Beijing, June 4th, 2021—— InnoCare (HKEX: 09969), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, presented the latest clinical data for the pan-FGFR inhibitor gunagratinib today at the 2021 American Society of Clinical Oncology (ASCO) annual meeting. This is the first time InnoCare has presented gunagratinib’s clinical data at an international academic conference, showing good safety and tolerability.
Updated Results from the Phase I Study of a highly selective irreversible FGFR inhibitor ICP-192 (gunagratinib) for patients with advanced solid tumors with abnormal FGFR gene
Abstract Number: 4092
ICP-192 (gunagratinib), developed by InnoCare Pharma, is a novel pan-FGFR (fibroblast growth factor receptors) inhibitor that potently and selectively inhibits FGFR activities irreversibly by covalent binding. Preclinical data showed that gunagratinib overcomes the acquired resistance to the first-generation reversible FGFR inhibitors,
Gunagratinib is currently in clinical phase I/II. The safety and tolerability as well as pharmacokinetics/pharmacodynamics (PK/PD) of gunagratinib were evaluated in patients with advanced solid tumors, and the preliminary anti-tumor activity was evaluated by RECIST1.1 in patients with FGF/FGFR gene aberrations.
As of February 2021, a total of 30 patients had received the treatment of gunagratinib. Gunagratinib performed well in safety and tolerance, the maximum tolerated dose (MTD) had not been reached. Among the 12 patients with FGF/FGFR gene aberrations who have completed at least one tumor assessment, the overall response rate (ORR) was 33.3%, including 1 patient (8.3%) of cholangiocarcinoma with complete response (CR) and 3 patients (25%) with partial response (PR), 7 patients achieved SD. The disease control rate (DCR) was 91.7%.
Professor Ye Guo, the Deputy Director of Oncology Medical Department of Shanghai Oriental Hospital and the Director of Clinical Center for PhaseⅠsaid, “Gunagratinib is safe and well-tolerated in patients with advanced solid tumors. Anti-tumor activity was demonstrated in patients with FGF/FGFR geneaberrations in multiple tumor types, including cholangiocarcinoma. Better response is expected with the increase of treatment durations.”
The 2021 ASCO Annual Meeting will be held online from June 4th to 8th, 2021. The ASCO annual meeting is the most important and professional academic event in the global oncology field, which will showcase the international cutting-edge clinical oncology research results and tumor treatment technologies.
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. We strategically focus on lymphoma, solid tumors, and autoimmune diseases with high unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, New Jersey, and Boston.