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AbCellera Receives Authorization from Health Canada to Initiate the Phase 1 Clinical Trial of ABCL635 for Vasomotor Symptoms Due to Menopause

By: via Business Wire

AbCellera anticipates starting the Phase 1 clinical trial for ABCL635 in Q3 2025

AbCellera (Nasdaq: ABCL) today announced it has received a No Objection Letter (NOL) from Health Canada authorizing its Clinical Trial Application (CTA) for ABCL635, an investigational antibody antagonist targeting neurokinin 3 receptor (NK3R) that is being developed for the non-hormonal treatment of moderate-to-severe vasomotor symptoms (VMS), commonly known as hot flashes, associated with menopause.

“Vasomotor symptoms of menopause affect millions of women, with significant impacts on their well-being, and their personal and professional lives,” said Natalya Nazarenko, MD, Executive Medical Director at AbCellera. “We are excited to advance ABCL635 into a Phase 1 trial and explore it as a potential non-hormonal, long-acting treatment option to address these highly disruptive symptoms.”

The Phase 1 study is anticipated to begin in Q3 of 2025 and will evaluate ABCL635's safety, pharmacokinetics, and pharmacodynamics in healthy participants and postmenopausal women with moderate-to-severe VMS.

About ABCL635

ABCL635 is a potential first-in-class antibody medicine for the non-hormonal treatment of moderate-to-severe vasomotor symptoms (VMS), commonly known as hot flashes, associated with menopause. ABCL635 specifically targets NK3R, a clinically validated G-coupled protein receptor (GPCR) expressed on kisspetin, 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. A Phase 1 clinical trial is anticipated to begin in Q3 of 2025.

About AbCellera Biologics Inc.

AbCellera (Nasdaq: ABCL) discovers and develops antibody medicines for indications across therapeutic areas, including cancer, metabolic and endocrine conditions, and autoimmune disorders. AbCellera’s platform integrates technology, data science, infrastructure, and interdisciplinary teams to solve the most challenging antibody discovery problems. AbCellera is focused on advancing an internal pipeline of first-in-class and best-in-class programs and collaborating on innovative drug development programs with partners. For more information, please visit www.abcellera.com.

AbCellera Forward-Looking Statements

This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to management. All statements contained in this release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize, and achieve market acceptance of our current and planned products and services, our research and development efforts, and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations.

In some cases, you can identify forward-looking statements by the words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors are described under “Risk Factors,” “Management's Discussion and Analysis of Financial Condition and Results of Operations,” and elsewhere in the documents we file with the Securities and Exchange Commission from time to time. We caution you that forward-looking statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. As a result, the forward-looking statements may not prove to be accurate. The forward-looking statements in this press release represent our views as of the date hereof. We undertake no obligation to update any forward-looking statements for any reason, except as required by law.

1Lé AM, Torres T. Pharmaceutics. 2022 Dec 8;14(12):2753.

2Guttman-Yassky E, et al. Br J Dermatol. 2024 Sep 18;191(4):488-496.

3Weidinger S, et al. J Allergy Clin Immunol. 2024 Nov 8:S0091-6749(24)01175-8.

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