Cardiovascular and metabolic CSL is focused on improving and extending the lives of patients with cardiovascular and metabolic diseases which are the leading cause of death globally, accounting for over 19.8 million deaths annually in 2022, a number that is expected to grow to over 23 million by 2030. Cardiovascular disease (CVD) is the primary cause of morbidity and mortality in patients with chronic kidney disease (CKD), particularly those with advanced CKD stages (4–5) who have a markedly elevated risk for CVD. CSL is addressing the unique cardiovascular and metabolic complications faced by the advanced CKD patient. Clazakizumab, an anti-interleukin-6 (anti-IL-6) monoclonal antibody is currently in Phase III and is being developed for the reduction of major adverse cardiovascular events (MACE) in dialysis patients with End Stage Kidney Disease (ESKD). By addressing the high inflammatory state in ESKD, clazakizumab has the potential to be the first therapy to demonstrate a reduction in the high MACE rate in these patients. Nephrology and transplant Most rare renal diseases, such as IgA nephropathy, have limited treatment options and often lead to kidney failure at a younger age compared to most patients with chronic kidney disease (CKD). This highlights the urgent need to develop novel therapies to preserve kidney function and delay, or avoid, dialysis. Despite advances in transplantation improving short-term survival, transplant rejection is 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 conditions that may lead to transplant organ failure, especially for kidney transplant where CSL’s vision may enable patients to have only one transplant in their lifetime. In haematopoietic stem cell transplantation, acute graft-versus‑host disease (GvHD) occurs when 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 GvHD therapies. CSL is investigating Alpha 1 Antitrypsin (AAT, ZEMAIRA®) for the prevention and treatment of acute GvHD in two Phase III studies. Vaccines CSL has built a foundation of success in developing and marketing a broad range of seasonal and pandemic influenza vaccines and continues its growth in influenza with expanded age indications and markets for FLUCELVAX® and FLUAD®. Developing new and better vaccines is a strategic priority for CSL with a focus on expanding beyond influenza with the first approval in Japan of its samRNA COVID-19 vaccine, KOSTAIVE®. Sa-mRNA technology offers significant benefits compared to conventional mRNA, including an enhanced immune response, and a longer duration of protection and breadth against emerging variants. In addition, CSL is further advancing cell-based manufacturing technology in products such as aTIVc (adjuvanted trivalent influenza vaccine), CSL’s MF59® adjuvant, and developing the messenger RNA (mRNA) platform, targeting seasonal and pandemic potential viruses. As a trusted partner to more than 30 countries throughout the world, CSL Seqirus is the leader in preparedness for pandemic influenza, and continues to strive to meet the evolving global pandemic preparedness needs of governments and health authorities and to address emerging pandemic threats by building capabilities to provide protection beyond influenza. PLATFORMS Plasma Protein Technology Recombinant Protein Technology Cell and Gene Therapy Adjuvant Cell-based Egg-based mRNA Find out more about Platforms on page 25 THERAPEUTIC AREAS Immunology Haematology Respiratory Cardiovascular and metabolic Nephrology and transplant Vaccines 21
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