ABVC announces FDA approved IND submission for study of ABV-1519

ABVC BioPharma announced that the US Food & Drug Administration notified the company that the IND application for the proposed clinical investigation of BLEX 404, the primary active ingredient in ABV-1519, for advanced inoperable or metastatic EGFR-mutated non-small cell lung cancer has been approved and the study can proceed. The treatment, which is being co-developed by BioKey, a wholly owned subsidiary of ABVC based in Fremont, California and by the Rgene Corporation was submitted to the FDA by Rgene on November 30, 2022. The application, designated IND 161602, was approved on December 30, 2022. It contained the clinical protocol for ABV-1519 and was entitled "A Phase I/II, Open Label Study to Evaluate the Safety and Efficacy of BLEX 404 Oral Liquid Combined with Pemetrexed + Carboplatin Therapy in Patients with Advanced Inoperable or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer Patients." "We are pleased the US FDA approved IND 161602 within the 30-day review period. As a result of that approval, our BioKey subsidiary has earned a milestone payment of $600,000 from Rgene, our development partner," said Dr. Howard Doong, Chief Executive Officer of the Company; "RGC-1501 is the first of three co-development projects with Rgene and will initially be conducted at Taipei Veterans General Hospital in Taiwan."