InnoCare Announces Dosing of First Patient in Clinical Study of the Combination of SHP2 Inhibitor SHP2 Inhibitor ICP-189 and EGFR Inhibitor Furmonertinib EGFR Inhibitor Furmonertinib

2024-03-29

临床1期免疫疗法突破性疗法上市批准

BEIJING, China--(BUSINESS WIRE)-- InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company announced 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). 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 pro 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 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.” About InnoCare InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases with unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States. For more information, please visit: . Forward-looking Statements This contains the disclosure of some forward-looking statements. Except for statements of facts, all other statements can be regarded as forward-looking statements, that is, about our or our management's intentions, plans, beliefs, or expectations that will or may occur in the future. Such statements are assumptions and estimates made by our management based on its experience and knowledge of historical trends, current conditions, expected future development and other related factors. This forward-looking statement does not guarantee future performance, and actual results, development and business decisions may not match the expectations of the forward-looking statement. Our forward-looking statements are also subject to a large number of risks and uncertainties, which may affect our short-term and long-term performance.

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