Full Press Release Details
Immunic, Inc. to Host Virtual R&D Day Today
to Provide an Update on the Preclinical and Clinical Development of IMU-935, a Potentially Best-in-Class ROR t Inverse Agonist
IMU-935 Has Been Observed In Vitro to Inhibit the Generation of Th17 Cells and Production of IL-17 Cytokines Without Impairing
ROR t Function Required for Normal Thymocyte
Development; May Avoid Risk of Lymphoma Formation Seen in Third-Party ROR t
Full Pharmacokinetic and Blinded Safety Data Set From the Completed Single-Ascending Dose Part of the Ongoing Phase 1 Clinical Trial of
IMU-935 in Healthy Volunteers Now Available -
Presentation Will Also Include New Preclinical Data Supporting IMU-935 as a Potential Treatment for Castration-Resistant Prostate Cancer;
Company Preparing for a Phase 1 Clinical Trial -
Conference Call and Webcast to be Held Today, July 12, 2021, at 4:00 pm ET -
July 12, 2021 - 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 ROR t
biology, will discuss new preclinical data for IMU-935, a highly potent and selective inverse agonist of the transcription factor ROR t,
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
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 ROR t-dependent gene expression during Th17 differentiation
without affecting either ROR t-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
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 ROR 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
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
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:
Featured key opinion leader:
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.
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 (ROR t) 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-
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.
is a highly potent and selective inverse agonist of ROR t (retinoic acid receptor-related
orphan nuclear receptor gamma truncated) with additional activity on DHODH (dihydroorotate
dehydrogenase). The nuclear receptor ROR t 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.
(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 ROR t, is targeted
for development in psoriasis, castration-resistant prostate cancer and Guillain-Barr 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.
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