Quince is dedicated to harnessing the power of a patient’s own biology to deliver innovative and life-changing therapeutics to those living with rare diseases. Our proprietary Autologous Intracellular Drug Encapsulation, or AIDE, technology platform is an innovative drug/device combination that uses an automated process to encapsulate a drug into a patient’s own red blood cells. We believe that advancing our innovative AIDE technology platform holds the potential to redefine the standard of care for underserved indications and provide meaningful benefit for rare disease patients, caregivers, and families.

First Patient Dosed in Pivotal Phase 3 NEAT Clinical Trial of EryDex in Patients with A-T

Our strategic focus is to complete the pivotal Phase 3 clinical trial of EryDex, called NEAT (Neurologic Effects of EryDex on Subjects with A-T), to evaluate the safety and efficacy of EryDex for the treatment of Ataxia-Telangiectasia (A-T). A-T is an inherited autosomal recessive neurodegenerative and immunodeficiency disorder with currently no approved therapeutic treatments in any global market for this rare pediatric disease.

Quince has dosed the first patient and is actively enrolling participants for our global Phase 3 NEAT study. Patients with A-T interested in participating can learn more about the NEAT study criteria and locations by visiting here.

The U.S. Food and Drug Administration granted Fast Track designation for our EryDex System for the treatment of patients with A-T, underscoring the high unmet medical need as there are currently no approved therapeutic treatments for A-T.

Patient Advocacy Support and Caregiver Resources

Quince is proud to work in partnership with the leading patient advocacy organizations focused on patients with A-T. For more information, please visit each organization’s website by clicking below:

Expanded Access Program Policy

At Quince Therapeutics, we are dedicated to unlocking the power of a patient’s own biology to deliver innovative and life-changing therapeutics to those living with rare diseases. To accomplish this, Quince conducts clinical trials to assess the safety and efficacy of our investigational therapies, which may allow us to obtain the necessary regulatory approvals and provide patients with broader access to these therapeutics.

As Quince advances our investigational therapies through clinical development, our goal is to provide access to these therapies at the appropriate time and in the correct manner for patients. Expanded access – or “compassionate use” – refers to a potential pathway for a patient with a serious or life-threatening disease or condition to try an investigational therapy outside a clinical trial when there is no comparable or satisfactory therapy available. Several factors consistent with guidelines by the U.S. Food and Drug Administration (FDA) and other regulatory agencies should be taken into account when considering expanded access, including:

  • The illness must be serious or life-threatening with no other satisfactory treatment options, such as approved products or enrolling clinical trials.
  • There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks based on available safety and efficacy information.
  • The ability to provide a product in a fair and equitable manner so that there is adequate manufacturing capacity for ongoing programs.
  • Whether granting expanded access would potentially compromise the scientific validity of broader development programs or interfere with or delay current clinical trials or regulatory filings designed to make the therapy available to many more patients.

At this time, Quince does not have an investigational product candidate available for expanded access. We believe that participation in our clinical trials, which are carefully designed to determine the safety and efficacy of an investigational therapy, is the most appropriate way for patients to access an investigational therapy until sufficient evidence is available that suggests the potential benefit outweighs the risk. For more information regarding Quince’s active clinical trials, please click here.