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InnoCare, ArriVent Get Regulatory Permission to Begin SHP2 Inhibitor NSCLC Trial in China

NEW YORK – InnoCare Pharma on Thursday said that regulators in China have approved an investigational new drug application granting it permission to conduct a clinical trial of its SHP2 inhibitor ICP-189 with ArriVent Biopharma's investigational EGFR inhibitor furmonertinib in patients with EGFR- or HER2-mutated advanced non-small cell lung cancer.

Beijing-based InnoCare is developing ICP-189 as a treatment for solid tumors. In a dose-escalation study, researchers observed preliminary efficacy and no dose-limiting toxicities at doses of the drug up to 120 mg. There was a confirmed partial response in one patient with cervical cancer in the 20-mg-dose cohort.

Furmonertinib is already approved in China as a first-line therapy for locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 substitution mutations. Newtown Square, Pennsylvania-based ArriVent is also developing the drug in NSCLC patients with EGFR or HER2 mutations and collaborating with Shanghai Allist Pharmaceuticals, which discovered furmonertinib, to study it in other indications.

InnoCare and ArriVent are jointly conducting the ICP-189-furmonertinib trial under a partnership agreement signed in July 2023.

"[A] SHP2 inhibitor is an ideal partner for combination with multiple targeted immune-oncology therapies in the field of solid tumors," InnoCare CEO, Cofounder, and Chairwoman Jasmine Cui said in a statement. "ICP-189 has demonstrated significant anti-tumor effect in tumor models driven by KRAS G12C mutation and EGFR over-expression."

InnoCare is also studying the pan-TRK inhibitor ICP-723 in adults and patients 12 to 18 years old with NTRK fusion-positive cancers that are resistant to first-generation TRK inhibitors and the pan-FGFR inhibitor ICP-192 in FGFR-aberrant cancers.