Xcovery SHP2 Inhibitor IND Approved by US FDA

On May 23, 2022 Xcovery Holdings, Inc., an oncology focused bio-pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has accepted its investigational New Drug application (IND) of BPI-442096 , a small molecule Src homology region 2 domain-containing phosphatase 2 (SHP2) inhibitor, in solid tumors. Xcovery will initiate a phase I clinical trial in the United States to assess the tolerability, safety, and efficacy of BPI-442096 (Press release, Xcovery, MAY 23, 2022, View Source [SID1234614960]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

BPI-442096 is a new molecular entity developed by Betta Pharmaceuticals in China. In preclinical studies, BPI-442096 demonstrated significant activity against a variety of cancer cells, including those with KRAS G12C mutation, KRAS G12D mutation, KRAS G12V mutation, KRAS G12A mutation, BRAF Class III mutation, NF1 LOF mutation, RTK mutation.

"I am very pleased to see BPI-442096 IND’s US approval," said Dr. Liu Fuqiang, Vice President of CMC at Betta Pharmaceuticals and at Xcovery. "Currently, there’s no SHP2 inhibitor drug on the market and we can fill the unmet need by bringing this compound to patients. With the earlier approved IND of BPI-361175, a 4th generation EGFR inhibitor, Betta and Xcovery are co-developing two very exciting assets in the US."

Giovanni Selvaggi, M.D., Xcovery’s CEO and CMO, commented, "The FDA’s acceptance of our INDs is an important validation of both Betta and Xcovery’s global capabilities in pre-clinical and clinical development in oncology. Together with BPI-361175, we can now establish our own small molecules pipeline against solid tumors."