Short course immune induction therapy

EQS-News: Immunic Receives Notice of Allowance for United States Patent Protecting the Treatment of Relapsing Multiple Sclerosis with Vidofludimus and Its Salts

Retrieved on: 
Tuesday, November 7, 2023
Patent, Food, Biotechnology, Multiple sclerosis, United States Patent and Trademark Office, MS, Lead, RMS, Patient, Calcium, Pharmaceutical industry, Short course immune induction therapy

The claims are expected to provide protection into 2041, unless extended further.

Key Points: 
  • The claims are expected to provide protection into 2041, unless extended further.
  • “Importantly, this patent for the dose strength in RMS patients covers all salt and free acid forms of vidofludimus calcium.
  • In the United States, these patents provide protection into 2041, unless extended further.
  • On top of the patent exclusivity, vidofludimus calcium, as a new chemical entity, should also benefit from regulatory data protection.

Immunic Receives Notice of Allowance for United States Patent Protecting the Treatment of Relapsing Multiple Sclerosis with Vidofludimus and Its Salts

Retrieved on: 
Thursday, November 2, 2023
Patent, Food, Biotechnology, Multiple sclerosis, United States Patent and Trademark Office, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, MS, Lead, RMS, Calcium, Patient, Pharmaceutical industry, Short course immune induction therapy

"Importantly, this patent for the dose strength in RMS patients covers all salt and free acid forms of vidofludimus calcium.

Key Points: 
  • "Importantly, this patent for the dose strength in RMS patients covers all salt and free acid forms of vidofludimus calcium.
  • Vidofludimus calcium is covered by several layers of granted patents in the United States, Europe and other jurisdictions around the world.
  • In the United States, these patents provide protection into 2041, unless extended further.
  • On top of the patent exclusivity, vidofludimus calcium, as a new chemical entity, should also benefit from regulatory data protection.

EQS-News: Immunic to Participate in Scientific and Industry Conferences in November

Retrieved on: 
Thursday, October 26, 2023
Coeliac disease, General assembly, Biotechnology, Treatment, Conference, Short course immune induction therapy, SIRT6, Clinical trial, Human, Regeneration, Patient, Pharmaceutical industry

NEW YORK, October 26, 2023 – Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced participation in the following scientific and industry conferences in November:

Key Points: 
  • NEW YORK, October 26, 2023 – Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced participation in the following scientific and industry conferences in November:
    November 2-5: Association of European Coeliac Societies (AOECS) 35th General Assembly Conference 2023.
  • The poster presentation will be accessible on the “Events and Presentations” section of Immunic’s website at: https://ir.imux.com/events-and-presentations .
  • Title: First In Human Trial of IMU-856, an Orally Available Epigenetic Modulator of Barrier Regeneration For the Treatment of Celiac Disease
    November 6-8: BIO-Europe.
  • Members of Immunic’s business development, investor relations and public relations teams will attend this conference in Munich, Germany and participate in partnering activities.

Immuneering Presents Preclinical Data Demonstrating Encouraging Anti-Tumor Activity for IMM-1-104 and IMM-6-415 at AACR-NCI-EORTC Conference

Retrieved on: 
Thursday, October 12, 2023
Lung cancer, RAF, KRAS, Female, China Bio-Immunity Corporation, 3D, AACR, BRAF, IND, Encorafenib, TGI, MEK, Benchmarking, Mutation, RAS, Binimetinib, Half-life, Cancer, Melanoma, Colorectal cancer, Paclitaxel, Mouse, Pancreatic cancer, MAPK, Conference, Patient, Combination therapy, Medical imaging, Cassette tape, Pharmaceutical industry, Vaccine, Short course immune induction therapy

Today’s findings add cytotoxic agents and RAF inhibitors to the list of promising combinations, building on our previously disclosed data supporting combinations with KRAS-G12C inhibitors and immuno-oncology agents.

Key Points: 
  • Today’s findings add cytotoxic agents and RAF inhibitors to the list of promising combinations, building on our previously disclosed data supporting combinations with KRAS-G12C inhibitors and immuno-oncology agents.
  • Pharmacogenomic data were used to generate a model predictive of response to IMM-1-104 and identify biomarker-aligned patient subpopulations.
  • IMM-1-104 was tested in combination with gemcitabine or paclitaxel in humanized 3D models of pancreatic cancer, demonstrating enhanced activity and combination therapy potential.
  • As monotherapy, IMM-6-415 demonstrated anti-tumor activity in over 50% (34 of 66) of the 3D-TGA models tested, including 30 BRAF mutant preclinical models in which 19 (63%) showed activity.

EQS-News: Immunic Presents Data From Phase 2 EMPhASIS Trial of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis at MSMilan2023: The 9th Joint ECTRIMS-ACTRIMS Meeting

Retrieved on: 
Tuesday, October 17, 2023
Calcium, Neuroprotection, MS, Inflammation, Multiple sclerosis, Safety, Neurofilament, Magnetic resonance imaging, Biotechnology, Barrow Neurological Institute, Clinical research coordinator, RRMS, Research, Emphasis, MRI, AFL, PMS, Patient, Cleveland Clinic, Frankincense, Pharmaceutical industry, Short course immune induction therapy

Immunic Presents Data From Phase 2 EMPhASIS Trial of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis at MSMilan2023: The 9th Joint ECTRIMS-ACTRIMS Meeting

Key Points: 
  • Immunic Presents Data From Phase 2 EMPhASIS Trial of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis at MSMilan2023: The 9th Joint ECTRIMS-ACTRIMS Meeting
    The issuer is solely responsible for the content of this announcement.
  • Immunic Presents Data From Phase 2 EMPhASIS Trial of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis at MSMilan2023: The 9th Joint ECTRIMS-ACTRIMS Meeting
    – NfL Effect Consistent With Recently Released Data from Separate, Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis –
    NEW YORK, October 11, 2023 – Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, announced that Robert J.
  • EMPhASIS was an international, multicenter, double-blind, placebo-controlled, randomized, parallel-group trial, designed to assess the efficacy and safety of vidofludimus calcium in patients with RRMS.
  • On October 9, 2023, Immunic announced positive interim data from its phase 2 CALLIPER trial of vidofludimus calcium in patients with progressive multiple sclerosis (PMS).

EQS-News: Immunic Reports Positive Interim Data from Phase 2 CALLIPER Trial of Vidofludimus Calcium in Progressive Multiple Sclerosis

Retrieved on: 
Tuesday, October 17, 2023
Calcium, SPMS, PPMS, MS, EDSS, EBioMedicine, GFAP, Magnetic resonance imaging, Disease, Teaching hospital, Webcast, RRMS, Patient, MRI, AFL, University Hospital of Basel, PMS, PIRA, Disability, Silviculture, Medical imaging, Pharmaceutical industry, Short course immune induction therapy

Serum NfL responses were consistently observed for vidofludimus calcium across progressive MS disease and all subpopulations.

Key Points: 
  • Serum NfL responses were consistently observed for vidofludimus calcium across progressive MS disease and all subpopulations.
  • At 48 weeks (N=79), vidofludimus calcium reduced serum NfL by 10.4% from baseline, compared to a 6.4% increase in placebo.
  • Although early, interim GFAP data also showed a promising signal: at 24 weeks (N=203), GFAP increased by 3.7% for vidofludimus calcium, and 4.4% for placebo.
  • Top-line data from the phase 2 CALLIPER trial of vidofludimus calcium in PMS is expected in April of 2025.

EQS-News: Immunic Presents Data From Phase 1b Clinical Trial of IMU-856 in Celiac Disease at the United European Gastroenterology Week 2023

Retrieved on: 
Tuesday, October 17, 2023
Histology, Coeliac disease, Irritable bowel syndrome, Pharmacokinetics, Biomarker, Abstract, Treatment, Physical examination, Human, Safety, United European Gastroenterology, Biotechnology, Vital signs, Ulcerative colitis, Clinical trial, Regeneration, Patient, SIRT6, Pharmaceutical industry, Short course immune induction therapy

In this phase 1b, double-blind, randomized, placebo-controlled trial in patients with celiac disease, IMU‑856 showed positive effects over placebo in four key dimensions of clinical outcome: protection of the gut architecture, improvement of patients’ symptoms, biomarker response and enhancement of nutrient absorption.

Key Points: 
  • In this phase 1b, double-blind, randomized, placebo-controlled trial in patients with celiac disease, IMU‑856 showed positive effects over placebo in four key dimensions of clinical outcome: protection of the gut architecture, improvement of patients’ symptoms, biomarker response and enhancement of nutrient absorption.
  • IMU-856 was also found to be safe and well-tolerated with a benign adverse event profile and with pharmacokinetics that allow once-daily dosing.
  • There were no systematic clinically relevant findings relative to safety and tolerability, as assessed by physical examination, clinical laboratory tests, vital signs, and 12-lead electrocardiograms.
  • “In our phase 1b clinical trial, IMU-856 showed the first clinical signals of its potential ability to restore a healthy gut by renewal of the gut wall in patients with celiac disease.

Immunic Presents Data From Phase 1b Clinical Trial of IMU-856 in Celiac Disease at the United European Gastroenterology Week 2023

Retrieved on: 
Sunday, October 15, 2023
Histology, Coeliac disease, Irritable bowel syndrome, Pharmacokinetics, Biomarker, Abstract, Treatment, Physical examination, Crohn's disease, Human, Safety, United European Gastroenterology, Biotechnology, Diarrhea, Vital signs, Ulcerative colitis, Clinical trial, Regeneration, Patient, SIRT6, Pharmaceutical industry, Short course immune induction therapy

In this phase 1b, double-blind, randomized, placebo-controlled trial in patients with celiac disease, IMU‑856 showed positive effects over placebo in four key dimensions of clinical outcome: protection of the gut architecture, improvement of patients' symptoms, biomarker response and enhancement of nutrient absorption.

Key Points: 
  • In this phase 1b, double-blind, randomized, placebo-controlled trial in patients with celiac disease, IMU‑856 showed positive effects over placebo in four key dimensions of clinical outcome: protection of the gut architecture, improvement of patients' symptoms, biomarker response and enhancement of nutrient absorption.
  • IMU-856 was also found to be safe and well-tolerated with a benign adverse event profile and with pharmacokinetics that allow once-daily dosing.
  • "In our phase 1b clinical trial, IMU-856 showed the first clinical signals of its potential ability to restore a healthy gut by renewal of the gut wall in patients with celiac disease.
  • IMU-856 may also offer extensive potential beyond celiac disease in other gastrointestinal diseases with high unmet needs such as ulcerative colitis, Crohn's disease, or irritable bowel syndrome with diarrhea."

Immunic Presents Data From Phase 2 EMPhASIS Trial of Vidofludimus Calcium in Relapsing-Remitting Multiple Sclerosis at MSMilan2023: The 9th Joint ECTRIMS-ACTRIMS Meeting

Retrieved on: 
Wednesday, October 11, 2023
Calcium, Neuroprotection, MS, Inflammation, Multiple sclerosis, Safety, Neurofilament, Magnetic resonance imaging, Barrow Neurological Institute, Clinical research coordinator, RRMS, Research, Emphasis, MRI, AFL, PMS, Observation, Patient, Cleveland Clinic, Pharmaceutical industry, Short course immune induction therapy

NEW YORK, Oct. 11, 2023 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, announced that Robert J. Fox, M.D., Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurological Institute, Cleveland Clinic, Cleveland, Ohio, today presented data from the company's phase 2 EMPhASIS trial of nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in relapsing-remitting multiple sclerosis (RRMS) at MSMilan2023: The 9th Joint ECTRIMS-ACTRIMS Meeting, taking place October 11-13 in Milan, Italy.

Key Points: 
  • Fox, M.D., Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurological Institute, Cleveland Clinic, Cleveland, Ohio, today presented data from the company's phase 2 EMPhASIS trial of nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in relapsing-remitting multiple sclerosis (RRMS) at MSMilan2023: The 9th Joint ECTRIMS-ACTRIMS Meeting, taking place October 11-13 in Milan, Italy.
  • Dr. Fox has served as Coordinating Investigator in Immunic's multiple sclerosis (MS) programs and receives consulting fees for serving as an advisor to Immunic.
  • EMPhASIS was an international, multicenter, double-blind, placebo-controlled, randomized, parallel-group trial, designed to assess the efficacy and safety of vidofludimus calcium in patients with RRMS.
  • On October 9, 2023, Immunic announced positive interim data from its phase 2 CALLIPER trial of vidofludimus calcium in patients with progressive multiple sclerosis (PMS).

EQS-News: Immunic to Participate in Scientific Conferences in October

Retrieved on: 
Wednesday, October 4, 2023
Abstract, Cleveland Clinic, Short course immune induction therapy, Metabolism, IBD, United European Gastroenterology, Biotechnology, UEG, Regeneration, Multiple sclerosis, Doctor of Philosophy, Netherlands, MS, Hepatology, MD, Gastroenterology, Neurofilament, Human, Regulatory affairs, Montreal Neurological Institute and Hospital, Research, Coeliac disease, Treatment, Pharmaceutical industry, Pharmacovigilance

NEW YORK, October 4, 2023 – Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced participation in the following scientific conferences in October:

Key Points: 
  • NEW YORK, October 4, 2023 – Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, today announced participation in the following scientific conferences in October:
    October 11-13: MSMilan2023: The 9th Joint ECTRIMS-ACTRIMS Meeting.
  • The poster presentation will be accessible on the “Events and Presentations” section of Immunic’s website at: https://ir.imux.com/events-and-presentations .
  • Title: Reduction in Neurofilament Light Chain by Vidofludimus Calcium: The EMPhASIS Study
    October 14-17: UEG (United European Gastroenterology) Week 2023.
  • Darius-Jean Namdjou, PhD, Head of Regulatory Affairs and Pharmacovigilance at Immunic, will speak during two sessions at this summit in Brussels, Belgium.