Pemgarda (pemivibart) / Invivyd - LARVOL DELTA

Real World Experience with Use of Pemivibart for COVID-19 Pre-exposure Prophylaxis in an Ambulatory Cancer Center (IDWeek 2026) - No abstract available

Clinical • Real-world • Real-world evidence • Infectious Disease • Novel Coronavirus Disease

Immunobridging Analysis of Pemivibart for the Treatment of COVID-19: A Therapeutic Gap for the Immune-Compromised Population Remains. (PubMed, Open Forum Infect Dis) - "Complementary methods included the following: (1) strict immunobridging of neutralizing antibody titers of pemivibart to its parent molecule adintrevimab, (2) benchmarking comparison of pemivibart to historical mAbs with demonstrated efficacy in COVID-19 treatment, and (3) dose-response analysis of pemivibart vs comparator mAbs based on a meta-analysis...Neutralizing titers of pemivibart were 4- to 12-fold higher than titers for sotrovimab and less than titers for other historical intravenously administered mAbs throughout a 14-day analysis period...Following a similar approach to prevention, immunobridging was demonstrated for pemivibart for the treatment of COVID-19, suggesting substantial antiviral activity. This development methodology provides a roadmap for accelerating novel COVID-19 treatment options amid a changing variant landscape."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Organoid-based evaluation of SA55 and Pemivibart against evolving SARS-CoV-2 variants. (PubMed, Emerg Microbes Infect) - "Topical administration, which models nasal spray, dramatically suppressed viral replication of BA.5.2 and XFG in organoid models. Our findings evidence the high potency of SA55, supporting its potential for clinical application against emerging SARS-CoV-2 variants."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Cross-neutralization of SARS-CoV-2 BA.3.2.2 lineage by JN.1 mRNA vaccine-induced immunity. (PubMed, Int J Infect Dis) - "AZD3152/sipavibart retained potent neutralization against BA.3.2.2 but completely lost activity against all F456L-harboring JN.1-descendant variants, while VYD222/pemivibart and SA55 maintained broad activity. Retention of wild-type F456 in BA.3.2.2 preserves class 1/2 antibody epitopes, providing a mechanistic basis for cross-neutralization and suggesting a potential therapeutic window for sipavibart should BA.3.2.2 expand globally, pending clinical confirmation."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Pemivibart for Prevention of COVID-19: Subset Analysis of CANOPY Solid Organ Transplant Recipients (ATC 2026) - P3 | "Pemivibart was well tolerated in the CANOPY SOT subset. These data support pemivibart as a preventative option against COVID-19 in this high-risk clinical group."

Clinical • Cardiovascular • Infectious Disease • Movement Disorders • Novel Coronavirus Disease • Respiratory Diseases • Solid Organ Transplantation • Transplantation

Real-World Use and Effectiveness of Pemivibart for the Prevention of COVID-19 Infection in Solid Organ Transplant Recipients: An Analysis Using the Epic Cosmos Database (ATC 2026) - "We did not find lower rates of COVID-19 or COVID-associated hospitalization with the use of pemivibart in SOT recipients. Larger studies evaluating pemivibart are needed to confirm the drug's effectiveness in COVID-19 prevention among the immunocompromised patient population."

Clinical • Real-world • Real-world evidence • Infectious Disease • Novel Coronavirus Disease • Solid Organ Transplantation • Transplantation

Pemivibart for prevention of COVID-19: Subset analysis of CANOPY participants with solid tumor or hematologic malignancies. (ASCO 2026) - P3 | "Pemivibart was well tolerated in the CANOPY Cohort A oncology subset. These data showed limited events overall and no development of symptomatic COVID-19 in the oncology subset through Month 6. Select outcomes through month 6."

Cardiovascular • Hematological Malignancies • Infectious Disease • Oncology • Respiratory Diseases • Solid Tumor

Serum Virus-Neutralizing Antibody Titers in Clinical Trial Participants With and Without Immunocompromise Receiving Pemivibart, a Long-Acting Monoclonal Antibody for COVID-19. (PubMed, J Infect Dis) - "These data show that previous immune experience to earlier pandemic variants provided limited cross-protection and demonstrate that pemivibart increased protective titers against newly circulating SARS-CoV-2 in individuals with and without immunocompromise. Notably, csVNA titers effectively predicted pemivibart's neutralization potential."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

CROI 2026: Acute and Postacute COVID-19. (PubMed, Top Antivir Med) - "Pemivibart administration to people with advanced HIV was well tolerated and associated with good levels of neutralizing antibodies...A blinded study of circulating SARS-CoV-2 antigen found no association between the presence of antigen and the likelihood of having long COVID. Most people with long COVID in a cohort study have experienced stigma or feeling dismissed in interactions with their clinicians."

