Biolojic Design Announces FDA Clearance for BD200 Cancer Trial

Biolojic Design announced on November 12 that the US Food and Drug Administration had cleared its investigational new drug application for BD200, a cancer drug candidate. The Ness Ziona company said the clearance enables a global Phase 1 study beginning in the United States, with patients whose selected solid tumors express the Trop2 and Nectin-4 antigens. Founder and CEO Yanay Ofran said, ‘The FDA’s clearance of our IND for BD200 is a significant step toward advancing the first multibody into clinical testing.’ The company uses artificial intelligence and computational design to develop antibody treatments. BD200 combines a multibody that can bind either of two targets with a topoisomerase inhibitor payload. Each of its two antibody arms can bind Trop2 or Nectin-4, allowing both arms to bind the same antigen or one of each. Chief Medical Officer Roger Waltzman said differences in antigen expression and treatment resistance pose challenges in cancer care. The company designed BD200’s flexible binding and linker-payload profiles to adapt to tumor expression, with the aim of improving efficacy and safety. The planned trial will assess safety, tolerability, pharmacokinetics and preliminary efficacy. Ofran said the company expects to begin Phase 1 in the coming weeks. After selecting optimal biologic doses, Biolojic intends to focus on appropriate tumor types and potential development as a standalone treatment or in combinations.