Tel Aviv, Israel and Basel, Switzerland, 12 August 2021 – Sheba Medical Center at Tel Hashomer, the largest hospital in the Middle East region, and Lonza, a leading global cell and gene therapy manufacturer, announced today that they have treated multiple patients with CD19 CAR-T cell immunotherapy targeting B-cell malignancies. Three patients have shown complete responses, and another patient is still being evaluated.

All patients were dosed with therapies manufactured in Lonza’s Cocoon^® Platform, an automated, customizable, patient-scale cell therapy platform that streamlines manufacturing to improve process efficiency and reliability.

Eytan Abraham Ph.D, Head of Personalized Medicine, Lonza, commented:

We have been successfully manufacturing Sheba’s CD19 CAR-T therapy in the Cocoon® Platform and observing positive clinical outcomes, which is exciting and promising. We are proving that the Cocoon^® Platform can be used to replace open, manual manufacturing processes which are in most cases expensive and difficult to scale. The Cocoon^® 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.

Professor Dror Harats, Deputy Director for Research and Development and Acting Director for Clinical Trials, Sheba Medical Center, added:

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.

The collaboration between Sheba Medical Center and Lonza was announced in 2019, with the goal of translating Sheba’s manual process to the Cocoon® Platform. The process aims to decrease manufacturing costs, reduce footprint, lower the risk of manufacturing failures and minimize turnaround time. Sheba’s process was successfully translated into the Cocoon® Platform in 2020, with the first patient dosed with CD19 CAR-T cell immunotherapy during the second half of 2020, following a successful clinical comparability study.

The data demonstrates the Cocoon^® Platform’s flexibility and capability to manufacture immunotherapies, compared with manual processes. As there are several commercially available CAR-T cell therapies that are approved in Israel, patients treated in the current trial are only eligible if they do not qualify for these therapies. As such, there is limited patient availability and these patients often present difficult cases. Lonza and Sheba Medical Center plan to dose additional patients using the Cocoon^® Platform for manufacturing. The Cocoon^® Platform is commercially available and gaining global traction as the go-to manufacturing platform for patient-scale cell therapies.