Biolojic Design Receives FDA Clearance for BD200 Clinical Trial

WASHINGTON and NESS ZIONA, Israel, Nov. 12, 2026 /CourierPR/ -- Biolojic Design, a biotechnology firm that leverages artificial intelligence to design antibodies, has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) granting clearance for its Investigational New Drug (IND) application for BD200. BD200 is a novel multibody drug conjugate that targets both Nectin-4 and Trop2, two validated oncology antigens often expressed on cancer cells.

BD200's unique design allows each arm of the antibody to bind to either Nectin-4 or Trop2, providing a flexible binding profile that can adapt to varying local tumor expression profiles. This adaptability is intended to help overcome resistance and improve the therapeutic index (TI) of the drug, which Biolojic Design estimates will be substantially greater than that of comparators.

The IND clearance allows Biolojic Design to proceed with its planned global Phase 1 clinical study in the United States, focusing on patients with select solid tumors known to express Trop2 and Nectin-4. The study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of BD200.

BD200 is a multibody drug conjugate carrying a potent topoisomerase inhibitor payload that targets Trop2 and Nectin-4, two antigens expressed in a variety of solid tumors. As a multibody, BD200 can bind to Nectin-4 with both arms, Trop2 with both arms, or Trop2 with one arm and Nectin-4 with a second arm. Preclinical studies have shown that BD200 can bind to both of these targets and adapt its specificity to the heterogeneous antigen expression on tumor cells, increasing efficacy and overcoming resistance when compared to standard monospecific antibody drug conjugates (ADCs) or a template bispecific ADC.

The Phase 1 clinical study will be conducted in the U.S. and globally, with the goal of selecting optimal biologic doses and focusing on one or more appropriate tumor types. Biolojic Design aims to explore both monotherapy and combination therapy development pathways. The company's pipeline focuses on autoimmune diseases and oncology, unlocking validated pathways that address large unmet needs. It is progressing its own pipeline and has partnerships with several leading biopharmaceutical companies to enhance its ability to bring important new therapeutic options to patients.