Data Readout

AbCellera heads toward Q3 readout for first-in-class menopause antibody

ABCL635's Phase 2 efficacy data will be the first test of whether an NK3R antibody can reduce hot flashes, after favorable Phase 1 safety and PK data in May.

By AppliedXLJuly 13, 2026Trial NCT07118891

Executive Summary

AbCellera is approaching its first efficacy test of an antibody built to block NK3R signaling for hot flashes, a target already validated by oral drugs but never before tested as a monthly-dosed antibody.
Interim safety data reported earlier this year cleared the tolerability bar and confirmed the antibody hits its target, leaving the efficacy question as the one still open.
The nearest comparator is an oral NK3R antagonist already in Phase 3 for the same symptom, so a positive signal here would matter less for proving the target and more for whether an antibody format can compete with an established dosing frequency and route.
The Phase 2 portion is a small, non-registrational proof-of-concept study, so its result will be hypothesis-generating for AbCellera's next development step rather than a basis for regulatory filing on its own.

The catalyst

AbCellera said in a January 12, 2026 release that it expects top-line results from both the Phase 1 and Phase 2 portions of its ABCL635 trial in the third quarter of 2026. The trial, registered as NCT07118891, is a Phase 1/2 study in postmenopausal women and healthy volunteers, running in Canada with a target enrollment of 136. The registered primary endpoints are safety measures: the frequency and severity of adverse events, 12-lead ECG abnormalities, laboratory abnormalities, and physical exam findings, not an efficacy measure. The efficacy question sits in the Phase 2 portion, described in the same release as a multicenter, randomized, double-blind, placebo-controlled study enrolling roughly 80 postmenopausal women to evaluate ABCL635's effect on the frequency and severity of VMS. AbCellera+1

Probability of Success

Endpoint Met49%

Completes95%

Clinical Significance4%

Regulatory62%

What's already reported

AbCellera disclosed interim Phase 1 data on its first-quarter earnings call in May 2026, ahead of the Q3 window, reporting favorable tolerability with no serious adverse events or liver enzyme elevations, an estimated half-life of about 24 days consistent with once-monthly dosing, and sustained, dose-dependent suppression of testosterone in male volunteers, evidence the antibody is engaging its target. Chief Medical Officer Sarah Noonberg said the company advanced the program "based on encouraging safety and pharmacodynamic data in the Phase 1 dose escalation portion, along with evidence of high target engagement and a strong mechanistic foundation". That interim data addressed tolerability and target engagement; it did not address whether the drug reduces hot flash frequency or severity, which is what the Q3 readout is designed to answer. AbCellera

The competitive frame

NK3R is a validated target in menopausal VMS: an oral NK3R antagonist, fezolinetant, is already in Phase 3 testing for the same symptom, and a second oral NK3R antagonist, elinzanetant, has completed Phase 3 testing in hot flashes, giving the mechanism itself an established human precedent. ABCL635 is the only industry trial in the competitive landscape scan pairing NK3R with vasomotor symptoms of menopause, and it is also the only asset in that pairing to reach even Phase 1. Its distinguishing feature is format and dosing: an antibody with an estimated half-life near 24 days, positioned for once-monthly dosing, against oral small molecules dosed daily. Given a target class already shown to reduce VMS frequency in oral form, the Phase 2 readout's informative bar is whether the antibody reproduces that reduction while offering a dosing interval oral competitors cannot match. AbCellera

Trial mechanics

The study moved from Recruiting to Active, not recruiting on June 15, 2026, consistent with enrollment closing at its unchanged target of 136 participants rather than any enrollment cut. The registry shows one eligibility-criteria amendment logged since the trial's August 2025 registration, and the primary completion date has held at February 1, 2027, without revision. That combination, a single routine amendment and a stable completion date, points to an on-track trial heading into its Phase 2 data lock rather than one showing signs of operational strain. NCT07118891

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