EMB-01 combined with Tagrisso is intended for the treatment of non-small cell lung cancer. Credit: Africa Studio / Shutterstock.

The US Food and Drug Administration (FDA) has granted clearance to EpimAb Biotherapeutics’ investigational new drug (IND) application enabling initiation of a Phase Ib/II study of EMB-01 combined with AstraZeneca’s Tagrisso (osimertinib) for the treatment of non-small cell lung cancer (NSCLC).

Under a non-exclusive clinical trial collaboration agreement with EpimAb, AstraZeneca is providing its third-generation EGFR-TKI, Tagrisso.

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The study will assess the tolerability and safety of EMB-01, a bispecific antibody, along with Tagrisso in NSCLC patients with EGFR mutations.

It will also evaluate immunogenicity, pharmacokinetics and the anti-tumour activity of the combined therapy.

EpimAb Biotherapeutics founder and CEO Dr Chengbin Wu said: “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.

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“EMB-01 has demonstrated efficacy in multiple preclinical models, as well as in our ongoing clinical trial programme.

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“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.”

Phase I/II studies of EMB for several GI indications are ongoing in China and the US.

EpimAb Biotherapeutics CMO Dr Bin Peng said: “The combination of EMB-01 and Tagrisso has the potential to synergistically inhibit tumour growth, ultimately expanding treatment options for patients.”

EMB-01 targets cMet on tumour cells alongside EGFR by utilising EpimAb’s proprietary FIT-Ig platform.