Immunic, Inc.

DGAP-News: Immunic to Present Preclinical Data for Vidofludimus Calcium at the 17th Congress of ECCO and Announces Blinded Baseline Characteristics of Phase 2 Trial of Vidofludimus Calcium in Ulcerative Colitis

Retrieved on: 
Friday, February 18, 2022
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- Vidofludimus calcium reduces proinflammatory immune cell responses by inducing regulatory macrophages, reducing pro-inflammatory cytokine secretion and reducing T cell proliferation.

Key Points: 
  • - Vidofludimus calcium reduces proinflammatory immune cell responses by inducing regulatory macrophages, reducing pro-inflammatory cytokine secretion and reducing T cell proliferation.
  • Additionally, Immunic announces the blinded baseline characteristics of its phase 2 CALDOSE-1 trial of vidofludimus calcium in moderate-to-severe UC.
  • Immunic believes that these blinded baseline characteristics of randomized patients and the methodology regarding endoscopic assessments contributes to ensuring an optimized study read-out.
  • Vidofludimus calcium 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.

DGAP-News: Immunic Receives Notice of Allowance for Composition-of-Matter Patents in the United States and in Europe for IMU-935, a Potentially Best-in-Class Oral IL-17 Inhibitor

Retrieved on: 
Wednesday, February 2, 2022
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Immunic Receives Notice of Allowance for Composition-of-Matter Patents in the United States and in Europe for IMU-935, a Potentially Best-in-Class Oral IL-17 Inhibitor

Key Points: 
  • Immunic Receives Notice of Allowance for Composition-of-Matter Patents in the United States and in Europe for IMU-935, a Potentially Best-in-Class Oral IL-17 Inhibitor
    The issuer is solely responsible for the content of this announcement.
  • The company also received notice of allowance of patent application EP18762111.5 in Europe, and notice of grant of patent application 2018330633 in Australia.
  • "We believe IMU-935 is a highly potent and selective oral inhibitor of IL-17, which so far, has shown a remarkably differentiated safety and tolerability profile.
  • Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release.

DGAP-News: Immunic, Inc. Publishes Positive Results from the Single and Multiple Ascending Dose Parts of its Phase 1 Clinical Trial of IMU-935, a Potentially Best-in-Class Oral IL-17 Inhibitor

Retrieved on: 
Monday, December 20, 2021
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Publishes Positive Results from the Single and Multiple Ascending Dose Parts of its Phase 1 Clinical Trial of IMU-935, a Potentially Best-in-Class Oral IL-17 Inhibitor

Key Points: 
  • Publishes Positive Results from the Single and Multiple Ascending Dose Parts of its Phase 1 Clinical Trial of IMU-935, a Potentially Best-in-Class Oral IL-17 Inhibitor
    The issuer is solely responsible for the content of this announcement.
  • Moreover, single ascending doses of IMU-935 were found to be safe and well-tolerated and no maximum tolerated dose was reached.
  • These favorable results allowed a smooth transition to the MAD part of the trial using the new formulation.
  • Multiple ascending doses of IMU-935 were found to be safe and well-tolerated and no maximum tolerated dose was reached.

DGAP-News: Immunic, Inc. Announces Enrollment of First Patient in its Phase 3 ENSURE Program of vidofludimus calcium (IMU-838) in Relapsing Multiple Sclerosis

Retrieved on: 
Monday, November 22, 2021
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The ENSURE program comprises twin multicenter, randomized, double-blind phase 3 trials designed to evaluate the efficacy, safety, and tolerability of vidofludimus calcium versus placebo in RMS patients.

Key Points: 
  • The ENSURE program comprises twin multicenter, randomized, double-blind phase 3 trials designed to evaluate the efficacy, safety, and tolerability of vidofludimus calcium versus placebo in RMS patients.
  • Patients will receive either 30 mg daily doses of vidofludimus calcium or placebo and the primary endpoint for both trials is time to first relapse up to 72 weeks.
  • Multiple sclerosis (MS) is an autoimmune disease that affects the brain, spinal cord and optic nerve.
  • To date, vidofludimus calcium has been tested in more than 800 individuals and has shown an attractive pharmacokinetic, safety and tolerability profile.

DGAP-News: Immunic, Inc. Announces Completion of Enrollment of its Phase 2 CALDOSE-1 Trial of IMU-838 in Moderate-to-Severe Ulcerative Colitis

Retrieved on: 
Thursday, October 28, 2021
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Top-line data for the induction phase is expected to be available in the second quarter of 2022.

Key Points: 
  • Top-line data for the induction phase is expected to be available in the second quarter of 2022.
  • We look forward to obtaining the unblinded top-line data in the second quarter of next year."
  • The phase 2 CALDOSE-1 trial is a multicenter, randomized, double-blind, placebo-controlled, dose-finding study being conducted at more than 100 sites in 19 countries, including the United States and Western, Central and Eastern Europe.
  • 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.

DGAP-News: Immunic, Inc. Announces First Psoriasis Patient Enrolled in Ongoing Phase 1 Trial of IMU-935

Retrieved on: 
Wednesday, October 27, 2021
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Part C is structured as a 28-day, double-blind, placebo-controlled trial designed to enroll approximately 52 patients, randomized 3:1 versus placebo with two treatment cohorts.

