Latest news with #IgG1
Medscape
5 days ago
- Health
- Medscape
Why Are RSV Vaccine Rates so Shockingly Low?
Respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract infections in infants and children younger than 2 years. The most severe and life-threatening cases typically affect infants younger than 6 months. However, older toddlers, adults with chronic illnesses or multiple comorbidities, and older adults are also at an elevated risk. Immunization Progress Research on both active and passive RSV immunization has advanced significantly in recent years. Following the approval of the first prophylactic antibody in 2022 and two vaccines in 2023, the prevention of severe RSV illnesses has become increasingly effective. Current strategies include maternal vaccination to protect newborns, immunization of older adults, and passive immunization of infants using the monoclonal antibody nirsevimab. In June, the FDA approved a second monoclonal antibody: clesrovimab. Nirsevimab Nirsevimab (Beyfortus) has been available in the European Union since November 2022. It is indicated for RSV prophylaxis in all infants during their first RSV season and in children up to 2 years of age who are at increased risk during their second season. Nirsevimab is a human monoclonal immunoglobulin G1 (IgG1) kappa antibody produced using recombinant DNA technology. It binds to a highly conserved site on the RSV fusion (F) glycoprotein, which is present only in the prefusion form of the viral surface protein. Nirsevimab has a markedly longer serum half-life than earlier antibodies. The drug is administered as a single intramuscular dose adjusted according to the child's weight. Germany's Standing Committee on Vaccination recommends that infants born between April and September receive antibodies in autumn before their first RSV season. Those born between October and March should receive the vaccine as soon as possible after birth. Clesrovimab Clesrovimab (Enflonsia) is a human monoclonal IgG1 kappa antibody. Unlike nirsevimab, it binds to two sites in both the pre- and post-fusion conformations of the F protein. It is administered as a single intramuscular injection and does not require weight-based dosing. The manufacturer has applied for approval from the European Medicines Agency, and the decision is pending. RSV Vaccines Three RSV vaccines, each targeting a different group, are currently authorized for use in Germany. Arexvy: A monovalent recombinant protein vaccine that includes the RSV F protein and the AS01E adjuvant. It is approved for adults aged 60 years or older. Abrysvo: A bivalent recombinant protein vaccine containing prefusion F antigens from RSV subtypes A and B. It is authorized for use in pregnant women to protect their infants up to 6 months of age and in adults aged 60 years or older. mResvia: Approved in mid-2024, this is the only mRNA RSV vaccine currently available. It is indicated for adults aged 60 years or older and was recently approved in the US for high-risk adults aged 18-59 years. Real-World Data Although clinical trials have demonstrated the strong efficacy of RSV vaccines and antibodies in preventing severe illnesses, data from real-world immunization programs are limited. A new systematic review by UK researchers addressed this gap. Between December 2024 and February 2025, they conducted monthly searches across the Ovid, Embase, MEDLINE, and global health databases. The review included 43 studies that evaluated nirsevimab, maternal RSV vaccination, and adult RSV vaccination. The goal was to assess uptake across countries and demographic groups. Data from more than 1.38 million individuals in Spain, France, Italy, Luxembourg, and the US were analyzed. One study combined records from Catalonia and Andorra. Most data (86%) were drawn from electronic health records and medical registries, and vaccine data were solely from the US. Nirsevimab Uptake In Spain, the uptake of nirsevimab during the 2023-2024 RSV season reached 90.1% (95% CI, 86.4-92.9), the highest of any country reviewed. Infants born during the RSV season and Spanish nationals had higher immunization rates. In the US, 51.2% of eligible infants received nirsevimab in 2023-2024. Uptake was greater among preterm infants, those with at least one comorbidity, and those from Hispanic backgrounds. France recorded 76.5% coverage, with higher rates in infants younger than 3 months than in those aged 3-12 months. Luxembourg reported 83.8%, Italy 68.7%, and Catalonia-Andorra combined 60.2%. Subgroup analyses revealed that children who experienced RSV or other acute respiratory infections were less likely to receive nirsevimab. Maternal Vaccination Maternal RSV vaccine coverage during pregnancy was 30.5% (95% CI, 20.6-42.6). Uptake was significantly lower among women without health insurance or with statutory coverage than among those with private insurance. Black and Hispanic women had lower rates than non-Hispanic White women. Older Adult Vaccination Four population-based studies assessed RSV vaccine uptake in adults aged 60 years or older, showing an average rate of 18.2% (95% CI, 10.8-28.9) in 2023-2024. Uptake was higher among adults older than 75 years, those with comorbidities, and immunocompromised individuals. As with maternal vaccination, the rates were lower among the Black and Hispanic populations. The researchers highlighted the concerningly low uptake among pregnant women and older adults despite the availability of effective prevention tools. They called for coordinated national, clinical, and public health efforts to improve immunization rates in high-risk populations. World Health Organization (WHO) Guidance In May, the WHO published its first position paper on RSV immunization in infants and young children, underscoring global urgency. RSV is the leading cause of pediatric morbidity and mortality. In 2019, an estimated 100,000 children younger than 5 years died from RSV-related lower respiratory tract infections, representing about 2% of all deaths in this age group. Approximately half of these deaths occur in infants younger than 5 months, with 97% occurring in low- and middle-income countries. Globally, RSV accounts for an estimated 3.6 million hospitalizations annually in children younger than 5 years. The WHO recommends that all countries implement immunization programs to prevent severe RSV disease in vulnerable groups. The choice between maternal vaccination and the use of long-acting monoclonal antibodies, such as nirsevimab, should be based on local factors, including health system integration, cost, and overall feasibility. Germany's Robert Koch Institute provides additional guidance in its fact sheets on RSV immunization, including details on nirsevimab and adult vaccinations.
