Japan's largest pharma and a Pennsylvania-based drug manufacturer have teamed up with four other companies to speed development and increase supply of a potential treatment for COVID-19, the disease caused by the novel coronavirus.
The alliance forged by Takeda and CSL Behring specifically focuses on a type of treatment made from the blood plasma of patients who have recovered from the coronavirus. The idea is that this donor plasma, which carries a type of antibody known as immunoglobulin, can be injected into sick patients and trigger an immune response that helps them survive the infection.
Takeda and CSL have extensive experience with plasma-derived therapies, each sporting multiple approved products that treat illnesses such as rabies, hepatitis and certain immune system deficiencies. Executives from the companies told BioPharma Dive that they see greater value in collaborating on a therapy, a view which helped spawn their new alliance.
"We recognize, collectively, that this is a race against the clock," said Julie Kim, president of Takeda's plasma-derived therapies business. "And so if we work together, unlike businesses as usual, we can be much faster to bring a potential treatment."
Rounding out the alliance are the plasma-derived drug manufacturers Biotest, Bio Products Laboratory, Octapharma and LFB, a French pharmaceutical group.
Takeda and CSL say the alliance will be developing one unbranded immunoglobulin medicine that, hopefully, has the potential to treat patients with serious complications from COVID-19. Specifically, they'll aim to develop a standardized, more concentrated product known as hyperimmune immunoglobulin.
In order to do that, though, they'll need blood plasma. While the virus' rapid spread has led to a greater number people who can donate the necessary plasma, it has also made trips to collection centers a more daunting prospect for patients.
"Even though plasma donation and blood donation have been deemed as essential services, and you can still go to do those activities, I would say that the human fear factor of leaving your home to go and donate still exists," Kim said.
"So I do believe that they work against each other — even though we have more cases, you have a very large human fear factor. And so that's what needs to be overcome for potential donors to walk into a center to donate."
There's also an element of regionality, according to Bill Mezzanotte, CSL's head of research and development.
The places where coronavirus has hit hardest are likely to have high numbers of recovered patients who could donate plasma. But they're also likely to have strained healthcare systems in the wake of the virus. Mezzanotte noted that collection centers in these areas may need more support than they normally would.
That, however, is where a network of partners can come in handy.
"The big challenge is driving enough plasma to make enough material that you can test in a pilot plan, and then finally in a much larger scale batch," Mezzanotte said.
"So by working together in both Europe and the U.S. to start, we'll be sending the material to one primary manufacturing site in each part of the world so that we can most quickly get batch material that can be both tested and then gotten out to the general public."
Kim said the alliance's first task is to pool their drugmaking know-how and use that information to figure out how to speed up the development timeline.
Takeda will take the work it had done for a medicine called TAK-888, including clinical trial and assay preparation, and transition it over to the alliance's unbranded medicine. All partners, Kim added, will do the same for any plasma therapies they have been developing for the coronavirus.
"What we are foregoing is a Takeda-branded hyperimmune [immunoglobulin]," she said. "But the work that has been done to date has not gone to waste."
Kim and Mezzanotte couldn't provide a timeline for how quickly the alliance's medicine would progress, citing the uncertainties associated with clinical trials and regulatory processes. Mezzanotte noted, however, that what they can control and ramp up are manufacturing efforts.
Kim said there are still companies considering joining the alliance, and that there's an invite for even more to become partners. Mezzanotte said any new partner that provides "substantive support" will get a seat on the alliance's joint steering committee, which he co-chairs with Kim.
Though plasma-derived therapies have been used against other infectious diseases — including SARS, itself a member of the coronavirus family — their usefulness for treating COVID-19 remains mostly unknown.
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, recently wrote how these therapies do hold some promise. Additionally, JAMA published a study in March that seemed to hint at signs of a benefit for five patients with the virus who were treated with plasma therapy and other medications. Still, the study's many caveats — among them its small sample size and lack of a control group — made the results hard to interpret.
"Despite these limitations, the study does provide some evidence to support the possibility of evaluating this well-known therapy in more rigorous investigations involving patients with COVID-19 and severe illness," wrote researchers who reviewed the study, in an accompanying editorial.