AbCellera Announces First Patients Dosed in Phase 2 Portion of its Phase 1/2 Clinical Trial of ABCL635 for the Treatment of Vasomotor Symptoms Due to Menopause

Key Terms

vasomotor symptoms (VMS) medical

Vasomotor symptoms are sudden changes in body temperature regulation, most commonly experienced as hot flashes and night sweats, caused by brief shifts in blood flow and nervous system signals that control heat. They matter to investors because they create demand for drugs, therapies and devices, influence healthcare spending and clinical trial activity, and can affect workforce productivity—making them a clear market and regulatory opportunity.

pharmacodynamic medical

Pharmacodynamic describes how a drug acts on the body — the biological effects it produces, how strong those effects are, and how long they last. For investors, pharmacodynamic data show whether a treatment actually works and at what dose, shaping expectations about a drug’s safety, effectiveness, regulatory success and market potential; think of it like testing how well a key turns a lock and whether it reliably opens the door.

randomized, double-blind, placebo-controlled medical

A "randomized, double-blind, placebo-controlled" process is a method used to test the effectiveness of a new treatment or intervention. Participants are randomly assigned to different groups, with one receiving the real treatment and the other a fake version, called a placebo. Neither the participants nor the researchers know who is receiving which, which helps ensure unbiased results. For investors, this rigorous approach increases confidence that the findings are accurate and not influenced by guesswork or bias.

proof-of-concept technical

A proof-of-concept is a demonstration that shows a new idea or method can work as intended, serving as a small-scale test before full development. For investors, it signals that a concept has been successfully tested in principle, reducing uncertainty about whether it can be practically implemented. This helps determine if further investment or effort is justified to develop the idea further.

VANCOUVER, British Columbia--(BUSINESS WIRE)-- AbCellera (Nasdaq: ABCL) today announced that the first patients have been dosed in the Phase 2 portion of its ongoing Phase 1/2 clinical trial for ABCL635. ABCL635 is a potential first-in-class non-hormonal treatment for moderate-to-severe vasomotor symptoms (VMS) associated with menopause.

The transition to Phase 2 follows an interim review of safety, tolerability, and pharmacodynamic data from healthy volunteers from the Phase 1 portion of the study. The Phase 2 portion is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy of ABCL635 in reducing the frequency and severity of VMS in 80 postmenopausal women.

“Advancing this program into Phase 2 marks an important milestone in our clinical development efforts. 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, we are eager to evaluate ABCL635 in a randomized, double-blind Phase 2 study,” said Sarah Noonberg, M.D., Ph.D., Chief Medical Officer of AbCellera. “Menopausal symptoms can have a profound impact on quality of life, and we look forward to evaluating the potential of ABCL635 to provide a safe and effective option for women seeking non-hormonal symptom relief.”

AbCellera has recently designated the ABCL635 Phase 1 trial as a Phase 1/2 trial, which includes a randomized Phase 2 Proof-of-Concept study (Part C) in the appropriate patient population. With Phase 2 enrollment underway, the company anticipates top-line clinical results for both phases in Q3 2026.

About ABCL635

ABCL635 is a potential first-in-class antibody medicine for the non-hormonal treatment of moderate-to-severe VMS, commonly known as hot flashes, associated with menopause. ABCL635 specifically targets NK3R, a clinically validated G protein-coupled receptor (GPCR) expressed on kisspeptin, neurokinin, and dynorphin (KNDy) neurons in the infundibular nucleus of the hypothalamus. ABCL635 is the first program from AbCellera’s GPCR and ion channel platform to advance into the pipeline, entering the clinic in July 2025. Additional details are available at ClinicalTrials.gov.

About AbCellera Biologics Inc.

AbCellera (Nasdaq: ABCL) is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology. For more information, please visit www.abcellera.com.

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Inquiries

Media: Tiffany Chiu; media@abcellera.com, +1(236)521-6774

Partnering: Murray McCutcheon, Ph.D.; partnering@abcellera.com, +1(604)559-9005

Investor Relations: Peter Ahn; ir@abcellera.com, +1(778)729-9116

Source: AbCellera Biologics Inc.