- Novartis has signed a deal with cold chain specialist Cryoport to provide cryogenic logistics and shipping support for the expected launch of the Swiss pharma's CAR-T therapy tisagenlecleucel-T
- The deal lays out an initial three-year term, during which Cryoport will provide Novartis with use of its shipping and chain-of-custody monitoring systems.
- Based in Irvine, CA, Cryoport already works with Kite Pharma and other cell therapy developers such as Bluebird Bio and Bellicum Pharmaceuticals. Novartis' tisagenlecleucel-T looks set to become the first CAR-T therapy to reach markets later this year and Kite is not far behind — good business for Cryoport if all goes according to plan.
As the clinical science behind CAR-T has matured, attention has turned to the complicated shipping and manufacturing hurdles that have to be met to ensure a safe and reliable supply.
Both Novartis' and Kite Pharma's treatments are autologous cell therapies — meaning T-cells must be collected from each patient, shipped to manufacturing sites,engineered to target tumors cells and then speedily returned and reinfused back into patients.
Key to this process for Novartis is the cryopreservation of the apheresed materials, enabling the company to ship the starting cell material to its production sites in New Jersey and Germany.
The deal with Cryoport will allow Novartis to access the logistics company's shipping containers, condition monitoring system and logistics management platform.
Cryopreservation of the cell material also gives physicians and patients flexibility in sequencing treatment — an advantage Vas Narasimhan, Novartis' global head of drug development, highlighted on a second quarter earnings call.
In clinical trials of tisagenlecleucel-T, Novartis shipped the engineered cells to 25 study sites in North America, Europe and Asia. Approval of the treatment would test Novartis' ability to scale further and ramp up commercial production.
Novartis hopes to bring its commercial vein-to-vein turnaround time to 22 days, slightly longer than the 16 or so days Kite Pharma is targeting with its own CAR-T therapy axi-cel.
The FDA is expected to decide on approval of Novartis' tisagenlecleucel-T in relapsed/refractory acute lymphoblastic leukemia by September, while Kite could see a decision on axi-cel by the end of the year in non-Hodgkin lymphoma.