COVID-HIG / CSL Behring, Emergent Biosolutions, Mount Sinai, ImmunoTek, Takeda, Grifols - LARVOL DELTA

Safety, Tolerability, and Pharmacokinetics of Anti-SARS-CoV-2 Immunoglobulin Intravenous (Human) Investigational Product (COVID-HIGIV) in Healthy Adults: a Randomized, Controlled, Double-Blinded, Phase 1 Study. (PubMed, Antimicrob Agents Chemother) - "The half-life of COVID-HIGIV per dose level was 24 d (583 h), 31 d (753 h), and 26 d (619 h) for the 100 mg/kg, 200 mg/kg, and 400 mg/kg groups, respectively. The safety and pharmacokinetics of COVID-HIGIV support its development as a single-dose regimen for postexposure prophylaxis or treatment of COVID-19."

Journal • P1 data • PK/PD data • Allergy • Immunology • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases

Pharmacokinetic and Pharmacodynamic Effects of Polyclonal Antibodies against SARS-CoV2 in Mice. (PubMed, Viruses) - "AUC increased and mean residence time, T, and Vd reduced in infected animals compared to healthy animals. These data suggest that COVID-HIGIV may be an effective treatment for SARS-CoV-2 infection when given early after exposure."

Journal • PK/PD data • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

INSIGHT12: Safety and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Outpatients in Early Stages of COVID-19 (clinicaltrials.gov) - P3; N=820; Recruiting; Sponsor: University of Minnesota; Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Efficacy of COVID-HIGIV in animal models of SARS-CoV-2 infection. (PubMed, Sci Rep) - P3 | "It has caused millions of hospitalizations and deaths, despite the use of COVID-19 vaccines. In hamsters, COVID-HIGIV treatment reduced infection-associated lung pathology including lung inflammation, and pneumocyte hypertrophy in the lungs. These results support ongoing trials for outpatient treatment with COVID-HIGIV for safety and efficacy evaluation (NCT04910269, NCT04546581)."

Journal • Preclinical • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

A COVID-19 Study to Evaluate Safety and PK of COVID-HIG Administered Through IM, SC, or IV Routes as a Single Dose Regimen to SARS-CoV-2 Uninfected Adults (clinicaltrials.gov) - P1 | N=23 | Completed | Sponsor: Emergent BioSolutions | Recruiting ➔ Completed | N=36 ➔ 23

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

A COVID-19 Study to Evaluate Safety and PK of COVID-HIG Administered Through IM, SC, or IV Routes as a Single Dose Regimen to SARS-CoV-2 Uninfected Adults (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: Emergent BioSolutions; Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

A Study to Evaluate Safety and PK of COVID-HIG Administered Through IM, SC, or IV Routes as a Single Dose Regimen to SARS-CoV-2 Uninfected Adults (clinicaltrials.gov) - P1; N=36; Not yet recruiting; Sponsor: Emergent BioSolutions

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A COVID-19 Study to Evaluate Safety and Pharmacokinetics of COVID-HIGIV Administered in Healthy Adults (clinicaltrials.gov) - P1; N=28; Completed; Sponsor: Emergent BioSolutions; Active, not recruiting ➔ Completed

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

Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC) (clinicaltrials.gov) - P3; N=593; Completed; Sponsor: University of Minnesota; Active, not recruiting ➔ Completed

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

A COVID-19 Study to Evaluate Safety and Pharmacokinetics of COVID-HIGIV Administered in Healthy Adults (clinicaltrials.gov) - P1; N=28; Active, not recruiting; Sponsor: Emergent BioSolutions; Recruiting ➔ Active, not recruiting; N=56 ➔ 28

Clinical • Enrollment change • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Emergent BioSolutions and Mount Sinai Health System Announce Initiation of DOD-Funded Clinical Program to Evaluate COVID-19 Human Hyperimmune Globulin (COVID-HIG) Product Candidate for Prophylaxis (GlobeNewswire) - "Emergent BioSolutions (NYSE: EBS) and Mount Sinai Health System today announced initiation of the clinical program to evaluate Emergent’s COVID-19 Human Hyperimmune Globulin (COVID-HIG) product candidate in the first of two Phase 1 studies...The first study will evaluate safety and pharmacokinetics of three dose levels administered as a single or repeat IV dose in healthy adults. The second study, once initiated, will evaluate safety, pharmacokinetics, and pharmacodynamics of two dose levels administered as a single IV dose...The clinical research program, including a planned Phase 2 study, is designed to assess whether prophylaxis with COVID-HIG could help protect individuals following high-risk exposure to SARS-CoV-2."

New P1 trial • New P2 trial • Trial status • Infectious Disease • Novel Coronavirus Disease

Safety and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Outpatients in Early Stages of COVID-19 (clinicaltrials.gov) - P3; N=820; Not yet recruiting; Sponsor: University of Minnesota

Clinical • New P3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Grifols starts production of its hyperimmune immunoglobulin as a potential passive immune therapy against Covid-19 (PRNewswire) - "Grifols...today announced the start of production of its anti-SARS-CoV-2 hyperimmune immunoglobulin....The first doses are expected to be available in July 2020 as part of a clinical trial....Grifols is moving forward with its clinical trial in Spain to assess the effectiveness of high-dose intravenous immunoglobulin....Trial aims to assess the action of neutralizing antibodies...as well as determine the immunomodulatory potential..."

Commercial • Cytokine storm • New trial • Infectious Disease • Novel Coronavirus Disease

Grifols delivers first manufactured batches of its anti-SARS-CoV-2 hyperimmune globulin for clinical trials (PRNewswire) - "Grifols...today announced it has delivered the first manufactured batches of its anti-SARS-CoV-2 hyperimmune globulin for clinical trials....The therapy...will undergo clinical trials this summer to test its safety and efficacy....The efforts form part of a collaboration agreement with U.S. government entities, including the Food and Drug Administration (FDA), the National Institutes of Health (NIH) and the Biomedical Advanced Research Development Authority....In addition to clinical trials in the U.S., Grifols is working on a European clinical trial of a hyperimmune globulin using convalescent plasma collected in Europe."

Commercial • Licensing / partnership • New trial • Infectious Disease • Novel Coronavirus Disease

Emergent BioSolutions Announces Topline Data from NIAID Phase 3 ITAC Trial (INSIGHT-013) Evaluating Immunoglobulins as a Treatment for Hospitalized Patients with COVID-19 (PRNewswire) - P3, N=593; ITAC (NCT04546581); "Topline data from the ITAC trial demonstrated that the addition of anti-SARS-CoV-2 hyperimmunoglobulin to standard of care, inclusive of remdesivir, for hospitalized adult COVID-19 patients with symptoms for less than 12 days did not provide clinical benefit when compared to standard of care plus placebo. There were no serious safety concerns identified."

P3 data: top line • Infectious Disease • Novel Coronavirus Disease

Inpatient Treatment With Anti-Coronavirus Immunoglobulin (ITAC) (clinicaltrials.gov) - P3; N=593; Active, not recruiting; Sponsor: University of Minnesota; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Phase 1 Study to Evaluate Safety and Pharmacokinetics of COVID-HIGIV Administered as a Single Dose or a Repeat Dose in Healthy Adults (clinicaltrials.gov) - P1; N=56; Recruiting; Sponsor: Emergent BioSolutions

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Emergent BioSolutions’ COVID-19 Human Immune Globulin Product Candidate to be Included in NIH-Sponsored Phase 3 Clinical Trial of Hyperimmune Intravenous Immunoglobulin to Treat COVID-19 (GlobeNewswire) - "Emergent is planning additional clinical trials to evaluate COVID-HIG for potential use in other patient populations or individuals at high risk of exposure; Emergent BioSolutions Inc....today announced the initiation of the Phase 3 clinical trial that will evaluate plasma-derived therapy COVID-HIG....Emergent’s COVID-HIG is being developed as a potential treatment for hospitalized patients as well as high-risk, acute symptomatic patients with $14.5 million in funding....COVID-HIG will also be evaluated as a potential post-exposure prophylaxis (PEP) therapeutic in populations at high risk of exposure to SARS-CoV-2..."

Trial status • Infectious Disease • Novel Coronavirus Disease

Mount Sinai Health System, Emergent BioSolutions, and ImmunoTek Bio Centers Form Collaboration to Develop Emergent’s COVID-19 Hyperimmune Globulin (COVID-HIG) Product Candidate with U.S. Department of Defense Funding (GlobeNewswire) - "The Mount Sinai Health System, Emergent BioSolutions...and ImmunoTek Bio Centers today announced that they will collaborate to develop, manufacture, and conduct clinical trials to evaluate Emergent’s COVID-19 hyperimmune globulin product, COVID-HIG, including a post-exposure prophylaxis (PEP) study on health care providers...with $34.6 million in funding from the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND)....Emergent will support ImmunoTek and Mount Sinai in other regulatory and compliance efforts..."

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease

Newly added product (Clinical Trials Arena) - Preclinical, Novel Coronavirus Disease

Pipeline update