Obecabatagene autoleucel

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional marketing authorisation to Autolus Therapeutics’ Aucatzyl (obecabtagene autoleucel) to treat acute lymphoblastic leukaemia (ALL). The CAR T-cell therapy has been specifically authorised for use in adults with relapsed or refractory (R/R) B-cell precursor ALL. Approximately 765 new cases of ALL, an aggressive blood cancer, are diagnosed in the UK every year. Up to 50% of patients will relapse following frontline treatment, and survival rates remain very poor in adults with R/R disease. Administered as an intravenous infusion, Aucatzyl works by taking patients’ T cells and transforming them into CD19-targeting CAR T cells. When transferred back into the body, these modified cells can recognise and destroy the cancer cells. The MHRA’s decision on the therapy was supported by data from the open-label FELIX trial, in which 52 of the 94 R/R B-cell ALL patients who were given at least one infusion of Aucatzyl showed complete remission of the disease with an 81% probability of overall survival at 12 months. Julian Beach, MHRA interim executive director, healthcare quality and access, said: “We are committed to making innovative treatment options, like CAR T-cell therapy, available to patients as quickly as possible, ensuring our approval is underpinned by robust evidence of efficacy alongside the highest standards of safety. “We are assured that the appropriate regulatory standards for the approval of this medicine have been met.” In line with its conditional marketing authorisation pathway, the MHRA will review new efficacy and safety information for Aucatzyl at least once every year. The therapy is now being evaluated by the National Institute for Health and Care Excellence (NICE) for potential use on the NHS. FELIX lead investigator, Claire Roddie, University College London Cancer Institute, said: “Having treated a number of patients with Aucatzyl as part of the FELIX clinical trial, I am delighted that we have moved closer to eligible R/R B-cell ALL patients being able to access Aucatzyl. “We now look forward to NICE completing its assessment of the medicine to potentially make it an option for eligible patients on the NHS.”

MILAN & SEATTLE--(BUSINESS WIRE)--AGC Biologics, your friendly CDMO expert, today announced the formation of a new Cell and Gene Technologies Division designed to focus and elevate existing AGC Biologics capabilities and further foster the company's performance as the most reliable, experienced and friendly advanced therapy CDMO worldwide. AGC Biologics announces a new dedicated Cell and Gene Technologies Division, providing resources for this market lacking technical CDMO expertise. AGC Biologics is investing and growing in a market with substantial capacity but limited scientific capabilities and technically qualified operators. While other cell and gene CDMOs are closing sites and downsizing their workforce, the new AGC Biologics Cell and Gene Technologies Division offers unparalleled support and scientific ability, backed by an abundant global development and manufacturing network in three regions (Milan, Italy; Longmont, CO, USA; Yokohama, Japan). Further, AGC Biologics' proprietary cell therapy and viral vector platforms, including ProntoLVV™ and BravoAAV™, offer developers the ability to increase their speed to GMP phases while controlling costs significantly. The AGC Biologics Milan Cell and Gene Center of Excellence will be the central location for this new Division. The site offers 30 years of experience in cell and gene therapy, with nine commercial approvals and hundreds of GMP batches produced successfully, and its teams of experts have a reputation for collaboration and working side-by-side with customers to find clinical, late-phase, and commercial successes. Recognized as one of the most accomplished cell and gene CDMO production sites in the world, it holds commercial manufacturing authorizations from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for viral vectors and cell therapies. The Cell and Gene Center of Excellence has also shown considerable momentum over the last 12 months, achieving two FDA commercial approvals (Lenmeldy™ and Aucatzyl®) and organic business growth of over 20 percent in a declining market. This year also started very fruitful for the site, with new agreements for commercial lentiviral vector services, adeno-associated viral vector services, autologous and allogenic cell therapy agreements, and an exosome project, reinforcing its leading position in this space. The 140,000-square-foot facility (13,000 m2) offers complete end-to-end services, including research and development (R&D) and innovation teams supporting initial development and early clinical phases, expanded large-scale viral vector suites with scales up to 2,000 L, new cell therapy suites, and a dedicated floor for quality control, which performs all necessary tests in-house. These unique features help the site deliver a safe path from IND to commercialization for customers. The Milan facility has guided five viral vectors and four cell therapy products from early clinical phases through commercialization, demonstrating a strong acumen for important late-stage and commercial manufacturing partnerships. The new Cell and Gene Technologies Division features expanded global capabilities, including AGC Biologics' Longmont facility and the new Yokohama facility, which will begin cell therapy operations in July 2025. The new Division aims to "Bring Hope to Life Together" with developers in the global cell and gene industry and inspire progress for these promising treatments. The Cell and Gene Technologies Division offers support for R&D initiatives, solves complexities in clinical stages, builds scalable manufacturing processes, and addresses the unique needs of developers based on the geographical regions they operate in. Luca Alberici has been appointed Executive Vice President of the Cell and Gene Technologies Division. He will report directly to Alberto Santagostino, President and CEO, and join the company's executive leadership team. Alberici will oversee this new Division's global strategy, operations, and commercial development, and he will keep his current role as General Manager of the Milan Cell and Gene Center of Excellence. "Luca is a veteran in this space, with a proven track record of success in launching CGT products in the market, and he has extensive leadership experience at our flagship Milan site," said Alberto Santagostino. "With 20 years in the industry, his expertise will be invaluable as we expand our capabilities and customer pipeline in this vital therapeutic area. Even more importantly, I am impressed by the decades-long relationships he built with our clients, which perfectly underscores the 'friendly' spirit in which we conduct our business. I am confident he will lead the resources entrusted to him to deliver exceptional results for our customers." "AGC Biologics has invested significant resources to make manufacturing of cell and gene therapies economically sustainable for the market. With our newest scales, we are focused on making life-saving treatments more cost-effective and aim to be able to offer lentiviral vectors for commercial applications at a cost as low as 1,000 USD per patient. Thanks to automation in cell therapy manufacturing, full quality control testing in-house, and a wide facility footprint in each global region, we believe we can now be the partner of choice for most late-stage CGT customers from CAR-T to viral vectors and new trailblazing modalities like exosomes," said Luca Alberici. "I am honored to take on this new role and lead AGC Biologics' cell and gene therapy efforts. This dedicated Division will allow us to serve our customers better and support the development of innovative therapies that bring hope to patients worldwide. I look forward to collaborating with our talented teams as we embark on this exciting new chapter," noted Alberici. To learn more about AGC Biologics and its global CDMO services, visit www.agcbio.com. About AGC Biologics AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, to provide friendly and expert services. We provide world-class development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with locations in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba and Yokohama, Japan. We currently employ more than 2,800 Team Members worldwide. AGC Biologics is a part of AGC Inc.’s Life Science Business. The Life Science Business runs 10+ facilities focused on biopharmaceuticals, advanced therapies, small molecule active pharmaceutical ingredients, and agrochemicals. To learn more, visit www.agcbio.com.