Viremia

NIAID-Sponsored Study Shows N-803 Combined with Neutralizing Antibodies Could Lead to Sustained HIV Viral Control After Discontinuation of Antiretroviral Therapy

Retrieved on: 
Wednesday, March 6, 2024
Pharmaceutical, AIDS, Health, Clinical Trials, Infection, Bangladesh Technical Education Board, SHIV, AD8, Research, Virology, BCG, NIAID, FDA, Safety, Animal, Hook effect, NMIBC, Rockefeller University, ART, Viremia, Patient, NK, Harvard Medical School, HIV, HIV/AIDS, Immune system, Vaccine

Treatment with N-803 and bNAbs led to immune activation and transient viremia, but only limited reductions in the SHIV reservoir.

Key Points: 
  • Treatment with N-803 and bNAbs led to immune activation and transient viremia, but only limited reductions in the SHIV reservoir.
  • Upon ART discontinuation, all animals experienced viral rebound, followed by long-term virus control for up to 10 months in approximately 70% of those treated with N-803 and bNAbs.
  • “When combined with broadly neutralizing antibodies, N-803 has the potential to provide viral control without significant reduction in the viral reservoir, which further suggests that the complete eradication of this reservoir may not be required to induce sustained remission after discontinuing antiretroviral therapy."
  • Safety and efficacy have not been established by any Health Authority or Agency, including the FDA.

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-14 February 2024

Retrieved on: 
Saturday, February 17, 2024
Penta, Committee, Infection, Leukopenia, Lotilaner, Atopic dermatitis, Cattle, Dog, Sheep, CVMP, InterDigital, Skin, Viral, Hyperthermia, Metritis, Chicken, Horse, Viremia, Classification, Drinking water, Cat, QRD, Guideline, The Committee

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Strangvac to implement the outcome of the MAH’s signal management process to add adverse reactions in the product information.

Key Points: 
  • The Committee adopted by consensus a positive opinion for a variation requiring assessment for Strangvac to implement the outcome of the MAH’s signal management process to add adverse reactions in the product information.
  • The respective target species were cattle, pigs and sheep (one product), chickens, and squirrel monkeys (one product each).
  • Concept papers, guidelines
    Quality
    The Committee adopted an annex to the Guideline on quality aspects of pharmaceutical veterinary medicines for administration via drinking water on compatibility studies between veterinary medicinal products and biocidal products (EMA/CVMP/QWP/592906/2022) following close of public consultation.
  • The comments received during the consultation procedure were taken into account for the revision of the annex.

GeoVax Hemorrhagic Fever Vaccine Data Presented at World Vaccine Congress

Retrieved on: 
Thursday, November 30, 2023
Viremia, Infection, Immunology, Survival, Biotechnology, NIAID, Primate, Virus, Vaccination, Weight loss, Vaccine, Disease, UTMB, Congress, Human, SUDV, GeoVax, University, Death, Associate professor, EBOV, MARV, Cancer, Immunization, MVA

ATLANTA, GA, Nov. 30, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced the presentation of data from recent preclinical studies of its vaccine candidates against Marburg virus and Sudan virus.

Key Points: 
  • The data were presented during the World Vaccine Congress, West Coast conference, being held in Santa Clara, CA from November 27-30, 2023.
  • Mark Newman, Ph.D., GeoVax Chief Scientific Officer, commented, “We are highly encouraged by the results of these studies of our MARV vaccine candidate.
  • The vaccine induced immune responses were characterized by MARV-specific binding and neutralizing antibodies as well as other effector functions like antibody-dependent phagocytosis.
  • The Angola strain is the most virulent strain of MARV characterized by a fatality rate of up to 90% in humans.

FDA Approves First Vaccine to Prevent Disease Caused by Chikungunya Virus

Retrieved on: 
Thursday, November 9, 2023
Priority review, Tenderness, Viremia, Safety, Heated tobacco product, Food, Rash, Headache, Risk, Disease, Myalgia, Clinical trial, Fatigue, Vaccination, Multimedia, Research, Rest, FDA, Animal, Vaccine, Cosmetics, Blood, Human services, Dietary supplement, Nausea, Infection, Gestational age, Trial of the century, Primate, Arthralgia, Pain, Fetus, Food and Drug Administration, Fever, Accelerated approval (FDA), Public, Pharmaceutical industry, Chikungunya

Chikungunya is an emerging global health threat with at least 5 million cases of chikungunya virus infection reported during the past 15 years.

