translational research, and business development. The IND clearance of LAE102 marks a key milestone for Laekna’s internal discovery efforts. This is also the first time that Laekna completed FDA filing independently, demonstrating the close collaboration and robust execution of our teams in China and the U.S."




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