NEW YORK and GOETTINGEN,
Germany, Sept. 22, 2021
/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 the execution of an in-license agreement with the
University Medical Center Goettingen, Germany, covering the combination of DHODH
inhibitors and nucleoside analogues to treat viral infections
(COVID-19 and Influenza). Terms of the agreement were not
disclosed.
Preclinical research recently completed by the parties and their
collaborators[1] has shown that certain DHODH
inhibitors, including Immunic's lead asset, IMU-838, strongly
synergize with selected nucleoside analogues to inhibit SARS-CoV-2
replication in vitro. For instance, in an in vitro
test system, IMU-838 alone showed an up to 99.9% reduction in viral
RNA at concentrations of 5 μM, which is well within the
exposure levels seen in prior clinical trials. Likewise,
N4-hydroxycytidine (NHC), the active metabolite of
molnupiravir[2], alone, was associated with an up to 99%
reduction in viral RNA at concentrations of 100 nM. Compared
to single agent activity, the combination of IMU-838 and NHC
achieved an extra-ordinary reduction in viral RNA, down to the
limit of detection, reducing SARS-CoV-2 RNA by up to seven log
units (corresponding to 0.00001% viral RNA remaining). This
powerful reduction of virus replication in vitro was
demonstrated across multiple SARS-CoV-2 variants, including alpha,
beta and delta, highlighting the independence of this approach to
mutant virus forms. In addition to molnupiravir, Immunic is
exploring alternate nucleoside analogues, some of which have shown
very promising antiviral activity in vitro. The company
plans to present detailed data at an upcoming scientific
conference.
"Research by the University Medical Center Goettingen and other
research partners revealed a profound degree of synergy in
vitro when combining certain nucleoside analogues with DHODH
inhibitors, including both our lead asset IMU-838 and other of our
preclinical molecules," stated Daniel
Vitt, Ph.D., Chief Executive Officer and President of
Immunic. "Recalling IMU-838's clinical activity against COVID-19 in
our phase 2 CALVID-1 trial published earlier this year, and in
light of recent exacerbations in COVID-19, worldwide, we are very
excited to have in-licensed this technology to incorporate into our
pandemic preparedness effort. However, with the extra-ordinary
wealth of activity already ongoing at the company in other
programs, we intend to evaluate and pursue the best possible
strategic option for this program, including potential partnership,
collaboration or external funding."
The company re-iterates its prior guidance that phase 2 top-line
data of IMU-838 in ulcerative colitis is expected to be available
in the second quarter of 2022, and that regarding IMU-935, data
from the multiple ascending dose part of the ongoing phase 1 trial
is expected in the fourth quarter of 2021, with initial clinical
data in psoriasis expected in the second quarter of 2022. The phase
1 trial of IMU-935 in metastatic castration-resistant prostate
cancer is expected to commence in the fourth quarter of 2021.
Moreover, the company continues to expect enrollment of the first
patient in the phase 2 CALLIPER trial of IMU-838 in progressive
multiple sclerosis later this month, and first patient in the phase
3 ENSURE program of IMU-838 in relapsing-remitting multiple
sclerosis in the fourth quarter of 2021.
Hella Kohlhof, Ph.D., Chief
Scientific Officer of Immunic, commented, "We are very excited to
see this remarkable synergistic antiviral activity, particularly as
it is found well within exposure levels for IMU-838 in humans,
associated with an extremely favorable safety profile. In addition
to IMU-838, we also have a number of preclinical compounds that we
believe are worth pursuing here, and we look forward to further
refining potential combinations and compounds, with the goal of
improving on the already strong antiviral activity demonstrated by
IMU-838 alone in the clinic. We believe that this combination
approach provides the most promising avenue for targeting potential
future pandemics for many reasons, including the fact that, by
focusing on the host cell-based mechanism, it should be insulated
from many of the risks posed by viral resistance and the
development of new strains."
