Gilead, which has already seen success with an autologous CAR-T therapy, says it hopes to submit an Investigational New Drug (IND) request for an off-the-shelf product in 2019.

In August 2017, Gilead Sciences acquired Kite Pharma for $11.9 billion (€10.5 billion). Weeks later, the firm became only the second to receive US Food and Drug Administration (FDA) approval for a chimeric antigen receptor (CAR) T-cell therapy through the Kite-developed product Yescarta (axicabtagene ciloleucel).

Yescarta is an autologous product, meaning it is made from a patient’s own cells. After isolating peripheral blood mononuclear cells – including T-cells – from the patient’s white blood cells, they are sent to the firm’s manufacturing facilities for proliferation and transduction with a retroviral vector. Once the CAR sequence is introduced into the patient’s T cells, they are grown in cell culture bags, washed and sent back to a clinical center to be administered back into the patient.

AFter success with an autologous CAR-T product, Gilead is aiming for ‘off-the-shelf’ therapies. Image: iStock/Bulat Silvia

But now Gilead/Kite is looking at developing allogeneic – or off-the-shelf – CAR-T products.

IND next year

Speaking at the Evercore ISI HealthCONx Conference 2018 last month, John McHutchison, chief scientific officer and head of R&D, said Gilead has an allogeneic program and is hoping to submit an IND application to the FDA next year.

“We have our own allogeneic program. Many of the things that we brought in-house after the acquisition of Kite was for that particular approach,” he said.

Allogeneic cell therapies come from healthy donor cells or from renewable stem cells and aim to provide a treatment option that can be accessed directly within an oncology infusion center, reducing the time to infusion for patients.

“It’s early days, it’s preclinical… but we are encouraged and if things go according to plan I am hopeful that the organization could file an IND next year.” The candidate would be for the same target as Yescarta, CD19, it was confirmed.

He noted Gilead’s allogeneic platform was brought about by its collaboration with Sangamo Therapeutics. The potential $3 billion deal struck in February gives Gilead/Kite access Sangamo’s zinc finger nuclease (ZFN) technology to modify genes for both autologous and allogeneic cell therapies.