Fast Track designation underscores the high
unmet medical need, with currently no approved therapeutic
treatments for the rare pediatric disease Ataxia-Telangiectasia
Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage
biotechnology company developing an innovative drug delivery
technology designed to leverage a patient’s own biology to deliver
rare disease therapeutics, today announced that the U.S. Food and
Drug Administration (FDA) has granted Fast Track designation for
its EryDex System for the treatment of patients with
Ataxia-Telangiectasia (A-T). EryDex is comprised of dexamethasone
sodium phosphate (DSP) encapsulated in a patient’s own red blood
cells utilizing Quince’s proprietary Autologous Intracellular Drug
Encapsulation (AIDE) technology platform. DSP is a corticosteroid
well known for its anti-inflammatory properties as well as its
dose-limiting toxicity due to adrenal suppression. EryDex is
designed to provide the efficacy of corticosteroids and to reduce
or eliminate the significant adverse effects that accompany chronic
corticosteroid treatment.
Fast Track designation has been granted based on the potential
for EryDex to address a high unmet medical need for patients with
A-T, a serious and life-threatening condition, and represents a
significant regulatory milestone for Quince. There are currently no
approved therapeutic treatments in any global market for this rare
pediatric disease.
A-T is an inherited autosomal recessive neurodegenerative and
immunodeficiency disorder with an estimated prevalence of
approximately 10,000 patients with A-T in the U.S., U.K., and EU4
countries. Data from a prior Phase 3 study of EryDex
(#IEDAT-02-2015/NCT02770807) showed encouraging efficacy results
and a favorable safety profile. Quince is actively enrolling
participants for its global Phase 3 NEAT clinical trial
(#IEDAT-04-2022/NCT06193200) to evaluate the neurological effects
of EryDex in patients with A-T, with plans to enroll approximately
86 patients with A-T ages six to nine years old (primary analysis
population) and approximately 20 patients ages 10 years or older.
This pivotal Phase 3 clinical trial is being conducted under a
Special Protocol Assessment (SPA) agreement with the FDA.
Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief
Medical Officer, said, “The granting of Fast Track status for
EryDex System marks another important milestone in our endeavor to
identify a beneficial therapeutic solution for patients with A-T.
We have initiated our pivotal Phase 3 NEAT clinical trial, which is
being conducted in the U.S., U.K., and the European Union.”
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), IQVIA Analytics
information, there are approximately 3,400 diagnosed patients with
A-T in the U.S., which aligns with an estimated U.S. prevalence of
approximately 5,000 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
EryDex is comprised of dexamethasone sodium phosphate (DSP)
encapsulated in a patient’s own red blood cells. DSP is a
corticosteroid well known for its anti-inflammatory properties as
well as its dose-limiting toxicity due to adrenal suppression.
EryDex 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, 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 (Nasdaq: QNCX) is a late-stage biotechnology
company dedicated to unlocking the potential of a patient’s own
biology to deliver innovative and life-changing therapeutics to
those living with 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,
and Twitter/X.
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 May 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/20240603425785/en/
Media & Investor Contact: Stacy Roughan Quince
Therapeutics, Inc. Vice President, Corporate Communications &
Investor Relations ir@quincetx.com
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