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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.

+Plus, news about Autolus, MacroGenics and BlissBio: Akeso bispecific looks promising in cervical cancer: The China-based biotech said Friday that all patients in a Phase 3 cervical cancer trial responded to treatment with a bispecific antibody called cadonilimab. The addition of the PD-1xCTLA-4 bispecific on top of chemoradiotherapy in the COMPASSION-18 study generated complete and partial response rates of 84.8% and 15.2%, respectively. Median PFS was not reached, but the 12-month PFS rate was 74.9%. Cadonilimab is already approved in China for patients with recurrent or metastatic cervical cancer who have not responded to platinum-based chemotherapy. — Elizabeth Cairns Pulmatrix to divest assets ahead of merger: The biotech will seek buyers for three of its pipeline programs as well as its iSPERSE platform technology. Pulmatrix in November agreed to a reverse merger with Cullgen, which was expected to close this month but is now set to close in the first half of 2025. — Max Gelman BioNTech’s option for Autolus CAR-T fizzles out: The German biotech allowed its option to lapse for AUTO1/22, a CAR-T cell therapy in Phase 1 trials for childhood acute lymphoblastic leukemia. Back in February 2024 , BioNTech paid $50 million in cash and bought $200 million of Autolus’ shares in a deal that granted it access to AUTO1/22. The deal also covered AUTO6NG, a programmed T-cell therapy in early trials in neuroblastoma, and Aucatzyl, which has since been approved for an aggressive form of leukemia. BioNTech declined to exercise its time-limited option to AUTO1/22 because of a pipeline prioritization , and it lapsed Feb. 8. — Elizabeth Cairns MacroGenics shelves prostate cancer ADC: The company had to stop dosing prostate cancer patients in a Phase 2 trial of its antibody-drug conjugate, called vobramitamab duocarmazine, in July . On Thursday , it said it would shut down all development and seek a partner for the product, which targets the tumor antigen B7-H3 and delivers a cytotoxic duocarmycin payload. MacroGenics said the results of the trial do not justify any more investment; in the patients treated before dosing was halted, mature median radiographic progression-free survival was 9.5 months with the lower dose and 10 months with the higher. — Elizabeth Cairns BlissBio to proceed with ADC on its own: Eisai had signed an option deal in 2023 to advance a BlissBio program called BB-1701, but last month said in its third-quarter earnings that it would no longer do so. Instead, BlissBio will develop BB-1701 on its own. Eisai had been partnered with liquid biopsy company Angle on development plans, and now Angle is planning to work with BlissBio. — Max Gelman