AGC Biologics to Manufacture LVV for CAR-T Therapy Approved by FDA for Autolus Therapeutics’ AUCATZYL®

CDMO's Cell and Gene Center of Excellence Achieves fifth commercial viral vector product approval, and second overall from FDA in 2024

Today, we announced that the U.S. Food and Drug Administration (FDA) approved our Milan Cell and Gene Center of Excellence site for commercial manufacturing of lentiviral vectors for Autolus Therapeutics' AUCATZYL® (obecabtagene autoleucel - obe-cel). The T-Cell therapy treatment is approved for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (r/r B-ALL); AUCATZYL received approval from the FDA on November 8, 2024.AUCATZYL is the first CAR-T therapy approved by the FDA with no requirement for Risk Evaluation Mitigation Strategy (REMS) programming. Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

This achievement follows the Milan site receiving FDA approval in March to manufacture a hematopoietic stem cell (HSC) gene therapy from Orchard Therapeutics. AGC Biologics' Cell and Gene Center of Excellence has one of the strongest track records in the industry, having supported the production of 30 percent of all ex-vivo gene therapies commercially approved on the market today, and producing 5 commercial viral vectors used for ex-vivo gene therapy.

"Autolus Therapeutics' milestone brings new hope for patients, demonstrating the power of cell and gene therapies. I congratulate Autolus on this pivotal achievement," said Alberto Santagostino, CEO and President, AGC Biologics. "Amidst unpredictability in the cell and gene market, AGC Biologics Milan wants to consistently be a safe harbor for our clients, continuing to offer expertise and consistency, while remaining truthful to a principle of friendly collaboration. AGC Biologics Milan offers uncomplicated and reliable CDMO services for developers when they are needed most. No team is better at supporting CGT products from small-scale development through commercial approval."

The Autolus and AGC Biologics Milan partnership started in 2020when the CDMO site (formerly MolMed S.p.A.) was entrusted to develop, manufacture and supply viral vectors for Autolus' obe-cel CAR-T product candidate, AUCATZYL.

"An FDA approval is a tremendous win for Autolus and for patients that need this treatment. For our site, it also means that we have done a great job in successfully collaborating with Autolus to build a true partnership that works well at all levels of our organizations," said Luca Alberici, General Manager, AGC Biologics Milan Facility. "I am proud of my team and our ability to understand Autolus' technical and CMC needs to help reach their goals. I believe we can take on any project in the industry and find success."

"AGC Biologics has been a valued manufacturing partner for us since 2020; providing reliable, high-quality and timely support as we have executed on the process of achieving FDA approval for our first product," said Christian Itin, Chief Executive Officer of Autolus. "I want to thank the team for their work thus far and look forward to a continued successful partnership as we transition to the commercial manufacture of AUCATZYL."

AGC Biologics' Milanlocation has 30 years of experience in the cell and gene field and expertise with complex projects. The team has guided five viral vector products and four cell therapy products to commercial stages and has manufactured hundreds of batches of material for clinical supply. The team has a history of meeting regulatory guidelines, achieving quality performance metrics, navigating the unique complexities of technology transfers, and scaling up and scaling out manufacturing based on client needs.

To learn more about AGC Biologics' global cell therapy services visit www.agcbio.com/capabilities/cell-therapy, go to www.agcbio.com/capabilities/viral-vectorand learn more about the CDMO's viral vector offerings.

AUCATZYL® (obecabtagene autoleucel - obe-cel) is a registered trademark of Autolus Therapeutics.