Allowance to extend into 2036 patent claims
related to method of treating patients with A-T using the company’s
proprietary EryDex process
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
that the U.S. Patent and Trademark Office (USPTO) has issued a
Notice of Allowance for U.S. Patent Application No. 17/083,771
entitled Process for the Preparation of Erythrocytes Loaded With
One or More Substances of Pharmaceutical Interest and So Obtained
Erythrocytes. The newly allowed application covers the method of
treating patients with Ataxia-Telangiectasia (A-T) and provides
patent coverage for preparing erythrocytes loaded with one or more
substances of pharmaceutical interest using the EryDex process. The
first independent claim of this application is not limited to any
particular pharmaceutical product and is broader than currently
granted parent patent claims. Supplementing the company’s existing
U.S. Patent No. 10,849,858, Quince now has issued patents directed
to the process for encapsulating erythrocytes with a therapeutic
drug as well as a method of treating a patient with encapsulated
erythrocytes.
Charles Ryan, J.D., Ph.D., Quince’s President and head of the
company’s corporate legal activities and intellectual property
portfolio, said, “Our growing intellectual property portfolio
strengthens the long-term market position for our lead asset EryDex
and further validates our proprietary AIDE technology platform.
Importantly, this allowance strengthens market exclusivity and
extends our patent claims to 2036 in the U.S. We are very pleased
with this Notice of Allowance and intend to continue to prosecute
additional patent applications to protect EryDex and our
proprietary encapsulation technology.”
Quince expects that the resulting patent will be listable in the
U.S. Food and Drug Administration’s publication Approved Drug
Products with Therapeutic Equivalence Evaluations (Orange Book). As
a result, any generic applicant that references EryDex for the
treatment of A-T would be required to certify against the company’s
patent. This will provide Quince notice of future generic
applicants and give the company other stay provisions under
applicable provisions of the Hatch-Waxman Act. This protection is
in addition to the expected market exclusivity provided by Orphan
Drug Designation in the U.S. and Europe.
A Notice of Allowance is issued after the USPTO determines that
the prosecution on the merits of a patent has been completed and
grants the patent upon payment of the patent issuance fee. As such,
Quince expects the U.S. patent to be issued after administrative
processes are complete.
Quince plans to pursue claims having a similar claim scope in
related cases pending before the European Patent Office as
well.
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
EryDex 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 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, 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 company’s patent portfolio, the
issuance of patents and related implications for the company; plans
to pursue claims, including those currently pending with regulatory
agencies, current and future clinical development of EryDex;
planned regulatory agency submissions and clinical trials and
timeline, prospects, and milestone expectations; 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 November 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/20250204400822/en/
Media & Investor Contact: Stacy Roughan Quince
Therapeutics, Inc. Vice President, Corporate Communications &
Investor Relations ir@quincetx.com
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