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EpimAb announces IND filing in China and US
SHANGHAI—Today brings news that EpimAb Biotherapeutics, a company specializing in bispecific antibodies, 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,” said 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 reportedly shown significant and long-lasting activity in multiple preclinical solid tumor models. EpimAb initiated formal preclinical development in May 2017 and since then has successfully completed all requirements for IND filing.
While EMB01 is progressing towards the clinic, EpimAb is advancing several other biologics based on its FIT-Ig platform. Back in April, EpimAb announced a development collaboration on a bispecific antibody program. Under the terms of the agreement, Zhejiang Teruisi Biopharmaceutical, Inc. gained access to EpimAb’s FIT-Ig program FIT012/TRS008 in order to develop it for the Chinese market. EpimAb retains all commercial rights to the program outside of China.
In return for commercialization rights in China, EpimAb is eligible to receive an upfront payment and total success-based milestones of up to US $21 million, plus royalties. EpimAb may use the development data generated by Zhejiang Teruisi in partnering discussions outside of China for an undisclosed share of its net receipts. Further financial details were not disclosed.
“In addition to EMB01, EpimAb’s frontrunner program that is on its way to clinical development, FIT012 is another great example of EpimAb’s first validated assets moving forward into preclinical and clinical development,” Wu noted. “Teruisi is an ideal partner for this innovative program and has proven its excellence in CMC capabilities with a successful track record of multiple IND filings as well as early clinical development.”
FIT012/TRS008 is a bispecific antibody program in oncology. The molecule was identified by EpimAb and validated by Zhejiang Teruisi Biopharmaceutical in an extensive series of preclinical tests. The targets of FIT012/TRS008 were not disclosed.
“We are delighted to work with EpimAb on this innovative program. FIT012/TRS008 will fit nicely in our development pipeline,” said Youling Wu, Chief Executive Officer and Founder of Zhejiang Teruisi Biopharmaceutical, Inc. “In addition to our rich pipeline of biosimilars and novel antibodies, a highly innovative bispecific antibody like FIT012/TRS008 will allow us to further expand our pipeline.”