On March 28, 2024 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company reported that the first patient in China has been dosed in the Phase 1b clinical study of the combination of InnoCare’s novel SHP2 (Src Homology 2 domain containing protein tyrosine phosphatase) allosteric inhibitor, ICP-189, with ArriVent’s furmonertinib, a highly brain-penetrant, broadly active mutation-selective EGFR (epidermal growth factor receptor) inhibitor in patients with advanced or metastatic non-small cell lung cancer (NSCLC) (Press release, InnoCare Pharma, MAR 28, 2024, View Source [SID1234641596]).
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NSCLC is the predominant subtype of lung cancer, accounting for approximately 85% of all cases. In July 2023, InnoCare and ArriVent BioPharma, Inc. (Nasdaq: AVBP) announced a clinical development collaboration, accelerating the clinical trial of ICP-189 in combination with furmonertinib in patients with advanced or metastatic NSCLC in China.
Furmonertinib is being advanced by ArriVent in global studies in patients with advanced or metastatic NSCLC with EGFR mutations, including exon 20 insertion mutations. It is approved in China as a first-line treatment for adults with locally advanced or metastatic NSCLC with EGFR exon 19 deletion (19DEL) or exon 21 (L858R) substitution mutations, where it is being further developed for additional indications with Allist Pharmaceuticals (SSE: 688578) who discovered furmonertinib. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for furmonertinib for the treatment of patients with previously untreated, locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. Furmonertinib is also being evaluated for the treatment of NSCLC patients with EGFR P-loop alpha-c helix compressing (PACC) mutations.
ICP-189 is a potent and selective oral allosteric inhibitor of SHP2, developed by InnoCare for the treatment of solid tumors as a single agent and/or in combination with other antitumor agents. Preliminary efficacy was observed in ICP-189 monotherapy. In the dose escalation study, the dosage has been escalated up to 120 mg with no DLT observed and a favorable PK and safety profile have been demonstrated.
Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said: "We are excited to see the latest progress of our clinical collaboration with ArriVent. SHP2 inhibitors are ideal for the treatment of solid tumors 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."