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Lonza and Sheba Medical Center have successfully dosed four patients with a CD19 autologous CAR-T cell therapy using Lonza’s Cocoon automated manufacturing platform.
On Aug. 12, 2021, Lonza and Sheba Medical Center, a Tel Hashomer, Ramat Gan, Israel-based hospital announced success in treating multiple patients with a CD19 chimeric antigen receptor (CAR) T cell immunotherapy targeting B-cell malignancies. Three out of four patients showed complete responses while the fourth patient is still under evaluation. The four patients were dosed with cell therapy product manufactured in Lonza’s Cocoon Platform, an automated, patient-scale cell therapy platform. According to Lonza, the platform streamlines manufacturing, improving process efficiency and reliability, and is customizable.
The data from these patients demonstrates that the Cocoon platform is flexible and has the capability to manufacture immunotherapies for personalized point-of-contact treatment, compared with manual processes. Because there are several CAR-T cell therapies approved in Israel and available commercially, patients treated in the current trial are eligible only if they do not qualify for those already-available therapies, Lonza stated in a company press release. Thus, there is limited patient availability, and patients who would use cell therapies from the Cocoon platform would represent some of the more difficult cases. Lonza and Sheba Medical Center plan to dose additional patients using the Cocoon platform to manufacture the product.
Lonza and Sheba Medical Center have been in collaboration since 2019 to translate Sheba’s manual process to the Cocoon platform. The hospital’s process was successfully transferred to the Cocoon platform in 2020, and the first patient dosed with the CD19 CAR-T cell immunotherapy was done in the second half of that year, following a successful clinical comparability study. The platform aims to decrease manufacturing costs, reduce footprint, lower the risk of manufacturing failures, and minimize turnaround time.
“We have been successfully manufacturing Sheba’s CD19 CAR-T therapy in the Cocoon [p]latform and observing positive clinical outcomes, which is exciting and promising. We are proving that the Cocoon [p]latform can be used to replace open, manual manufacturing processes, which are in most cases expensive and difficult to scale. The [platform] is showing significant advantages when used for centralized, decentralized, and point-of-care manufacturing. We continue to gain traction in the market, with the aim of revolutionizing the production of patient-scale cell therapy and making these lifesaving therapies available to more patients in need,” said Eytan Abraham, head of Personalized Medicine, Lonza, in the press release.
“This unique effort initiated between a leading biotechnology company and Sheba is a prime example of how we are dealing with today's and tomorrow's medicine. The collaborative relationship between innovative medical technologies and medicine enables leading hospitals such as Sheba to create breakthrough personalized medical treatments that are amongst the best within the world of biomed,” said Professor Dror Harats, deputy director for Research and Development and acting director for Clinical Trials, Sheba Medical Center, in the press release.