Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that the US Food and Drug Administration (FDA) has granted Fast-Track designation to its antibody-drug conjugate (ADC), IBI343. This CLDN18.2-targeted therapy has been previously cleared for clinical studies in patients with advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC) who have relapsed and/or become refractory to at least one line of prior therapy. The Fast-Track status has been awarded for the same indication.
In June 2021, Innovent entered into a licensing agreement with Synaffix B.V., a US-based subsidiary of Lonza Group AG (SIX:LONN), to utilize Synaffix’s ADC technology platforms on a target-specific, non-exclusive basis for the development of IBI343. This ADC is designed to bind to tumor cells expressing CLDN18.2, internalize the ADC, and release toxin drugs that cause DNA damage, leading to tumor cell apoptosis. Additionally, free toxin drugs can diffuse through the plasma membrane, extending their effect to adjacent tumor cells, a phenomenon known as the bystander effect. Phase I clinical trials of IBI343 in pancreatic cancer patients who have been previously treated showed promising results, with an objective response rate (ORR) of 40% observed in CLDN18.2 IHC1/2/3+≥ 60% pancreatic cancer subjects (n=10) administered a 6 mg/kg dose of IBI343.- Flcube.com
