Bionyra’s Long-Acting Anti-TL1A Antibody BYN-002 Shows Roughly 80-Day Half-Life in Phase 1

Bionyra Pharma’s long-acting anti-TL1A monoclonal antibody BYN-002 (TL-001) showed a terminal half-life of roughly 78 to 82 days and sustained suppression of its target in healthy volunteers, according to interim phase 1 results presented at United European Gastroenterology (UEG) Week 2026 in Barcelona.¹^,² The company said the data support potential every-3-to-6-month maintenance dosing as it develops the antibody for inflammatory bowel disease (IBD) and other TL1A-driven diseases.¹

“These interim phase 1 results provide compelling evidence that BYN-002 combines potent TL1A pathway inhibition with a pharmacokinetic profile that may enable highly convenient dosing intervals,” Frédéric Marrache, MD, PhD, MBA, chief executive officer of Bionyra Pharma, said in a press release.¹

What is BYN-002, and how is it engineered?

BYN-002 is a humanized IgG1 monoclonal antibody against TL1A.² TL1A is a cytokine that signals through the receptor DR3 and drives mucosal inflammation in IBD, and it has also been linked to intestinal fibrosis, as BioPharm International® reported when Bionyra launched in June.

According to the poster, BYN-002 carries YTE substitutions in its Fc region to extend half-life and LALA substitutions to reduce Fc-mediated effector functions.² Bionyra licensed BYN-002 and a TL1A×IL-23p19 bispecific antibody, BYN-003 (TL-003), from TrueLab Biopharmaceutical and holds exclusive worldwide rights outside Greater China.¹

What did the phase 1 study show?

The ongoing randomized, double-blind, placebo-controlled study (NCT06867796) is evaluating safety, pharmacokinetics, pharmacodynamics, and immunogenicity in healthy volunteers.¹ In the single ascending dose (SAD) portion, 24 participants received intravenous BYN-002 and 8 received placebo.² In the multiple ascending dose (MAD) portion, 12 participants received BYN-002 and 4 received placebo, with intravenous doses on Days 1, 15, and 29.² According to Bionyra, the interim results met all primary objectives of the study.¹

Pharmacokinetics were dose-proportional, with preliminary terminal half-life estimates of 77.8 to 82.0 days in the MAD cohorts and 35.7 to 78.2 days in the SAD cohorts.¹,² Free soluble TL1A remained below the lower limit of quantification across all dose levels evaluated.¹

No treatment-related serious adverse events, infusion reactions, deaths, or treatment-related discontinuations were reported.¹ The most common adverse events in the SAD cohorts were upper respiratory tract infection and headache, and adverse events in the MAD cohorts were mostly Grade 1 or 2.² One Grade 3 and one Grade 4 adverse event occurred in the MAD portion, and both were judged unrelated to treatment.²

Anti-drug antibodies (ADAs) were observed primarily in the lower-dose cohorts.¹ Through Day 85, the poster reported ADAs in 7 of 23 SAD participants (30.4%) and 1 of 11 MAD participants (8.3%), with no treatment-enhanced ADA responses.² The investigators noted that the half-life estimates remain preliminary.²

Why does dosing frequency matter in IBD?

Bionyra is positioning BYN-002’s extended pharmacokinetics as a way to reduce the treatment burden of maintenance therapy.¹ Convenience has been a recurring theme in BioPharm International’s coverage of IBD biologics. In an interview about subcutaneous infliximab, Juby Jacob-Nara, MD, senior vice president and chief medical officer of Celltrion USA, described what at-home dosing can mean for patients. “Technically, it is a game changer for patients with IBD,” she said.

“TL1A has emerged as one of the most important targets in inflammatory bowel disease and other TL1A-driven diseases, and we are excited by the profile emerging from this study and its ability to deliver durable target suppression and improved convenience,” Marrache said.¹

What happens next?

Bionyra said the findings support continued clinical development of BYN-002 in IBD and other TL1A-driven diseases.¹ BYN-003, the company’s bispecific antibody built on BYN-002 as a backbone, entered a Phase 1 study in April 2026.³

References

1. Bionyra Pharma. Bionyra Pharma Announces Positive Interim Phase 1 Results for BYN-002, a Long-Acting Anti-TL1A Antibody. Press release. Business Wire. Published October 20, 2026. Accessed October 20, 2026.
2. Petkova M, Lei R, Li Z, et al. BYN-002 (TL-001), a next-generation anti-TL1A antibody demonstrating potent neutralization, extended pharmacokinetics, durable TL1A suppression and favorable immunogenicity: interim Phase 1 SAD/MAD results. Late-breaking poster LBP27 presented at: UEG Week 2026; Barcelona, Spain. Accessed October 20, 2026.
3. Sofinnova Partners. Bionyra Pharma launches with USD165 million oversubscribed Series A to advance clinical-stage pipeline of next-generation biologics for immune-mediated inflammatory diseases. Published June 22, 2026. Accessed October 20, 2026.