Biolojic Design Receives U.S. FDA Clearance of Investigational New Drug (IND) Application for BD200, the First Multibody to Enter Clinical Trials

BD200 is a multibody drug conjugate, in which each arm of the antibody can alternatively bind to either Nectin-4 or Trop2, two validated oncology antigens that may be expressed on cancer cells

Combined with a unique linker and payload, BD200 can adapt to various local tumor expression profiles, and potentially overcome resistance

BD200’s therapeutic index (TI) is estimated to be substantially greater than comparators

WASHINGTON and NESS ZIONA, Israel, Nov. 12, 2026 (GLOBE NEWSWIRE) -- Biolojic Design, a biotechnology company that uses AI to create antibodies that act as programmable, intelligent therapeutic candidates, today announced that the U.S. FDA has cleared the Investigational New Drug (IND) application for BD200, a multibody drug conjugate that targets both Trop2 and Nectin-4. The IND clearance enables initiation of Biolojic’s 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 FDA’s clearance of our IND for BD200 is a significant step toward advancing the first multibody into clinical testing,” said Yanay Ofran, Ph.D., CEO and founder of Biolojic Design. “In addition to marking an important milestone in the evolution of multi-specific antibodies, it is also an important achievement in the application of AI to drug design by showing that AI can support the creation of antibodies with unique properties and potentially transformative capabilities. We look forward to starting our Phase 1 study in the coming weeks.”

“As we look to improve cancer treatment, the heterogeneity of tumor antigen expression and the development of resistance are significant challenges,” said Roger Waltzman, M.D., Chief Medical Officer of Biolojic Design “As a multibody, BD200 has been designed to help overcome these hurdles with a flexible binding profile and a unique linker-payload profile that enables it to adapt to an individual patient’s tumor expression, potentially improving efficacy and safety.”

Multibodies are standard-format, multi-specific antibodies in which each arm can alternatively bind to one or both of two targets. Targeting the validated oncology antigens Nectin-4 and Trop2, both of which may be expressed by a cancer cell, each arm of BD200 can individually bind to either antigen, with the goal of overcoming target expression heterogeneity and enabling BD200 to address a patient’s specific tumor antigen expression profile.

The BD200 Phase 1 Clinical Study

The Phase 1 clinical study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of BD200 in patients with tumors known to express these antigens. The study will be conducted in the U.S and globally. Once optimal biologic doses have been selected, the study will focus on one or more appropriate tumor types as well as potential monotherapy and combination therapy development pathways.

About BD200

BD200 is a multibody drug conjugate carrying a potent topoisomerase inhibitor payload that targets Trop2 and Nectin-4, two antigens that are 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. In preclinical studies, BD200 was able to 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.

About Biolojic Design

Biolojic Design transforms antibodies into targeted drug candidates through AI and computational design. Biolojic’s platform generated the first AI-designed antibody to enter the clinic, imneskibart, which is now in phase 2 clinical trials. Biolojic’s platform turns human antibodies into multifunctional, programmable switches with specific functions: agonism, antagonism and conditional binding, enhancing their functionality and the precision of their effect. 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. For more information about Biolojic Design and its science and pipeline, please visit https://biolojic.com/ or follow us on LinkedIn.

Media Contact

Todd Cooper
Biongage Communications
todd@biongage.com