To stop the Covid-19 pandemic, both medicines and vaccines are needed. Researchers around the world are searching for the right active ingredients and life-saving substances. Biotech company CSL Behring is taking a special path as co-founder of a globally active plasma alliance – which has quickly presented the first drug development successes against Covid-19.
It’s a marathon at a sprint: Scientists around the globe are searching feverishly for a medicine against Covid-19, and initial milestones on the road to success are published almost daily. But to be able to act both efficiently and remain scientifically correct in these times, cooperation is needed: the Australian biotech group CSL Behring also recognized this at an early stage and allied itself with other leading companies to found a plasma alliance – an extraordinary research cooperation among industry leaders who are otherwise competitors.
Plasma-Alliance develops new therapeutic approach
The consortium already comprises ten companies. In addition to CSL Behring, these include other well-known companies such as Takeda, Biotest, bpL, LFB and Octapharma. Other industry members such as ADMA Biologics, Biopharma Plasma, GC Pharma and Sanquin have also joined. The cornerstone of the alliance was laid by CSL Behring and Takeda Pharmaceutical Company Limited; both companies have a high level of expertise in the field of plasma-based therapies. The consortium is also supported by other organizations that are advancing the alliance’s goal through optimized bidding (Bing, Edelmann, Facebook, Google, MSN), technical consulting (Microsoft) and logistical planning (PALL, Uber Health).
CoVIg-19: Clinical studies as a milestone
The researchers started at full speed – and quickly found what they were looking for. Within a short time, the consortium was able to present a first drug candidate: The promising “Anti-SARS-CoV-2” is a so-called polyclonal hyperimmunoglobulin drug that could be used to treat Covid-19 patients. The drug contains special antibodies – so-called immunoglobulins – which are extracted from blood plasma. The researchers also quickly found a name for the drug: both the drug and the alliance are called CoVIg-19. The scientists hope to ensure tolerability and efficacy of the so-called hyperimmunoglobulin therapy in adult patients with Covid-19. Many questions remain open: “We not only have to define precisely the optimal dosage for the treating physicians in order to achieve a guaranteed therapeutic success, but we also aim, of course, to create a drug that has a shelf-life of two-to-three years,” explains Bonacker. And the researchers are optimistic: if the current studies are positive, they might be able to submit a regulatory application to the European Medicines Agency (EMEA) and the United States’ Food & Drug Administration (FDA).
Blood plasma saves lives
The raw material for this preparation is blood plasma, which cannot be produced artificially. Therefore, the consortium has launched a worldwide appeal to people who have survived Covid-19. The goal: donations of their blood plasma. This is because blood plasma contains not only coagulation factors but also the immunoglobulins necessary for the medicine. These antibodies are the body’s own defence substances and are formed as soon as the human organism fights against foreign pathogens such as the novel coronavirus SARS-CoV-2. The researchers extract this so-called immune response – the antibodies – from the blood plasma of patients who have already recovered and purify this material. These antibodies then form the basis for their potentially life-saving new drug CoVIG-19.
The advantage of a plasma alliance also becomes clear in the search for the antibodies: “The probability of success increases enormously if more companies initiate a plasma donation appeal than if only one company takes on this task alone,” says Bonacker. CSL Behring individually has over 240 plasma centers worldwide that are available as contact points for specific blood donations – but more will follow. “We were able to open nearly 40 new plasma centers last year, despite the restrictions imposed by Covid-19,” Bonacker says. These centers are well prepared in spite of the Covid-19 pandemic: Employees have been trained intensively, and there are strict distance and hygiene regulations.
Innovative research with great expertise
The CSL Behring research division in Marburg has a differentiated portfolio and is divided into five therapeutic areas: Immunology, Hematology, Transplantation, Cardiovascular and Metabolic Diseases, and Respiratory Diseases. “We are concentrating on these research areas because we have great expertise and presence in these fields,” explains Dr. Lutz Bonacker, Senior Vice President and General Manager Europe of CSL Behring GmbH.
New therapeutic approaches against Covid-19
Researchers around the world are also searching feverishly for a vaccine against COVID-19, but even if one were to be found soon, this would not make the work on a medicine obsolete. Bonacker adds, “The probability that people will continue to be exposed to the novel coronavirus and also fall ill with it remains, regardless.” Currently, the World Health Organization (WHO) counts more than 130 vaccine projects. CSL Behring’s parent company, CSL Limited, is also working cooperatively to find a vaccine that will save lives:
The CSL subsidiary Seqirus, for example, is collaborating with Australia’s University of Queensland and is contributing extensive knowledge about so-called adjuvants, a pharmacological or immunological agent that improves the immune response of a vaccine. Pharmacological adjuvants also play an important role in influenza vaccines. “At CSL, we have been conducting intensive research on influenza vaccines for many years, and these have to be redesigned every year because the virus mutates again and again,” explains Bonacker. This experience helps: the first phase of mass production of the UQ COVID-19 vaccine is to take place in CSL’s biotechnological production facilities in Melbourne, Australia. CSL assumes that the production technology can be scaled up, so that up to 100 million doses can be produced towards the end of 2021.
In order to offer the most comprehensive help possible against the coronavirus, CSL Behring is also pursuing other approaches. The plasma company is starting the 2nd clinical phase of a Factor XIIa antagonistic monoclonal antibody. The active ingredient CSL312 (garadacimab) is intended for the treatment of severe respiratory distress due to severe coronavirus. “The greatest clinical challenge in treating patients with severe COVID-19 infection and improving outcome is our ability to treat the severe respiratory complications associated with this disease,” said Lars Groenke, R&D Lead, Respiratory Therapy Division, CSL Behring. “It is our hope that CSL312 will stop the progression of COVID-19, improve treatment outcomes and provide physicians with an effective tool in the fight against this deadly virus.”
For further antibody developments, CSL Behring also brought researchers from SAB Biotherapeutics onboard as key partners. The scientists of this US biopharmaceutical company are contributing a development platform for antibodies. SAB Biotherapeutics is taking a new path: the development of a therapy based on advanced gene technology, in which so-called human polyclonal antibodies simulate the human body’s natural immune response. This novel immunotherapy could be produced without human blood plasma donations from recovered Covid-19 patients. The start of clinical trials is planned for this summer in North America. It is these diverse, solution-oriented approaches that show how a joint research network is helping to overcome the crisis – sprinting together, toward solutions.
CSL Behring – a member of the CSL group of companies based in King of Prussia, USA – is a leading global biotech company. Its focus is the development of safe therapies to treat people with life-threatening diseases. The company’s Marburg location is specialized in the production and research of plasma-based and recombinant therapies.