Polyomaviridae

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.

Memo Therapeutics AG Receives FDA Fast Track Designation for AntiBKV as Treatment of BKV Infection in Renal Transplant Patients

Retrieved on: 
Tuesday, May 2, 2023
FDA, Health, Infectious Diseases, Clinical Trials, Pharmaceutical, Biotechnology, Infection, Therapy, Survival, Polyomaviridae, Fast Track, Patient, Risk, Kidney transplantation, BKV, Longevity, Immunosuppression, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BK, BLA, Food, Pharmaceutical industry

Memo Therapeutics AG (“MTx”), a biotech company developing best-in-class therapeutic antibodies, announced today that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation to AntiBKV, MTx’s lead antibody therapeutic that targets BK polyomavirus (“BKV”) infection commonly seen in renal transplant patients.

Key Points: 
  • Memo Therapeutics AG (“MTx”), a biotech company developing best-in-class therapeutic antibodies, announced today that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation to AntiBKV, MTx’s lead antibody therapeutic that targets BK polyomavirus (“BKV”) infection commonly seen in renal transplant patients.
  • “Receiving Fast Track designation from the FDA is a significant achievement for Memo, validating the potential of AntiBKV and expediting its development.
  • We believe AntiBKV could be a first- and best-in-class treatment option for kidney transplant patients suffering from BKV infection,” said Dr. Karsten Fischer, Chief Executive Officer of Memo Therapeutics AG.
  • Due to the immunosuppressive drug regimen transplant patients receive, reactivation of BKV is triggered in 40 to 50% of kidney transplant recipients.

Memo Therapeutics AG Announces Positive Phase I Data with AntiBKV for Treatment of BKV Infection in Renal Transplant Patients

Retrieved on: 
Tuesday, January 24, 2023
Biotechnology, Infectious Diseases, Health, Pharmaceutical, Clinical Trials, BK, Trial of the century, MTX, Safety, Patient, Clinical trial, Risk, USD, BKV, Kidney transplantation, Survival, Infection, Volunteering, Polyomaviridae, Immunosuppression, Pharmacokinetics, Longevity, Pharmaceutical industry

Memo Therapeutics AG (“MTx”), an innovator in the field of antibody discovery and development, announced today positive safety and tolerability data from a Phase I clinical trial with AntiBKV, an antibody targeting BK polyomavirus (“BKV”) infection in renal transplant patients, meeting its primary endpoint.

Key Points: 
  • Memo Therapeutics AG (“MTx”), an innovator in the field of antibody discovery and development, announced today positive safety and tolerability data from a Phase I clinical trial with AntiBKV, an antibody targeting BK polyomavirus (“BKV”) infection in renal transplant patients, meeting its primary endpoint.
  • “AntiBKV has the potential to be a best- and first-in-class antibody for the treatment of BKV infection in kidney transplant recipients.
  • BKV infection poses a significant threat in kidney transplantation, with serious adverse effects on graft function and ultimately patient survival.
  • Up to 10% of these cases progress to BKV associated nephropathy, which poses a serious threat to the transplant.

Vera Therapeutics to Present at Upcoming Investor Conferences

Retrieved on: 
Tuesday, November 22, 2022
Degenerative disease, IgA nephropathy, Vera, BK virus, Autoantibody, Therapy, B-cell activating factor, Patient, Virus, Immunoglobulin A, Standard of care, Lupus nephritis, B cell, Calendar, BK, Polyomaviridae, Online shopping, Vaccine

A replay of the presentations will be available for 90 days and can be accessed by visiting the Investor Calendar section of the Vera Therapeutics website.

Key Points: 
  • A replay of the presentations will be available for 90 days and can be accessed by visiting the Investor Calendar section of the Vera Therapeutics website.
  • Vera Therapeutics is a late-stage biotechnology company focused on developing treatments for serious immunological diseases.
  • Veras mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients.
  • In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful.

Vera Therapeutics to Host Key Opinion Webinar on Targeting the Source of IgA Nephropathy (IgAN) Featuring Jonathan Barratt, Ph.D., FRCP

Retrieved on: 
Thursday, November 17, 2022
COVID-19, Degenerative disease, Diagnosis, ASN, American Society of Nephrology, BYU College of Life Sciences, Immunoglobulin A, FRCP, BK virus, Union, ESRD, Food, University, Autoantibody, Dialysis, Radar, Therapy, College, B-cell activating factor, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Virus, TACI, Clinical trial, Cytokine, Biomarker, Surrogate, Coagulation, Chronic kidney disease, Standard of care, University of Leicester, Lupus nephritis, Society, International, Security (finance), B cell, Barratt, Research, BK, Kidney failure, Polyomaviridae, KOL, Vera, Pharmaceutical industry, Vaccine, IgA nephropathy

BRISBANE, Calif., Nov. 17, 2022 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced that it will host a key opinion leader (KOL) webinar on IgA nephropathy (IgAN), a common cause of kidney failure. The webinar will be held on Monday, November 28, 2022 at 2:00pm ET.

Key Points: 
  • Recent data presented by Dr. Barratt at the American Society of Nephrology (ASN) Kidney Week 2022 showed atacicept reduced immune complex levels in patients with IgAN.
  • In addition, the Vera Therapeutics leadership team will provide an overview of the ongoing Phase 2b ORIGIN trial of atacicept in IgAN and the Companys pipeline.
  • If the data from the ORIGIN trial are supportive, Vera Therapeutics expects to initiate a pivotal Phase 3 clinical trial of atacicept in 2023.
  • Atacicept showed a dose-dependent effect on key biomarkers and clinical markers in a Phase 2a clinical study in patients with IgAN.

Vera Therapeutics Provides Business Update and Reports Third Quarter 2022 Financial Results

Retrieved on: 
Wednesday, November 9, 2022
GLOBE, IgA nephropathy, Private Securities Litigation Reform Act, Vera, Autoantibody, Viremia, U.S. Securities and Exchange Commission, Immunosuppression, Annual general meeting, Nasdaq, COMPASS, B cell, Cytokine, Society, BKV, Virus, Immunoglobulin A, B-cell activating factor, Coagulation, Disease, Mortality, Therapy, Chronic kidney disease, Lupus nephritis, Degenerative disease, Safety, BK virus, Proteinuria, Biomarker, Program, Polyomaviridae, Clinical trial, Standard of care, ASN, Patient, American Society of Nephrology, Pfizer, CEO, TACI, Infection, Security (finance), Kidney failure, Quarter, COVID-19, Bank, Pharmaceutical industry, Vaccine, BK

During the third quarter of 2022, we continued to make progress advancing our late-stage clinical pipeline of atacicept and MAU868, said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics.

Key Points: 
  • During the third quarter of 2022, we continued to make progress advancing our late-stage clinical pipeline of atacicept and MAU868, said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics.
  • IgAN is a common cause of kidney failure and there is a high unmet medical need for treatment of IgAN globally.
  • We are also pleased to announce initiation of our pivotal Phase 3 COMPASS clinical trial of atacicept in lupus nephritis.
  • Vera reported $114.4 million in cash, cash equivalents, and marketable securities as of September 30, 2022.

Vera Therapeutics to Present Final Phase 2 Results of MAU868 in Kidney Transplant Recipients with Reactivated BK Virus Infection and New Analysis of Phase 2a JANUS Trial of Atacicept in IgA Nephropathy at the American Society of Nephrology Kidney Week 202

Retrieved on: 
Monday, October 17, 2022
Securities and Exchange Commission (Philippines), BK virus, B-cell activating factor, Therapy, Polyomaviridae, BKV, IgA nephropathy, Cytokine, BK, Degenerative disease, Society, Barratt, Patient, FRCP, Standard of care, Pfizer, Security (finance), B cell, Nephrology, Lupus nephritis, University, Autoantibody, Virus, Private Securities Litigation Reform Act, Biomarker, Vera, Immunosuppression, Immunoglobulin A, TACI, Coagulation, COVID-19, University of Leicester, Vaccine

BK Virus is a polyoma virus that can be reactivated in settings of immunosuppression, such as in kidney transplant.

Key Points: 
  • BK Virus is a polyoma virus that can be reactivated in settings of immunosuppression, such as in kidney transplant.
  • It is a leading cause of kidney transplant loss and transplant-associated morbidity; there are currently no approved treatments for BKV.
  • Vera holds an exclusive worldwide license from Amplyx Pharmaceuticals, Inc., a wholly owned subsidiary of Pfizer Inc., for the development and commercialization of MAU868 in all indications.
  • Atacicept showed a dose-dependent effect on key biomarkers and clinical markers in a Phase 2a clinical study in patients with IgAN.

Vera Therapeutics to Present at Upcoming Conferences in September 2022

Retrieved on: 
Wednesday, September 7, 2022
B-cell activating factor, Immunoglobulin A, B cell, IgA nephropathy, Degenerative disease, Therapy, Lupus nephritis, Polyomaviridae, Standard of care, Calendar, Autoantibody, Conference, Virus, BK, BK virus, Vera, Patient, Vaccine

Vera Therapeutics is a late-stage biotechnology company focused on developing treatments for serious immunological diseases.

Key Points: 
  • Vera Therapeutics is a late-stage biotechnology company focused on developing treatments for serious immunological diseases.
  • Veras mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients.
  • In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful.
  • Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant.

Vera Therapeutics Provides Business Update and Reports Second Quarter 2022 Financial Results

Retrieved on: 
Wednesday, August 10, 2022
Lupus nephritis, U.S. Securities and Exchange Commission, BKV, Association, Autoantibody, ATC, Mortality, IgA nephropathy, Kidney disease, CEO, GLOBE, Standard of care, Private Securities Litigation Reform Act, B cell, Congress, Security (finance), Research, Immunoglobulin A, Patient, Virus, Therapy, COVID-19, Program, BK, Chronic kidney disease, B-cell activating factor, Polyomaviridae, Disease, Â, European Renal Association – European Dialysis and Transplant Association, BK virus, Vera, Nasdaq, Degenerative disease, Pharmaceutical industry, Cryptocurrency, Viremia

In the first half of 2022, we continued to successfully execute our development strategy and are on track to realize several significant milestones.

Key Points: 
  • In the first half of 2022, we continued to successfully execute our development strategy and are on track to realize several significant milestones.
  • Topline results from the study are expected to be presented early in the first quarter of 2023.
  • During the past quarter, we presented at multiple congresses highlighting our clinical data for each program.
  • Vera reported $131.9 million in cash, cash equivalents, and marketable securities as of June 30, 2022.

Vera Therapeutics to Participate in the 13th Annual Wedbush PacGrow Healthcare Conference

Retrieved on: 
Thursday, August 4, 2022
Standard of care, Vera, IgA nephropathy, Autoantibody, Degenerative disease, Patient, Virus, BK virus, B-cell activating factor, Lupus nephritis, Therapy, BK, B cell, Immunoglobulin A, Polyomaviridae, Calendar, Online shopping, Vaccine

A replay of the event will be available for 90 days and can be accessed by visiting the Investor Calendar section of the Vera Therapeutics website.

Key Points: 
  • A replay of the event will be available for 90 days and can be accessed by visiting the Investor Calendar section of the Vera Therapeutics website.
  • Vera Therapeutics is a late-stage biotechnology company focused on developing treatments for serious immunological diseases.
  • Veras mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients.
  • In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful.