COVID-2019 immune globulins - Emergent BioSolutions
Alternative Names: Anti-coronavirus hIVIG - Emergent BioSolutions; Anti-coronavirus hyperimmune intravenous immunoglobulin - Emergent BioSolutions; Anti-SARS-CoV-2 immune globulin intravenous (Human) - Emergent BioSolutions; COVID-HIG - Emergent BioSolutions; NP-028Latest Information Update: 28 Jan 2024
At a glance
- Originator Emergent BioSolutions
- Developer Emergent BioSolutions; National Institute of Allergy and Infectious Diseases
- Class Antivirals; Immunoglobulins; Polyclonal antibodies
- Mechanism of Action Immunomodulators
-
Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Phase III COVID 2019 infections
Most Recent Events
- 28 Jan 2024 No recent reports of development identified for phase-I development in COVID-2019-infections(Prevention, In volunteers) in USA (IV, Infusion)
- 31 May 2022 Emergent BioSolutions completes a phase I trial in Healthy volunteers in USA (IV, IM, SC) (NCT05142306)
- 07 Dec 2021 Emergent BioSolutions initiates enrolment in a phase-I trial for COVID-2019 infections (In volunteers) in USA (IV) (NCT05142306)
Development Overview
Introduction
Purified gamma globulin (IgG), containing polyclonal antibodies, designated as COVID HIG, is being developed by Emergent BioSolutions, for the treatment and prevention of severe COVID-2019 infections. The company has utilised its hyperimmune platform, which allows the isolation of purified gamma globulin containing polyclonal antibodies to specific antigens of SARS-CoV-2 from humans. Hyperimmunes are polyclonal antibodies derived from plasma that leverage the immune response in human and can provide protection from infection. Clinical development is underway in the UK, Mexico and the US. Clinical development for the prevention of COVID-2019 infections is underway in the US.
As at January 2024, no recent reports of development had been identified for phase-I development in COVID-2019-infections (Prevention, In volunteers) in USA (IV, Infusion).
Company Agreements
In July 2020, Emergent BioSolutions, ImmunoTek Bio Centers and Mount Sinai Health System entered into a reserch and development agreement to develop, manufacture, and conduct clinical trials to evaluate Emergent’s COVID-2019 immune globulins (COVID HIG), including a post-exposure prophylaxis (PEP) study on health care providers at high risk of COVID-2019 infections, with $US34.6 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). Under the terms of agreement, the collaborators will establish plasma collection capabilities at Mount Sinai through an extension of ImmunoTek’s FDA-approved establishment license and the transfer of technical know-how to Mount Sinai. Plasma from recovered donors will support the development and manufacture of COVID-2019 immune globulins for evaluation of the product candidate in clinical trials, and for potential emergency use or broader patient use as allowed by the US FDA. The JPEO-CBRND will collaborate with Emergent to collect convalescent plasma to manufacture COVID HIG for use in a clinical study under a potential Expanded Access Programme to support military personnel. In turn, Emergent will support ImmunoTek and Mount Sinai in other regulatory and compliance efforts related to plasma collection and supply, as well as activities leading up to an Investigational New Drug application submission to the US FDA. [1]
Key Development Milestones
As of March 2022, COVID HIG has been provided under emergency Investigational New Drug (IND) to treat hospitalized patients in need [2] .
In August 2021, the University of Minnesota in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) initiated the phase III Outpatient Treatment with Anti-Coronavirus Immunoglobulin (OTAC), trial to evaluate the safety and efficacy of anti-coronavirus hyperimmune intravenous immunoglobulin in patients with COVID-2019 infections (NCT04910269; INSIGHT12; INSIGHT012). The multicenter, randomised, double-blind, placebo-controlled trial will enrol approximately 820 patients in the US [3] .
In September 2020, the University of Minnesota, the National Institute of Allergy and Infectious Diseases (NIAID), and the National Institutes of Health (NIH), initiated a phase III ITAC trial to evaluate the safety, tolerability and efficacy of anti-coronavirus hyperimmune intravenous immunoglobulin (hIVIG) versus placebo, along with remdesivir [see adis profile 800043325] as standard of care, in adult patients hospitalised for COVID-19 and have had symptoms for 12 days or fewer without life-threatening organ dysfunction or end-organ failure (INSIGHT013; EudraCT2020-002542-16; INSIGHT 013; NCT04546581). The Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) trial is a double-blind, placebo-controlled, randomised, adaptive and enrolling approximately 500 patients in the US, Mexico, the UK and 15 other countries in Africa, Asia, Europe, North America and South America. The primary outcome of the trial is to compare the health status of participants in each group on day seven, based on an ordinal outcome with seven mutually exclusive categories ranging from no limiting symptoms due to COVID-19, to death [4] . Emergent BioSolutions, Grifols [see adis profile 800057941] and, CSL Behring with Takeda [see adis profile 800057734] will provide anti-coronavirus hIVIG for the trial. In October 2020, NIAID announced that primary analysis was planned after all participants finish 28 days of follow-up. An independent data and safety monitoring board (DSMB) will review interim safety and efficacy data to ensure patient well-being and safety as well as study integrity. In April 2021, Emergent BioSolutions announced topline data from the study whereby anti-coronavirus hyperimmune intravenous immunoglobulin (hIVIG) did not provide clinical benefit when compared to standard of care plus placebo [5] [6] [7] .
In August 2020, the Investigational New Drug (IND) application to enable use of COVID-HIG in the ITAC study received approval from the US FDA. The IND supported the use of COVID-HIG in NIAID’s current ITAC trial and will also support the additional treatment and PEP indications to be investigated in future clinical studies [6] .
In May 2022, Emergent BioSolutions completed a phase I trial that evaluated the safety and pharmacokinetics of COVID-HIG administered through intramuscular, subcutaneous and intravenous routes in healthy volunteers (NCT05142306; EBS-CVH-006). The open-label, randomised was initiated in December 2021 and enrolled 23 volunteers in the US [8] .
In December 2020, Emergent BioSolutions initiated the U.S. Department of Defense’s (DOD) funded clinical program for COVID HIG. The program included two phase I trials for the prevention of COVID-19 infection. The first study assess the safety and pharmacokinetics of three dose levels of COVID HIG administered as a single or repeat IV dose in healthy adults. The second study, evaluate the safety, pharmacokinetics, and pharmacodynamics of two dose levels administered as a single IV dose to adults with SARS-CoV-2 infection [9] .
As of May 2020, Emergent BioSolutions is conducting preclinical trials of COVID HIG, for the prevention and treatment of severe COVID-2019 infections (Emergent BioSolutions pipeline, May 2020).
In March 2020, Emergent BioSolutions reported initiation of plasma collection from humans in order to isolate and manufacture antibodies against SARS-CoV-2 virus [10] .
Financing information
As of October 2020, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, was sponsoring and funding the phase III ITAC trial [see above] [7] .
In July 2020, Emergent solutions received $US34.6 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) to support development of COVID-2019 immune globulins [1] .
In April 2020, Emergent solutions received $US14.5 million from the Biomedical Advanced Research and Development Authority (BARDA) to support development of COVID-2019 immune globulins [11] .
Drug Properties & Chemical Synopsis
- Route of administration IM, IV, Parenteral, SC
- Formulation Infusion, unspecified
- Class Antivirals, Immunoglobulins, Polyclonal antibodies
- Mechanism of Action Immunomodulators
-
WHO ATC code
J06B (Immunoglobulins)
-
EPhMRA code
J6H (Specific Immunoglobulins - Antiviral)
Biomarkers Sourced From Trials
Biomarker
| Drug Name | Biomarker Name | Biomarker Function |
|---|---|---|
| COVID-2019 immune globulins - Emergent BioSolutions | C-reactive protein (CRP) | Eligibility Criteria, Outcome Measure |
| D-dimer | Eligibility Criteria | |
| Ferritin | Eligibility Criteria | |
| Interleukin-6 (IL-6) | Eligibility Criteria, Outcome Measure |
Development Status
Summary Table
| Indication | Qualifier | Patient Segment | Phase | Countries | Route / Formulation | Developers | Event Date |
|---|---|---|---|---|---|---|---|
| COVID 2019 infections | - | - | Phase III | Mexico, USA, United Kingdom | IV / Infusion | Emergent BioSolutions, National Institute of Allergy and Infectious Diseases | 08 Oct 2020 |
| COVID 2019 infections | - | In volunteers | Phase I | USA | IM / unspecified | Emergent BioSolutions | 07 Dec 2021 |
| COVID 2019 infections | - | In volunteers | Phase I | USA | SC / unspecified | Emergent BioSolutions | 07 Dec 2021 |
| COVID 2019 infections | - | In volunteers, Prevention | No development reported (I) | USA | IV / Infusion | Emergent BioSolutions | 28 Jan 2024 |
Commercial Information
Involved Organisations
| Organisation | Involvement | Countries |
|---|---|---|
| Emergent BioSolutions | Originator | USA |
| Emergent BioSolutions | Owner | USA |
| Department of defence | Funder | USA |
| Biomedical Advanced Research and Development Authority | Funder | USA |
| Mount Sinai Health System | Collaborator | USA |
| National Institute of Allergy and Infectious Diseases | Collaborator | USA |
| University of Minnesota | Collaborator | USA |
Scientific Summary
Adverse Events
Future Events
| Expected Date | Event Type | Description | Updated |
|---|---|---|---|
| 31 Dec 2020 | Trial Update | Emergent BioSolutions plans a phase II trial for COVID-2019 infections in the third quarter of 2020 (Parenteral) (9298733) [10] | 29 Jul 2020 |
Development History
| Event Date | Update Type | Comment |
|---|---|---|
| 28 Jan 2024 | Phase Change - No development reported | No recent reports of development identified for phase-I development in COVID-2019-infections(Prevention, In volunteers) in USA (IV, Infusion) Updated 28 Jan 2024 |
| 31 May 2022 | Trial Update | Emergent BioSolutions completes a phase I trial in Healthy volunteers in USA (IV, IM, SC) (NCT05142306) Updated 27 Jun 2022 |
| 30 Dec 2021 | Biomarker Update | Biomarkers information updated Updated 01 Jan 2022 |
| 07 Dec 2021 | Trial Update | Emergent BioSolutions initiates enrolment in a phase-I trial for COVID-2019 infections (In volunteers) in USA (IV) (NCT05142306) Updated 07 Mar 2022 |
| 07 Dec 2021 | Phase Change - I | Phase-I clinical trials in COVID-2019 infections (In volunteers) in USA (IM) (NCT05142306) Updated 02 Feb 2022 |
| 07 Dec 2021 | Phase Change - I | Phase-I clinical trials in COVID-2019 infections (In volunteers) in USA (SC) (NCT05142306) Updated 02 Feb 2022 |
| 06 Aug 2021 | Trial Update | University of Minnesota in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) initiates the phase III Outpatient Treatment with Anti-Coronavirus Immunoglobulin (OTAC) trial in COVID-2019 infections in USA (IV, Infusion) (NCT04910269) [3] Updated 27 Aug 2021 |
| 02 Apr 2021 | Scientific Update | Efficacy and adverse events from the phase III trial in COVID-2019 infections released by Emergent BioSolutions [5] Updated 26 Jun 2021 |
| 29 Dec 2020 | Phase Change - I | Phase-I clinical trials in COVID-2019 infections (Prevention, In volunteers) in USA (IV) [9] Updated 03 Jan 2021 |
| 29 Dec 2020 | Trial Update | Emergent BioSolutions initiates enrolment in a phase I pharmacokinetics trial for COVID-2019 infections in USA [9] Updated 03 Jan 2021 |
| 09 Oct 2020 | Trial Update | Emergent BioSolutions also plans a clinical trial for post exposure prevention prophylaxis therapeutic in COVID-2019 infections who are at high risk of exposure [6] Updated 14 Oct 2020 |
| 08 Oct 2020 | Phase Change - III | Phase-III clinical trials in COVID-2019 infections in USA (Parenteral) Updated 15 Oct 2020 |
| 08 Oct 2020 | Phase Change - III | Phase-III clinical trials in COVID-2019 infections in USA and Mexico (IV) [7] (NCT04546581) Updated 15 Oct 2020 |
| 30 Sep 2020 | Phase Change - III | Phase-III clinical trials in COVID-2019 infections in United Kingdom (IV) (EudraCT-2020-002542-16) [6] Updated 14 Oct 2020 |
| 31 Aug 2020 | Regulatory Status | Emergent BioSolutions and National Institute of Allergy and Infectious Diseases receives IND approval from the US FDA for use of COVID-HIG in the ITAC study [6] Updated 14 Oct 2020 |
| 31 Aug 2020 | Regulatory Status | Emergent BioSolutions in collaboration with National Institute of Allergy and Infectious Diseases submits an IND application to the US FDA for ITAC trial before August 2020 [6] Updated 14 Oct 2020 |
| 08 Jul 2020 | Licensing Status | Emergent BioSolutions enters into an agreement with Mount Sinai Health System and ImmunoTek Bio Centers to develop, manufacture, and conduct clinical trials for COVID-2019 immune globulins [1] Updated 13 Jul 2020 |
| 08 Jul 2020 | Regulatory Status | Emergent BioSolutions announces intention to submit IND application to US FDA for COVID-2019 infections [1] Updated 13 Jul 2020 |
| 29 May 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections (Prevention) in USA (Parenteral), prior to May 2020 (Emergent BioSolutions pipeline, May 2020) Updated 29 May 2020 |
| 29 May 2020 | Phase Change - Preclinical | Preclinical trials in COVID-2019 infections in USA (Parenteral), prior to May 2020 (Emergent BioSolutions pipeline, May 2020) Updated 29 May 2020 |
| 03 Apr 2020 | Licensing Status | Emergent solutions receives funding from Biomedical Advanced Research and Development Authority (BARDA) to support development of COVID-2019 immune globulins [11] . Updated 08 Apr 2020 |
| 11 Mar 2020 | Trial Update | Emergent BioSolutions plans a phase II trial for COVID-2019 infections in the third quarter of 2020 (Parenteral) [10] Updated 29 Jul 2020 |
| 11 Mar 2020 | Phase Change | Early research in COVID-2019 infections (Prevention) in USA (Parenteral) [10] Updated 18 Mar 2020 |
| 11 Mar 2020 | Phase Change | Early research in COVID-2019 infections in USA (Parenteral) [10] Updated 18 Mar 2020 |
References
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Mount Sinai Health System, Emergent BioSolutions, and ImmunoTek Bio Centers Form Collaboration to Develop Emergents COVID-19 Hyperimmune Globulin (COVID-HIG) Product Candidate with U.S. Department of Defense Funding.
Media Release -
Emergent BioSolutions updates. Internet-Doc 2022;.
Available from: URL: https://www.sec.gov/ix?doc=/Archives/edgar/data/1367644/000136764422000024/ebs-20211231.htm -
Emergent BioSolutions COVID-19 Human Immune Globulin Product Candidate to be Evaluated in NIH-Sponsored Phase 3 Clinical Trial (INSIGHT-012) of Hyperimmune Intravenous Immunoglobulin for Outpatient Treatment of COVID-19.
Media Release -
An International Multicenter, Adaptive, Randomized Double-Blind, Placebo-Controlled Trial of the Safety, Tolerability and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Hospitalized Patients at Onset of Clinical Progression of COVID-19
ctiprofile -
Emergent BioSolutions Announces Topline Data from NIAID Phase 3 ITAC Trial (INSIGHT-013) Evaluating Immunoglobulins as a Treatment for Hospitalized Patients with COVID-19.
Media Release -
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.
Media Release -
NIH clinical trial testing hyperimmune intravenous immunoglobulin plus remdesivir to treat COVID-19 Begins.
Media Release -
A Phase 1, Open-Label, Randomized Study to Evaluate Safety and Pharmacokinetics of Anti-SARS-CoV-2 Immunoglobulin (Human) Investigational Product (COVID-HIG) Administered Through Intramuscular, Subcutaneous or Intravenous Routes as a Single Dose Regimen to SARS-CoV-2 Uninfected Adults
ctiprofile -
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.
Media Release -
Emergent BioSolutions Initiates Development of Plasma-Derived Product Candidates for the Treatment and Prevention of Coronavirus Disease.
Media Release -
Emergent BioSolutions Partners with U.S. Government for Comprehensive Response to Expedite Development of Plasma-Derived Therapy for COVID-19.
Media Release
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