EpimAb Biotherapeutics Announces U.S. FDA Clearance of IND Application for Phase Ib/II Trial of EMB-01 in Combination with Tagrisso® for Non-Small Cell Lung Cancer

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SHANGHAI & SUZHOU, China–()–EpimAb Biotherapeutics, a clinical-stage biotechnology company specializing in bispecific antibody development, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for a Phase Ib/II study in patients with non-small cell lung cancer (NSCLC) evaluating the combination of EMB-01, a bispecific antibody designed to simultaneously target EGFR and cMET on tumor cells, and Tagrisso® (osimertinib), AstraZeneca’s (LSE/STO/Nasdaq: AZN) third-generation EGFR-TKI. AstraZeneca is providing Tagrisso® for this trial under a non-exclusive clinical trial collaboration agreement.

“This is an important milestone for EpimAb as we continue on our trajectory to advance our bispecific pipeline and look to explore the potential of our assets for combination therapy,” said Dr. Chengbin Wu, founder and CEO of EpimAb. “EMB-01 has demonstrated efficacy in multiple preclinical models as well as in our ongoing clinical trial program. We look forward to evaluating the potential synergies of this asset with Tagrisso in this study, alongside our ongoing global Phase I/II study of EMB-01 as a monotherapy.”

“Non-small cell lung cancer is one of the most common oncology indications worldwide, yet there remains a huge unmet need among NSCLC patients with EGFR mutations who develop resistance to third-generation TKIs,” said Dr. Bin Peng, CMO of EpimAb. “The combination of EMB-01 and Tagrisso has the potential to synergistically inhibit tumor growth, ultimately expanding treatment options for patients.”

The planned Phase Ib/II trial will evaluate the safety and tolerability of EMB-01 in combination with Tagrisso® in patients with NSCLC with EGFR mutations. Pharmacokinetics, immunogenicity, and the anti-tumor activity of EMB-01 combined with Tagrisso® will also be assessed.

About EMB-01

EMB-01 is a novel bispecific antibody developed based on EpimAb’s proprietary FIT-Ig® platform to simultaneously target EGFR and cMet on tumor cells. It is being studied in Phase I/II clinical trials in NSCLC as well as several GI indications in the U.S. and China.

About EpimAb Biotherapeutics, Inc.

EpimAb Biotherapeutics is a clinical-stage biopharmaceutical company specializing in the development of multispecific antibodies, with research and CMC facilities in Shanghai and Suzhou. Utilizing our broad range of in-house research and technology capabilities, including the proprietary FIT-Ig® (Fabs-In-Tandem Immunoglobulin) bispecific platform, EpimAb is generating and globally advancing a unique pipeline of transformative preclinical and clinical assets that aim to benefit cancer patients. For further information, please visit www.epimab.com.

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