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, today
announced the presentation of two posters at the 2024 International
Congress for Ataxia Research (ICAR) of data from its prior Phase 3
ATTeST (Ataxia-Telangiectasia Trial with the
EryDex SysTem; #IEDAT-02-2015/NCT02770807)
clinical trial of the company’s lead asset, EryDex
(intra-erythrocyte dexamethasone sodium phosphate), for the
treatment of Ataxia-Telangiectasia (A-T).
Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief
Medical Officer, said, “We continue to gain valuable insights from
the robust dataset provided from our prior Phase ATTeST clinical
trial, which is the largest study of patients with A-T completed to
date. We are pleased to share new analyses of these data at the
2024 International Congress for Ataxia Research that showcase
EryDex’s strong safety profile and provide validation of the
primary efficacy endpoint utilized in our study of EryDex for the
treatment of A-T.”
The objective of the poster titled Growth and Bone Mineral
Density (BMD) in Children with Ataxia-Telangiectasia (A-T) Treated
with Intra-Erythrocyte Dexamethasone (EryDex) for 24 months
describes growth and bone mineral density in patients with A-T
treated for 24 months with EryDex. Key findings reported in the
poster presentation include:
- 24 months of EryDex treatment did not adversely affect growth
and bone mineral density of patients with A-T.
- Results compare favorably to natural history of patients with
A-T who experience height and weight faltering, in addition to
abnormal bone mineral density.
- No weight gain, adverse growth, or bone health typically
associated with the use of corticosteroids in children were
observed.
The objective of the poster titled Cross-sectional Analysis of
International Cooperative Ataxia Rating Scale (ICARS) Subcomponent
Scores in Children with Ataxia-Telangiectasia (A-T) describes the
baseline ICARS subcomponent scores by age in a cross-sectional
analysis of treatment-naive patients from the ATTeST dataset and
identifies ICARS subcomponents that best reflect progression of
disease by age. Key findings reported in the poster presentation
include:
- ICARS subcomponents in the mICARS (modified International
Cooperative Ataxia Rating Scale) and RmICARS (Rescored modified
International Cooperative Ataxia Rating Scale) analyses capture the
fastest neurological symptom progression in patients with A-T
between the ages of six to 10 year olds who were ambulatory at
baseline.
- Posture and gait category of ICARS showed progression with age
in untreated patients with A-T between the ages of six and 10 years
old.
- Scales with reduced kinetic function domain may be more
sensitive than full ICARS scores when assessing disease progression
over shorter periods of time in younger children.
- mICARS and RmICARS measures focus on assessment of the
participant’s posture and gait as opposed to kinetic function and
speech.
- mICARS and RmICARS subcomponents of ICARS best reflect
progression of disease by age and capture the fastest neurological
symptom progression in patients with A-T between the ages of six to
10 years.
Pivotal Phase 3 NEAT Clinical Trial
Quince is currently enrolling a pivotal Phase 3 NEAT
(Neurologic Effects of EryDex on Subjects with
A-T; #IEDAT-04-2022/NCT06193200) clinical trial,
which is an international, multi-center, randomized, double-blind,
placebo-controlled clinical trial evaluating the neurological
effects of EryDex in patients with A-T. The company plans to enroll
approximately 86 patients with A-T ages six to nine years old
(primary analysis population) and approximately 20 patients with
A-T ages 10 years or older.
The Phase 3 NEAT trial is being conducted under a Special
Protocol Assessment (SPA) agreement with the U.S. Food and Drug
Administration (FDA), and the company expects to report topline
results in the fourth quarter of 2025 with a potential New Drug
Application (NDA) submission to the FDA and a Marketing
Authorization Application (MAA) submission to the European
Medicines Agency (EMA) in 2026, assuming positive study results.
Additionally, Quince was granted Fast Track designation by the FDA
for the company’s EryDex System for the treatment of patients with
A-T based on the potential for EryDex to address a high unmet
medical need in A-T.
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 EryDex for A-T
The EryDex System is a novel drug/device combination product
comprised of dexamethasone sodium phosphate (DSP) which is
encapsulated and administered using 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 EryDex 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.
EryDex leverages Quince’s proprietary Autologous Intracellular
Drug Encapsulation (AIDE) technology platform that uses an
automated process designed to encapsulate and administer a drug
using a 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 (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 Therapeutics 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 current and future clinical
development of EryDex, including for the potential treatment of
Ataxia-Telangiectasia (A-T) and other potential indications,
related development and commercial-stage inflection point for
EryDex, the company’s proprietary Autologous Intracellular Drug
Encapsulation (AIDE) technology for treatment of other rare
diseases; the strategic development path for EryDex; planned
regulatory agency submissions and clinical trials and timeline,
prospects, and milestone expectations; the timing and success of
the clinical trials and related data, including plans and the
ability to initiate, fund, enroll, conduct, and/or complete current
and additional studies; the company’s future development plans and
related timing; the company’s focus, objectives, plans, and
strategies; and the potential benefits of EryDex, AIDE technology
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 Quarterly Report on Form 10-Q filed with the Securities
and Exchange Commission (SEC) on August 13, 2024, 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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version on businesswire.com: https://www.businesswire.com/news/home/20241112415817/en/
Media & Investor Contact: Stacy Roughan Quince
Therapeutics, Inc. Vice President, Corporate Communications &
Investor Relations ir@quincetx.com
Quince Therapeutics (NASDAQ:QNCX)
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