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Highlights:

  • Health Canada grants No Objection Letter for ABCL635 clinical trial targeting menopausal vasomotor symptoms
  • Phase 1 trial expected to commence in Q3 2025 to assess safety and pharmacological properties
  • ABCL635 targets NK3R for a potential non-hormonal treatment of moderate-to-severe hot flashes

AbCellera Biologics Inc. (Nasdaq: ABCL) has received a No Objection Letter (NOL) from Health Canada, authorizing the company to proceed with a Phase 1 clinical trial for its investigational drug candidate ABCL635. The study is focused on addressing moderate-to-severe vasomotor symptoms (VMS), commonly referred to as hot flashes, associated with menopause.

ABCL635 is being developed as a potential non-hormonal treatment option targeting the neurokinin 3 receptor (NK3R), a G protein-coupled receptor (GPCR) expressed in specific neurons of the hypothalamus. These neurons known as KNDy neurons (kisspeptin, neurokinin, and dynorphin) are believed to play a key role in regulating body temperature and are implicated in the onset of VMS in postmenopausal women.

The Phase 1 trial, slated to begin in the third quarter of 2025, will assess the safety, pharmacokinetics (how the drug is absorbed and processed in the body), and pharmacodynamics (the drug’s effect on the body) of ABCL635. The study will include healthy participants as well as postmenopausal women experiencing moderate-to-severe VMS.

“Vasomotor symptoms of menopause affect millions of women, with significant impacts on their well-being, and their personal and professional lives,” said Dr. Natalya Nazarenko, Executive Medical Director at AbCellera. She noted that ABCL635 aims to offer a non-hormonal treatment approach for those affected by these symptoms.

The development of ABCL635 reflects a broader effort to find alternatives to hormone replacement therapy (HRT), which has been the traditional treatment for menopausal symptoms but may not be suitable for all patients due to associated health risks. By focusing on a non-hormonal mechanism of action, ABCL635 may offer a different therapeutic pathway for individuals who are unable or unwilling to use hormone-based treatments.

This investigational drug marks the first program from AbCellera’s GPCR and ion channel discovery platform to enter clinical development. The company has stated its intention to evaluate ABCL635’s potential across a range of parameters before considering further clinical advancement.

AbCellera’s pipeline includes antibody-based therapies across multiple therapeutic areas such as oncology, metabolic conditions, and autoimmune diseases. The company also collaborates with pharmaceutical partners while maintaining a focus on internal drug development efforts.

While ABCL635 remains in early-stage clinical testing, the regulatory clearance from Health Canada represents a key milestone in advancing its development. Future updates on trial progress and outcomes will likely inform the potential next steps in its clinical evaluation.