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


SHANGHAI & SUZHOU, China–(BUSINESS WIRE)–EpimAb Biotherapeutics, a clinical-stage biotechnology company specializing in the development of bispecific antibodies, today announced that the U.S. Food and Drug Administration (FDA) has authorized 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 to tumor cells, and Tagrisso® (osimertinib), AstraZeneca’s (LSE/STO/Nasdaq: AZN) third-generation EGFR-TKI drug. AstraZeneca supplies Tagrisso® for this trial under a non-exclusive collaborative clinical trial agreement.

“This is an important milestone for EpimAb as we continue our trajectory to advance our bispecific pipeline and seek to explore the potential of our assets for combination therapy,” said Dr. Chengbin Wu, Founder and CEO of ‘Epim Ab. “EMB-01 has demonstrated efficacy in several 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 monotherapy.

“Non-small cell lung cancer is one of the most common oncology indications worldwide, but there remains a huge unmet need in NSCLC patients with EGFR mutations that develop resistance to TKIs. generation,” 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. The pharmacokinetics, immunogenicity and antitumor activity of EMB-01 associated with Tagrisso® will also be evaluated.

About the EMB-01

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

About EpimAb Biotherapeutics, Inc.

EpimAb Biotherapeutics is a clinical-stage biopharmaceutical company specializing in the development of multi-specific antibodies, with research and CMC facilities in Shanghai and Suzhou. Using our wide 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 preclinical assets and transformative clinics that aim to benefit cancer patients. For more information, visit www.epimab.com.


EpimAb Biotherapeutics

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Dr. Stephan Lensky, COO/CBO

Direct: +1 978-870-6276

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Dr. David Gu, CFO and Yuan Wang, International Relations Officer

Direct: +86-21-61951011

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Dr. Jason Tang, Comics Director

Direct: +86-21-61951014

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Media inquiries


Emily Wong

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