CSL Limited Annual Report 2022/23 13 Cardiovascular and metabolic CSL is focused on improving and extending the lives of patients with cardiovascular and metabolic diseases. Many patients with cardiovascular disease also have some degree of renal impairment and CSL recognises the critical need to address the unique challenges faced by this patient population. CSL112, apolipoprotein A-I (human), is being developed to reduce the risk of recurrent cardiovascular events during the 90-day high-risk period following a heart attack, the period when the majority of first-year recurrent cardiovascular events occur. If successful, CSL112 will be the first therapy to demonstrate cardiovascular risk reduction through the novel apoA-I mechanism and has the potential to transform how acute myocardial infarction patients at high risk of recurrent cardiovascular events are treated. In addition, clazakizumab, first-in-class anti-interleukin-6 (anti-IL-6) monoclonal antibody is being developed for the reduction of major adverse cardiovascular events (MACE) in End Stage Kidney Disease (ESKD) dialysis patients. Transplant While advances in transplantation techniques and therapies have markedly improved short-term patient survival, transplant rejection remains one of the greatest limitations to long-term graft and patient survival for both solid organ and haematopoietic stem cell transplant recipients. CSL is focused on developing therapies to address transplant rejection and while current solid organ focus lies in kidney transplants, this vision encompasses a broader scope to help treat patients undergoing various solid organ transplantations. In kidney transplant recipients, antibody-mediated rejection (AMR) is a leading cause of allograft loss, and there is significant unmet need for effective treatments. Clazakizumab, our anti-IL-6 monoclonal antibody, is currently being investigated in a Phase III clinical trial (IMAGINE) for the potential treatment of chronic active antibody-mediated rejection. In haematopoietic stem cell transplantation, acute graft-versus-host disease (GvHD) is a life-threatening type of rejection where the donor cells attack the recipient; it is a leading cause of mortality and morbidity following transplant. There is a significant unmet need for more effective, less toxic therapies for GvHD. We are investigating alpha-1 antitrypsin (AAT, ZEMAIRA®) for the prevention and treatment of acute GvHD in two Phase III studies. CSL Seqirus CSL Seqirus’ broad range of influenza vaccines addresses the needs of different populations around the world. In Australia and New Zealand, CSL Seqirus is also a leading provider of in-licensed vaccines and specialty pharmaceuticals. It is also the world’s only supplier of a unique range of products of national significance for the Australian Government, including Q fever vaccine and antivenoms for venomous creatures in Australia and other Pacific countries. Vaccines Developing new and better vaccines across all age groups in expanded markets is a strategic priority for CSL Seqirus. CSL Seqirus is focused on developing differentiated vaccines protecting against respiratory viruses, influenza and COVID-19 utilising innovative technologies, including further advancing our cell-based manufacturing technology, our MF59® adjuvant, and developing the next-generationmessenger RNA (mRNA) platform, targeting seasonal and pandemic potential viruses. Through these technologies, CSL Seqirus aims to enhance the immune response of those particularly vulnerable to influenza and COVID-19, such as children and older adults. The portfolio includes a number of key investigational products, including a higher dose adjuvanted cell-based influenza vaccine (aQIVc), multiple monovalent and quadrivalent influenza candidates using the sa-mRNA technology and a COVID-19 seasonal booster. In addition, our collaboration with sa-mRNA-focused Arcturus Therapeutics complements our long-term strategy in vaccines with benefits including faster clinical development with higher probability of success; application to additional pathogens including those with pandemic potential; access to an established manufacturing network; and access to lipid nanoparticles and a lipid library with application across vaccines. Key CSL Seqirus influenza vaccines on the market include AGRIPPAL®, AFLURIA®, FLUAD®, and FLUCELVAX® for seasonal use, and AFLUNOV® for zoonotic use. As a trusted partner to more than 30 countries throughout the world, CSL Seqirus is the leader in preparedness for pandemic influenza, and is constantly working to expand its offerings to new countries and to address emerging pandemic threats. Key approved CSL Seqirus pandemic vaccines include PANVAX®, FOCLIVIA® and AUDENZ®. In-licensed vaccines and pharmaceuticals Key CSL Seqirus in-licensed products on the market in Australia and New Zealand include CATIONORM®, GARDASIL-9®, IKERVIS®, PALEXIA®, REAGILA®, RYALTRIS®, XADAGO® and ZOSTAVAX®.
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