Candidates: COVID-HIG and COVID-EIG
Types: Hyperimmune globulin, also known as polyclonal antibodies, is a concentrated antibody product derived from the antibody-rich plasma of people previously infected with and recovered from COVID-19 (COVID-HIG) for severe hospitalized patients and protection for at-risk individuals; Equine-derived polyclonal hyperimmune with antibodies to SARS-CoV-2 (COVID-EIG) for severe hospitalized patients
Status: Emergent said October 8 that it had launched the Phase III Inpatient Treatment with Anti-Coronavirus Immunoglobulin trial (ITAC or INSIGHT-013; (NCT04546581). The trial, sponsored by the NIHs National Institute of Allergy and Immune Diseases (NIAID), is designed to assess the safety, tolerability, and efficacy of placebo, COVID-HIG and three other hyperimmune globulin products, all administered with a background therapy of Gilead Sciences’ Veklury® (remdesivir) in hospitalized patients with COVID-19.
Emergent said it was one of four companies providing hyperimmune globulin products for the trial, set to enroll about 500 patients across U.S. and international clinical trial sites. The company plans additional trials evaluating COVID-HIG for potential use in other patient populations or individuals at high risk of exposure.
In July, Emergent joined The Mount Sinai Health System and ImmunoTek Bio Centers to launch a collaboration aimed at developing, manufacturing, and conducting clinical trials to assess COVID-HIG, including a post-exposure prophylaxis (PEP) study on health care providers at high risk of COVID-19 infection and other high-risk populations. The clinical research program is designed to assess whether COVID-HIG can help protect individuals at high risk of exposure and limit the spread of disease, the partners said.
Work is being funded with $34.6 million awarded by the U.S. Department of Defense (DOD) Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND).
Under the agreement with the JPEO-CBRND, Emergent will collaborate to collect convalescent plasma to manufacture COVID-HIG for use in a clinical study under a potential Expanded Access Program to support military personnel. ImmunoTek has agreed to provide technical, scientific, and industry expertise in plasma collection, and will extend its FDA license as an approved source plasma collection establishment to enable plasma collection onsite at Mount Sinai. ImmunoTek will also provide staff training and compliance information to assist in establishing standard operating procedures and plasma criteria.
The collaborators said they plan to establish plasma collection capabilities at Mount Sinai through an extension of ImmunoTek’s FDA-approved establishment license and the transfer of technical expertise to Mount Sinai. Plasma from recovered donors will support development and manufacture of COVID-HIG for evaluation of the product candidate in clinical trials, as well as for potential emergency use or broader patient use as allowed by the FDA.
Mount Sinai and Emergent said they will evaluate COVID-HIG in a post-exposure prophylaxis study in individuals at high risk of exposure to COVID-19, such as front-line health care workers and military personnel.
In June, Emergent said it had been issued a task order valued at approximately $628 million from the Biomedical Advanced Research and Development Authority (BARDA) toward to deploy its contract development and manufacturing (CDMO) capacities, capabilities, and expertise to support the U.S. government’s Operation Warp Speed effort to accelerate delivery of COVID-19 vaccines.
Emergent agreed to deploy its molecule-to-market CDMO offering, committing manufacturing capacity, valued at approximately $542.7 million, to produce COVID-19 vaccine candidates through 2021—creating for various Emergent partners increased capacity for drug substance manufacturing at the company’s Baltimore Bayview facility and for drug product manufacturing at Emergent’s Baltimore Camden and Rockville, MD, locations. The task order also includes approximately $85.5 million toward rapid expansion of Emergent’s viral and non-viral CDMO drug product fill/finish capacity at Baltimore Camden and Rockville.
The order is being issued under a 2012 contract with BARDA that established Emergent’s Baltimore Bayview facility as a Center for Innovation in Advanced Development and Manufacturing (CIADM) for pandemic preparedness. That partnership is being expanded to include investments in Emergent’s Baltimore Camden and Rockville facilities, in order to create a U.S.-based manufacturing supply chain for pharmaceutical and biotechnology innovators of COVID-19 vaccine candidates.
Emergent said in April that it had initiated development of COVID- HIG, a human plasma-derived product candidate, for which the company subsequently received $14.5 million in funding from the U.S. Department of Health and Human Services (HHS), and a commitment from NIAID to assess COVID-HIG among potential treatments for COVID-19 in severe hospitalized and high-risk patients.
In March, Emergent said it began development of COVID-HIG and COVID-EIG using its hyperimmune platforms. Hyperimmunes are polyclonal antibody therapeutics derived from plasma that leverage the immune response in humans or animals and can provide immediate protection from infection. Emergent said it has initiated plasma collection efforts for both human and equine platforms, with a goal of manufacturing clinical material within the next four to five months in anticipation of beginning a clinical study as early as the third quarter.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: