Pemgarda (pemivibart) / Invivyd - LARVOL DELTA

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

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

Safety and Efficacy of Pemivibart, a Long-Acting Monoclonal Antibody, for Prevention of Symptomatic COVID-19: Interim Results From a Phase 3 Randomized Clinical Trial (CANOPY). (PubMed, Clin Infect Dis) - P3 | "Pemivibart provided prophylactic efficacy against COVID-19 and was well-tolerated by most participants. Anaphylaxis was an important safety risk."

Clinical • Journal • P3 data • P3 data: top line • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Cross-reactive sarbecovirus antibodies induced by mosaic RBD nanoparticles. (PubMed, Proc Natl Acad Sci U S A) - "Here, we describe neutralizing mAbs isolated from mosaic-8b-immunized rabbits, some on par with Pemgarda, the only currently FDA-approved therapeutic mAb...Rabbit mAbs included critical D-gene segment RBD-recognizing features in common with human anti-RBD mAbs, despite rabbit genomes lacking an equivalent human D-gene segment, thus demonstrating that the immune systems of humans and other mammals can utilize different antibody gene segments to arrive at similar modes of antigen recognition. These results suggest that animal models can be used to elicit anti-RBD mAbs with similar properties to those raised in humans, which can then be humanized for therapeutic use, and that mosaic RBD nanoparticle immunization coupled with multiplexed screening represents an efficient way to generate and select broadly cross-reactive therapeutic pan-sarbecovirus and pan-SARS-CoV-2 variant mAbs."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Invivyd Announces Continued Neutralizing Activity of PEMGARDA (pemivibart) Against Currently Dominant SARS-CoV-2 Variant LP.8.1 (GlobeNewswire) - "New in vitro neutralization data show continued, consistent neutralizing activity of PEMGARDA (pemivibart) against LP.8.1; Centers for Disease Control reports LP.8.1, XEC and KP.3.1.1 together constitute the majority of current national SARS-CoV-2 variants; current dominant variants are all susceptible to PEMGARDA; Pemivibart antiviral activity remains within the range of expected assay variability since Omicron BA.2; affirms structural biology within Invivyd’s unique technology and reflects consistently stable epitope for pemivibart; VYD2311 also demonstrates stable epitope and clinically meaningful in vitro neutralization against LP.8.1; Data provided to U.S. FDA, with update to PEMGARDA Fact Sheet for Healthcare Providers anticipated..."

Preclinical • Novel Coronavirus Disease

SA55 broadly neutralizes SARS-CoV-2 and robustly prevents viral escape by JN.1 sublineages. (PubMed, bioRxiv) - "Moreover, an immunobridging analysis suggests that SA55 may have superior clinical efficacy to pemivibart in preventing SARS-CoV-2 infection under the current variant landscape. Together, this work highlights the promise of SA55 as a potential therapeutic option in the prevention and treatment of COVID-19, especially in immunocompromised populations."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

FDA Declined Invivyd’s Request to Expand Existing Emergency Use Authorization of PEMGARDA (pemivibart) to Include Treatment of Mild-to-Moderate COVID-19 For Immunocompromised Persons Who Have No Alternative Therapeutic Options; No Change to the Existing PEMGARDA EUA for Pre-Exposure Prophylaxis of COVID-19 in Certain Immunocompromised Patients (GlobeNewswire) - "Invivyd, Inc...today announced that Invivyd’s request to expand the existing emergency use authorization (EUA) for pre-exposure prophylaxis of COVID-19 EUA for PEMGARDA (pemivibart) to provide a treatment option for mild-to-moderate COVID-19 in adults and adolescents who have moderate-to-severe immune compromise due to certain medical conditions such as cancer and organ transplant, and for whom alternative COVID-19 treatment options are not accessible or clinically appropriate, was declined by the U.S. Food and Drug Administration (FDA)...Invivyd plans in the near term to share detailed data and regulatory correspondence regarding pemivibart, VYD2311 and immunobridging of COVID-19 antibodies..."

FDA event • Infectious Disease • Novel Coronavirus Disease

The Therapeutic Monoclonal Antibody Pemivibart Causes Persistent Interference in Immunofixation Electrophoresis. (PubMed, J Appl Lab Med) - No abstract available

Journal

Invivyd Announces Preliminary Fourth Quarter 2024 Financial Results, Strong Revenue Growth, and Reiterates Goal of Near-Term Profitability (GlobeNewswire) - "Based on currently available information, the company is announcing preliminary Q4 2024 PEMGARDA (pemivibart) net product revenue of $13.8 million, representing a 48% increase over Q3 2024 net product revenue of $9.3 million."

Commercial • Novel Coronavirus Disease

A Phase 3 Study to Evaluate Efficacy and Safety of Pemivibart, an IgG1 Monoclonal Antibody for Prevention of COVID-19 (CANOPY): Subset Analysis of Participants with Chronic Lymphocytic Leukemia (TCT-ASTCT-CIBMTR 2025) - P3 | "Nine participants (31.0%) were receiving antineoplastic agents including venetoclax (n = 3), acalabrutinib (n =2), and ibrutinib (n = 2). Conclusions : Pemivibart was well tolerated in a subset of adult participants with CLL. No participants developed COVID-19 in the 6 months following administration of pemivibart."

Clinical • P3 data • Cardiovascular • Chronic Lymphocytic Leukemia • Fatigue • Hematological Malignancies • Infectious Disease • Leukemia • Novel Coronavirus Disease • Oncology • Pain • Respiratory Diseases

Invivyd Provides Another Positive SARS-CoV-2 Variant Data Analysis to Satisfy U.S. FDA’s Gating Request for Completing Its Review of EUA Request for PEMGARDA (pemivibart) for the Treatment of Mild-to-Moderate COVID-19 in Certain Immunocompromised Patients (GlobeNewswire) - "Invivyd, Inc...today announced the submission to the U.S. Food and Drug Administration (FDA) of an updated immunobridging analysis of pemivibart as ongoing support of a potential amendment to the Emergency Use Authorization (EUA) for pemivibart...This updated treatment immunobridging analysis, incorporating dominant SARS-CoV-2 variant XEC neutralization data, is similar to the approach and data that supported the PEMGARDA PrEP EUA...The comparison between pemivibart and adintrevimab illustrates serum virus neutralizing antibody (sVNA) titers, the clinical measure of antiviral activity, conferred by pemivibart substantially exceed those of adintrevimab for the first four days post dosing, after which titers fall modestly below."

FDA event • Infectious Disease • Novel Coronavirus Disease

Cross-reactive sarbecovirus antibodies induced by mosaic RBD-nanoparticles. (PubMed, bioRxiv) - "Here, we describe neutralizing mAbs from mosaic-8b-immunized rabbits, some on par with Pemgarda (the only currently FDA-approved therapeutic mAb)...Rabbit mAbs included critical D-gene segment features in common with human anti-RBD mAbs, despite rabbit genomes lacking an equivalent human D-gene segment. Thus, mosaic RBD-nanoparticle immunization coupled with multiplexed screening represent an efficient way to generate and select therapeutic pan-sarbecovirus and pan-SARS-2 variant mAbs."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Investigate the Prevention of COVID-19 WithVYD222 in Adults with Immune Compromise and in Participants Aged 12 Years or Older Who Are At Risk of Exposure to SARS-CoV-2 (clinicaltrials.gov) - P3 | N=790 | Completed | Sponsor: Invivyd, Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Activity of Research-Grade Pemivibart against Recent SARS-CoV-2 JN.1 Sublineages. (PubMed, N Engl J Med) - No abstract available

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases