eClinical Technology and Industy News

HUYABIO Announces FDA Clearance to Initiate a Phase 1 Trial of SHP2 Inhibitor in Patients with KRAS and EGFR Mutated Tumors

Excerpt from the Press Release:

SAN DIEGO, Oct. 28, 2021 /PRNewswire/ — HUYABIO International (HUYABIO™), the leader in accelerating global development of China’s pharmaceutical innovations, announced today the FDA clearance of HBI-2376 as an Investigational New Drug, or IND, for a Phase 1 study. The authorization to proceed enables the first testing in patients for whom this novel SHP2 inhibitor might show clinical benefit. 

“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.”

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