ABCL575 / AbCellera - LARVOL DELTA

A First-in-Human Phase 1 Single-Ascending Dose Study of ABCL575 in Healthy Participants (clinicaltrials.gov) - P1 | N=40 | Active, not recruiting | Sponsor: AbCellera Biologics Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • First-in-human

Additional Pipeline Readouts Expected (The Globe and Mail) - "Hansen said AbCellera expects a top-line Phase 1 readout for ABCL575 in the fourth quarter of 2026. The company describes ABCL575 as a potential best-in-class OX40L antagonist."

P1 data • Immunology

A First-in-Human Phase 1 Single-Ascending Dose Study of ABCL575 in Healthy Participants (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: AbCellera Biologics Inc. | Trial completion date: Nov 2026 ➔ Apr 2027 | Trial primary completion date: Nov 2026 ➔ Apr 2027

First-in-human • Trial completion date • Trial primary completion date

AbCellera Doses First Participants in a Phase 1 Clinical Trial of ABCL575 (Businesswire) - "The Phase 1 clinical trial of ABCL575 (NCT07108894) is a randomized, placebo-controlled, double-blind study to assess safety and tolerability in healthy participants following subcutaneous doses of ABCL575. Data from this study is expected in mid 2026."

P1 data • Trial status • Atopic Dermatitis

A First-in-Human Phase 1 Single-Ascending Dose Study of ABCL575 in Healthy Participants (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: AbCellera Biologics Inc.

New P1 trial

AbCellera Receives Authorization from Health Canada to Initiate a Phase 1 Clinical Trial of ABCL575 (Businesswire) - "AbCellera...announced it has received a No Objection Letter (NOL) from Health Canada authorizing its Clinical Trial Application (CTA) for ABCL575, an investigational antibody antagonist targeting OX40 ligand (OX40L) that is being developed for the treatment of moderate-to-severe atopic dermatitis (AD), with potential applications to other inflammatory and autoimmune conditions. The Phase 1 study is anticipated to begin in Q3 of 2025 and will evaluate the safety and pharmacokinetics of ABCL575 administered subcutaneously in healthy participants."

New P1 trial • Atopic Dermatitis

Preclinical development of ABCL575, a half-life extended anti-OX40L monoclonal antibody for the treatment of autoimmune conditions (SID 2025) - "ABCL575 is formatted as a high-concentration formulation to support subcutaneous administration and exhibits low viscosity and favorable stability/product quality attributes. Together, these data show that ABCL575 is a potential best-in-class antibody for the treatment of T cell-mediated autoimmune conditions and support further clinical evaluation."

Preclinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • TNFSF4

AbCellera Presents Positive Preclinical Data on ABCL575 at the 2025 SID Annual Meeting (Businesswire) - "AbCellera’s presentation...describes key properties of ABCL575, including: (i) Potent functional activity that is equivalent to the most advanced clinical benchmark, with inhibition of OX40L signalling and T-cell activation in vitro and significant reduction of Th2 cytokines in vivo; (ii) Modified Fc domain that supports Fc-silencing and half-life extension, with a predicted human half-life of more than 60 days from preclinical in vivo PK data; (iii) Positive nonclinical safety profile and favorable stability when formulated at high concentration....'We look forward to advancing this molecule into the clinic and are on track to do so this year'."

New trial • Preclinical • Atopic Dermatitis

AbCellera Reports Full Year 2024 Business Results (Businesswire) - "'We also maintained our strong cash position, closing the year with over $800 million in available liquidity to execute on our strategy,'...As a result, we enter 2025 on track to initiate Phase 1 clinical trials for our first two programs, ABCL635 and ABCL575, and to start activities in our new clinical manufacturing facility.'...Revenue – Total revenue was $28.8 million, compared to $38.0 million in 2023. In both periods, the majority of revenues were research fees generated by our partnerships."

Commercial • New P1 trial • Immunology • Metabolic Disorders

AbCellera Reports Q2 2024 Business Results (Businesswire) - "Q2 2024 Business Summary: ABCL635 and ABCL575 remain on track for anticipated Clinical Trial Applications (CTAs) in the second quarter of 2025."

New trial • Atopic Dermatitis