NEW
YORK, Aug. 16, 2022 /PRNewswire/
-- Immunic, Inc. (NASDAQ: IMUX), a clinical-stage
biopharmaceutical company developing a pipeline of selective oral
immunology therapies focused on treating chronic inflammatory and
autoimmune diseases, today announced that the company has received
a Notice of Allowance from the U.S. Patent and Trademark Office
(USPTO) for patent application 16/646130, entitled, "Compound
Having Cyclic Structure." The patent covers composition-of-matter
of IMU-856 and related pharmaceutical compositions and is expected
to provide protection into at least 2038, without accounting for
potential Patent Term Extension (PTE).
The patent application was originally filed by Daiichi Sankyo
Co., Ltd. (Daiichi Sankyo), which discovered IMU-856. In 2018,
Immunic and Daiichi Sankyo entered into a global option and license
agreement, granting Immunic the exclusive right to license IMU-856,
which was subsequently exercised by Immunic in 2020. The license
included exclusivity on the composition-of-matter patent.
"Allowance of this composition-of-matter patent significantly
strengthens our intellectual property estate and is key to the
clinical development of IMU-856, which we believe to be a highly
potent small molecule oral epigenetic regulator. In particular,
IMU-856 appears to influence the tightly regulated network of genes
and proteins associated with intestinal epithelial cell interaction
and adhesion which could present an entirely new and innovative
approach to the treatment of a significant number of
gastrointestinal diseases," stated Daniel
Vitt, Ph.D., Chief Executive Officer and President of
Immunic. "In May 2022, we reached an
important milestone with the initiation of part C of our phase 1
clinical trial of IMU-856 in patients with celiac disease, to
confirm the drug's ability to restore intestinal barrier function
without affecting the immune system. We also look forward to
reporting unblinded safety data from the single and multiple
ascending dose parts of the phase 1 clinical trial in healthy human
subjects in the third quarter of this year."
About IMU-856
IMU-856, which Immunic believes to be novel, is an orally
available small molecule modulator that targets a protein which
serves as a transcriptional regulator of intestinal barrier
function and regeneration of bowel epithelium. Based on preclinical
data, the compound may represent a new treatment approach, as the
mechanism of action targets the restoration of the intestinal
barrier function and bowel wall architecture in patients suffering
from gastrointestinal diseases such as celiac disease, inflammatory
bowel disease, irritable bowel syndrome with diarrhea and other
intestinal barrier function associated diseases. Immunic believes
that, because IMU-856 has been shown in preclinical investigations
to avoid suppression of immune cells, it may therefore maintain
immune surveillance for patients during therapy, an important
advantage versus chronic treatment with potentially
immunosuppressive medications. IMU-856 is an investigational drug
product that has not been approved in any jurisdiction.
IMU-856 was discovered by Daiichi Sankyo Co., Ltd. (Daiichi
Sankyo). In November 2018, Immunic
and Daiichi Sankyo entered into a global option and license
agreement, granting Immunic the exclusive right to license IMU-856.
The license also includes exclusivity on a patent application filed
by Daiichi Sankyo, covering IMU-856's composition of matter.
Immunic exercised the option in January
2020.
About Immunic, Inc.
Immunic, Inc. (NASDAQ: IMUX) is a clinical-stage
biopharmaceutical company with a pipeline of selective oral
immunology therapies focused on treating chronic inflammatory and
autoimmune diseases. The company is developing three small molecule
products: its lead development program, vidofludimus calcium
(IMU-838), a selective immune modulator that inhibits the
intracellular metabolism of activated immune cells by blocking the
enzyme DHODH and exhibits a host-based antiviral effect, is
currently being developed as a treatment option for multiple
sclerosis, and primary sclerosing cholangitis. IMU-935, a selective
inverse agonist of the transcription factor RORγ/RORγt, is targeted
for development in psoriasis, and castration-resistant prostate
cancer. IMU-856, which targets the restoration of the intestinal
barrier function, is targeted for development in diseases involving
bowel barrier dysfunction. For further information, please visit:
www.imux.com.
Cautionary Statement Regarding
Forward-Looking Statements
This press release contains "forward-looking statements" that
involve substantial risks and uncertainties for purposes of the
safe harbor provided by the Private Securities Litigation Reform
Act of 1995. All statements, other than statements of historical
facts, included in this press release regarding strategy, future
operations, future financial position, future revenue, projected
expenses, sufficiency of cash, expected timing and results of
clinical trials, prospects, plans and objectives of management are
forward-looking statements. Examples of such statements include,
but are not limited to, statements relating to Immunic's three
development programs and the targeted diseases; the potential for
IMU-856 to safely and effectively target diseases; preclinical and
clinical data for IMU-856; the timing of current and future
clinical trials and anticipated clinical milestones; the nature,
strategy and focus of the company and further updates with respect
thereto; and the development and commercial potential of any
product candidates of the company. Immunic may not actually achieve
the plans, carry out the intentions or meet the expectations or
projections disclosed in the forward-looking statements and you
should not place undue reliance on these forward-looking
statements. Such statements are based on management's current
expectations and involve substantial risks and uncertainties.
Actual results and performance could differ materially from those
projected in the forward-looking statements as a result of many
factors, including, without limitation, the COVID-19 pandemic,
impacts of the Ukraine –
Russia conflict on planned and
ongoing clinical trials, risks and uncertainties associated with
the ability to project future cash utilization and reserves needed
for contingent future liabilities and business operations, the
availability of sufficient financial and other resources to meet
business objectives and operational requirements, the fact that the
results of earlier preclinical studies and clinical trials may not
be predictive of future clinical trial results, the protection and
market exclusivity provided by Immunic's intellectual property,
risks related to the drug development and the regulatory approval
process and the impact of competitive products and technological
changes. A further list and descriptions of these risks,
uncertainties and other factors can be found in the section
captioned "Risk Factors," in the company's Annual Report on Form
10-K for the fiscal year ended December 31,
2021, filed with the SEC on February
24, 2022, and in the company's subsequent filings with the
Securities and Exchange Commission. Copies of these filings are
available online at www.sec.gov or ir.imux.com/sec-filings. Any
forward-looking statement made in this release speaks only as of
the date of this release. Immunic disclaims any intent or
obligation to update these forward-looking statements to reflect
events or circumstances that exist after the date on which they
were made. Immunic expressly disclaims all liability in respect to
actions taken or not taken based on any or all the contents of this
press release.
Contact Information
Immunic, Inc.
Jessica Breu
Head of Investor Relations and Communications
+49 89 2080 477 09
jessica.breu@imux.com
US IR Contact
Rx Communications Group
Paula Schwartz
+1 917 633 7790
immunic@rxir.com
US Media Contact
KOGS Communication
Edna Kaplan
+1 617 974 8659
kaplan@kogspr.com
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SOURCE Immunic, Inc.