August 27, 2019, Shanghai, China - HaiHe Biopharma, a biopharmaceutical company focusing on the discovery, development and commercialization of innovative anti-tumor drugs, announced that the first patient?has been dosed?in the Phase Ib clinical trial of the company's innovative drug, Glumetinib, for the treatment of MET-positive advanced non-small cell lung cancer. The principal investigator of this clinical trial in China is Professor Lu Shun from Shanghai Chest Hospital.?
This is a multi-country, multi-center, open-label Phase Ib clinical trial to evaluate the efficacy and safety of Glumetinib in advanced NSCLC patients with c-MET mutations. It has been initiated in several sites nationwide, mainly enrolling the patients with locally advanced or metastatic non-small cell lung cancer diagnosed by histology or by cytology who had failed to respond to the previous standard treatment and were intolerant to or unsuitable for chemotherapy with at least one MET mutation (skipping , amplification, or overexpression) .
Lung cancer is the leading cause of cancer deaths in men and women, accounting for about one-fifth of all cancer deaths, more than the deaths caused by breast, prostate and colorectal cancer combined. Lung cancer can be divided into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), and 80%~85% of them are NSCLC. The abnormal activation of MET pathway can be divided into three cases: MET exon 14 skipping mutation, MET amplification and overexpression of MET protein. The incidence of MET exon 14 skipping mutation in NSCLC was 1-3%. The incidence of primary MET amplification in lung adenocarcinoma was about 2.4% (3 to 21%), and MET amplification resulted in 5-22% EGFR-TKI resistance. The incidence of MET protein overexpression was 22.2%-74.6%. Positive MET is associated with poor clinical prognosis, and no treatment targeting the mutation has been approved.
Glumetinib (code: SCC244) is a potent and selective small molecule MET kinase inhibitor with global proprietary intellectual property rights developed by HaiHe Biopharma Co., Ltd and the Shanghai Institute of Materia Medica of the Chinese Academy of Sciences. Preclinical studies have shown that Glumetinib potently and specifically targets the inhibition of MET kinase in vitro activity. Preliminary clinical studies have shown that Glumetinib has better human pharmacokinetic characteristics than small molecule MET kinase inhibitors with the same selectivity, including longer metabolic half-life, good permeability through the blood-brain barrier, etc. It showed initial efficacy as well as good safety and tolerability in patients with MET-positive advanced non-small cell lung cancer.
Haihe Biopharma focuses on discovery, development and commercialization of innovative anti-tumor drugs. Guided by our mission, “Inclusive and open to diversity, innovation oriented to win together and benefit the mankind”, Haihe Biopharma insists on the way of independent innovation and pursues for global development of Chinese original innovative drugs in partnership with Shanghai Institute of Materia Medica, Chinese Academy of Science (SIMM). The company is led by an academician of the Chinese Academy of Engineering. The senior management team has extensive experiences in drug research and development in China and abroad. Haihe Biopharma has built a precision medical platform guided by biomarkers, and established a fully integrated pre-clinical evaluation technical platform and clinical study system for innovative drugs, with advanced technology and operation in consistence with international standards and norms, covering subunits from compound synthesis, CMC study, biomarker discovery and validation, medical strategy and clinical study, etc. The company has established a globally competitive innovative drug R&D system and robust product pipeline. There are 7 compounds in clinical and 3 compounds in preclinical studies, among which 7 compounds are discovered in-house.
Please visit the company website for more information:?http://www.iacubed.com