First-in-human • Journal • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Novel Coronavirus Disease • Renal Disease • Respiratory Diseases

CLO26-086: Pre-Exposure Prophylaxis With Pemivibart in Adults With Hematologic Malignancies: A Single-Center Cohort. (PubMed, J Natl Compr Canc Netw) - No abstract available

Journal • Hematological Disorders • Hematological Malignancies • Oncology

CLO26-086: Pre-Exposure Prophylaxis With Pemivibart in Adults With Hematologic Malignancies: A Single-Center Cohort. (PubMed, J Natl Compr Canc Netw) - No abstract available

Journal • Hematological Disorders • Hematological Malignancies • Oncology

Phase 3 Study to Evaluate Efficacy and Safety of Pemivibart, an IgG1 Monoclonal Antibody, for the Prevention of COVID-19 (CANOPY): Subset Analysis of Participants With Chronic Lymphocytic Leukemia (HOPA 2026) - P3 | "In all, 9 (31%) participants were receiving antineoplastic agents, including venetoclax (n=3), acalabrutinib (n=2), and ibrutinib (n=2). Pemivibart was well tolerated in a subset of adults with CLL. None of the study patients had COVID-19 in the 6 months after the administration of pemivibart."

Clinical • P3 data • Chronic Lymphocytic Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Novel Coronavirus Disease • Respiratory Diseases

Pre-Exposure Prophylaxis With Pemivibart in Adults With Hematologic Malignancies: A Single-Center Cohort (NCCN 2026) - " We included 180 pemivibart recipients; 159 (88.3%) were vaccinated and 90 (50.0%) had prior tixagevimab–cilgavimab. In this real-world single-center cohort, pemivibart pre-exposure prophylaxis was well tolerated and associated with low breakthrough infection rates and no COVID-19–related hospitalizations. These findings support integration of pemivibart into preventive care for adults with blood cancers while variant surveillance and durability studies continue. View Full Size CLO26-086: FIGURE."

Clinical • Cough • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Oncology • Preventive care • Respiratory Diseases • Septic Shock

A Statistical Immune Correlates of Protection Model for Predicting Efficacy from Neutralizing Antibody Titers to Establish Immunobridging of Monoclonal Antibodies for Prevention of COVID-19. (PubMed, Infect Dis Ther) - P3 | "The Cox model enables evaluation of suitable neutralizing titer targets to guide dosing, predict estimated clinical benefit for related mAbs derived from the same platform, and support immunobridging in both immunocompromised and non-immunocompromised populations."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Real-world outcomes following pemivibart for COVID-19 pre-exposure prophylaxis in immunocompromised patients with hematologic malignancies (ASH 2025) - "Pemivibart was well-tolerated in immunocompromised patients with lymphoid malignancies, with a low incidence of adverse reactions and breakthrough infections. No patients on Pemivibart were hospitalized, highlighting the continued importance of layered COVID-19 prevention strategies. Additionally, our observed incidence rate of breakthrough infection was comparable to or superior to that of immunocompromised patients receiving vaccination alone."

Clinical • Real-world • Real-world evidence • Chronic Lymphocytic Leukemia • Hematological Malignancies • Infectious Disease • Novel Coronavirus Disease • Oncology

Pathogenicity, virological features, and immune evasion of SARS-CoV-2 JN.1-derived variants including JN.1.7, KP.2, KP.3, and KP.3.1.1. (PubMed, Nat Commun) - "The unique S31del mutation on KP.3.1.1 spike confers further evasion to the clinically authorized mAb Pemivibart and reduces convalescent serum neutralization efficiency...Overall, our study indicates that a single spike mutation can confer both enhanced immune escape and increased viral infectivity. The opposing effects of spike and non-spike mutations highlight the complex interplay of viral genomic elements in shaping their overall fitness, and reveal the high plasticity of coronavirus evolution."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Exploring the Effects of Pemivibart Monoclonal Antibody Infusion in Long COVID: A Case Series Offering Initial Clinical Insights. (PubMed, Cureus) - "These preliminary findings highlight the need for controlled, biomarker-guided studies to determine efficacy, durability, and patient subgroups most likely to respond. Pemivibart remains authorized only for preexposure prophylaxis in immunocompromised individuals and is not approved for the treatment of PCC."

