ICP-189 / InnoCare - LARVOL DELTA

ArriVent BioPharma Reports Third Quarter 2024 Financial Results (GlobeNewswire) - "Upcoming Milestones: Dose expansion for SHP2 inhibitor combination. Initiation of dose expansion cohort for the ongoing Phase 1b trial evaluating firmonertinib in combination with SHP2 inhibitor ICP-189 by InnoCare in patients with classical EGFR mutations expected in the fourth quarter of 2024; EGFR PACC pivotal study plan. Data from the FURTHER Phase 1b (NCT05364043) trial continues to mature for first-line firmonertinib monotherapy in patients with EGFR PACC mutant NSCLC. ArriVent expects to provide an update on EGFR PACC plans in the first half of 2025."

P1 data • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

InnoCare Announces Dosing of First Patient in Clinical Study of the Combination of SHP2 Inhibitor ICP-189 and EGFR Inhibitor Furmonertinib (Businesswire) - "InnoCare Pharma...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)."

Trial status • Non Small Cell Lung Cancer

InnoCare Announces Approval of Clinical Trial of SHP2 Inhibitor ICP-189 in Combination with EGFR Inhibitor Furmonertinib (Businesswire) - "InnoCare Pharma...announced today the approval of the Investigational New Drug (IND) to conduct the clinical trial of ICP-189, a novel SHP2 (Src Homology 2 domain containing protein tyrosine phosphatase) allosteric inhibitor, in combination with furmonertinib, a highly brain-penetrant, broadly active mutation-selective EGFR (epidermal growth factor receptor) inhibitor, in China."

New trial • Non Small Cell Lung Cancer

InnoCare and ArriVent Announce Clinical Development Collaboration (GlobeNewswire) - "InnoCare Pharma...and ArriVent Biopharma...announced a clinical development collaboration to evaluate 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. Under the agreement, InnoCare and ArriVent will jointly conduct a clinical study to evaluate the anti-tumor activity and safety of ICP-189 combined with furmonertinib in patients with advanced non-small cell lung cancer (NSCLC)."

Licensing / partnership • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Preclinical development of SHP2 allosteric inhibitor ICP-189 (AACR 2023) - "ICP-189 has also shown strong synergies in tumor killing when combined with MEK inhibitor trametinib, KRASG12C inhibitor sotorasib, EGFR inhibitor osimertinib in xenograft models; and when combined with anti-PD-1 antibody in EMT6 syngeneic tumors. ICP-189 is a novel allosteric inhibitor of SHP2 with broad-spectrum anti-tumor activities as a single agent or in combination with other targeted or immune modulating anti-cancer therapeutics. ICP-189 is now in phase I clinical trial in China and United States."

IO biomarker • Preclinical • Oncology • BRAF • DUSP6 • KRAS • NF1

Data of InnoCare’s Robust Oncology Pipelines Presented at the 2023 AACR Annual Meeting (Businesswire) - "Data of InnoCare’s...robust oncology pipelines were presented at the 2023 American Association for Cancer Research (AACR) Annual Meeting....ICP-189 has demonstrated robust in vitro efficacies in a panel of tumor cell lines bearing activated RTK, RAS, NF1 loss-of-function, or BRAF class III mutations....The in vivo efficacy of ICP-189 is well accompanied by pharmacodynamic modulations, where ICP-189 exposure levels correlate with reduced p-ERK and DUSP6 mRNA levels in tumors."

Preclinical • Oncology • Solid Tumor • BRAF • DUSP6 • NF1 • PERK • RAS

InnoCare Announces First Patient Dosed in Clinical Trial of Novel SHP2 Allosteric Inhibitor ICP-189 in China (Businesswire) - "InnoCare Pharma...announced today that the first patient has been dosed in clinical trial of the Company’s novel SHP2 (Src Homology 2 domain containing protein tyrosine phosphatase) allosteric inhibitor ICP-189 in China. ICP-189 is a potent and selective oral allosteric inhibitor of SHP2, developed for the treatment of solid tumors as a single agent and/or in combination with other antitumor agents."

Trial status • Oncology • Solid Tumor

A Study of ICP-189 and ICP-189 in Combination With Anti-PD-1 Monoclonal Antibody in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=22 | Not yet recruiting | Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Combination therapy • New P1 trial • Oncology • Solid Tumor

InnoCare Announces the Clearance of Clinical Trial of Novel SHP2 Allosteric Inhibitor ICP-189 by U.S. FDA (PRNewswire) - "InnoCare Pharma...announced today the Investigational New Drug (IND) clearance of its SHP2 (Src Homology 2 domain containing protein tyrosine phosphatase) allosteric inhibitor ICP-189 by the US Food and Drug Administration (FDA) for starting clinical trial in the United States. This open, single-arm, multicenter study aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ICP-189 as a monotherapy and combined treatment in patients with advanced solid tumors."

IND • Oncology • Solid Tumor

InnoCare Announces Approval of Clinical Trial of Novel SHP2 Allosteric Inhibitor ICP-189 in China (PRNewswire) - "InnoCare Pharma...announced today that the Company has received Investigational New Drug (IND) approval from the NMPA for its SHP2 (Src Homology 2 domain containing protein tyrosine phosphatase) allosteric inhibitor ICP-189, which is the company's 9th innovative drug candidate entering clinical development. This China-based Phase Ia/Ib open, single-arm, multicenter study aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ICP-189 as a monotherapy and combined treatment in patients with advanced solid tumors."

New P1 trial • Oncology • Solid Tumor

[VIRTUAL] Next generation sequencing reveals the genetic landscape of PTPN11 in Chinese lung cancer patients (ESMO 2021) - "Several SHP2 allosteric inhibitors, such as ICP-189 and RMC-4630, have been entered into clinical trials. The mutational characteristics of PTPN11 in Chinese lung cancer population was first revealed in this study, which provides a broad range of scenarios for the future clinical application of SHP2 inhibitors in lung cancer."

Biomarker • Clinical • Next-generation sequencing • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • FGFR1 • HER-2 • KRAS • MAP2K1 • NTRK • PTPN11 • ROS1

ANNUAL RESULTS ANNOUNCEMENT FOR THE YEAR ENDED DECEMBER 31, 2020 (PRNewswire) - “ICP-189: It is being developed for the treatment of solid tumors as a single agent and/or in combinations with other anti-tumor agents. We plan to submit the IND application for ICP-189 to the CDE in the second half of 2021; ICP-033: ICP-033 is intended to be used in combination with immunotherapy and other targeted therapy drugs for liver cancer, renal cell carcinoma, colorectal cancer and other solid tumors. We expect to file the IND application for ICP-033 in the first half of 2021; ICP-248: We intend to develop ICP-248 in combination with Orelabrutinib for the treatment of AML, ALL, FL, CLL, DLBCL and other hematological malignancies. We expect to file the IND application for ICP-248 in the first half of 2022; ICP-B03 – a tumor-conditional pro-interleukin (IL) – 15 targeting…We plan to apply for the IND application for ICP-B03 in the second half of 2022.”

IND • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Lymphocytic Leukemia • Colorectal Cancer • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Gastrointestinal Cancer • Genito-urinary Cancer • Hematological Malignancies • Hepatocellular Cancer • Liver Cancer • Non-Hodgkin’s Lymphoma • Oncology • Renal Cell Carcinoma • Solid Tumor