AI-Designed Antibody HXN-1001 Enters Phase 2 Clinical

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AI-Designed Antibody HXN-1001 Enters Phase 2 Clinical

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Earendil Labs, an AI-driven biotechnology company advancing next-generation biologics, has announced the first patient has been dosed in a Phase IIa clinical trial of HXN-1001, a half-life extended anti-TL1A antibody, in patients with ulcerative colitis. The company has also completed enrollment in the Phase I trial of the antibody in healthy volunteers carried out in Australia. The Phase IIa trial is a randomized, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HXN-1001 in ulcerative colitis patients. TL1A is a cytokine implicated in inflammatory and autoimmune pathology, and several companies are pursuing anti-TL1A approaches across indications including inflammatory bowel disease. HXN-1001 is the lead candidate of Earendil Labs' AI-native platform, which integrates artificial intelligence across the full R&D lifecycle. The platform has produced more than 40 programs to date, spanning multiple disease areas and modalities including half-life extended antibodies and bispecific antibodies. Additional IND submissions are planned for 2026 and 2027. Earendil Labs closed one of the largest AI drug discovery rounds to date with $787M in financing from Sanofi, Pfizer's Biotech Development Fund, and Dimension Capital. This follows Sanofi's $2.56B partnership with Earendil in January 2026 for next-generation bispecific antibodies. Earendil Labs and its affiliate Helixon Therapeutics are building a scalable engine to systematically generate and advance high-quality therapeutic programs targeting autoimmune diseases, cancer, and other areas of significant unmet medical need. "AI is at the core of everything we do — not as a research tool, but as a production engine for real therapeutic programs," said Jian Peng, PhD, Founder and CEO of Earendil Labs. The financing allows Earendil Labs to operate at a fundamentally different scale, advancing multiple programs toward the clinic while building an R&D organization designed for long-term impact.