TrueLab Biopharmaceutical Announces Positive Interim Phase 1 Results for TL-001 at UEGW 2026
Favorable interim safety and tolerability profile observed across single and multiple ascending dose cohorts in healthy volunteers
Favorable immunogenicity, with single digit percentage Anti-drug Antibody (ADA) incidence at predicted therapeutic dose levels
Extended pharmacokinetics and target suppression support potential for every-3-to-6-month maintenance dosing
Findings support continued clinical development of TL-001 (BYN-002) in inflammatory bowel disease and other TL1A-driven diseases
Data presented at United European Gastroenterology (UEG) Week 2026 in Barcelona
China, October 19th, 2026 – TrueLab Biopharmaceutical, an immunology-driven innovator leveraging a proprietary, AI-powered R&D platform to develop transformative therapies for immune-mediated inflammatory diseases, today announced positive interim results from its ongoing Phase 1 first-in-human study of TL-001 (BYN-002), a long-acting anti-TL1A monoclonal antibody being developed to treat inflammatory bowel disease (IBD) and other TL1A-driven diseases.
The data are being presented in a late-breaking poster at United European Gastroenterology (UEG) Week 2026 in Barcelona: “TL-001 (BYN-002), A Next-Generation Anti-TL1A Antibody Demonstrating Potent Neutralization, Extended Pharmacokinetics, Durable TL1A Suppression and Favorable Immunogenicity: Interim Phase 1 SAD/MAD Results”. The interim results from the ongoing randomized, double-blind, placebo-controlled Phase 1 healthy volunteer study evaluating the safety, pharmacokinetics, pharmacodynamics and immunogenicity of TL-001 (TL-001-101, NCT06867796) met all primary objectives of the study.
" These interim Phase 1 findings provide strong support that TL-001 (BYN-002) achieves potent TL1A pathway inhibition while offering a pharmacokinetic profile potentially enabling highly convenient dosing intervals," said Dr. Francis Fan, Founder, Chairman and CEO of TrueLab Biopharmaceutical. "TL1A has established itself as a key target in inflammatory bowel disease and other TL1A-driven diseases, and the profile we are seeing in this study — with durable target suppression and the prospect of improved convenience — is highly encouraging.”
Interim Phase 1 Highlights
In the ongoing study, healthy volunteers received either single ascending doses (SAD) or multiple ascending doses (MAD) of TL-001 (BYN-002). Interim results showed:
Favorable safety and tolerability, with no treatment-related serious adverse events, infusion reactions, deaths, or treatment-related discontinuations reported.
Dose-proportional pharmacokinetics, with terminal half-life ranging from 77.8 to 82.0 days in multiple-dose cohorts.
Sustained target suppression, with free soluble TL1A below the lower limit of quantification across all dose levels evaluated.
ADA responses primarily observed in lower-dose cohorts and immunogenicity at 9.1 % across MAD cohorts.
Preliminary terminal half-life estimates support potential for every-3-to-6-month maintenance dosing and further clinical development in IBD and in other TL1A-driven diseases.
TrueLab has exclusively out-licensed worldwide rights outside Greater China for TL-001 and TL-003 to Bionyra and holds rights within Greater China.
About TL-001
TL-001 (also known as BYN-002) is an extended half-life, humanized IgG1 monoclonal antibody targeting human tumor necrosis factor-like cytokine 1A (TL1A). It is designed to block TL1A-mediated signaling by inhibiting the interaction between TL1A and its receptor, a well-validated pathway implicated in the pathogenesis of multiple immune-mediated inflammatory diseases, including IBD. TL-001 has the potential to be a best-in-class therapy for IBD and other TL1A-relevant indications. TrueLab has completed enrollment for a Phase I clinical trial in Australia, including both single ascending dose and multiple ascending dose cohorts.
About TL-003
TL-003 (also known as BYN-003) is a novel, extended half-life, bispecific antibody designed to bind both human TL1A and interleukin-23 (IL-23) with high affinity, either individually or simultaneously. Through dual targeting of TL1A and IL-23, TL-003 has the potential to be a best-in-class therapy for IBD and other TL1A and IL-23 relevant immune-mediated inflammatory diseases. TrueLab has completed enrollment for a Phase I clinical trial in Australia, including both single ascending dose and multiple ascending dose cohorts.
About TrueLab Biopharmaceutical
TrueLab Biopharmaceutical is an immunology-driven biopharmaceutical company focused on discovering and developing differentiated therapies for immune-mediated inflammatory diseases. Leveraging deep expertise in disease biology, antibody engineering and drug development, the Company advances innovative therapeutics from discovery through early clinical development. Through its TRUEFORGE™ AI-powered R&D platform and strong internal discovery capabilities, TrueLab is building a diversified pipeline of next-generation monoclonal, bispecific, and multispecific antibodies designed to address significant unmet medical needs worldwide. For more information, visit https://www.truelab-bio.com/
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