PALM BEACH GARDENS, Fla.--(BUSINESS WIRE)--Xcovery Holdings, Inc., an oncology focused bio-pharmaceutical company, today announced 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 .
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.”
Xcovery is a biopharmaceutical company working to improve the lives of patients with cancer by discovering and developing small molecules that precisely target cancer growth mechanisms. Xcovery is developing a pipeline of drugs targeting a wide range of advanced solid tumors with a focus on lung cancer. For more information, visit www.xcovery.com.
This press release contains forward‐looking statements that are based on company management’s current beliefs and expectations and are subject to currently unknown information, risks and circumstances and actual results may vary from what is being currently projected.