InnoCare Pharma, a commercial-stage biotech company, announced 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.

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 US. This is our fourth innovative drug entering clinical stage in the US. 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."

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.