Obecabatagene autoleucel

CDMO's Cell and Gene Center of Excellence Achieves fifth commercial viral vector product approval, and second overall from FDA in 2024 SEATTLE, WA and MILAN, ITALY / ACCESSWIRE / December 12, 2024 / AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced the U.S. Food and Drug Administration (FDA) approved its 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 2020 when 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' Milan location 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-vector and learn more about the CDMO's viral vector offerings.AUCATZYL® (obecabtagene autoleucel - obe-cel) is a registered trademark of Autolus Therapeutics.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 cGMP-compliant facilities in Seattle, Washington; Boulder, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 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.Media ContactHannah LehmanBoulder, CO+1 (720) 910-0406 | [email protected] | agcbio.comSOURCE: AGC BIOLOGICS

WEDNESDAY, Dec. 11, 2024 -- For patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL), obecabtagene autoleucel (obe-cel), an autologous 41BB-ζ anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, results in a high incidence of durable response, according to a study published online Nov. 27 in the New England Journal of Medicine . Claire Roddie, M.D., from University College London, and colleagues conducted a phase 1b-2 multicenter study of obe-cel in 153 adults with relapsed or refractory B-cell ALL. Patients in cohort 2A (94 patients) had morphologic disease, while those in cohort 2B had measurable residual disease. Overall, 127 patients received at least one infusion of obe-cel and were evaluable. The researchers found that overall remission occurred in 77 percent of patients in cohort 2A, with complete remission in 55 percent and complete remission with incomplete hematologic recovery in 21 percent. The prespecified null hypotheses (overall remission [≤40 percent] and complete remission [≤20 percent]) were rejected. The median event-free survival was 11.9 months in the 127 patients who received at least one obe-cel infusion, while the estimated six- and 12-month event-free survival was 65.4 and 49.5 percent, respectively. The median overall survival was 15.6 months, with 80.3 and 61.1 percent estimated six- and 12-month overall survival, respectively. In 2.4 percent of the patients, grade 3 or higher cytokine release syndrome developed, while grade 3 or higher immune effector cell-associated neurotoxicity syndrome developed in 7.1 percent. "Obe-cel was associated with durable responses, particularly in patients with a low-to-intermediate bone marrow burden, including patients who did not receive consolidative allogeneic stem-cell transplantation," the authors write. The study was funded by Autolus Therapeutics.