Juno Therapeutics Enters Battle Over CAR Cancer Immunotherapy Technology
This article was originally published in The Pink Sheet Daily
Executive Summary
University of Pennsylvania seeks court order that its cancer immunotherapy does not infringe St. Jude’s patent; Juno, which licensed the patent for the potential leukemia treatment, has joined the settlement talks.
Juno Therapeutics Inc.’s intervention into a dispute between the University of Pennsylvania and St. Jude Children's Research Hospital may help resolve who owns rights to specific chimeric antigen receptor (CAR) technologies to treat cancer.
The Trustees of the University of Pennsylvania filed suit against St. Jude in March 2013 seeking a declaratory judgment that the university is not infringing St. Jude’s patent 8,399,645 and that the claims of the patent are invalid. The patent, issued on March 19, relates to a chimeric receptor capable of signaling both a primary and a co-stimulating pathway.
“St. Jude Children’s Research Hospital is confident in the validity of the recent patent awarded to us by the U.S. Patent and Trademark Office for a groundbreaking innovation enabling human immune cells to recognize and attack certain cells that cause leukemia and other cancer,” a St. Jude spokesperson said in an email.
The technology is important to Juno, which obtained an exclusive license to St. Jude’s patented CAR technology for cancer immunotherapies in a Dec. 3 agreement.
“Juno has paid a significant sum for the right to exclude others from making, using, or selling products covered by St. Jude’s patented technology,” Juno stated in a memorandum in support of its motion to intervene. “Maintaining the validity of the ‘645 patent is vital to protecting Juno’s investment in the patent; if the patent is declared invalid, Juno will effectively lose its investment.”
“In addition,” Juno stated, “defending Penn’s claim that its activities do not infringe the ‘645 patent, and defining the scope of activities that do infringe the ‘645 patent, is vital to preserving Juno’s interest in excluding others form making, using, or selling the patented technology.” The court granted Juno’s request to intervene on Dec. 18.
The terms of Juno’s licensing agreement with St. Jude, which was submitted to the court under seal, are not public.
CAR Immunotherapy Has Eliminated Cancer In A Few Patients
Juno noted that as of the date of its agreement with St. Jude it is responsible for 80% of the expenses incurred in the litigation, while St. Jude is responsible for the remaining 20%. After reimbursement of St. Jude’s litigation costs to date, any net recovery will be shared, with 70% of the proceeds going to Juno and 30% to St. Jude.
Juno, a partnership between three leading cancer centers – Fred Hutchinson Cancer Research Center, Memorial Sloan Kettering Cancer Centerand Seattle Children's Research Institute – was launched on Dec. 3. It is focused on developing CAR technology, which is designed to target cell surface antigens expressed on cancer cells, and T cell receptor technology to detect alterations in intracellular proteins present in tumor cells (Also see "Embracing Rival Programs, Juno Ventures Forth With Talk Of Cancer Cure" - Pink Sheet, 9 Dec, 2013.).
The University of Pennsylvania states in its amended complaint that Carl June, director of the university’s Translational Research Program, developed a “groundbreaking immunotherapy for treatment of cancer (the ‘Penn Immunotherapy’).” It says the immunotherapy involves use of a CD19 ScFv DNA lentiviral construct that, using proprietary technologies that June and his colleagues developed while at the university, “causes T cells to express chimeric antigen receptors in patients such that their cancer is treated.”
June’s lab created T-cells that express the receptor CART 19, a synthetic fusion protein consisting of antibodies that attach to the CD-19 protein commonly expressed in chronic lymphocytic (CLL) and other B-cell mediated leukemias. In 2011 he and his group reported the first three clinical experiences using a first-generation anti-CD-19 drug candidate to treat patients with advanced CLL.
All three patients responded to a single infusion of treatment, two completely and one partially. The findings led to a deal with Novartis AG (Also see "A New Industry-Academic Model: Novartis And Penn Make A Splash In Cancer Immunotherapy" - In Vivo, 26 Nov, 2012.).
Other academic groups are also working on chimeric antigen receptor programs, including Memorial Sloan-Kettering, which announced in March that five leukemia patients receiving treatment based on its scientific breakthrough had a “complete response,” i.e., the disappearance of their cancer.
Did U Penn Develop Its Immunotherapy With St. Jude’s Biological Material?
In a separate dispute, St. Jude filed a complaint against the University of Pennsylvania in July 2012 alleging that the university breached two materials transfer agreements related to St. Jude’s provision of biological material to the university and June. The material included an anti-CD19 chimeric T-cell receptor construct which St.Jude said was created in the lab of its researcher Dario Campana, who has since left St. Jude. That complaint was consolidated with the University of Pennsylvania’s suit.
In a Dec. 20 answer to Penn’s amended complaint, Juno said the university “has failed to describe with any specificity the nature of the purported ‘Penn Immunotherapy.” It alleged that the immunotherapy contains or was developed using material as defined in the materials transfer agreements.
A spokesperson for St. Jude said that under the terms of the two material transfer agreements, St. Jude provided the University of Pennsylvania with an innovative molecular receptor now covered by the ‘645 patent.
Penn said that it could not comment on ongoing litigation.
In November, Judge Stewart Dalzell, of the U.S. District Court for the Eastern District of Pennsylvania, denied Penn’s motion for partial summary judgment with respect to the validity of the ‘645 patent. The judge will hold a status conference with the parties on Jan. 28.
The case may settle before it goes to trial. In its memorandum seeking to intervene, Juno noted that it is participating in ongoing settlement discussions with St. Jude and Penn.