Matthias Dobbelstein, M.D.,
Professor of Molecular Oncology, University Medical Center
Goettingen, added, "We are proud of the results of our preclinical
work. These results identify a potential therapeutic strategy to
inhibit the replication of SARS-CoV-2 in infected individuals. The
synergistic antiviral effects of these combinations were
astounding, and we are not aware of any other approaches which
match this level of synergy against coronaviruses in vitro.
We were very pleased with this license agreement with Immunic and
look forward to future results with these very promising
combinations."
[1] Immunic would like to thank its research partners, including
Prof. Dr. med. Matthias Dobbelstein,
University Medical Center Goettingen, Jr.-Prof. Dr. Stephanie
Pfänder, Ruhr-University Bochum, Prof. Dr. rer. nat. Manfred Marschall, Universitätsklinikum
Erlangen, Brett L. Hurst, Ph.D.,
Utah State University, and MBM
ScienceBridge GmbH.
[2] The nucleoside analogue which was most extensively studied
in these tests was N4-hydroxycytidine (NHC), the active metabolite
of molnupiravir, which is a drug candidate invented at Emory
(DRIVE), LLC and licensed by Ridgeback Biotherapeutics, LP in
collaboration with Merck & Co., Inc. (Europe: Merck Sharp & Dohme, or MSD) and
which is currently in phase 3 development for COVID-19. Although
the technology in-licensed by Immunic includes the potential
combination of DHODH inhibitors with nucleoside analogues,
including molnupiravir, Immunic does not have any rights to
molnupiravir itself. As such, Immunic is currently focusing future
research on combinations employing nucleoside analogues other than
molnupiravir.
About IMU-838
IMU-838 is an orally available,
next-generation selective immune modulator that inhibits the
intracellular metabolism of activated immune cells by blocking the
enzyme dihydroorotate dehydrogenase (DHODH). IMU-838 acts on
activated T and B cells while leaving other immune cells largely
unaffected and allows the immune system to stay functioning, e.g.
in fighting infections. In previous trials, IMU-838 did not show an
increased rate of infections compared to placebo. In addition,
DHODH inhibitors, such as IMU-838, are known to possess a
host-based antiviral effect, which is independent with respect to
specific virus proteins and their structure. Therefore, DHODH
inhibition may be broadly applicable against multiple viruses.
IMU-838 was successfully tested in two phase 1 clinical trials in
2017 and is currently being tested in a phase 2 trial in patients
with ulcerative colitis. In the third quarter of 2020, the company
reported positive results from its phase 2 EMPhASIS trial of
IMU-838 in relapsing-remitting multiple sclerosis, achieving both
primary and key secondary endpoints with high statistical
significance. In the first quarter of 2021, Immunic announced that
IMU-838 showed evidence of clinical activity in its phase 2
CALVID-1 trial in hospitalized patients with moderate COVID-19.
Also, in the first quarter of 2021, the company reported positive
top-line data from an investigator-sponsored phase 2
proof-of-concept clinical trial of IMU-838 in primary sclerosing
cholangitis which was conducted in collaboration with Mayo Clinic.
To date, IMU-838 has been tested in more than 800 individuals and
has shown an attractive pharmacokinetic, safety and tolerability
profile. IMU-838 is not yet licensed or approved in any
country.
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,
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, ulcerative colitis, Crohn's disease, and primary
sclerosing cholangitis. IMU-935, a selective inverse agonist of the
transcription factor RORγt, is targeted for development in
psoriasis, castration-resistant prostate cancer and Guillain-Barré
syndrome. 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.
Immunic refers to Immunic, Inc. and/or its affiliates and
subsidiaries.
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 to safely and effectively target diseases;
preclinical and clinical data for IMU-838; the timing of current
and future clinical trials; 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 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, 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 "Risk Factors," in the company's
Annual Report on Form 10-K for the fiscal year ended December 31, 2020, filed with the SEC on
February 26, 2021, 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
+1-917-322-2216
immunic@rxir.com
US Media Contact
KOGS Communication
Edna Kaplan
+1 781 639 1910
kaplan@kogspr.com
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