NEW YORK, July 12, 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, announced that it will host a virtual R&D Day today
at 4:00 pm ET. Immunic's management
and Zuoming Sun, Ph.D., a key opinion leader specializing in
RORγt biology, will discuss new preclinical data for IMU-935,
a highly potent and selective inverse agonist of the transcription
factor RORγt, and provide an update on its clinical development
strategy as a potential treatment for psoriasis and metastatic
castration-resistant prostate cancer (mCRPC). The full data sets
will be publicly disclosed in a Current Report on Form 8-K and will
be available on Immunic's website at ir.imux.com.
Topics to be discussed during the event include the
following:
IMU-935 Inhibits Cytokine Production While Maintaining
Physiological Functions of Maturing T Lymphocytes
In ex vivo mouse cell differentiation and maturation
assays, IMU-935 was recently observed to selectively inhibit
RORγt-dependent gene expression during Th17 differentiation without
affecting either RORγt-dependent gene regulation relevant to
thymocyte development, or the viability of these cells. In
third-party research[1], impairment of thymocyte
development has been shown to be associated with serious safety
issues, including, among others, T cell malfunction and potential
lymphoma formation. Immunic believes that IMU-935's observed
selectivity may enable it to inhibit both the generation of Th17
cells and the production of IL-17 cytokines that are responsible
for the development of autoimmune diseases, without impairing
thymocyte development, which is associated with the potential risk
of lymphoma seen with other, third-party RORγt
programs.[2]
Full Pharmacokinetic and Blinded Safety Data From the
Single-Ascending Dose Part of the Ongoing Phase 1 Trial of IMU-935
Now Available
Analysis of the full pharmacokinetic data set from the completed
single-ascending dose part of the ongoing phase 1 clinical trial of
IMU-935, which is being conducted in Australia, in healthy volunteers revealed
dose-linear pharmacokinetics and a blood half-life that Immunic
believes may be appropriate for once or twice daily dosing.
Although the trial is still blinded, no significant safety findings
have been detected to date in the single-ascending dose cohort (up
to 400 mg IMU-935 daily).
The multiple ascending dose part of the phase 1 trial with
14-day daily dosing in healthy volunteers is ongoing and
progressing. Immunic expects to extend the trial in the third
quarter of 2021 by including moderate-to-severe psoriasis patients
given IMU-935 daily over 28 consecutive days, in order to assess
safety and exploratory disease endpoints in psoriasis patients.
New Preclinical Data Highlights IMU-935's Therapeutic Potential
in Castration-Resistant Prostate Cancer
Recently published third-party studies[3] have shown
that RORγ plays an important pro-tumor role by driving expression
of the androgen receptor (AR), leading to tumor growth. During
tumor progression, AR tends to mutate into AR-V7, leading to
resistance of AR-axis-targeted therapies.
In preclinical studies, IMU-935 was observed to inhibit the
expression of mutated AR-V7, and the tumor growth of prostate
cancer cell lines in vitro. Finally, Immunic believes
IMU-935's potency in inhibiting tumorigenesis-promoting IL-17 and
Th17 cells in vitro may result in further antitumoral
activity in humans.
Preparation for a Phase 1 Clinical Trial of IMU-935 in
Metastatic Castration-Resistant Prostate Cancer
Based on these strong preclinical results, Immunic is currently
preparing an open-label phase 1 dose escalation trial designed to
establish a recommended phase 2 dose and to assess safety,
tolerability, anti-tumor activity, biomarkers and pharmacokinetics
of IMU-935 in patients with progressive mCRPC. The Principal
Investigator of the trial is Johann
Sebastian de Bono, M.D., Ph.D., Regius Professor of Cancer
Research and Professor in Experimental Cancer Medicine, The
Institute of Cancer Research and The Royal Marsden NHS Foundation
Trust, London, United Kingdom.
"There are currently few effective treatments for patients with
metastatic CRPC, leading to an extremely poor prognosis for this
patient population," stated Dr. de Bono. "IMU-935 possesses a
unique mechanism of action which may prove transformative in its
ability to effectively treat a range of underserved diseases.
Preclinical studies have shown that IMU-935 potently suppresses the
expression of IL-17, indicating that it may also inhibit
tumorigenesis, and suppresses the expression of AR-V7 in prostate
cancer cell lines, thus potentially inhibiting tumor growth in CRPC
patients. I am looking forward to collaborating with Immunic on
this important phase 1 clinical trial in metastatic CRPC."
Conference Call and Webcast Information
Immunic's management team will host a virtual R&D Day today,
July 12, 2021, at 4:00 p.m.
Eastern Time to discuss the updates on the preclinical and
clinical development of the company's IMU-935 program.
Speakers from Immunic:
- Daniel Vitt, Ph.D., Chief
Executive Officer and President
- Hella Kohlhof, Ph.D., Chief
Scientific Officer
- Andreas Muehler, M.D., Chief
Medical Officer
Featured key opinion leader:
- Zuoming Sun, Ph.D., Professor, Department of Molecular Imaging
& Therapy, City of Hope, Duarte,
CA, USA
To participate in the conference call, dial 1-877-870-4263
(USA) or 1-412-317-0790
(International) and ask to be joined into the Immunic, Inc. call. A
live, listen-only webcast of the conference call can be accessed at
https://www.webcaster4.com/Webcast/Page/2301/41824 or on the
"Events and Presentations" section of Immunic's website at
ir.imux.com/events-and-presentations.
An archived replay of the conference call and webcast will be
available approximately one hour after the completion for one year
on Immunic's website at ir.imux.com.
[1] Guntermann, C. et al. Retinoic-acid-orphan-receptor-C
inhibition suppresses Th17 cells and induces thymic aberrations,
JCI Insight. 2017;2(5):e91127.
https://doi.org/10.1172/jci.insight.91127.
[2] Gege, C. (2021). Retinoic acid-related orphan receptor gamma t
(RORγt) inverse agonists/antagonists for the treatment of
inflammatory diseases – where are we presently?, Expert Opinion on
Drug Discovery. https://doi.org/10.1080/17460441.2021.1948833.
[3] Wang, J., Zou, J., Xue, X. et al. ROR-γ drives androgen
receptor expression and represents a therapeutic target in
castration-resistant prostate cancer. Nat Med 22, 488–496 (2016).
https://doi.org/10.1038/nm.4070.
About IMU-935
IMU-935 is a highly potent and selective
inverse agonist of RORγt (retinoic acid receptor-related orphan
nuclear receptor gamma truncated) with additional activity on DHODH
(dihydroorotate dehydrogenase). The nuclear receptor RORγt
is believed to be the main driver for the differentiation of
Th17 cells and the expression of cytokines involved in various
inflammatory and autoimmune diseases. This target is believed to be
an attractive alternative to approved antibodies for targets such
as IL-23, IL-17 receptor and IL-17, itself. IMU-935 shows strong
cytokine inhibition targeting both Th17 and Th1 responses in
preclinical testing, as well as indications of activity in animal
models for psoriasis and inflammatory bowel disease. Preclinical
experiments indicate that, while leading to a potent inhibition of
Th17 differentiation and cytokine secretion, IMU-935 did not affect
thymocyte maturation. IMU-935 is an investigational drug product
that has not been approved in any jurisdiction.
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.
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-935 to safely and effectively target diseases;
preclinical and clinical data for IMU-935; 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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