Key Points: 
  • Chikungunya is an emerging global health threat with at least 5 million cases of chikungunya virus infection reported during the past 15 years.
  • However, chikungunya virus has spread to new geographical areas causing a rise in global prevalence of the disease.
  • It contains a live, weakened version of the chikungunya virus and may cause symptoms in the vaccine recipient similar to those experienced by people who have chikungunya disease.
  • Transmission of chikungunya virus to newborn babies from pregnant individuals with viremia (virus present in the blood) at delivery has been reported and can cause severe, potentially fatal chikungunya virus disease in newborns.

GeoVax Receives Notice of Allowance for Marburg Vaccine Patent

Retrieved on: 
Monday, October 9, 2023
Patent, Infection, Matrix (biology), Cancer, COVID-19, GeoVax, Death, Vaccine, Weight loss, Intellectual property, Survival, Biotechnology, MVA, FDA, Vaccination, Immunization, Virus-like particle, VP40, Viremia

ATLANTA, GA, Oct. 09, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire -- GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for Patent Application No.

Key Points: 
  • ATLANTA, GA, Oct. 09, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire -- GeoVax Labs, Inc. (Nasdaq: GOVX), a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for Patent Application No.
  • A recent presentation of data from nonhuman primate studies demonstrated that immunization with GeoVax’s vaccine candidate, GEO-MM01, conferred 80% survival in cynomolgus macaques following a lethal dose of Marburg virus.
  • GeoVax is currently evaluating study designs to assess the potential for administering different dose levels of the vaccine and different routes of vaccine delivery to optimize utility and efficacy.
  • This patent allowance adds to our growing portfolio of wholly owned, co-owned, and in-licensed intellectual property, now standing at over 115 granted or pending patent applications spread over 24 patent families.”

Assembly Biosciences Nominates Development Candidate ABI-6250, an Orally Bioavailable HDV Entry Inhibitor

Retrieved on: 
Monday, October 2, 2023
Injection, Viremia, NTCP, Assembly, Bio, Biotechnology, HDV, Viral, Liver injury, Hepatitis B virus, Doctor of Philosophy, Liver cancer, Patient, SAN, Viral hepatitis, Cirrhosis, IND, HBV, Vaccine

SOUTH SAN FRANCISCO, Calif., Oct. 02, 2023 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative antiviral therapeutics targeting serious viral diseases, today announced the selection of development candidate ABI-6250 to progress to IND-enabling studies. ABI-6250, an orally bioavailable small molecule entry inhibitor, is the first development candidate nominated by the company for the treatment of chronic hepatitis D virus (HDV) infection, and the second development candidate selected in 2023, following ABI-5366 for high-recurrence genital herpes.

Key Points: 
  • ABI-6250, an orally bioavailable small molecule entry inhibitor, is the first development candidate nominated by the company for the treatment of chronic hepatitis D virus (HDV) infection, and the second development candidate selected in 2023, following ABI-5366 for high-recurrence genital herpes.
  • “We’re pleased to nominate ABI-6250 as a development candidate targeting chronic HDV infection, the most severe form of viral hepatitis,” said William Delaney, PhD, chief scientific officer of Assembly Bio.
  • Patients with chronic HDV infection experience much higher rates of cirrhosis and liver cancer than those with chronic HBV infection only.
  • Inhibiting viral entry by blocking NTCP is a clinically validated target for reducing HDV viremia and liver injury in patients.

Vir Biotechnology Presents New Data Evaluating the Potential for VIR-2218 and VIR-3434 as Therapies for Chronic Hepatitis B and Hepatitis D

Retrieved on: 
Saturday, June 24, 2023
Learning, Auckland City Hospital, Viremia, University, Conditional sentence, Safety, NRTI, HDV, Clinical trial, Pharmacokinetics, PEG, Hepatitis B, Small RNA, Congress, Hong Kong, Spectrochimica Acta Part B, Hepatology, Patient, European Association for the Study of the Liver, Division, SAN, Clinical research, Poster, HBV, Vaccine, Tea, Medical device, Pharmaceutical industry, Health insurance, Medicine, HBsAg, Gastroenterology

SAN FRANCISCO, June 24, 2023 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced new data from its robust hepatitis B and D virus (HBV and HDV) portfolio that were presented at the EASL™ (European Association for the Study of the Liver) Congress.

Key Points: 
  • These data further support the clinical development of these investigational medicines for the treatment of HDV.
  • “I am very excited by the progress we are making toward our goal of achieving HBV functional cure.
  • Our data to-date with VIR-2218 and PEG-IFN-⍺ support our hypothesis of using a cocktail of antivirals combined with immunomodulators.
  • The majority of adverse events were consistent with the known effects of PEG-IFN-⍺ and resolved after the end of treatment.

Memo Therapeutics AG Starts U.S. Pivotal Phase II/III Clinical Trial with AntiBKV for Treatment of BKV Infection in Renal Transplant Patients

Retrieved on: 
Thursday, June 22, 2023
Biotechnology, Infectious Diseases, Health, Pharmaceutical, Clinical Trials, Infection, Viremia, MTX, Survival, Clinical trial, Polyomaviridae, Fast Track, Patient, TFS, Risk, Blood, Kidney transplantation, Viral load, BKV, Longevity, Phase, Immunosuppression, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BK, Food, Pharmaceutical industry

Phase II/III trial of AntiBKV, MTx’s antibody therapeutic that targets BK polyomavirus (“BKV”) infection in renal transplant patients.

Key Points: 
  • Phase II/III trial of AntiBKV, MTx’s antibody therapeutic that targets BK polyomavirus (“BKV”) infection in renal transplant patients.
  • “The start of this U.S. pivotal Phase II/III clinical trial with AntiBKV is a significant milestone for us.
  • We believe that AntiBKV, with its 100x more potent neutralization capacity than benchmark antibodies, has great potential to help renal transplant patients.
  • The Phase II part is a randomized, placebo-controlled trial designed to evaluate the therapeutic efficacy of AntiBKV in 60 renal transplant patients with BK viremia.

AlloVir Presents Positive Final Results From A Phase 2 Randomized, Placebo-Controlled Trial Evaluating Posoleucel Treatment of BK Infection in Kidney Transplant Recipients at the American Transplant Congress (ATC 2023)

Retrieved on: 
Monday, June 5, 2023
Health, Infectious Diseases, Surgery, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, Infection, Viremia, Survival, Cell, Trial of the century, Dialysis, Patient, Viral, Kidney, VST, BKV, Immunodeficiency, ATC, Transplant, FDA, BK virus, BK, Safety, Vaccine, Pharmaceutical industry

The findings, presented yesterday at the American Transplant Congress (ATC 2023) in San Diego, CA, during a late-breaking oral abstract session (LB001), support the safety and antiviral activity of posoleucel in adult kidney transplant recipients with BK virus (BKV) infection.

Key Points: 
  • The findings, presented yesterday at the American Transplant Congress (ATC 2023) in San Diego, CA, during a late-breaking oral abstract session (LB001), support the safety and antiviral activity of posoleucel in adult kidney transplant recipients with BK virus (BKV) infection.
  • Currently, there are no effective treatment options for BKV infection.
  • "The Phase 2 data presented at ATC continue to support the potential benefits of posoleucel use across transplant indications.
  • Approximately half of those will develop BKV-associated nephropathy (BKVAN)iii, which can lead to decreased kidney survival and a return to end-stage renal disease and dialysis.

AlloVir Announces Positive Results Including Long-Term Mortality Data in Phase 2 Posoleucel Multi-Virus Prevention Study in Oral Presentation at EBMT 2023

Retrieved on: 
Wednesday, April 26, 2023
Research, Infectious Diseases, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Other Science, Science, Infection, EBMT, Viremia, City of Hope, Cytomegalovirus, Hospital, Human polyomavirus 2, ADV, Death, JCV, City, MD, Patient, Polymerase chain reaction, Division, CMV, Disease, Viral, Mortality, BKV, European Society of Clinical Microbiology and Infectious Diseases, BK virus, Abstract, JC, BK, Virus, PCR, EBV, Safety, Vaccine, Pharmaceutical industry

These data were highlighted today in an oral presentation (Abstract OS08-03) at the 49th annual meeting of the European Society for Blood and Marrow Transplantation (EBMT 2023).

Key Points: 
  • These data were highlighted today in an oral presentation (Abstract OS08-03) at the 49th annual meeting of the European Society for Blood and Marrow Transplantation (EBMT 2023).
  • “The data presented today provide further evidence supporting the potential benefits of using posoleucel to prevent viral infection in high-risk allo-HCT patients.
  • "Our global, registrational Phase 3 clinical trial further exploring the potential of posoleucel for multi-virus prevention is well underway and we anticipate data from this registrational study in 2024.
  • More information on the ongoing, global, registrational, Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial of posoleucel for multi-virus prevention can be found on clinicaltrials.gov under the study ID ( NCT05305040 ).