Gilead Sciences announced today plans to enter the cell therapy space through the acquisition of Kite Pharma, a California-headquartered cell therapy maker with a lead product – axicabtagene ciloleucel (axi-cel) for refractory diffuse large B-cell lymphoma – awaiting regulatory approval in the US and Europe.
The $11.9bn (€10bn) deal, expected to close in the fourth quarter this year, propels Gilead into the cell therapy space “and provides a foundation from which to drive continued innovation for people with advanced cancers,” CEO John Milligan said in a statement.
“The field of cell therapy has advanced very quickly, to the point where the science and technology have opened a clear path toward a potential cure for patients.”
Gilead will also add a chimeric antigen receptor (CAR) T-cell manufacturing facility in El Segunda, California which opened in June last year and has the capacity to produce volumes of the autologous therapy for up to 4,000-5,000 patients per year.
The product is made by isolating peripheral blood mononuclear cells, including T-cells, from the patient’s own white blood cells. These are then sent to El Segunda where they are stimulated to proliferate and transduced with a retroviral vector to introduce the CAR sequence into the patient’s T cells before being propagated in cell culture bags.
Once there are a sufficient number of cells available for infusion back into the patient, they are washed and frozen at the cell processing site before being shipped back to the clinical centre where they can be administered to the patient. The process takes an average of 17 days from receipt of the patient’s white blood cells.
Axicabtagene ciloleucel was submitted to the US Food and Drug Administration (FDA) under priority review earlier this year and has an action date of November 29. If successful, it will become the second CAR T-cell therapy to be recommended for approval by the Agency after Novartis’s CTL019 (tisagenlecleucel) was unanimously endorsed in July.
And last month, Kite Pharma became the first firm to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Axicabtagene ciloleucel.