On November 14, 2021 InnoCare Pharma (HKEX: 09969), a commercial-stage biotech company, reported 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 (Press release, InnoCare Pharma, NOV 14, 2021, View Source [SID1234595528]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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.
ICP-189 is being developed for the treatment of solid tumors as a single agent and/or in combinations with other antitumor agents.
Preclinical study shows that ICP-189 is a potent oral allosteric inhibitor of SHP2 with excellent selectivity over other phosphatases. SHP2 is a non-receptor protein tyrosine phosphatase involved in mediating MAPK signaling pathway and immune checkpoint pathway for the regulation of cellular proliferation and survival.
Dr. Jasmine Cui, Co-Founder, Chairwoman and CEO of InnoCare, said, "In less than a month after clinical approval of ICP-189 in China, our ICP-189 got clinical approval in the U.S. This is our fourth innovative drug entering clinical stage in the U.S. This year, our innovative drug candidates have been continuously recognized by the FDA: Orphan Drug Designation to pan-FGFR inhibitor gunagratinib for the treatment of cholangiocarcinoma; Breakthrough Therapy Designation to orelabrutinib for the treatment of relapsed or refractory mantle cell lymphoma; clinical approval of the second-generation pan-TRK inhibitor ICP-723… InnoCare will continue to innovate to meet the unmet clinical needs of the entire world. "