FDA Clears IND for Biolojic’s BD200, the First AI-Designed Multibody ADC to Enter Clinical Trials

FDA has cleared Biolojic Design’s Investigational New Drug (IND) application for BD200, an AI-designed bispecific antibody-drug conjugate (ADC) targeting Trop2 and Nectin-4 that the company describes as the first “multibody” to enter clinical trials.¹ The clearance allows Biolojic to begin a global phase 1 study in patients with select solid tumors that express both antigens.¹

Yanay Ofran, PhD, chief executive officer and founder of Biolojic Design, called the clearance “a significant step toward advancing the first multibody into clinical testing.”¹ He said the company expects to begin the study in the coming weeks.¹

What is a multibody?

Multibodies are multispecific antibodies in a standard format in which each arm can bind either of two targets.¹ In BD200, each arm can bind Nectin-4 or Trop2, so the molecule can engage Nectin-4 with both arms, Trop2 with both arms, or one of each.¹ The design is intended to let the drug adapt its binding to the mix of antigens expressed on a patient’s tumor cells.¹ BD200 carries a topoisomerase inhibitor payload attached through what the company describes as a unique linker.¹

Biolojic uses artificial intelligence and computational design to turn antibodies into drug candidates.¹ Its platform produced imneskibart, which the company says was the first AI-designed antibody to enter the clinic and is now in Phase 2 trials.¹ That antibody, previously known as AU-007, was designed by Biolojic for Aulos Bioscience, a company Biolojic co-founded, to selectively target the CD25-binding portion of interleukin-2.²

Why target Trop2 and Nectin-4?

Both antigens are validated ADC targets. In December 2019, FDA granted accelerated approval to enfortumab vedotin, which became the first Nectin-4-directed ADC approved by the agency, for advanced urothelial cancer.³ Enfortumab vedotin, marketed as Padcev, has since moved into earlier disease settings, including the approval of Padcev plus Keytruda as the first platinum-free regimen for muscle-invasive bladder cancer, as BioPharm International® reported in July.

Single-target ADCs can lose effectiveness over time. A 2026 review in Cancer Biology & Medicine described how “tumor heterogeneity further complicates the picture, allowing antigen-negative subclones to survive and repopulate,” and identified bispecific ADCs that target two antigens at once as one strategy to counter that resistance.⁴

“Tumor antigen heterogeneity and resistance” are major challenges in cancer treatment, said Roger Waltzman, MD, chief medical officer of Biolojic Design.¹ He said BD200’s flexible binding profile and linker-payload design allow it to adapt to each patient’s tumor antigen expression, which could improve both efficacy and safety.¹

In preclinical studies, BD200 bound both targets and adapted its specificity to heterogeneous antigen expression on tumor cells, showing greater efficacy and the ability to overcome resistance compared with standard monospecific ADCs or a template bispecific ADC, according to the company.¹ Biolojic did not disclose the models used.¹

How is ADC design changing?

BD200 combines two areas of active ADC innovation: multispecific antibody formats and newer payloads. In a BioPharm International video interview, Sabeen Mekan, MD, of Zymeworks, said, “I think the biggest innovation moving forward is on the payload side.” Developers are also turning to bispecific formats to improve targeting, and bispecific ADCs have produced notable late-stage results this year, including izalontamab brengitecan, an EGFR×HER3 bispecific ADC that more than doubled progression-free survival in HR-positive, HER2-negative breast cancer.⁵

What happens next?

The phase 1 study will be conducted in the US and other countries and will evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy.¹ After optimal doses are selected, the study is designed to focus on one or more tumor types and potential monotherapy and combination pathways.¹ Biolojic said it has partnerships with several biopharmaceutical companies but did not name them in the announcement.¹

References

1. Biolojic Design receives U.S. FDA clearance of Investigational New Drug (IND) application for BD200, the first multibody to enter clinical trials. News release. Biolojic Design; November 12, 2026. Accessed November 12, 2026.
2. Aulos Bioscience announces preclinical data demonstrating ability of novel IL-2 therapeutic AU-007 to eliminate solid tumors. News release. Aulos Bioscience; March 21, 2022. Accessed November 12, 2026.
3. FDA grants accelerated approval to enfortumab vedotin. ONS Voice. Published December 19, 2019. Accessed November 12, 2026.
4. Liu Y, et al. “Drug resistance to antibody-drug conjugates: mechanisms, challenges, and perspectives.” Cancer Biol Med. April 2026. doi:10.20892/j.issn.2095-3941.2025.0707
5. Bispecific ADC may offer new treatment option for HR-positive, HER2-negative breast cancer. The ASCO Post. Published November 4, 2026. Accessed November 12, 2026.