A new, worldwide coalition of plasma companies seeking to develop and deliver a hyperimmune immunoglobulin therapy for fighting COVID-19 takes the view that many hands make light work.
Takeda Pharmaceutical Co. Ltd. and CSL Behring LLC created the group, with Germany’s Biotest AG, the U.K.’s Bio Products Laboratory, France’s LFB SA and Switzerland’s Octapharma AG joining the alliance to immediately begin developing a single, unbranded anti-SARS-CoV-2 polyclonal hyperimmune immunoglobulin treatment for individuals with serious complications from COVID-19. The group will direct its efforts to jointly collecting plasma, developing clinical trials and setting up manufacturing sites. The hyperimmune therapy’s creation is to come from fully recovered COVID-19 patients whose blood may have antibodies for fighting the virus.
Bill Mezzanotte, head of R&D at CSL, said the two largest issues facing the coalition were finding enough convalescent plasma and, if the therapy works, ensuring there would be enough to go around. To do that successfully, all the companies involved would have to work in concert, an altogether different approach than the typical path to drug development. For the moment, Mezzanotte said, business as usual has been set aside.
“It’s not a competition between companies in the alliance,” Mezzanotte told BioWorld. “We believe this is the best way we can get to a reliable, sustainable product. It’s a humanitarian effort.”
In addition to pooling industry resources, the group said it will collaborate with governmental and academic efforts as an alliance when possible, including when conducting clinical trials.
Julie Kim, president of Takeda’s Plasma-derived Therapies Business Unit, downplayed the complexity of organizing companies to work together on a single project to accelerate development.
“There is no luxury of time. Time is our enemy,” Kim told BioWorld. “If we had that luxury, each could do it on their own. In normal times, you would never see this happening, I’d venture to say. It was easy for people to set aside a specific company agenda and typical competitive nature.”
Standing in the alliance’s way are regulations across the globe governing plasma medicines and their use. Kim said that because of the unusual nature of the pandemic, regulatory agencies the group has reached out to have been supportive and willing to help bring an effective medicine to market. She cited help from the Austrian government, which notified recovered COVID-19 patients that the coalition needs their help.
“That is an example of working a government agency to raise awareness,” she said. “In a normal situation, they would not be doing things like this.”
This isn’t the only collaboration going after convalescent plasma. On April 6, Xbiotech Inc., of Austin, Texas, and the San Antonio, Texas-based nonprofit blood and tissue supply organization Biobridge Global agreed to work together to participate in an FDA program encouraging the development of a potential COVID-19 treatment based on convalescent plasma. Xbiotech has developed a clinical test that Qualtex Laboratories, a subsidiary of Biobridge, will use to identify natural antibodies present in the blood of convalescent donors.
A somewhat similar, more localized effort is underway at Hackensack Meridian Health, a 17-hospital network with three academic medical centers in New Jersey. Researchers study the blood of recovered patients to find those with the highest levels of targeted antibodies. The chosen patients, all volunteers between the ages of 18 and 60, are asked to donate their plasma.
The FDA has expressed interest in convalescent plasma. It highlighted therapies such as convalescent plasma and hyperimmune globulin in a March 31 update on COVID-19 that also detailed the agency’s new Coronavirus Treatment Acceleration Program, which is intended to speed the development of potentially safe and effective life-saving treatments. It previously released a FAQ document on the topic.
There is also a cross-agency effort at the U.S. Department of Health and Human Services directed toward the use of convalescent plasma, which was discussed in recent articles in The Lancet and in the Journal of Clinical Investigation. The underlying concept is to introduce immunoglobulins from recovered coronavirus patients to boost the immune system of those who still are recovering.
Some preliminary reports on the successful use of convalescent plasma transfusions in critically ill patients suggest that systemic delivery of antibodies may work, but the numbers involved are too low to draw any firm conclusions at this point. Prospective trials of convalescent plasma are underway, as are trials of antibodies that are already approved in other indications, which generally target immune signaling molecules, such as interleukin-6 (IL-6) or IL-2.