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.

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.

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

“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.