AbCellera disclosed that dosing has begun in the Phase 2 portion of its Phase 1/2 clinical trial for ABCL635, a first‑in‑class antibody that targets the neurokinin‑3 receptor (NK3R) to treat moderate‑to‑severe vasomotor symptoms in post‑menopausal women. The milestone marks the first time the company’s internally developed antibody program has entered a Phase 2 study, underscoring its transition from a partnership‑driven royalty model to a clinical‑stage biotechnology focused on proprietary drug candidates.
The Phase 2 study is a multicenter, randomized, double‑blind, placebo‑controlled trial that will enroll 80 post‑menopausal women. The design is intended to evaluate the efficacy of ABCL635 in reducing the frequency and severity of hot flashes, with top‑line results expected in the third quarter of 2026. The trial’s size and rigorous design reflect the company’s commitment to generating robust data that can support regulatory approval and market entry.
Strategically, the advance of ABCL635 into Phase 2 validates AbCellera’s pivot toward internal pipeline development. The company has historically generated revenue primarily from research‑fee partnerships, a model that has been declining as it invests more heavily in its own candidates. Despite reporting net losses in recent periods, AbCellera maintains a strong liquidity position, with substantial cash reserves and government funding that provide a financial cushion for continued pipeline development.
The market for non‑hormonal treatments of vasomotor symptoms is sizable—estimated at roughly $2 billion—yet unmet needs remain. Competitors such as fezolinetant, an NK3R antagonist approved in 2023, illustrate the therapeutic space’s viability. ABCL635’s mechanism of action, targeting the same receptor, positions it as a potential alternative for women seeking non‑hormonal relief, potentially capturing a share of this growing market.
Chief Medical Officer Sarah Noonberg emphasized the clinical promise of ABCL635, noting that encouraging safety and pharmacodynamic data from Phase 1, coupled with strong target engagement, justify the progression to a randomized Phase 2 study. CEO Carl Hansen highlighted the milestone as a “landmark achievement” that completes the company’s transition to a clinical‑stage biotech, while underscoring the importance of maintaining liquidity to support ongoing development.
Financially, AbCellera’s recent earnings reports show continued net losses, driven in part by the high cost of clinical development and a shift away from partnership revenue. However, the company’s robust cash position and strategic focus on internal programs suggest a long‑term commitment to building a proprietary pipeline, even as it navigates the costs associated with early‑stage drug development.
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