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.

Corporate Offices

Quince Therapeutics, Inc.
611 Gateway Blvd, Suite 273
South San Francisco, CA 94080
Phone: +1 415 910 5717

Quince Therapeutics S.p.A.
Via A. Meucci, 3
20091 Bresso (MI) Italy
Phone: +39 02 36504470

Manufacturing Facility

Quince Therapeutics S.p.A.
Via Statale, 135
41036 Medolla (MO) Italy
Phone: +39 0535 1948160