Boan Biotech (HKG: 6955), a Chinese biotechnology company, has announced that it has received orphan drug designation (ODD) awards from the US Food and Drug Administration (FDA) for two of its pipeline candidates. The ODDs were granted to the antibody BA1105 and the antibody-drug conjugate (ADC) BA1301, both of which target Claudin18.2 (CLDN18.2) for the treatment of gastric cancer, including cancer of the gastroesophageal junction. Both candidates have previously been awarded ODD statuses in the United States for their use in pancreatic cancer.
BA1105, which is being developed to treat Claudin18.2 positive advanced solid tumors, is currently in Phase I clinical trials in China. BA1301, the company’s first ADC to enter clinical trials, is also undergoing Phase I studies in the country.- Flcube.com
