AbCellera Biologics reported positive Phase II data for its lead asset ABCL635, a first-in-class antibody targeting the neurokinin-3 receptor, at the 12th Annual Cantor Fitzgerald Global Healthcare Conference on Wednesday.
The drug, which aims to treat vasomotor symptoms such as hot flashes associated with menopause, reduced moderate-to-severe hot flash frequency by approximately 5.1 events per day from a baseline of roughly 10 daily events, according to President and CEO Carl Hansen. That represents roughly twice the efficacy of two approved small-molecule competitors in reducing frequency and four to five times the efficacy in lowering severity scores on a three-point scale.
Hansen said 37% of patients achieved zero hot flash events per day and 24% to 25% reached zero severity scores. About 80% of patients reported feeling much better or better. The single 600-milligram intravenous dose also produced a statistically significant improvement in sleep quality comparable to Lynkuet, without the off-target somnolence side effect linked to the NK1 receptor.
A clean safety profile was noted, with no evidence of elevated liver enzymes — avoiding the hepatotoxicity liability, boxed warnings and mandatory monitoring required by approved small-molecule alternatives. Dosing simulations suggest a once-monthly 300-milligram regimen could achieve steady-state antibody concentrations.
Hansen pointed to current commercial performance of Bayer's VEOZAH — projected to generate about CAD 400 million in sales this year, including CAD 90 million in the final quarter, up 40% year over year — and Astellas's program as indicators of a multi-billion dollar opportunity. Prolia, another menopause-adjacent therapy, generates about CAD 4 billion annually. "How do you miss on that?" Hansen said of the likelihood of success in Phase III. "I'm very bullish on that."
Top-line four-week Phase II data were released about three weeks before the conference. A 12-week readout and open-label extension are expected by year-end 2024. AbCellera is engaging with the FDA under its Model-Informed Drug Development Program, as well as regulators in Canada, Europe and potentially Australia, ahead of a Phase III plan.
The registrational trial, targeting about 1,500 patients over roughly 2.5 years, is expected to begin in the second half of 2025. An oncology indication — starting with breast cancer and followed by prostate cancer — is planned to enter Phase II before the vasomotor symptoms trial. A follow-on NK3R antibody with an extended half-life is already in IND-enabling studies.
Two other pipeline assets, ABCL688 and ABCL386, remain on track for clinical entry in 2025. AbCellera transitioned from a platform company to building internal assets in September 2023.
Shares closed regular trading at $11.05, down 3.41%, and edged up slightly in after-hours trading. The stock has returned 158% over the past year and gained 223% year to date, with a market capitalization of about $3.58 billion.
Hansen said a commercial alliance with the right partner under the right terms could be a game changer for the company's future value.
