Candidate: Anti-SARS-CoV-2 hyperimmune globulin therapy
Type: Plasma from convalescent COVID-19 patients with specific antibodies, processed into a hyperimmune immunoglobulin
Status: Grifols said October 9 that its anti-SARS-CoV-2 hyperimmune globulin had started the Phase III Treatment with Anti-Coronavirus Immunoglobulin trial (ITAC; NCT04546581), designed to test its safety, efficacy, and tolerability. The randomized controlled clinical trial will include 500 hospitalized adults with COVID-19 in up to 58 hospitals covering 18 countries including the U.S. and Spain. For the trial, Grifols said, it has collected convalescent plasma from healthy recovered COVID-19 donors in the U.S., using its plasma-center network, and in Spain through a collaboration with blood banks.
The Phase III trial is sponsored and funded by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID).
On June 11, Grifols said that it began production of its anti-SARS-CoV-2 hyperimmune immunoglobulin using the plasma of people who have overcome the disease. Grifols developed the anti-COVID-19 passive immune therapy through a collaboration with the FDA, the NIH, and the Biomedical Advanced Research Development Authority (BARDA), among other healthcare agencies. The agreement also encompassed the development of preclinical and clinical trials required to determine treatment efficacy.
Grifols’ anti-SARS-CoV-2 hyperimmune immunoglobulins are being produced in its Clayton, NC, facility, which has been specifically designed to process specialty immunoglobulins. The company is also working to establish collaborations in Europe.
Two days earlier, North Carolina Gov. Roy Cooper joined Grifols in announcing the company’s plan to add 300 employees to its Clayton workforce as part of a $351.6 million expansion there. Grifols plans to build a specialized blood plasma facility and logistics center at its Johnston County campus.
The announced expansin is the latest for Grifols, which opened a $400 million plasma-fractionation plant in Clayton in 2014 and is building a new, $90 million fractionation facility there that is set to open in 2021. Grifols is also building a $120 million purification and filling facility in Clayton that will mainly produce immune globulin and factor VIII protein therapies. The three-story, 150,000-square-foot facility, is scheduled to begin operating in 2022.
In March, Grifols announced the launch of the collaboration with BARDA, the FDA and other federal public health agencies to support preclinical and clinical studies to determine if anti-SARS-CoV-2 hyperimmune globulin therapy can successfully be used to treat COVID-19 disease.
Grifols said it volunteered its expertise and resources by using its network of FDA-approved plasma donor centers; testing and qualifying donors in conjunction with other health agencies; processing plasma into hyperimmune globulin in its Clayton, NC, facility; and supporting studies to determine whether the treatment can be a viable treatment for COVID-19 and future emerging infectious diseases.
COVID-19: 300 Candidates and Counting
To navigate through the >300 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:
● ANTIVIRAL
● VAX
● ANTIBODY
● RNA
