On June 24, 2024, local time, the U.S. Food and Drug Administration (FDA) notified the approval of Orphan Drug Designation (ODD) for CBP-1019, the second-generation Bi-XDC bispecific ligand drug conjugate independently developed by Coherent Biopharma, for the treatment of small cell lung cancer (SCLC). To date, CBP-1019 has been granted ODD for three indications, including the treatment of pancreatic cancer, esophageal cancer, and small cell lung cancer. Receiving ODD for three indications in succession is a recognition of the development strategy of CBP-1019, and the product will proceed through an accelerated approval process, speeding up the drug’s market launch.
Dr. Robert Huang, founder, chairman, and CEO of Coherent Biopharma, said, “CBP-1019 has received Orphan Drug Designation from the FDA three times in just one year, which not only recognizes the product’s design concept and data performance but also increases our confidence in the pan-cancer development strategy. With a broader range of indications and lower receptor expression requirement for FRα/TRPV6, CBP-1019 will have a very broad patient population and exert significant market potential in the future.”
About CBP-1019
CBP-1019 is a second-generation Bi-XDC technology product of Coherent Biopharma, with a drug design that uses dual ligands FRα/TRPV6 to carry a new generation of Camptothecin derivatives, further innovating and optimizing on the basis of CBP-1008. According to preclinical data, it has shown tumor-inhibiting effects in various cancers such as gynecological tumors, lung cancer, pancreatic cancer, and colorectal cancer. In terms of clinical performance, CBP-1019 has initiated a Phase I/II international multicenter clinical study. As of April 2024, CBP-1019 has escalated to the 4.0 mg/kg dose group, showing good safety and preliminary efficacy.