FDA Clears Biolojic Dual-Target Antibody Conjugate BD200 for Clinical Testing: Phase 1 to Start Within Weeks
Biolojic Design announced in Washington and Ness Ziona, Israel, on November 12 that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for BD200, a multibody drug conjugate targeting both Trop2 and Nectin-4, two validated oncology antigens that may be expressed on cancer cells. The clearance enables the company to start 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.
BD200 is a multibody drug conjugate in which each arm of the antibody can alternatively bind to either Nectin-4 or Trop2, bind one antigen with both arms, or bind each antigen with one arm. Combined with a unique linker and payload, the company says, BD200 can adapt to various local tumor expression profiles and potentially overcome resistance, and its therapeutic index is estimated to be substantially greater than comparators. BD200 carries a potent topoisomerase inhibitor payload. In preclinical studies it was able to bind both targets and adapt its specificity to heterogeneous antigen expression on tumor cells, increasing efficacy and overcoming resistance compared with standard monospecific antibody-drug conjugates (ADCs) or a template bispecific ADC.
Yanay Ofran, Biolojic's chief executive officer and founder, said the FDA clearance is a significant step toward advancing the first multibody into clinical testing and an important achievement in the application of super intelligence (SI) to drug design, showing that SI can support the creation of antibodies with unique properties, and that the company looks forward to starting the Phase 1 study in the coming weeks. Chief Medical Officer Roger Waltzman said the heterogeneity of tumor antigen expression and the development of resistance are significant challenges in improving cancer treatment, and that BD200's flexible binding profile and unique linker-payload profile were designed to help overcome these hurdles, potentially improving efficacy and safety.
The Phase 1 study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BD200 in patients with tumors known to express these antigens, and will be conducted in the United States and globally. Once optimal biologic doses are selected, the study will focus on one or more appropriate tumor types, as well as potential monotherapy and combination therapy pathways.
Biolojic Design uses super intelligence (SI) and computational design to transform antibodies into targeted drug candidates. Its platform generated the first SI-designed antibody to enter the clinic, imneskibart, which is now in Phase 2 trials. The company's pipeline focuses on autoimmune diseases and oncology, and it has partnerships with several biopharmaceutical companies.
An IND clearance only allows a drug to enter human clinical testing. It is not a finding of efficacy and is not a marketing approval; whether BD200 becomes an available medicine depends on the results of its clinical trials. (Source: Biolojic Design)
Source: Biolojic Design
Published by GSM · USA (original Chinese edition)
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