Yahoo
11-06-2025
- Health
- Yahoo
Memo Therapeutics AG Publishes Study in Frontiers in Pharmacology Demonstrating Therapeutic Antibody Transcytosis Across the Kidney Barrier After Intravenous Administration
Results demonstrate that intravenously administered therapeutic IgG antibodies can be detected in urine, supporting the conclusion that these antibodies are capable of crossing the kidney endothelial barrier This proof-of-concept study provides compelling support for the selected dosing regimen of MTx's investigational BK polyomavirus-neutralizing antibody Schlieren / Zurich, Switzerland, 11 June, 2025 – Memo Therapeutics AG (or 'MTx'), a late-stage biotechnology company developing antibody-based therapies for viral infections and cancer, has published a study in Frontiers in Pharmacology detailing the transport of therapeutic IgG1 antibodies across the kidney endothelial barrier. This quantitative analysis provides a scientific basis for the selected dosing strategy of MTx's highly potent human anti-BKV IgG1 therapeutic antibody, potravitug, currently in Phase II clinical development. The study reports that, 0.015% (median) of the serum concentration of therapeutic antibody rituximab is found in the urine, with levels reaching up to 4.2%. These findings suggest that therapeutic IgG antibodies can cross the kidney filtration barrier in measurable amounts, challenging prior assumptions about size-exclusion limitations and supporting the feasibility of antibody-based interventions for renal infections. Christoph Esslinger, CSO of MTx, commented: 'This data reinforces the notion that potravitug can access infected renal tissue and supports the continued development of this first-in-class candidate for the treatment of BK viremia in kidney transplant recipients.' BKV nephropathy affects up to 70% of kidney transplant recipients with established BK viremia and is associated with compromised graft function and reduced long-term graft survival. Despite this, therapeutic options remain limited, partly due to the prevailing belief that large-molecule biologics cannot effectively penetrate kidney tissue. This study contributes to a growing body of evidence suggesting otherwise. MTx is currently conducting a Phase II double-blind, randomized, placebo-controlled trial with 90 patients in the USA for the treatment of BK viremia in kidney transplant recipients, with top line results anticipated later in 2025. The full publication can be accessed here. -Ends- Contacts Memo Therapeutics AG info@ ICR Healthcare Amber Fennell, Ashley Tapp memotx@ +44 (0)20 3709 5700 About Memo Therapeutics AGMemo Therapeutics AG ('MTx') is a late-stage biotech company translating unique human immune responses into superior medicines through the development of best-in-class antibodies to treat viral infections and cancer. The Company's lead program, potravitug, is in Phase II development targeting BK viremia in kidney transplant recipients, an infection which can result in decreased kidney functionality and longevity and reduced patient survival. Potravitug has the potential to become a first-in-class BKV disease-modifying therapy for kidney transplant patients with a market potential of up to $2bn. Alongside potravitug, MTx is focused on discovering novel oncology targets. Underpinning MTx's core assets is its proprietary DROPZYLLA® technology, an antibody repertoire copying engine with high-throughput screening capabilities. MTx is a private company located in Schlieren / Zurich and backed by investors including Ysios Capital, Kurma Partners, Pureos Bioventures, Swisscanto, Vesalius Biocapital and Adjuvant Capital. Learn more at and on in to access your portfolio
Yahoo
11-06-2025
- Health
- Yahoo
Memo Therapeutics AG Publishes Study in Frontiers in Pharmacology Demonstrating Therapeutic Antibody Transcytosis Across the Kidney Barrier After Intravenous Administration
Results demonstrate that intravenously administered therapeutic IgG antibodies can be detected in urine, supporting the conclusion that these antibodies are capable of crossing the kidney endothelial barrier This proof-of-concept study provides compelling support for the selected dosing regimen of MTx's investigational BK polyomavirus-neutralizing antibody Schlieren / Zurich, Switzerland, 11 June, 2025 – Memo Therapeutics AG (or 'MTx'), a late-stage biotechnology company developing antibody-based therapies for viral infections and cancer, has published a study in Frontiers in Pharmacology detailing the transport of therapeutic IgG1 antibodies across the kidney endothelial barrier. This quantitative analysis provides a scientific basis for the selected dosing strategy of MTx's highly potent human anti-BKV IgG1 therapeutic antibody, potravitug, currently in Phase II clinical development. The study reports that, 0.015% (median) of the serum concentration of therapeutic antibody rituximab is found in the urine, with levels reaching up to 4.2%. These findings suggest that therapeutic IgG antibodies can cross the kidney filtration barrier in measurable amounts, challenging prior assumptions about size-exclusion limitations and supporting the feasibility of antibody-based interventions for renal infections. Christoph Esslinger, CSO of MTx, commented: 'This data reinforces the notion that potravitug