Takeda and its plasma-focused peers are wasting no time. One month after joining forces to create an unbranded plasma-based treatment for COVID-19, the partners, along with the National Institutes of Health, are gearing up for a global clinical trial set to kick off this summer.
The group, dubbed the CoVIg-19 Plasma Alliance, will work with the National Institute of Allergy and Infectious Diseases (NIAID) to test the safety and efficacy of the treatment in adults with COVID-19. That study will lay the groundwork for a regulatory submission for the medicine.
The treatment is based on the plasma of patients who have recovered from COVID-19. Known as hyperimmune immunoglobulins, these drugs are made by purifying antibodies from donated plasma. Before forming the alliance, Takeda had been working on a polyclonal hyperimmune globulin against SARS-CoV-2, the virus that causes COVID-19, but is now working with its partners on a single, unbranded medicine.
“Hyperimmune globulin therapy has the potential to be one of the earliest treatment options for COVID-19, and we look forward to working with NIAID and health authorities to bring this therapy to patients as early as possible,” Bill Mezzanotte, CSL Behring’s R&D chief and co-leader of the alliance, said in a statement.
RELATED: Takeda, CSL-led plasma players band together on COVID-19
“One of the stated goals of the alliance is to be an effective partner for important institutions such as NIAID and also to help develop coherent regulatory strategies that can give global health authorities the confidence to streamline the approval process of hyperimmune globulin therapy for COVID-19,” he added.
Takeda and CSL Behring teamed up with Biotest, Bio Products Laboratory, Octapharma and LFB in early April. Since then, four more plasma players have joined the alliance. But that’s not all—making plasma-derived treatments relies on a steady supply of convalescent plasma, so the group has enlisted partners in other sectors to encourage recovered patients to donate their plasma.
“Partnership and collaboration are critical to the success of the CoVIg-19 program,” Julie Kim, president of Takeda’s plasma-derived therapies unit and co-leader of the CoVIg-19 Plasma Alliance, said in a statement. “We now have enough plasma to initiate clinical manufacturing, but more is needed to ensure both speed and scale.”
To help the alliance’s mission, Microsoft is offering an online screening tool called Plasma Bot to help people determine whether they can donate plasma, while Uber Health is offering 25,000 round trips to transport potential donors to and from plasma collection centers.