On September 15, 2020 EpimAb Biotherapeutics, a clinical stage biotech company specializing in bispecific antibodies, reported that it has received "STUDY MAY PROCEED" letter from the U.S. Food and Drug Administration (FDA) on an Investigational New Drug (IND) application for the Company’s second therapeutic development candidate, EMB-02 (Press release, EpimAb Biotherapeutics, SEP 15, 2020, View Source [SID1234565178]). The application was submitted to the FDA to investigate the treatment of solid tumors with EpimAb’s novel bispecific antibody.
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"The advancement of our second bispecific antibody into the clinic expands our clinical portfolio and also shows that our FIT-Ig technology can generate a variety of clinical candidates," commented Dr. Chengbin Wu, founder and CEO of EpimAb Biotherapeutics. "We expect to file additional applications in the near future for novel bispecific antibody programs being developed to treat patients suffering from serious cancer types. In 2021, we expect to have a total of three programs under investigation in clinical trials."
EMB-02 is a bispecific antibody based on EpimAb’s proprietary FIT-Ig (Fabs-In-Tandem Immunoglobulin) technology to generate bispecific molecules with superior properties. EMB-02 simultaneously targets two checkpoint proteins, PD-1 and LAG-3, and has shown strong anti-tumor activities in preclinical models resistant to standard anti-PD-1 monotherapies.
While EMB-02 is progressing towards the clinic, EpimAb continues to investigate EMB-01, its lead candidate, in a Phase I/II clinical study in both China and the U.S., and is generating several additional 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 unmet medical need in cancer.