Pemgarda (pemivibart) / Invivyd - LARVOL DELTA

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

Immunobridging for Pemivibart, a Monoclonal Antibody for Prevention of Covid-19. (PubMed, N Engl J Med) - No abstract available

Journal • Infectious Disease • Novel Coronavirus Disease

2024 Clinical Practice Guideline Update by the Infectious Diseases Society of America on the Management of COVID-19: Anti-SARS-CoV-2 Neutralizing Antibody Pemivibart for Pre-exposure Prophylaxis. (PubMed, Clin Infect Dis) - "The recommendation is based on evidence derived from a systematic review and adheres 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. Information on pemivibart is included in the U.S. Food and Drug Administration Emergency Use Authorization for this agent."

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

Escape of SARS-CoV-2 Variants KP.1.1, LB.1, and KP3.3 From Approved Monoclonal Antibodies. (PubMed, Pathog Immun) - "AZD3152/Sipavibart neutralized JN.1.1 but lost antiviral efficacy against KP.1.1, LB.1, and KP3.3. Our results highlight the need for a close clinical monitoring of VYD222/Pemivibart and raise concerns about the clinical efficacy of AZD3152/Sipavibart."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Results from a Phase 1 First in Human Study of Pemivibart: An Extended Half-Life Monoclonal Antibody (mAb) (IDWeek 2024) - No abstract available

P1 data • Infectious Disease • Novel Coronavirus Disease

Pharmacokinetics (PK) and Serum Virus Neutralizing Antibody (sVNA) Titers Following the 2nd dose of Pemivibart in the Phase 3 CANOPY Trial (IDWeek 2024) - No abstract available

P3 data • PK/PD data • Infectious Disease • Novel Coronavirus Disease

Clinical Efficacy Endpoints from the Phase 3 CANOPY Study Evaluating Pemivibart (IDWeek 2024) - No abstract available

Clinical • P3 data • Human Immunodeficiency Virus • Infectious Disease • Novel Coronavirus Disease

New Guidance Helps Clinicians Use Pemivibart to Protect Immunocompromised Patients From COVID-19. (PubMed, JAMA) - No abstract available

Journal • Infectious Disease • Novel Coronavirus Disease

A phase 3 study to evaluate efficacy and safety of VYD222, an IgG1 monoclonal antibody for prevention of COVID-19 (CANOPY): Subset analysis of participants with significant immune compromise in the setting of solid tumor or hematologic malignancies. (ASCO 2024) - P3 | "VYD222 4500 mg IV was well tolerated in a subset of adult participants with solid tumor or hematologic malignancies. VYD222 produced high calculated sVNA titer levels against SARS-CoV-2 variants of interest."

Clinical • P3 data • Cardiovascular • Chronic Lymphocytic Leukemia • Fatigue • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease • Oncology • Respiratory Diseases • Solid Tumor

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of the Monoclonal Antibody VYD222 in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Invivyd, Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

Invivyd to Present Data at 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and 2024 American Transplant Congress (ATC) (GlobeNewswire) - "Invivyd, Inc...announced that it will present preliminary, subset analyses from the CANOPY Phase 3 clinical trial of VYD222 (pemivibart) for pre-exposure prophylaxis of COVID-19 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and at the 2024 American Transplant Congress (ATC)."

P3 data • Hematological Malignancies • Oncology • Solid Tumor

Preliminary Results for Solid Organ Transplant Patients Enrolled in CANOPY, a Phase 3 Study to Evaluate Efficacy and Safety of VYD222, an IgG1 Monoclonal Antibody for Prevention of COVID-19 (ATC 2024) - P2/3 | "VYD222 is a re-engineered version of adintrevimab, an Fc-modified mAb that has a robust safety data package and demonstrated clinically meaningful results in Phase 2/3 clinical trials for both treatment and prevention of COVID-19 (NCT04805671, NCT04859517).* CANOPY included 2 cohorts. A single dose of VYD222 4500 mg IV was well tolerated in a subset of adult solid organ transplant recipients including those on active therapy post-transplant."

Clinical • P3 data • P3 data: top line • Back Pain • Cardiovascular • Infectious Disease • Movement Disorders • Musculoskeletal Pain • Novel Coronavirus Disease • Pain • Respiratory Diseases • Solid Organ Transplantation • Transplantation

An update on the anti-Spike monoclonal antibody pipeline for SARS-CoV-2. (PubMed, Clin Microbiol Infect) - "The anti-Spike monoclonal antibody clinical pipeline is currently limited to few agents (most being single antibodies) with unknown efficacy against the dominant JN.1 sublineage. The field of antibody-based therapies requires boosting by both manufacturers and institutions."

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

In vitro neutralisation of VYD222 against Omicron sublineages (ECCMID 2024) - No abstract available

Preclinical • Infectious Disease • Novel Coronavirus Disease