can access infected renal tissue and supports the continued development of this first-in-class candidate for the treatment of BK viremia in kidney transplant recipients.' BKV nephropathy affects up to 70% of kidney transplant recipients with established BK viremia and is associated with compromised graft function and reduced long-term graft survival. Despite this, therapeutic options remain limited, partly due to the prevailing belief that large-molecule biologics cannot effectively penetrate kidney tissue. This study contributes to a growing body of evidence suggesting otherwise. MTx is currently conducting a Phase II double-blind, randomized, placebo-controlled trial with 90 patients in the USA for the treatment of BK viremia in kidney transplant recipients, with top line results anticipated later in 2025. The full publication can be accessed here. -Ends- Contacts Memo Therapeutics AG info@ ICR Healthcare Amber Fennell, Ashley Tapp memotx@ +44 (0)20 3709 5700 About Memo Therapeutics AGMemo Therapeutics AG ('MTx') is a late-stage biotech company translating unique human immune responses into superior medicines through the development of best-in-class antibodies to treat viral infections and cancer. The Company's lead program, potravitug, is in Phase II development targeting BK viremia in kidney transplant recipients, an infection which can result in decreased kidney functionality and longevity and reduced patient survival. Potravitug has the potential to become a first-in-class BKV disease-modifying therapy for kidney transplant patients with a market potential of up to $2bn. Alongside potravitug, MTx is focused on discovering novel oncology targets. Underpinning MTx's core assets is its proprietary DROPZYLLA® technology, an antibody repertoire copying engine with high-throughput screening capabilities. MTx is a private company located in Schlieren / Zurich and backed by investors including Ysios Capital, Kurma Partners, Pureos Bioventures, Swisscanto, Vesalius Biocapital and Adjuvant Capital. Learn more at and on in to access your portfolio
Associated Press
11-06-2025
- Health
- Associated Press
Memo Therapeutics AG Publishes Study in Frontiers in Pharmacology Demonstrating Therapeutic Antibody Transcytosis Across the Kidney Barrier After Intravenous Administration
Schlieren / Zurich, Switzerland, 11 June, 2025 – Memo Therapeutics AG (or 'MTx'), a late-stage biotechnology company developing antibody-based therapies for viral infections and cancer, has published a study in Frontiers in Pharmacology detailing the transport of therapeutic IgG1 antibodies across the kidney endothelial barrier. This quantitative analysis provides a scientific basis for the selected dosing strategy of MTx's highly potent human anti-BKV IgG1 therapeutic antibody, potravitug, currently in Phase II clinical development. The study reports that, 0.015% (median) of the serum concentration of therapeutic antibody rituximab is found in the urine, with levels reaching up to 4.2%. These findings suggest that therapeutic IgG antibodies can cross the kidney filtration barrier in measurable amounts, challenging prior assumptions about size-exclusion limitations and supporting the feasibility of antibody-based interventions for renal infections. Christoph Esslinger, CSO of MTx, commented: 'This data reinforces the notion that potravitug can access infected renal tissue and supports the continued development of this first-in-class candidate for the treatment of BK viremia in kidney transplant recipients.' BKV nephropathy affects up to 70% of kidney transplant recipients with established BK viremia and is associated with compromised graft function and reduced long-term graft survival. Despite this, therapeutic options remain limited, partly due to the prevailing belief that large-molecule biologics cannot effectively penetrate kidney tissue. This study contributes to a growing body of evidence suggesting otherwise. MTx is currently conducting a Phase II double-blind, randomized, placebo-controlled trial with 90 patients in the USA for the treatment of BK viremia in kidney transplant recipients, with top line results anticipated later in 2025. The full publication can be accessed here. -Ends- About Memo Therapeutics AG Memo Therapeutics AG ('MTx') is a late-stage biotech company translating unique human immune responses into superior medicines through the development of best-in-class antibodies to treat viral infections and cancer. The Company's lead program, potravitug, is in Phase II development targeting BK viremia in kidney transplant recipients, an infection which can result in decreased kidney functionality and longevity and reduced patient survival. Potravitug has the potential to become a first-in-class BKV disease-modifying therapy for kidney transplant patients with a market potential of up to $2bn. Alongside potravitug, MTx is focused on discovering novel oncology targets. Underpinning MTx's core assets is its proprietary DROPZYLLA® technology, an antibody repertoire copying engine with high-throughput screening capabilities. MTx is a private company located in Schlieren / Zurich and backed by investors including Ysios Capital, Kurma Partners, Pureos Bioventures, Swisscanto, Vesalius Biocapital and Adjuvant Capital. Learn more at and on LinkedIn.
Business Wire
28-05-2025
- Health
- Business Wire
Resolve Therapeutics and Duke Medical School Initiate Observational Study of Cell-free RNA in Polytrauma Patients
MIAMI--(BUSINESS WIRE)--Resolve Therapeutics, a leader in the emerging field of cell-free nucleic acid therapeutics, today announced a collaboration with the Department of Surgery, Duke University School of Medicine to analyze the role of cell-free RNA (cfRNA) in polytrauma A significant number of trauma patients admitted to the hospital each year suffer from polytrauma, with multiple, life-threatening injuries requiring immediate surgical intervention. Many of these patients experience poor clinical outcomes due to Systemic Inflammatory Response Syndrome (SIRS). The mechanism of SIRS in polytrauma patients is not completely understood but the current view holds that that massive tissue injury results in the release of large amounts of RNA into the blood overwhelming the activity of circulating RNase, which protects cells from the inflammatory effects of cfRNA under normal circumstances. The accumulating cfRNA activates several key mechanisms driving local and systemic inflammation which leads to increased morbidity and mortality. 'Preventing systemic inflammation in polytrauma would be a large step forward in the treatment paradigm for these patients,' said Allan D. Kirk, MD, PhD, Chair of the Department of Surgery at Duke University. Share Working closely with the world's foremost trauma surgeons at Duke University, Resolve and Duke will conduct an observational study to analyze the presence, structure, and drug targeting of cfRNA in a selected population of polytrauma patients. Based on the results of this work, a proof-of-concept clinical trial with RSLV-132 (a fully human, catalytically active, RNase Fc fusion protein) may be undertaken seeking to improve clinical outcomes for polytrauma patients by removing circulating inflammatory nucleic acids. 'We are thrilled to work with the world class physician scientists within the Duke University School of Medicine and are hopeful our work together may lead to an improvement in the outcome for patients with polytrauma,' commented Dr. James Posada chief executive officer of Resolve Therapeutics. 'Duke Surgery offers a unique environment, coupling state of the art patient care with basic research expertise and infrastructure to enable systematic molecular analysis of plasma-borne inflammatory nucleic acids.' 'Preventing systemic inflammation in polytrauma would be a large step forward in the treatment paradigm for these patients,' said Allan D. Kirk, MD, PhD, Chair of the Department of Surgery at Duke University. 'We look forward to the collaboration with Resolve and learning more about the underlying mechanisms of inflammation in critically injured patients,' he added. About RSLV-132 RSLV-132 is a safe, fully-human, non-immunosuppressive, non-immunogenic, biologic drug with a three-week serum half-life. The drug is comprised of catalytically active human RNase fused to an engineered Fc region of human IgG1. It is designed to remain in circulation and digest extracellular pathogenic RNA in diseases where the presence of cfRNA drives the inflammatory process. RSLV-132 has proven safe in five clinical trials and has demonstrated improvement in autoimmune symptoms in phase 2 clinical trials in both systemic lupus erythematosus and Sjogren's syndrome. About Resolve Therapeutics Resolve is a biopharmaceutical company at the forefront of the emerging field of cell-free nucleic acids in disease. We are developing RSLV-132 and RSLV-145 in a broad range of acute and chronic diseases that are driven by cell-free RNA, cell-free DNA, and Neutrophil Extracellular Traps (NETs). For more information or to discuss our programs please visit:
