Quince Therapeutics Announces CPT: Pharmacometrics & Systems Pharmacology Publication of eDSP Population Pharmacokinetic Modeling Study
Quince Therapeutics, Inc. (NASDAQ: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases, announced the publication of an advanced population pharmacokinetic (PK) modeling study of pediatric patients with Ataxia-Telangiectasia (A-T) and healthy adults treated with its Phase 3 lead asset, eDSP (dexamethasone sodium phosphate [DSP] encapsulated in a patient's own red blood cells), in the scientific journal CPT: Pharmacometrics & Systems Pharmacology (PSP). The journal is an official open access journal of the American Society for Clinical Pharmacology and Therapeutics (ASCPT).
Giovanni Mambrini, MSc, Quince's Chief Technology Officer, said, "We are pleased to continue to advance new research further elucidating the sustained release properties and demonstrated safety profile of our Phase 3 lead asset, eDSP, for the treatment of A-T. Notably, the data revealed eDSP's ability to maintain low, sustained plasma concentrations of DSP for 20 to 30 days without drug accumulation with the aim of providing efficacy while reducing the risk of toxic corticosteroid-related side effects. This PK modeling supports prediction of DSP drug exposure in children with A-T who may benefit from chronic corticosteroid administration to treat this devastating neurodegenerative rare disease."
PSP Publication Highlights
The PSP publication entitled Exposure of Dexamethasone Sodium Phosphate Encapsulated in Erythrocytes (eDSP) Administered Monthly for Treatment of Neurological Symptoms of Patients With Ataxia Telangiectasia addresses the development of a pediatric PK model based on data from the study of healthy adults and pediatric patients with A-T administered monthly with eDSP and predicts the exposure data in the A-T patient population over a six-month period.
Highlights include:
- Detailed Population PK Model Developed: A population PK model was developed using dense PK data from prior eDSP clinical trials, including a Phase 1 study in healthy adults and sparse PK data from a Phase 3 study in pediatric patients with A-T. The overall PK population included 24 healthy adults and 109 pediatric patients with A-T. The PK of DSP released from eDSP was described using a simplified two-compartment model without need for overparameterization. This model enabled simulation of detailed pediatric PK profiles, confirming the sustained release properties of eDSP.
- Sustained Release and No Accumulation: The simulated PK profiles demonstrated that eDSP maintains sustained release of DSP following a monthly infusion with no drug accumulation observed. The study found that DSP delivered via the eDSP System achieves a rapid peak in DSP levels within 0.67 hours post-infusion followed by a controlled, sustained release over 20 to 30 days. Data suggests that most of the drug is released systemically over time, supporting the assumption of full bioavailability.
- Favorable Safety Profile: Quince's prior Phase 3 ATTeST clinical trial and Open Label Extension (OLE) study reported a favorable toxicity profile for eDSP with no drug accumulation observed following repeated monthly dosing. This latest analysis further supports the long-term safety profile of eDSP therapy with minimized side effects typically associated with conventional corticosteroid use, such as adrenal suppression or cushingoid features, which were rarely observed with eDSP treatment – even after several years of use.
About Ataxia-Telangiectasia
A-T is an inherited autosomal recessive neurodegenerative and immunodeficiency disorder caused by mutations in the ATM gene, which is responsible for cell homeostatic and cell division functions including but not limited to double-stranded DNA repair. Typically, A-T is first diagnosed before the age of five as children begin to develop an altered gait and fall with greater frequency. Neurological symptoms worsen and patients with A-T frequently become wheelchair-bound by adolescence. Teenage years for patients with A-T are typically marked by repeated infections, pulmonary impairment, and malignancies. The median lifespan is approximately 25 to 30 years old with mortality due to infections and malignancy. Based on IQVIA Medical Claims (Dx), PharmetricsPlus (P+), and IQVIA Analytics information, there are approximately 4,600 diagnosed patients with A-T in the U.S. Quince estimates that there are approximately 5,000 patients with A-T in the U.K. and EU4 countries. There are currently no approved therapeutic treatments in any global market for A-T.
About eDSP for A-T
eDSP is comprised of dexamethasone sodium phosphate (DSP) encapsulated in a patient's own red blood cells (autologous erythrocytes). DSP is a corticosteroid well known for its anti-inflammatory properties as well as its dose-limiting toxicity due to adrenal suppression. The eDSP System is designed to provide the efficacy of corticosteroids and to reduce or eliminate the significant adverse effects that accompany chronic use of corticosteroid treatment.
eDSP leverages Quince's proprietary Autologous Intracellular Drug Encapsulation, or AIDE, technology platform, which is a novel drug/device combination that uses an automated process designed to encapsulate a drug into the patient's own red blood cells. Red blood cells have several characteristics that make them a potentially effective vehicle for drug delivery, including potentially better tolerability, enhanced tissue distribution, reduced immunogenicity, and prolongation of circulating half-life. Quince's AIDE technology is designed to harness these benefits to allow for the chronic administration of drugs that have limitations due to toxicity, poor biodistribution, suboptimal pharmacokinetics, or immune response.
About Quince Therapeutics
Quince Therapeutics, Inc. (NASDAQ: QNCX) is a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases. For more information on the company and its latest news, visit www.quincetx.com and follow Quince on social media platforms LinkedIn, Facebook, X, and YouTube.
Forward-looking Statements
Statements in this news release contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the "safe harbor" created by those sections. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements contained in this news release may be identified by the use of words such as "believe," "may," "should," "expect," "anticipate," "plan," "believe," "estimated," "potential," "intend," "will," "can," "seek," or other similar words. Examples of forward-looking statements include, among others, statements relating to the results of clinical trials and related data; current and future clinical development of eDSP, including for the potential treatment of Ataxia-Telangiectasia (A-T); the strategic development path for eDSP; planned regulatory agency submissions and clinical trials and timeline, prospects, and milestone expectations; and the potential benefits of eDSP and the company's market opportunity. Forward-looking statements are based on Quince's current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled "Risk Factors" in the company's Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 24, 2025, Quarterly Report on Form 10-Q filed with the SEC on August 11, 2025, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Quince undertakes no duty to update such information except as required under applicable law.
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Media & Investor Contact:
Stacy Roughan
Quince Therapeutics, Inc.
Vice President, Corporate Communications & Investor Relations
[email protected]