m3n4.net September 25, 2018

Engineering Immune Cells to Treat Cancer — CAR T Cells

01 September 2017, 01:44 | Louis Holland

First gene therapy coming to US after FDA approval

Novartis' CAR-T gene therapy, the first approved by FDA, to be priced based on cancer patients' outcomes

The FDA approved the first-ever gene therapy in the United States on Wednesday.

Known as gene therapy, the treatment involves removing immune cells called T cells from the patient's blood and then genetically altering them in a lab.

The complexity of the treatment, involving the harvesting the patient cells and the subsequent genetic editing, is undoubtedly time-consuming and labor-intensive, so it remains to be seen how widely this kind of customized gene therapy could be rolled out. Novartis came up with the gene therapy with the University of Pennsylvania.

"We're entering a new frontier in medical innovation with the ability to reprogram a patient's own cells to attack a deadly cancer", FDA Commissioner Scott Gottlieb said in a statement.

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Kymriah has a $475,000 price tag; however, patients who do not respond within a month of treatment will not be charged, according to Novartis. The FDA has taken necessary steps to check the side effects that are generated due to the CAR-T treatment. After being infused back into patients' bodies, these newly built "hunter" cells both multiply and attack, targeting cells that express a protein called CD19. Satwani - who hasn't delivered the CAR-T therapy himself but is heading up the program at Columbia, one of the 32 sites that Novartis will use - said patients need to be closely monitored for a month or so, meaning they'll need to be less than a two hour drive away from their hospital.

Many patients in the ALL trials experienced a side effect called cytokine release syndrome (CRS) including grade 3 or grade 4, which includes varying degrees of flu-like symptoms, with high fevers, nausea, and muscle pain, and temporary neurologic symptoms, including delirium, but also low blood pressure and breathing difficulties requiring ICU-level care in the most severe cases. This also applies to those patients of this particular leukaemia who have suffered a relapse of the cancer. "The therapies that we're using to treat children 20 years from now will emerge from the investment in science that we make today".

The treatment will only be used once and is made custom for each patient.

"This transformational therapy for patients is the result of true collaboration between industry, academia, healthcare professionals, patients and caregivers", said Bruno Strigini, CEO, Novartis Oncology. About 3100 people under age 21 are diagnosed with ALL each year in the United States, though most respond to standard therapy.

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Shares of Gilead Sciences Inc, which this week announced an $11.9 billion deal to buy Kite Pharma, were up 6.2 percent to $80.47 on Wednesday afternoon, as Kite is widely expected to receive the next USA approval of a CAR-T therapy for a different blood cancer. Instead of getting a better, updated therapy for a disease every decade or so, we might begin to see second-generation cell therapies in a few years. "Through our collaboration with Novartis, we are creating the next wave of immunocellular cancer treatments, and are eager to progress CAR-T therapy in a host of haematologic and other cancer types".

Kymriah is the first CAR-T cell therapy to get approved, and there are several more in the works.

Over the last few years, CAR-T cell research has exploded, and there are now nearly 300 clinical trials underway experimenting with the treatment.

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