For any company entering the immunotherapy field, manufacturing and logistics are huge challenges. At newly formed Juno Therapeutics, they have a plan to overcome these obstacles--find a CEO who has done it before and back him with $120 million.
The Seattle-based startup has raised a massive amount of Series A funding and named Hans Bishop, the man who built Dendreon's ($DNDN) manufacturing network, as CEO. Although Dendreon has struggled to control the cost of producing its cancer vaccine Provenge, the fact that it even managed to manufacture it on a commercial scale is remarkable. Before Dendreon, some thought it was virtually impossible. Now Bishop will take this experience and try to build Juno into an immunotherapy powerhouse.
Major manufacturing challenges lie ahead, but the people behind the startup were wowed enough by the data to commit big bucks to working round the issues. "Once I saw the data behind Juno, it was a matter of saying 'OK, how are we going to make this work? There is no other choice. It's compelling enough so that there's no choice but to make it work," venture capitalist Bob Nelsen told Xconomy. Juno is based on discoveries from Fred Hutchinson Cancer Research Center and Memorial Sloan-Kettering Cancer Center.
Both organizations--which along with Seattle Children's Research Institute have stakes in Juno--possess manufacturing capabilities built using federal grants and philanthropic support. Even so, the process for producing therapies in Juno's pipeline is fraught with difficulties. The chimeric antigen receptor-modified T cells (CART) approach, one of two pursued by Juno, involves taking blood from a patient and enriching it to find the desired T cells. Performing gene therapy on these cells equips them to target the cancer.
From blood withdrawal to infusion of the tweaked T cells takes 15 days. If Juno is to fulfill its ambitions, it must scale up this process from small, single-site trials to global, commercial distribution. Shipping of the blood to and from processing sites is just one of the challenges. The manufacturing facilities must also try to prevent blood mix-ups which could cause a patient to be given someone else's T cells.