EpimAb Biotherapeutics Announces IND Filing for EMB01 in China and the US
- Category: Antibodies
- Published on Friday, 14 September 2018 12:20
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IND Filing Marks Further Progress Towards the First Clinical Trial with the Company’s Novel Bispecific Antibody Format
SHANGHAI, China I September 13, 2018 I EpimAb Biotherapeutics, an emerging Shanghai-based biopharmaceutical company specializing in bispecific antibodies, announced today that it has filed an IND for its most advanced therapeutic development candidate EMB01. The applications were simultaneously submitted to the U.S. Food and Drug Administration (FDA) and the National Medical Products Administration (NMPA) in China to investigate the treatment of solid tumors with EpimAb’s novel bispecific antibody.
“Advancing our first compound into the clinic just three years after founding the company is a significant and transformational milestone for EpimAb,” commented Chengbin Wu, PhD, CEO and founder of EpimAb Biotherapeutics. “This achievement proves that our FIT-Ig® technology delivers bispecific antibodies with drug-like properties and manufacturing efficiency that can rapidly be advanced into clinical trials. We are now eager to learn how these novel drug candidates can impact patients’ lives.”
EMB01 is a bispecific antibody based on EpimAb’s proprietary FIT-Ig® (Fabs-In-Tandem Immunoglobulin) technology to generate bispecific molecules with superior properties. EMB01 simultaneously targets two receptors, which are widely expressed on cancer cells, EGFR and cMET, with a unique and synergistic mechanism and has shown significant and long-lasting activity in multiple preclinical solid tumor models. EpimAb initiated formal preclinical development in May 2017 and since then successfully completed all requirements for IND filing.
While EMB01 is progressing towards the clinic, EpimAb is advancing several biologics creating a proprietary pipeline based on its FIT-Ig® platform. These earlier-stage assets are focused on immuno-oncology approaches 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
SOURCE: EpimAb Biotherapeutics