InnoCare Pharma has dosed the first subject in a Phase Ib clinical trial assessing a combination its ICP-189 plus ArriVent BioPharma’s furmonertinib for the treatment of non-small cell lung cancer (NSCLC).

Developed by InnoCare, ICP-189 is an Src Homology 2 domain containing protein tyrosine phosphatase (SHP2) allosteric inhibitor while furmonertinib is a brain-penetrant, mutation-selective inhibitor of epidermal growth factor receptor (EGFR).

ICP-189 is designed to target solid tumours either as a monotherapy or in combination with other antitumor agents.

This asset has shown promising preliminary efficacy when used as a monotherapy with a favourable pharmacokinetic and safety profile, having been escalated up to 120mg without dose-limiting toxicity (DLT) observed.

In July last year, InnoCare and ArriVent entered into a clinical development partnership to expedite the clinical trial of ICP-189 plus furmonertinib for advanced or metastatic NSCLC patients in China.

Furmonertinib is currently being analysed by ArriVent in global studies for NSCLC patients with specific EGFR mutations, including exon 20 insertion mutations.

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In China, it is approved as a first-line treatment in adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 substitution mutations.

Allist Pharmaceuticals, which discovered furmonertinib, is further developing the drug for additional indications.

Notably, the US FDA has granted breakthrough therapy designation to furmonertinib for the treatment of people with priorly untreated, locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.

This asset is also under evaluation for NSCLC patients with EGFR P-loop alpha-c helix compressing mutations.

InnoCare co-founder, chairwoman and CEO Dr Jasmine Cui said: “We are excited to see the latest progress of our clinical collaboration with ArriVent.

“SHP2 inhibitors are ideal for the treatment of solid tumours by combination with various targeted drugs and immunotherapies and are expected to address the huge unmet medical needs. We will accelerate the clinical study and expect this innovative therapy to benefit more NSCLC patients early.”

The latest development comes after the company received clearance for an investigational new drug application to conduct a clinical trial of ICP-248 plus orelabrutinib in China for lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL).