Novartis and University of Pennsylvania form broad-based R&D alliance

NovartisNovartis and the University of Pennsylvania (Penn) announced today an exclusive global collaboration to research, develop and commercialize targeted chimeric antigen receptor (CAR) immunotherapies for the treatment of cancers. In addition, the parties will jointly establish a new research and development facility on the Penn campus, called the Center for Advanced Cellular Therapies (CACT).

"By combining Penn's expertise on this pioneering technology with Novartis' strength in bringing innovative therapies to patients, we have the potential to transform the future of cancer treatment," said Hervé Hoppenot, President, Novartis Oncology.

In CAR immunotherapy, immune cells (T cells) are drawn from a patient's blood. Then, using CAR technology, the T cells are re-coded to identify and seek out cells that express proteins present on a patient's cancerous tumor. When the T cells are re-introduced into the patient's blood, they bind to the targeted cancer cells and destroy them.

As part of the transaction, Novartis acquired exclusive rights from Penn to CART-19, a novel investigational CAR therapy, currently being studied by Penn in a pilot clinical trial. CART-19 targets a protein called CD19 that is associated with a number of B-cell malignancies such as chronic lymphocytic leukemia (CLL), B-cell acute lymphocytic leukemia and diffuse large B-cell lymphoma.

To accelerate the discovery and development of additional therapies using CAR immunotherapy, Novartis and Penn will build the Center for Advanced Cellular Therapies on the Penn campus in Philadelphia. This will be a first-of-its-kind research and development center established specifically to develop and manufacture adoptive T-cell immunotherapies under the research collaboration guided by scientists and clinicians from Novartis and Penn.

"This collaboration underscores our commitment to working with partners that are at the forefront of science and medicine," said Mark Fishman, President of the Novartis Institutes for BioMedical Research. "Immunotherapy is one of the exciting frontiers in cancer research and the CAR technology developed by the team at Penn has shown early promise as a new way for treating cancer."

Early results from a clinical trial of CART-19, conducted by Penn, showed potent antileukemic effects in three patients with advanced CLL who had previously undergone multiple courses of chemotherapy and biological therapy. Two of the patients were still in complete remission more than a year into the CART-19 trial, and the third patient maintained partial remission for more than seven months. An immune deficiency known as hypogammaglobulinemia, an expected chronic toxic effect, was corrected with infusions of intravenous immune globulin. Patients were also treated for symptoms associated with tumor lysis syndrome, an effect of tumor breakdown[1],[2]. Novartis expects to initiate a Phase II clinical trial with CART-19 in collaboration with Penn during the fourth quarter of 2012.

"Initial data provide proof that this CAR therapy can activate a patient's own immune system to fight cancerous tumors," said Carl June, MD, director of Translational Research and professor of Pathology and Laboratory Medicine in the University of Pennsylvania's Abramson Cancer Center and Perelman School of Medicine. "In partnering with Novartis, we aim to develop CAR therapies into commercial agents in the battle against cancer."

"Penn's intellectual resources combined with a pharmaceutical industry leader like Novartis offers a powerful symbiotic relationship in our mutual goal of finding more effective treatments for cancer," said J. Larry Jameson, MD, PhD, dean of the Perelman School of the Medicine at the University of Pennsylvania and executive vice president for the Health System. "With our shared commitment to rapidly advancing new therapies and cures, this new alliance will provide the support for the essential clinical trials with engineered T cells, which may open doors for use of this promising treatment option for cancer patients who have reached the end of currently available treatments."

Under the terms of the agreement, Penn grants Novartis an exclusive worldwide license to CARs developed through the collaboration for all indications and CART-19. In addition Novartis will provide an up-front payment, research funding, funding for the establishment of the CACT and milestone payments for the achievement of certain clinical, regulatory and commercial milestones and royalty payments.

About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2011, the Group achieved net sales of USD 58.6 billion, while approximately USD 9.6 billion (USD 9.2 billion excluding impairment and amortization charges) was invested in R&D throughout the Group. Novartis Group companies employ approximately 126,000 full-time-equivalent associates and operate in more than 140 countries around the world.

1. Porter DL, Levine BL, Kalos M, et al. Chimeric antigen receptor-modified T cells in chronic lymphoid leukemia. N Engl J Med. 2011 Aug 25;365(8):725-33.
2. Kalos M, Levine BL, Porter DL, et al. T cells with chimeric antigen receptors have potent antitumor effects and can establish memory in patients with advanced leukemia. Sci Transl Med. 2011 Aug 10;3(95):95ra73.

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