Journal • Cognitive Disorders • Fatigue • Immunology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Human antibody targeting of coronavirus spike S2 subunit is associated with protection mediated by Fc effector functions. (PubMed, J Virol) - "Though less potent than receptor-binding domain-directed antibodies-approximately 500-fold lower neutralization potency than the emergency use authorized receptor-binding domain (RBD)-directed Pemgarda mAb against wild-type SARS-CoV-2-mAb 1871 provides protective efficacy in a mouse model...Here, we describe a human mAb that targets a conserved epitope in the S2 subunit, demonstrating broad β-CoV binding, sarbecovirus neutralization, and in vivo protection mediated by Fc effector functions in a mouse model. These findings have important implications for pan-β-CoVs therapeutics and vaccine development."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Spike mutations that affect the function and antigenicity of recent KP.3.1.1-like SARS-CoV-2 variants. (PubMed, J Virol) - "Finally, we measure how spike mutations affect neutralization by three clinically relevant SARS-CoV-2 antibodies: VYD222, BD55-1205, and SA55...It also shows the importance of mutations that move the spike's receptor-binding domain up or down. Overall, these results are useful for forecasting viral evolution and assessing which newly emerging variants have reduced recognition by immunity and antibody prophylactics."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Structural and functional analysis of VYD222: a broadly neutralizing antibody against SARS-CoV-2 variants. (PubMed, bioRxiv) - "However, here we describe VYD222 (pemivibart), a human mAb re-engineered from ADG20 (adintrevimab), which maintains potency despite substantial virus evolution. Deep mutational scanning indicates that SARS-CoV-2's ability to escape VYD222 is constrained by structural compatibility and the need to maintain receptor binding. These findings provide crucial insights into the escape-resistant neutralization of VYD222 against a broad panel of clinically relevant SARS-CoV-2 variants and offer valuable guidance for risk assessment of emergent variants."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Spike mutations that affect the function and antigenicity of recent KP.3.1.1-like SARS-CoV-2 variants. (PubMed, bioRxiv) - "Finally, we measure how spike mutations affect neutralization by three clinically relevant SARS-CoV-2 antibodies: VYD222, BD55-1205, and SA55. Overall, these results illuminate the current constraints and pressures shaping SARS-CoV-2 evolution, and can help with efforts to forecast possible future antigenic changes that may impact vaccines or clinical antibodies."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Early Experience with Use of Pemivibart for the Pre-exposure Prophylaxis of Coronavirus Disease 2019 (IDWeek 2025) - No abstract available

Infectious Disease • Novel Coronavirus Disease

2025 Clinical Practice Guideline Update by the Infectious Diseases Society of America on the Treatment and Management of COVID-19: Pemivibart for Pre-exposure Prophylaxis, Vilobelimab for Critical Illness, and Abatacept or Infliximab for Severe or Critical Illness. (PubMed, Clin Infect Dis) - "These recommendations include pre-exposure prophylaxis for immunocompromised persons and treatment of severe or critical COVID-19. The panel's recommendations are based upon evidence derived from systematic literature reviews and adhere to a standardized methodology for rating the certainty of evidence and strength of recommendation according to the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) approach."

Clinical guideline • Journal • Infectious Disease • Novel Coronavirus Disease

Efficacy and Safety of Pemivibart Monoclonal Antibody Prophylaxis in Immunocompromised Transplant Patients: A Retrospective Cohort Study (WTC 2025) - "Pemibivart was well-tolerated in this retrospective cohort of SOT patients, without any significant infusion-related or hypersensitivity reactions, or other adverse events in follow-up. In the 3-month period following pemibivart, 8% developed COVID-19, all when XEC and KP.3.1.1 were the dominant variants. While our cohort was limited in size, these findings add to the body of literature supporting the safety and tolerability of COVID-19 monoclonal antibodies for pre-exposure prophylaxis in immunocompromised patients."

Retrospective data • Fatigue • Immunology • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases • Solid Organ Transplantation • Transplantation

Dynamics of SARS-CoV-2 variants and mutations in Central Sweden between 2023 and 2024 and their potential implications on monoclonal antibodies pemivibart and sipavibart as PrEP in the region. (PubMed, Infect Dis (Lond)) - "The use of sipavibart or pemivibart as PrEP for COVID-19 in the region may currently not be effective unless new SARS-CoV-2 variants appear not containing these resistance mutations. Further, new mAbs under development as PrEP for COVID-19 can be effectively used by routinely sequencing SARS-CoV-2 in patients to identify variants and resistance mutations."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases