Immune system

Orphan designation: (6aR, 10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydro-cannabinol-9-carboxylic acid Treatment of systemic sclerosis, 12/01/2017 Withdrawn

Retrieved on: 
Tuesday, April 9, 2024
Eurostat, Diagnosis, Civil service commission, Finger, Growth, Face, Blood, Disease, Inflammation, Patient, Committee, Knowledge, Regulation, Systemic scleroderma, EMA, IRIS, Protein, Scleroderma, CB2, European, Collagen, COMP, Connective tissue, Skin, Heart, Sponsor, European Commission, Immune system, The, Safety, Swelling, Marketing, Pharmaceutical industry

Orphan designation: (6aR, 10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydro-cannabinol-9-carboxylic acid Treatment of systemic sclerosis, 12/01/2017 Withdrawn

Key Points: 


Orphan designation: (6aR, 10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydro-cannabinol-9-carboxylic acid Treatment of systemic sclerosis, 12/01/2017 Withdrawn

Orphan designation: Genetically modified serotype 5/3 adenovirus coding for granulocyte macrophage colony-stimulating factor for the treatment of ovarian cancer Treatment of ovarian cancer, 29/04/2014 Withdrawn

Retrieved on: 
Tuesday, April 9, 2024
Eurostat, Diagnosis, Civil service commission, Ovarian cancer, GM, Gene, Survival, Disease, Patient, Committee, Knowledge, GM-CSF, Cancer, Female, Regulation, EMA, IRIS, Woman, European, Therapy, COMP, Sponsor, European Commission, Immune system, Safety, Marketing, Medicine, Pharmaceutical industry

Orphan designation: Genetically modified serotype 5/3 adenovirus coding for granulocyte macrophage colony-stimulating factor for the treatment of ovarian cancer Treatment of ovarian cancer, 29/04/2014 Withdrawn

Key Points: 


Orphan designation: Genetically modified serotype 5/3 adenovirus coding for granulocyte macrophage colony-stimulating factor for the treatment of ovarian cancer Treatment of ovarian cancer, 29/04/2014 Withdrawn

Orphan designation: fidanacogene elaparvovec Treatment of haemophilia B, 19/11/2018 Withdrawn

Retrieved on: 
Tuesday, April 9, 2024
Eurostat, Diagnosis, Civil service commission, Brain, Disease, Coagulation, Patient, Committee, Knowledge, Internal, Regulation, Haemophilia, EMA, IRIS, Joint, Human, Wound healing, European, COMP, Bleeding, Spinal cord, Antibody, Sponsor, European Commission, Immune system, Safety, Factor IX, Blood, Marketing, Haemophilia B, Medicine, Pharmaceutical industry

Orphan designation: fidanacogene elaparvovec Treatment of haemophilia B, 19/11/2018 Withdrawn

Key Points: 


Orphan designation: fidanacogene elaparvovec Treatment of haemophilia B, 19/11/2018 Withdrawn

Indaptus Therapeutics Previews Positive Mechanism of Action Data to be Presented at the American Association for Cancer Research Annual Meeting

Retrieved on: 
Monday, March 25, 2024
Toxicity, B cell, CD8, Research, Cancer research, AACR, Chemokine, Therapy, Cytokine, Immune system, Poster, Viral, Decoy, Bacteria, Vaccine

NEW YORK, March 25, 2024 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc, (Nasdaq: INDP), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, announces that Dr. Michael Newman, Founder and Chief Scientific Officer of Indaptus, will present a poster at the 2024 Annual Meeting of the American Association for Cancer Research (AACR) in San Diego on Wednesday morning, April 10th. An abstract of the data to be presented has been published online in the AACR Journal, Cancer Research. The data confirm and significantly extend the proposed mechanism of action of the Company’s proprietary platform technology of attenuated and killed, non-pathogenic bacteria containing multiple immune receptor agonists for pulsed anti-tumor immunotherapy.

Key Points: 
  • An abstract of the data to be presented has been published online in the AACR Journal, Cancer Research.
  • The data confirm and significantly extend the proposed mechanism of action of the Company’s proprietary platform technology of attenuated and killed, non-pathogenic bacteria containing multiple immune receptor agonists for pulsed anti-tumor immunotherapy.
  • The activity was associated with induction of human tumor cell killing by Decoy bacteria in the presence of immune cells.
  • Potentially unacceptable toxicity from this breadth of immune activation is avoided by using systemically administered killed bacteria as a delivery vehicle.

Three Patients with Invasive Fusarium Infection in Matinas BioPharma’s Oral MAT2203 Compassionate/Expanded Use Access Program Achieve Complete Clinical Response

Retrieved on: 
Friday, March 22, 2024
Nephrotoxicity, Urinary tract infection, Fungal infection, Culture, Ventilator-associated pneumonia, Burns, Internal medicine, Amphotericin B, Emphysema, Azole, Coronary artery disease, Debridement, Carcinoma, Risk, Hyperlipidemia, Patient, Lung, LNC, Fusarium, Female, Malignancy, University, Doctor of Philosophy, MD, Aspergillosis, Echinocandin, Fever, Immune system, Division, Hypertension, Voriconazole, Physician, Infection, Pharmaceutical industry

The successful MAT2203 treatment outcome in these patients therefore adds to our confidence for the upcoming ORALTO Phase 3 trial in patients suffering from invasive aspergillosis with limited treatment options.

Key Points: 
  • The successful MAT2203 treatment outcome in these patients therefore adds to our confidence for the upcoming ORALTO Phase 3 trial in patients suffering from invasive aspergillosis with limited treatment options.
  • She was transitioned to oral MAT2203 for two weeks, which led to clinical resolution of her fungal infection.
  • She began to show clinical improvement following two weeks of oral MAT2203 treatment and her skin wounds completely healed following six months of MAT2203 treatment.
  • “MAT2203 continues to demonstrate its potential to effectively treat invasive fungal infections and help patients achieve complete clinical resolution.

Eledon Pharmaceuticals Announces Use of Tegoprubart in First-ever Transplant of Genetically Modified Kidney from a Pig to a Human

Retrieved on: 
Thursday, March 21, 2024
Organ transplantation, Kidney disease, University of Minnesota, Massachusetts General Hospital, Risk, Patient, Immunosuppression, Research, Kidney transplantation, University, Kidney, Hope, Tacrolimus, Doctor of Philosophy, MD, Person, Hospital, Heart, Immune system, Calcineurin, Division, CD40L, Dentistry

IRVINE, Calif., March 21, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that tegoprubart, the company’s investigational anti-CD40L antibody, was used as a component of the immunosuppressive treatment regimen following the first-ever transplant of a kidney from a genetically modified pig to a human. The procedure was completed on March 16, 2024, at Massachusetts General Hospital on a 62-year-old man living with end-stage kidney disease.

Key Points: 
  • The procedure was completed on March 16, 2024, at Massachusetts General Hospital on a 62-year-old man living with end-stage kidney disease.
  • “Eledon has now participated in both heart and kidney xenotransplant procedures, further demonstrating tegoprubart’s broad potential in transplant.
  • Tegoprubart has been observed to be safe and well-tolerated in multiple studies and in multiple indications, including for the prevention of rejection following kidney transplantation.
  • In parallel, Eledon is running two global clinical studies evaluating tegoprubart for the prevention of organ rejection in persons receiving a de novo kidney transplant.

X4 Pharmaceuticals Reports Fourth-Quarter and Full-Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 21, 2024
Security (finance), WHIM, WHIM syndrome, Conference call, Conference, RPD, New Drug Application, Ageing, Orphan, Wart, NDA, Priority review, Research and development, Immune system, File, ID, FDA, X4, PDUFA, Pharmaceutical industry

BOSTON, March 21, 2024 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today reported financial results for the fourth quarter and full year ended December 31, 2023, and highlighted key 2023 events and expected upcoming milestones.

Key Points: 
  • “Following an incredibly productive 2023, we are expecting a transformative year in 2024,” said Paula Ragan, Ph.D., President and Chief Executive Officer of X4 Pharmaceuticals.
  • X4 will host a conference call and webcast today at 8:30 am ET to discuss these financial results and business highlights.
  • The live webcast can be accessed on the investor relations section of X4 Pharmaceuticals’ website at www.x4pharma.com .
  • Following the completion of the call, a webcast replay of the conference call will be available on the company website.

Barinthus Bio Reports Full Year 2023 Financial Results and Update on Corporate Developments

Retrieved on: 
Wednesday, March 20, 2024
MERS, Patient, Ethics, Epidemic, NUC, Group 3, Clinical trial, Liver, Depreciation, Vaccine, Hepatitis, PD-1, Research, Coalition, Arbutus, Hepatology, Coeliac disease, Nivolumab, Safety, Immune system, CHB, Prostate cancer, CEPI, AASLD, University, Șaeș, Cancer, HBV, Conference, AstraZeneca, Autoimmunity, Infection, Human papillomavirus infection, Oxford University Innovation, SNAP, HPV, APOLLO, Pharmaceutical industry

Barinthus Bio is a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases, autoimmunity, and cancer.

Key Points: 
  • Barinthus Bio is a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases, autoimmunity, and cancer.
  • We presented the final data in June 2023 at the European Association for the Study of the Liver Congress 2023 – The International Liver CongressTM.
  • We presented this data during an oral presentation at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2023.
  • In November 2023, we announced the company’s renaming as Barinthus Biotherapeutics plc to represent the evolution and expansion of its focus beyond vaccines.

SPEVIGO® approved for expanded indications in China and the US

Retrieved on: 
Tuesday, March 19, 2024
Arthralgia, Urinary tract infection, Uncertainty, Human, NMPA, Psoriasis, Disease, Multiple organ dysfunction syndrome, Incidence, Risk, GPP, Boehringer Ingelheim, Patient, Ageing, Executive officer, Immunoglobulin G, Anxiety, Doctor of Philosophy, MD, Quality of life, Flare, Injection site reaction, Clinical trial, Skin, Fever, Immune system, Pain, Itch, Food, FDA, Yale University, Fear

In the trial with 123 patients, no flares were observed after week 4 of SPEVIGO® subcutaneous treatment in the high-dose group (n=30).13,14,15,16 In the Effisayil® 2 trial, SPEVIGO® was associated with an increased incidence (≥9 cases per 100 patient-years) of injection site reaction, urinary tract infection, arthralgia, and pruritus compared to placebo.

Key Points: 
  • In the trial with 123 patients, no flares were observed after week 4 of SPEVIGO® subcutaneous treatment in the high-dose group (n=30).13,14,15,16 In the Effisayil® 2 trial, SPEVIGO® was associated with an increased incidence (≥9 cases per 100 patient-years) of injection site reaction, urinary tract infection, arthralgia, and pruritus compared to placebo.
  • “Until now, people living with GPP have not had any approved options to treat their disease,” said Bruce Strober, MD, PhD, Clinical Professor, Dermatology, Yale University and Central Connecticut Dermatology.
  • “Experiencing GPP can be mentally and physically devastating, leaving those affected with uncertainty and fear of the next episode.
  • Therefore, expanding the treatment of GPP is a critical step towards addressing patients’ needs.”

Evaxion Hosts R&D Day and Unveils the Broad Potential of Its AI-Immunology™ Platform

Retrieved on: 
Tuesday, March 19, 2024
MSD, EST, Koala retrovirus, Learning, AI, Neoplasm, Immune system, Machine learning, Vaccine, Collection, Medical device

The event will be hosted at our facilities in Hørsholm, Denmark, between 14.00 – 18.00 CET / 9.00 a.m. - 1.00 p.m. EST and can be accessed remotely here .

Key Points: 
  • The event will be hosted at our facilities in Hørsholm, Denmark, between 14.00 – 18.00 CET / 9.00 a.m. - 1.00 p.m. EST and can be accessed remotely here .
  • The R&D Day features a series of talks providing in-depth insights into Evaxion's clinically validated AI-Immunology™ platform for vaccine target discovery, design and development.
  • Christian Kanstrup, CEO of Evaxion, expresses enthusiasm: “We have been looking forward to this exciting day and welcome everyone interested in learning more about our technology and its potential for saving and improving lives.
  • We believe that we hold a truly differentiated position driven by our validated AI-Immunology™ platform and the multi-disciplinary capability set we have built around it.