Apexigen/Simcere file for IND in China
Apexigen, a biopharmaceutical company focusing on the development of monoclonal antibody therapeutics, said its partner, Simcere Pharmaceutical Group of China, filed an Investigational New Drug (IND) application with the State Food and Drug Administration (SFDA) of China to evaluate APX003 (also known as BD0801) as a potential cancer therapy, according to Fierce Biotech.
APX003 is a humanized monoclonal antibody directed against VEGF and is intended for the treatment of multiple malignancies. Upon review and approval of the IND application by the SFDA, Simcere plans to initiate phase I safety and tolerability studies in cancer patients.
The initiation of this phase I clinical study will mark a significant milestone for Apexigen. APX003 will be the first humanized antibody generated through the use of its technology to be administered to humans.
"This is an exciting time for Apexigen. We are eager to see the first of our antibodies demonstrate safety, tolerability and efficacy in man as a first step toward the development of best-in-class therapeutics," said Dr. Xiaodong Yang, president and CEO of Apexigen. "The collaboration with Simcere has been very productive. We look forward to continuing to collaborate with Simcere on the clinical development program, which will provide the first clinical validation of our technology."