Quince Therapeutics (QNCX) presented updates on its inhaled rapamycin development program Wednesday at the 12th Annual Institutional Cantor Fitzgerald Global Healthcare Conference, describing preclinical pharmacokinetics and clinical trial timelines for two late-stage studies targeting lung complications after transplantation and in patients with pulmonary hypertension.
Chief Executive Officer Brigette Roberts and Chief Operating Officer Keith Fandrick participated in the session moderated by Cantor senior biotech analyst Olivia Brayer.
The company’s lead candidate, LAM-001, is a proprietary inhaled formulation of rapamycin delivered through a dry powder inhaler as a once-daily puff. It targets the mTOR pathway. The inhaled dose is roughly one-twentieth of the oral dose, and at the 100-microgram level, systemic blood levels remain below 1 nanogram per milliliter — far below the 5 to 15 nanograms per milliliter targeted by standard oral rapamycin at a 2-milligram dose. The formulation’s mass median aerodynamic diameter falls between 2.7 and 3.1 microns, placing it within the deep lung deposition range of 1 to 5 microns.
In animal models, a single dose equivalent to the 100-microgram human dose produced more than 90% mTOR target inhibition at 24 hours, according to the company.
Quince is advancing two clinical programs. A Phase II placebo-controlled, single-center trial at UCSF led by principal investigator Dr. Steven Hays is evaluating LAM-001 for bronchiolitis obliterans syndrome, a severe form of chronic rejection following lung transplantation that carries no approved treatments. Nearly all lung transplant recipients develop the condition, and survival after diagnosis averages approximately 2.5 years. The study has enrolled 19 patients within the first year of diagnosis, most within six months, with baseline FEV1 ranging from 51% to 85% of predicted. The primary endpoint is the percent change in FEV1 over 48 weeks, with a 5% to 10% difference between treatment and placebo groups considered a successful outcome and 10% or greater deemed exceptional. Topline data are expected in the first quarter of 2027.
A separate Phase II-B study in patients with pulmonary hypertension associated with interstitial lung disease is testing 100-microgram and 200-microgram doses against placebo. Enrollment requires Functional Class II or III, a pulmonary vascular resistance above 4 mmHg and stable background therapy for at least 90 days. The trial is powered to detect a 20% difference versus placebo in change in pulmonary vascular resistance over 24 weeks, with results expected in the first quarter of 2028.
The company also outlined a planned Phase II study targeting sarcoidosis-associated pulmonary hypertension.
Quince completed a reverse merger and secured a $150 million private investment in public equity financing in May 2027. The company expects to present additional BOS data at the American Thoracic Society meeting and has indicated further presentations at the European Respiratory Society.
Shares closed at $29.55, up 2.04%. The stock has risen 46% over the past six months and 10% over three months, though it remains down 91% from its 52-week high of $910 over the past year.
