SHANGHAI--(BUSINESS WIRE)--EpimAb Biotherapeutics, an emerging Shanghai-based biopharmaceutical company specializing in bispecific antibodies, announced today completed recruitment of the first dose cohort in a global Phase I/II clinical study for its most advanced therapeutic program EMB01. EpimAb is investigating EMB01 for the treatment of solid tumors in about 60 patients in the US and China. The respective IND applications were simultaneously submitted in the US and China at the end of August 2018. The U.S. Food and Drug Administration (FDA) approved the trial within 28 days after filing and the National Medical Products Administration (NMPA) in China within 45 business days.
“Our development team is excited to see rapid progress with our lead program EMB01. The short turn-around times and swift approval from the regulatory authorities in two of the most important pharmaceutical markets underscore the quality of our data set and our trial applications,” commented Dr. Bin Peng, CMO of EpimAb Biotherapeutics. “We are now looking forward to obtain first results demonstrating the safety and preliminary efficacy of EMB01 in cancer patients. EMB01 represents a potential first-in-class approach in solid tumors with a novel mode-of-action unattainable with other drug classes such as monoclonal antibodies.”
EMB01 is a bispecific antibody based on EpimAb’s proprietary FIT-Ig® (Fabs-In-Tandem Immunoglobulin) technology capable of generating bispecific molecules with superior properties. EMB01 simultaneously targets two receptors, which are widely expressed on cancer cells, EGFR and cMET, and has shown significant and long-lasting activity in multiple preclinical solid tumor models by co-degradation of the two receptors that are required for tumor growth. This novel mechanism of action uniquely available to EGFR/cMet bispecifics could enable EMB01 to treat a much wider patient population than with currently available EGFR or cMet treatments.
While EMB01 advances through clinical studies, EpimAb is constantly growing its proprietary pipeline based on its FIT-Ig® platform and is advancing the next FIT-Ig®-based program towards IND filing. This second asset is focused on an immuno-oncology approach in areas of high medical need in cancer.
About EpimAb Biotherapeutics, Inc.
EpimAb Biotherapeutics is a privately-owned biopharmaceutical R&D company based in Shanghai with a proprietary unique and efficient technology called FIT-Ig® (Fabs-In-Tandem Immunoglobulin) to generate bispecific molecules with antibody-like properties. With this platform EpimAb is creating a pipeline of its own novel bispecific antibody therapeutics focused around immuno-oncology and other areas of high value to patients. EpimAb is also committed to diversifying its pipeline through selective licensing of its platform to partners worldwide. For further information, please visit www.epimab.com.