Apexigen, Inc., an emerging biopharmaceutical company focusing on the development of monoclonal antibody therapeutics, announced today that its partner, Simcere Pharmaceutical Group (NYSE: SCR), a leading pharmaceutical company in 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. 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 1 safety and tolerability studies in cancer patients.
Simcere will develop and commercialize APX003 in China under a license agreement with Apexigen. In 2008, Simcere acquired rights to APX003 from Epitomics, Inc. Then in July of 2010, Epitomics created Apexigen as an independent therapeutic antibody company, licensed to Apexigen exclusive rights to the use of its antibody technologies for the development and commercialization of antibody therapeutics, and assigned to Apexigen the license and collaboration agreement with Simcere. Apexigen and Simcere collaborated on the IND enabling studies and on the completion of the IND for APX003.
The initiation of this Phase 1 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 & 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."
"This IND filing is the outcome of dedicated effort and collaboration between Apexigen and Simcere," said Mr. Jinsheng Ren, chairman and chief executive officer of Simcere.
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