InnoCare Announces IND Approval for SHP2 Inhibitor ICP-189 in Combination with EGFR Inhibitor Furmonertinib for NSCLC

On September 14, 2023, InnoCare (HKEX: 09969; SSE: 688428), a high-tech biopharmaceutical company, announced today that ICP-189, a novel allosteric inhibitor of the protein tyrosine phosphatase SHP2, has been approved in China to initiate clinical trials in combination with furmonertinib, an oral EGFR kinase inhibitor targeting epidermal growth factor receptor (EGFR) mutations.

In mid-July this year, InnoCare and ArriVent entered into a clinical collaboration to evaluate the efficacy and safety of ICP-189 in combination with furmonertinib for the treatment of patients with advanced non-small cell lung cancer (NSCLC).

ArriVent is conducting global clinical trials of furmonertinib for advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR or HER2 mutations, including exon 20 insertion mutations and other uncommon EGFR mutations. Furmonertinib has been approved in China as a first-line treatment for adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. Shanghai Allist Pharmaceuticals Co., Ltd. (SSE Code: 688578), the developer of furmonertinib, is further developing additional indications for this innovative drug in China.

ICP-189 is a highly selective oral SHP2 allosteric inhibitor developed by InnoCare for the treatment of solid tumors, which can be used as monotherapy and/or in combination with other anti-tumor agents. In the dose-escalation study, doses were increased to 120 mg without observing dose-limiting toxicity (DLT), demonstrating favorable pharmacokinetics (PK) and safety. Preliminary efficacy was observed with ICP-189 monotherapy, with one patient with cervical cancer achieving partial response in the 20 mg dose cohort.

Dr. Cui Jisong, Co-founder, Chairman, and CEO of InnoCare, stated: “SHP2 inhibitors are ideal agents for combination therapy with various targeted drugs and immunotherapies in the treatment of solid tumors. ICP-189 in KRAS^G12CThe tumor models driven by mutations and EGFR overexpression demonstrated significant antitumor activity. We will collaborate with ArriVent to accelerate the clinical development of the combination therapy of ICP-189 and furmonertinib, bringing this innovative treatment to patients with advanced non-small cell lung cancer as soon as possible.”

Non-small cell lung cancer is the major subtype of lung cancer, accounting for approximately 85% of all cases.

InnoCare is a commercial-stage, high-tech biopharmaceutical company focused on the development of first-in-class novel drugs for malignancies and autoimmune diseases. The company currently has multiple drug candidates in various stages of commercialization, clinical development, and preclinical research. InnoCare maintains branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States.