NEW YORK, Jan. 8, 2020 /PRNewswire/ -- Immunic, Inc.
(Nasdaq: IMUX), a clinical-stage biopharmaceutical company
focused on developing best-in-class, oral therapies for the
treatment of chronic inflammatory and autoimmune diseases, today
announced that its subsidiary, Immunic AG, under the terms of its
existing option and license agreement with Daiichi Sankyo Co., Ltd.
(hereinafter, Daiichi Sankyo), has exercised its exclusive
global option to license a group of compounds, designated by
Immunic as IMU-856. The company intends to begin phase 1 clinical
studies for this program in the first half of 2020. IMU-856 is an
orally available, small molecule modulator that targets a yet
undisclosed protein which serves as a transcriptional regulator of
the intestinal barrier function. As such, IMU-856 represents a new
and potentially disruptive approach for the treatment of intestinal
diseases with the potential to restore the intestinal barrier
function while maintaining immunocompetency.
IMU-856 was discovered and developed by Daiichi Sankyo. The
option and license agreement gives Immunic the exclusive rights to
commercialization of IMU-856 in all countries, including
the United States, Europe and Japan. The option also
includes exclusivity on a patent application filed by Daiichi
Sankyo, covering IMU-856's composition of matter. Concurrent with
the option exercise, Immunic will pay to Daiichi Sankyo a one-time
upfront licensing fee. Going forward, Daiichi Sankyo is eligible to
receive certain future development, approval and sales milestone
payments, as well as royalties related to IMU-856. Financial terms
of the agreement have not been disclosed.
"Exercising this option is an important milestone, as it
indicates that we are convinced of the preclinical safety profile
of IMU-856 and are ready to take this program into phase 1 clinical
trials, which we intend to initiate during the first half of 2020,"
stated Daniel Vitt, Ph.D., Chief
Executive Officer and President of Immunic. "Our recently presented
preclinical data reinforced our belief that IMU-856 has
disease-modifying properties for a variety of intestinal diseases
and demonstrates potential significant advantages over current
immunosuppressive treatments which address inflammation while
unintentionally decreasing the body's immune surveillance. We are
hopeful that the planned phase 1, single and multiple ascending
dose studies will serve as a further important step in the
development of IMU-856 as a safe treatment option for patients
suffering from gastrointestinal diseases by restoring function to
the intestinal barrier without impairing the immune system."
"We are delighted that Immunic executed the option right for
IMU-856," said Junichi Koga, Senior
Executive Officer and Global Head of R&D, Daiichi Sankyo.
"Daiichi Sankyo is committed to delivering innovative medicines to
patients across the world as quickly as possible, either by
ourselves or through strategic partnerships. We are confident that
Immunic is our best partner and will rapidly drive the development
of this novel compound for patients with intestinal diseases."
About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a
clinical-stage biopharmaceutical company developing a pipeline of
selective oral immunology therapies aimed at treating chronic
inflammatory and autoimmune diseases, including relapsing-remitting
multiple sclerosis, ulcerative colitis, Crohn's disease, and
psoriasis. The company is developing three small molecule products:
IMU-838 is a selective immune modulator that inhibits the
intracellular metabolism of activated immune cells by blocking the
enzyme DHODH; IMU-935 is an inverse agonist of RORĪ³t; and IMU-856
targets the restoration of the intestinal barrier function.
Immunic's lead development program, IMU-838, is in phase 2 clinical
development for relapsing-remitting multiple sclerosis and
ulcerative colitis, with an additional phase 2 trial planned in
Crohn's disease. An investigator-sponsored proof-of-concept
clinical trial for IMU-838 in primary sclerosing cholangitis is
ongoing at the Mayo Clinic. For further information, please visit:
www.immunic-therapeutics.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, 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-838, IMU-935 and IMU-856 to safely and
effectively target diseases; preclinical data for IMU-856; the
timing of future clinical trials; the nature, strategy and focus of
the company; 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 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, 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 resources to meet business objectives
and operational requirements, the fact that the results of earlier
studies and 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 "Item 1A. Risk Factors," in the
company's Current Report on Form 8-K filed on July 17, 2019, 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.immunic-therapeutics.com/sec-filings and on request from
Immunic. 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
Manager IR and Communications
+49 89 250 0794 69
jessica.breu@immunic.de
Or
Rx Communications Group
Melody
Carey
+1-917-322-2571
immunic@rxir.com
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SOURCE Immunic, Inc.