- First cancer patient dosed at Sheba Medical Center, Isreal with autologous CAR-T therapy manufactured using Lonza's Cocoon® Platform
- Israeli Ministry of Health (MOH) approved use of the Cocoon Platform to manufacture a CD19 CAR-T cell immunotherapy for an ongoing Phase II clinical trial for B-cell malignancies
- MOH approval follows an extensive study that showed comparability of the therapy whether manufactured using the manual, open process or the automated, functionally closed Cocoon Platform
Quote from Eytan Abraham, Head of Personalized Medicine, Lonza Pharma & Biotech:
“Treatment of the first patient is a significant milestone for Lonza and demonstrates the Cocoon's capability to manufacture patient-scale cellular immunotherapies in a cGMP setting for clinical use. Moreover, this project has demonstrated the feasibility and attractiveness of moving open processes into the automated and functionally closed Cocoon Platform, and the ability to enable decentralized manufacturing at point-of-care.
Ahead of treating the first patient, the full qualification and CE1 marking of the Cocoon Platform was also a key achievement. We continue to work with multiple partners on extending the use of the Cocoon Platform for clinical manufacturing of additional cell therapies. Lonza's goal is to provide the flexibility to efficiently manufacture patient-scale cell therapies in a centralized or decentralized model, with a lower cost, and a scalable approach. Ultimately, we believe that this approach will make these lifesaving therapies available to many more patients in need.”
Quote from Professor Dror Harats, VP for Research & Development, Sheba Medical Center:
“Sheba Medical Center is proud to work with Lonza on this unique, cutting-edge Cocoon Platform. This groundbreaking technology will take us one step closer to mass manufacture of CD-19 CAR-T cells in order to save the lives of many critically ill cancer patients.”
Basel, Switzerland and Tel Aviv, Israel, 8 September 2020 – Lonza and Sheba Medical Center announced the first patient has been treated at Sheba Medical Center with a CD19 CAR-T cell immunotherapy manufactured using Lonza's Cocoon® Platform. The Cocoon Platform is an automated and functionally closed system for patient-scale cell therapy manufacturing, designed to overcome some of the manufacturing challenges of manually producing personalized medicines, including autologous CAR-T cell therapies.
With the goal of increasing access to innovative cell therapies, Sheba Medical Center and Lonza have collaborated to translate Sheba's open, manual manufacturing process into the Cocoon Platform since mid-2019. In less than a year, teams from Lonza Personalized Medicine and Collaborative Innovation Center (CIC) in Haifa, IL worked closely with Sheba Medical Center to complete process development, tech transfer, training and a full clinical comparability study requiring regulatory approval before the first patient could be treated. The successful approval of the Cocoon Platform clinical comparability study illustrates the platform's flexibility and ability to manufacture a final cell immunotherapy which is comparable to the original manual process while meeting the extensive patient safety criteria.
The current Phase II clinical trial2 at Sheba has successfully dosed over 100 patients over the last two years with positive clinical results. Sheba and Lonza plan to treat additional patients under the same CD19 CAR-T cell immunotherapy protocol using the Cocoon Platform. The Cocoon Platform will enable Sheba to reduce immunotherapy manufacturing costs by lowering manpower, time, and space requirements. It is hoped that this will ultimately allow Sheba to deliver potentially curative cellular immunotherapies to more patients.
1CE marking is a designation ensuring that products meet EU standards for health, safety, and environmental protection
2https://clinicaltrials.gov/ct2/show/NCT02772198?term=NCT02772198&draw=2&rank=1