Quince Therapeutics Gets U.S. FDA Fast Track for EryDex System

Quince Therapeutics, a biotechnology company specializing in advanced drug delivery systems, has announced that its EryDex System has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for treating Ataxia-Telangiectasia (A-T). The EryDex System incorporates dexamethasone sodium phosphate (DSP) encapsulated in a patient’s red blood cells using Quince’s unique Autologous Intracellular Drug Encapsulation (AIDE) technology platform. DSP is a corticosteroid known for its anti-inflammatory benefits but is limited by potential adrenal suppression. EryDex aims to offer the therapeutic advantages of corticosteroids while minimizing the adverse effects linked with their long-term use.

The FDA’s Fast Track designation is a significant regulatory milestone for Quince, given the urgent need for effective treatments for A-T—a severe, life-threatening condition with no currently approved therapeutic options. The recognition underscores EryDex's potential to address this high unmet medical need.

A-T is a rare inherited disorder characterized by neurodegeneration and immunodeficiency. The condition is caused by mutations in the ATM gene, which plays a crucial role in cellular homeostasis and DNA repair. A-T typically manifests before the age of five with symptoms such as altered gait and frequent falls. As the disease progresses, patients often become wheelchair-bound during adolescence and face recurrent infections, pulmonary complications, and increased cancer risk. The median life expectancy for those affected is between 25 and 30 years, with mortality primarily due to infections and malignancies. Estimates indicate about 10,000 individuals with A-T across the U.S., U.K., and EU4 countries.

Prior Phase 3 studies of EryDex have shown promising efficacy and a favorable safety profile. Quince is currently enrolling participants for a global Phase 3 NEAT clinical trial, evaluating the neurological impact of EryDex in A-T patients. This trial, conducted under a Special Protocol Assessment (SPA) agreement with the FDA, aims to enroll approximately 86 patients aged six to nine years old for primary analysis and an additional 20 patients aged ten years or older.

Dr. Dirk Thye, Quince’s CEO and Chief Medical Officer, highlighted the significance of the Fast Track designation, stating it represents a crucial step towards providing a beneficial treatment for A-T patients. He also noted the initiation of the pivotal Phase 3 NEAT clinical trial, ongoing in the U.S., U.K., and the European Union.

The EryDex System utilizes Quince’s AIDE technology, an innovative drug/device combination designed to encapsulate drugs within a patient’s red blood cells through an automated process. Red blood cells serve as an effective drug delivery vehicle, offering benefits such as enhanced tissue distribution, reduced immunogenicity, better tolerability, and prolonged circulation time. These advantages aim to enable the chronic administration of drugs limited by toxicity, poor biodistribution, and other pharmacokinetic challenges.

Quince Therapeutics, listed on Nasdaq under the ticker QNCX, is focused on harnessing a patient’s biological potential to develop groundbreaking treatments for rare diseases. The company continues to advance its clinical programs, aiming to bring life-changing therapeutics to patients in need.

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