A newly formed ‘Plasma Alliance’ of the world’s leading blood plasma companies believed that plasma from those who have recovered from COVID-19 could be a key piece of the puzzle in the fight against the unfolding global pandemic and speed up the search for an effective and accessible treatment.
By bringing together our brightest minds, sharing information and leveraging our collective expertise and infrastructure, we are confident that we can make progress faster
Julie Kim, Takeda
During the 30 April IFPMA virtual media briefing on COVID-19 treatments, the two co-leads of the CoVIg-19 Plasma Alliance, Julie Kim (President of the Plasma-Derived Therapies Business Unit for Takeda Pharmaceutical) and Bill Mezzanotte (EVP of Research and Development for CSL Behring) took the opportunity to introduce the collective hyperimmune globulin therapy the Alliance is currently developing.
As their website states, “the CoVIg-19 Plasma Alliance is an unprecedented partnership of the world’s leading plasma companies, spanning plasma collection, development, production, and distribution. Rather than pursue our individual research, we are putting public and patient health first by working together. Our goals are to accelerate the development of a potential treatment, improve our chances of success, and increase supply of the potential treatment. Plasma from people who have recovered from COVID-19 — known as ‘convalescent plasma’ — could be a key part of the fight against the new coronavirus.”
As co-lead Julie Kim, president of plasma-derived therapies business unit of Takeda Pharmaceuticals, proclaimed, “the Alliance is a unique partnership between global and regional manufacturers of plasma drug therapies. By bringing together our brightest minds, sharing information and leveraging our collective expertise and infrastructure, we are confident that we can make progress faster. We have a special responsibility and opportunity to make a difference in the interest of global public health.” She also specified, “our objective is to develop an unbranded plasma-derived therapy, a hyperimmune globulin that we refer to as ‘CoVIg-19.”
CSL Behring EVP of research and development Bill Mezzanotte, the other co-lead of the Alliance, introduced the therapy in more depth: “convalescent plasma transfusion is currently being done frequently in hospitals, which is very good. The challenge is that it has to be [directly transfused] from one recovered patient to another patient so it’s a quite local solution. The antibodies in each individual patient are not always reliable and you can’t manage it on any type of scale. Hyperimmune globulins are made by collecting and pooling the convalescent plasma donations of many patients [to] create one concentrated antibody solution.”
This therapy would have four major advantages over the standard convalescent plasma transfusion, as Mezzanotte highlighted, “we can concentrate and standardize the antibody levels in the hyper immune; we can determine a specific effective dose’ we can reduce the risk of viral transmission; and we can package and manufacture it so that we can ship it to locations and hospitals around the world.”
To accelerate development and commercialization, Mezzanotte indicated that the Alliance would also serve to streamline clinical trials. “Instead of doing six individual development programs, we’re doing one combined clinical trial that will serve the needs of Europe and the US. We’re hoping to start that clinical trial in the summer. We also hope to make that clinical trial data available widely so that governments and companies around the world can reference these data. They don’t have to start from square one when they want to make their own hyperimmune.”
Both co-leads underscored the essential element to the success of this approach: plasma donations from recovered COVID-19 patients. Human plasma cannot be manufactured in a lab or by artificial methods; it can only be extracted from healthy adults. Mezzanotte exhorted, “donations are critical. Lots of governments are now talking and encouraging plasma donations. We will only succeed in reaching this goal if we journey together”, while Kim echoed, “we do need to continue to build awareness of the need for convalescent plasma donation. Unlike some of the other therapies being discussed, we are dependent upon that plasma to make the medicine.”
In addition to the six founding members – Biotest, BPL, CSL Behring, LFB, Octapharma, and Takeda – a number of other players have since joined the Alliance, namely ADMA Biologics, BioPharma Plasma, GC Pharma, and Sanquin, with the Bill & Melinda Gates Foundation providing advisory support. Kim underlined, “with our combined footprint in the U.S, we can reach more than half of all the potential donors as they live within a 15-mile radius of an existing centre.” Currently, the Alliance already counts over 500 collection centres in the US and over 100 collection centres in Europe.
Kim was also enthused and grateful about the support the Alliance had received from external organizations, including Microsoft, which is providing technical support including the Alliance website and the plasma bot for donor recruitment, and UberHealth, which is donating 25 thousand trips for individuals to visit plasma collection centres in the US. She added, “we’re very grateful to have such vital support towards encouraging more people to donate plasma and we appreciate all efforts to raise awareness of this critical initiative.”
In 2019, the global plasma-derived therapeutics market was estimated at USD 24 billion with an expected CAGR of nine percent until 2024. Such therapeutics have typically been used in autoimmune and immunological conditions, neurological diseases and bleeding disorders. Should the Alliance find a viable and effective plasma-derived therapy for COVID-19, the growth rate will only skyrocket further.