EpimAb Biotherapeutics, a clinical stage biotech company specializing in bispecific antibodies, today announced dose administration for the first patient in a Phase 1/2 clinical trial of EMB-02, a bispecific antibody targeting PD-1 and LAG-3, in patients with advanced solid tumors, as well as in a Phase 1/2 clinical trial of EMB-06, a bispecific antibody targeting B cell maturation antigen (BCMA) and cluster of differentiation 3 (CD3), in patients with recurrent and refractory multiple myeloma. The company also announced the approval of its Investigational New Drug (IND) application for EMB-02 by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA).
“We are excited to continue the momentum of our pipeline advancement with the dosing of the first patients in Phase 1/2 trials for our two new clinical programs, EMB-02 and EMB-06, as well as the IND clearance for EMB-02 in China,” said Dr. Chengbin Wu, founder and CEO of EpimAb Biotherapeutics. “This validates the power of our FIT-Ig platform to efficiently generate novel bispecific programs, as well as its broad applicability across a variety of targets, which is important as we continue to pursue promising target combinations. We look forward to advancing additional preclinical and clinical assets derived from our FIT-Ig platform as well as expanding into utilizing additional proprietary platform technologies to develop complex multi-functional molecules with unique capabilities.”
“The target combination of PD-1 and LAG-3 has received industry attention recently for its potential in difficult-to-treat cancers that do not respond to standard anti-PD-1 monotherapies. Our preclinical data revealed that EMB-02 can show significant improvement in tumor models resistant to standard anti-PD-1 monotherapies,” said Bin Peng, MD, Ph.D. CMO of EpimAb Biotherapeutics. “We look forward to establishing ourselves as a leader in the development of best-in-class bispecific therapeutics as we further evaluate the potential of EMB-02 in global clinical trials in the U.S., China and Australia. We are also eager to continue the advancement of EMB-06, a bispecific antibody targeting BCMA and CD3, and evaluate its potential to benefit patients with multiple myeloma.”
The EMB-02 Phase 1/2 study is a multi-center, open label, multiple-dose, first in human study to assess the safety and tolerability of EMB-02 in patients with advanced solid tumors. The primary objective for the Phase 1 portion of the study is to identify the recommended Phase 2 dose (RP2D) and schedule assessed to be safe for EMB-02. Pharmacokinetics, immunogenicity, and the anti-tumor activity of EMB-02 will also be assessed. After a recommended dose for the Phase 2 portion of the trial is determined, the efficacy of EMB-02 will be evaluated in an expanded cohort at the RP2D. The trial is being conducted at two clinical trial sites in the U.S. and one in Australia. More information about this trial may be accessed at www.clinicaltrials.gov (identifier: NCT04618393).
The EMB-06 Phase 1/2, multi-center, open label, multiple-dose, first in human study is designed to assess the safety and tolerability of EMB-06 in patients with relapsed or refractory multiple myeloma. The primary objective for the study is to identify the recommended Phase 2 dose (RP2D) and schedule assessed to be safe for EMB-06. Pharmacokinetics, immunogenicity, and the anti-multiple myeloma activity of EMB-06 will also be assessed. In the Phase 1 portion of the trial, patients will receive EMB-06 once weekly at different ascending dose levels. Once the RP2D is determined, an expanded cohort will receive EMB-06 at the RP2D. The trial is being conducted at 4 clinical trial sites in Australia and is being expanded to further countries. More information about this trial may be accessed at www.clinicaltrials.gov (identifier: NCT04735575).
About EpimAb Biotherapeutics, Inc.
EpimAb Biotherapeutics is a privately-owned biopharmaceutical R&D company with research and manufacturing facilities in Shanghai and Suzhou 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 and pipeline assets to partners worldwide. For further information, please visit www.epimab.com