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

Rhea-AI Summary

AstraZeneca's Tagrisso® is now part of a clinical trial evaluating EMB-01, a bispecific antibody from EpimAb Biotherapeutics, for non-small cell lung cancer (NSCLC). The U.S. FDA has approved an IND application for a Phase Ib/II study, which intends to assess the safety, pharmacokinetics, and anti-tumor activity of this combination therapy. Dr. Chengbin Wu emphasized the importance of this milestone. The trial aims to tackle the unmet needs of NSCLC patients with EGFR mutations resistant to third-generation TKIs, potentially enhancing treatment options.

Positive

• FDA clearance of IND application for Phase Ib/II study with EMB-01 and Tagrisso.
• Potential to address unmet needs in NSCLC patients with EGFR mutations.

Negative

• None.

SHANGHAI & SUZHOU, China--(BUSINESS WIRE)-- 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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EpimAb Biotherapeutics

In the U.S.:

Dr. Stephan Lensky, COO/CBO

Direct: +1 978-870-6276

Stephan.lensky@epimab.com

In China:

Dr. David Gu, CFO and Yuan Wang, IR Officer

Direct: +86-21-61951011

IR@epimab.com

Dr. Jason Tang, BD Director

Direct: +86-21-61951014

yesheng.tang@epimab.com

Media Inquiries

MacDougall

Emily Wong

+1 781-235-3060

epimab@macdougall.bio

Source: EpimAb Biotherapeutics, Inc.

FAQ

What recent trial has AstraZeneca's Tagrisso been included in?

AstraZeneca's Tagrisso® has been included in a Phase Ib/II clinical trial alongside EpimAb's EMB-01 for treating non-small cell lung cancer.

What is the focus of the Phase Ib/II trial involving AZN?

The Phase Ib/II trial focuses on evaluating the safety and anti-tumor activity of EMB-01 in combination with Tagrisso in NSCLC patients.

When was the IND application for EMB-01 approved by the FDA?

The FDA cleared the IND application for EMB-01 for the trial as announced by EpimAb Biotherapeutics.

What type of cancer is being targeted in this new trial?

The trial is targeting non-small cell lung cancer (NSCLC) patients.

What are the expected benefits of combining EMB-01 with Tagrisso?

The combination of EMB-01 and Tagrisso is expected to synergistically inhibit tumor growth and expand treatment options for NSCLC patients resistant to other therapies.