Key Points: 
  • Part C is structured as a 28-day, double-blind, placebo-controlled trial designed to enroll approximately 52 patients, randomized 3:1 versus placebo with two treatment cohorts.
  • The primary objective is to evaluate the safety and tolerability of IMU-935 in moderate-to-severe psoriasis patients.
  • The trial also assesses pharmacodynamic marker changes, including serum cytokines, ex vivo peripheral blood mononuclear cell gene expression profiles and histological biomarker analysis in skin biopsies.
  • IMU-935, a selective inverse agonist of the transcription factor RORt, is targeted for development in psoriasis, castration-resistant prostate cancer and Guillain-Barr syndrome.

DGAP-News: Immunic, Inc. Enrolls First Patient in Its Phase 2 CALLIPER Trial of IMU-838 in Progressive Multiple Sclerosis

Retrieved on: 
Thursday, September 30, 2021
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The trial, which is intended to run concurrently with and as a complement to the company's twin phase 3 ENSURE trials in relapsing-remitting multiple sclerosis (RRMS), is focused on progressive forms of multiple sclerosis (MS) and designed to corroborate IMU-838's neuroprotective potential in this patient population.

Key Points: 
  • The trial, which is intended to run concurrently with and as a complement to the company's twin phase 3 ENSURE trials in relapsing-remitting multiple sclerosis (RRMS), is focused on progressive forms of multiple sclerosis (MS) and designed to corroborate IMU-838's neuroprotective potential in this patient population.
  • If the CALLIPER trial is successful in showing beneficial data, we believe this could be an essential differentiator for IMU-838 in the MS market."
  • Multiple sclerosis (MS) is an autoimmune disease that affects the brain, spinal cord and optic nerve.
  • Progressive multiple sclerosis (PMS) includes both primary progressive MS (PPMS) and secondary progressive MS (SPMS).

DGAP-News: Immunic and the University Medical Center Goettingen Sign License Agreement Covering the Combination of DHODH Inhibitors and Nucleoside Analogues to Treat Viral Infections, Including COVID-19

Retrieved on: 
Wednesday, September 22, 2021
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Immunic and the University Medical Center Goettingen Sign License Agreement Covering the Combination of DHODH Inhibitors and Nucleoside Analogues to Treat Viral Infections, Including COVID-19- Preclinical Combination Data Suggests Extra-Ordinary Synergy Between Certain DHODH Inhibitors and Nucleoside Analogues -- Combination of IMU-838 and N4-Hydroxycytidine Reduced SARS-CoV-2 Virus Levels, Including the Delta Variant, Down to the Detection Limit -NEW YORK and GOETTINGEN, Germany, September 22, 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, 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."

Key Points: 
  • Immunic and the University Medical Center Goettingen Sign License Agreement Covering the Combination of DHODH Inhibitors and Nucleoside Analogues to Treat Viral Infections, Including COVID-19
    The issuer is solely responsible for the content of this announcement.
  • In addition to molnupiravir, Immunic is exploring alternate nucleoside analogues, some of which have shown very promising antiviral activity in vitro.
  • Matthias Dobbelstein, M.D., Professor of Molecular Oncology, University Medical Center Goettingen, added, "We are proud of the results of our preclinical work.
  • 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.

DGAP-News: 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 RORγt Inverse Agonist

Retrieved on: 
Monday, July 12, 2021
Branches of biology, Pharmacodynamics, Receptor agonists, Health sciences, Biology, Psoriasis, Agonist, Inverse agonist, IMU-935, Immunic, Inc., IMU-935, IMMUNIC, INC.

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 RORt Inverse Agonist

Key Points: 
  • 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 RORt Inverse Agonist
    The issuer is solely responsible for the content of this announcement.
  • The multiple ascending dose part of the phase 1 trial with 14-day daily dosing in healthy volunteers is ongoing and progressing.
  • 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.
  • IMU-935, a selective inverse agonist of the transcription factor RORt, is targeted for development in psoriasis, castration-resistant prostate cancer and Guillain-Barr syndrome.

DGAP-News: Immunic and 4SC AG Sign Agreement Regarding the Settlement of Royalty Obligations for Immunic's Lead Program, IMU-838

Retrieved on: 
Wednesday, March 31, 2021
Expense, Intellectual property law, Patent law, Royalty payment, Immunic, Inc., 4SC

Immunic and 4SC AG Sign Agreement Regarding the Settlement of Royalty Obligations for Immunic's Lead Program, IMU-838

Key Points: 
  • Immunic and 4SC AG Sign Agreement Regarding the Settlement of Royalty Obligations for Immunic's Lead Program, IMU-838
    The issuer is solely responsible for the content of this announcement.
  • Immunic acquired lead program IMU-838 in September 2016 from 4SC AG through an asset acquisition, in exchange for a one-time upfront cash payment, future milestone payments and a royalty on net sales for a certain period.
  • With completion of this transaction, no further payment obligations remain between Immunic and 4SC.
  • "Execution of this agreement with 4SC is key, as it provides us with 100% of the future sales potential of our lead asset, IMU-838," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic.