On April 11, 2022, InnoCare Pharma unveiled the preclinical data of ICP-723. The research results demonstrate that ICP-723 effectively inhibits the kinase activity of TRKA, TRKB, and TRKC (IC50 value less than 1 nM). Not only does ICP-723 exhibit potent in vitro efficacy in TRK-driven tumors, but it also overcomes resistance mutations commonly seen after treatment with first-generation TRK inhibitors, such as TRKA G595R and TRKC G623R/E.

TGI  89.5%

Further in vivo efficacy studies have confirmed the robust anti-tumor effect of ICP-723 in animal models. At a dosage of 1 mg/kg, ICP-723 achieves a tumor growth inhibition rate (TGI) of 89.5% in the KM12 tumor model. With high oral bioavailability, ICP-723 demonstrates overall favorable pharmacokinetic parameters.

Next-Generation NTRK Inhibitor

ICP-723, a Chinese developed next-generation NTRK inhibitor, holds promise in treating advanced or metastatic solid tumors harboring NTRK fusion genes, including breast cancer, colorectal cancer, lung cancer, thyroid cancer, and patients resistant to first-generation NTRK inhibitors like larotrectinib and entrectinib.

On August 31, 2021, InnoCare Pharma announced the Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to initiate Phase I clinical trials of its second-generation pan-TRK inhibitor ICP-723 in the United States.

In the major financial performance report released by InnoCare Pharma in 2022, the efficacy of ICP-723 was also disclosed.

Objective Response Rate (ORR)

As of February 11, 2022, in the Phase I dose-escalation trial, 17 patients received treatment with ICP-723 at doses ranging from 1 to 8 mg once daily. The safety profile was favorable, with no dose-limiting toxicities (DLT) observed. Among the 17 patients, 5 were confirmed positive for NTRK gene fusion, with an objective response rate (ORR) of 80%, including partial responses in 4 cases, and a disease control rate (DCR) of 100%. In the 4 mg and above dose group, the objective response rate was 100%.

As a novel small molecule second-generation pan-TRK inhibitor, ICP-723 exhibits potent activity and high selectivity, offering the potential to overcome resistance to first-generation TRK inhibitors and better serve patients.

(Note: This clinical trial is still recruiting participants. Patients who have undergone genetic testing can review their reports. Once NTRK1/2/3 fusion is detected, they can immediately contact us Advanced Medicine in China )

WhatsApp: +8613717959070

Email: doctor.huang@globecancer.com