- CSL Behring is part of the CoVIg-19 Plasma Alliance, an unprecedented industry partnership to develop CoVIg-19, a potential plasma-derived therapy for treating COVID-19. The CoVIg-19 Plasma Alliance will work toward developing the unbranded anti-SARS-CoV-2 polyclonal hyperimmune immunoglobulin medicine with the potential to treat individuals with serious complications from COVID-19, and to support national governments in their efforts to fight the current pandemic. The collaboration will leverage leading-edge expertise and work that the companies already have underway. The Alliance is working with the National Institute of Allergy and Infectious Diseases (NIAID) at the NIH to test the safety, tolerability and efficacy of the hyperimmune therapy in adult patients with COVID-19. This global study is anticipated to start in the summer.
- The CoVIg-19 Plasma Alliance, which includes CSL Behring, has joined the “The Fight Is In Us” campaign - a coalition of world-leading medical and research institutions, blood centers, life science companies, technology companies, philanthropic organizations, and COVID-19 survivor groups has come together to support the rapid development of potential new therapies for patients with COVID-19. The coalition is seeking to mobilize tens of thousands of people in the United States who have recovered from COVID-19 to donate their blood plasma, which contains vital antibodies that have fought off the disease and could now help others do the same.
- CSL Behring Australia is developing an anti-SARS-CoV-2 plasma product for the Australian market with the potential to treat people with serious complications of COVID-19, particularly those whose illness is progressing towards the need for ventilation. The investigational product, to be known as COVID-19 Immunoglobulin, is under development at the company’s advanced manufacturing facility located in Broadmeadows, Victoria.
- CSL is partnering with the Coalition for Epidemic Preparedness Innovations (CEPI) and The University of Queensland (UQ) to accelerate the development, manufacture and distribution of a COVID-19 vaccine candidate. CEPI and CSL will fund the development and manufacture of UQ’s “molecular clamp” enabled vaccine. Funding will provide support for the pending phase 1 safety study being led by UQ followed by subsequent late stage clinical trials, and industrial-scale manufacturing, should the product be approved. The initial phase of large-scale production is planned to take place at CSL’s biotech manufacturing facilities in Melbourne, Australia. CSL anticipates that the production technology can be scaled to produce up to 100 million doses towards the end of 2021. The Phase 1 clinical trial commenced on 13 July, with the first humans dosed to assess safety. Should this be successful, CSL will manage phase 2 and 3 clinical trials.
- Donation of Seqirus’ well-established adjuvant technology – MF59® – to multiple entities searching for a COVID-19 vaccine, including the University of Queensland vaccine development program. MF59® is used in the company’s adjuvanted seasonal flu vaccine for the over-65 age group -- one of the most vulnerable populations to COVID-19. Adjuvants can help improve immune response and reduce the amount of antigen needed for each vaccine, enabling more doses to be manufactured more rapidly. In parallel, Seqirus remains focused on the production of seasonal influenza vaccines for upcoming season, the importance of which is very much underscored by the COVID-19 pandemic.
- Launching a clinical trial into the use of CSL312 (garadacimab, Factor XIIa antagonist monoclonal antibody) to treat patients suffering from severe respiratory distress, a leading cause of death in patients with COVID-19 related pneumonia. The first patient enrolled in a Phase 2 study to assess the safety and efficacy of the potential treatment in July.
- Engaging with investigators regarding the company’s monoclonal antibodies, including CSL324, to identify treatment candidates from the portfolio that have the potential to treat Diffuse Alveolar Damage – one of the devastating respiratory consequences of COVID-19. These are considered much more experimental approaches, but still potentially very important therapies for people who have suffered the potentially devastating impact of COVID-19.
- Partnering with SAB Biotherapeutics, a clinical-stage biopharmaceutical company, to advance and deliver a novel immunotherapy targeting COVID-19. The potential therapy would be produced without the need for blood plasma donations from recovered COVID-19 patients. Clinical trials could begin this summer in North America.
- Additionally, from the time the coronavirus was first identified in Wuhan, China – where CSL Behring has a manufacturing facility – the company has been assisting in the fight against COVID-19 in a number of ways including offering expertise, technologies, equipment and materials on a humanitarian basis.
For the latest information from CSL Behring around its work in the fight against COVID-19, please visit: www.cslbehring.com
CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company’s products are also used in cardiac surgery, burn treatment and to prevent hemolytic disease of the newborn. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL;USOTC:CSLLY), headquartered in Melbourne, Australia, employs more than 26,000 people, and delivers its life-saving therapies to people in more than 70 countries. For inspiring stories about the promise of biotechnology, visit Vita CSLBehring.com/vita and follow us on Twitter.com/CSLBehring.
Media Contact: Natalie de Vane, Natalie.deVane@cslbehring.com, 610-999-8756