- Juno Therapeutics Inc. has inked a long-term deal with Thermo Fisher Scientific to secure supply of a key component used in the production of the biotech's CAR-T cell therapies.
- The seven-year agreement with Thermo Fisher gives Juno access to a type of reagent made by the life sciences giant that activates and expands the genetically modified T cells before infusion back into a patient.
- While few details were disclosed, the partnership is another step in Juno's efforts to build out its clinical and commercial manufacturing capabilities as development of its cell therapy candidates gathers momentum.
In CAR-T therapy, patient T cells are extracted through a process known as leukapheresis, engineered ex vivo to target a specific protein found on the surface of B-cell cancers and then reinfused back into the patient.
As the starting material from each patient is by nature variable, producing a cell product that delivers a consistent therapeutic effect requires some engineering. Part of that process is activating the extracted T cells and, following genetic modification, expanding the engineered cells to sufficient numbers to create a product.
Through the deal with Thermo Fisher, Juno will gain non-exclusive access to the scientific instrument maker's "CTS Dynabeads," a type of magnetic beads that act as an activation reagent for T cells. A statement from Juno indicated the licensing and supply agreement would cover both clinical and commercial manufacturing.
Juno manufactures its lead JCAR017 candidate at its manufacturing facility in Bothell, Washington, which would be tapped for commercial production as well if JCAR017 were to win U.S. approval.
Positive data from Juno's TRANSCEND study, released at the annual meeting of the American Society of Hematology earlier this month, showed competitive safety and efficacy in a type of B-cell lymphoma. The biotech expects to file sometime in the second half of 2018, and says approval could come as soon as the end of next year.
Juno believes manufacturing could be a competitive edge as it looks to challenge rival treatments from Novartis AG and Gilead Sciences Inc. in lymphoma. In particular, JCAR017's defined cell composition — indicating a fixed ratio of CD4 and CD8 T cells used in the final cell product — could result in a more precise dose, Juno says.
How quickly CAR-T companies are able to turn around a finished cell product after leukapheresis will be another area of competition. Juno is initially targeting a commercial turnaround time of less than 21 days, which is slightly longer than Gilead's expected time but on par or better than Novartis'.