InnoCare Announces First Subject Dosed in Phase I Trial of pan-TRK Inhibitor, ICP-723

Beijing, Nov. 2, 2020——InnoCare Pharma (HKEX: 09969), a clinical-stage biopharmaceutical company, announced today that the first subject had  been dosed in a Phase 1 clinical trial with its second generation pan-TRK inhibitor , ICP-723, at the Sun Yat-sen University Cancer Center.

Preclinical studies have shown that ICP-723 has a good safety profile and high activity against a variety of solid tumors, and the potential to provide a broad-spectrum anti-cancer therapy for patients with solid tumors with NTRK gene fusion. The dosing of the first subject marks the start of the ICP-723 Phase 1 clinical trial, which will evaluate the safety, tolerability and pharmacokinetic properties of ICP-723 in patients with solid tumors, and evaluate the anti-tumor efficacy of ICP-723 on NTRK fusion-positive cancers.

ICP-723 was developed to treat advanced or metastatic solid tumors harboring NTRK fusion genes, including breast cancer, colorectal cancer, lung cancer, thyroid cancer, etc., and for patients resistant to the first generation of TRK inhibitors.

In May 2020, ICP-723 was approved for clinical trial by the National Medical Products Administration. The first clinical trial site for the Phase 1 trial with ICP-723 is Sun Yat-sen University Cancer Center, which is also the leading site for this multi-center clinical trial.

"The research and development of innovative drugs has been a long and rigorous process. We are committed to advancing clinical research of innovative drugs in a safe and efficient way to meet unmet needs of patients. As a novel small molecule second generation pan-TRK inhibitor, ICP-723, has potent activity and high selectivity in preclinical experiments, which is expected to overcome the resistance to the first-generation TRK inhibitor. The dosing of the first patient with ICP-723 further enriches the company's drug pipelines in solid tumor and most critically starts the process to bring new therapies to patients. Currently, we have a total of more than 20 clinical trials in progress," said Dr. Jasmine, the co-founder, chairman and CEO of InnoCare.

About NTRK and ICP-723

Neurotrophic tyrosine receptor kinase (NTRK) genes NTRK1, NTRK2, and NTRK3 encode TRKA/B/C proteins respectively, which are all tyrosine kinases collectively known as the TRK protein family. ICP-723 is a novel second generation small molecule TRK inhibitor with optimal design developed for the treatment of advanced or metastatic solid tumors with NTRK gene fusion. ICP-723 had strong inhibitory activity against TRKA/B/C. In preclinical experiments, ICP-723, has demonstrated high oral bioavailability as well as good ADME profile, pharmacokinetics and metabolic properties. NTRK fusions are a therapeutic target that have been clinically proven to show benefit in several tumors.

About InnoCare Pharma

InnoCare Pharma is a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of 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 disease with high unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, New Jersey, and Boston.