On October 28, 2021 HUYABIO International (HUYABIO), the leader in accelerating global development of China’s pharmaceutical innovations, reported the FDA clearance of HBI-2376 as an Investigational New Drug, or IND, for a Phase 1 study (Press release, HUYA Bioscience, OCT 28, 2021, View Source [SID1234592181]). The authorization to proceed enables the first testing in patients for whom this novel SHP2 inhibitor might show clinical benefit.
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"We are pleased to see that our partner HUYABIO is initiating clinical testing of our SHP2 inhibitor in the US, which will complement Genhouse’s clinical development program in China. We are expecting IND approval in November in China. We believe our SHP2 inhibitor will bring clinical benefit to cancer patients worldwide," said Dr. Kuifeng Wang, CEO of Genhouse.
The HUYABIO-sponsored Phase 1 trial is an open-label dose escalation study using the Company’s SHP2 inhibitor to measure the safety and tolerability in patients with solid tumors harboring KRAS or EGFR mutations. Anti-tumor effects of the monotherapy, determined according to RECIST 1.1, included among the secondary endpoints of the study. Up to 6 sites in the US will be involved in the study that will enroll 42 patients.
Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, "We are excited to have FDA clearance to begin clinical testing of HBI-2376 because of the enormous potential of the drug against a number of different tumors. This represents another important milestone for HUYABIO in building a strong oncology pipeline with products that address significant unmet need and provide potential benefit to patients afflicted with debilitating malignancies."
About HBI-2376
HBI-2376 is an oral small molecule inhibitor of SHP2 targeting multiple tumor types whose cellular growth is dependent on the activity of receptor tyrosine kinases in the mitogen-activated protein kinase, or MAPK, pathway. Extensive biochemical characterization has shown that HBI-2376 is a highly potent and selective inhibitor of SHP2 phosphatase with the potential for activity as a single agent or in combination with various other targeted agents, including checkpoint inhibitors.