March 31, 2017
By Mark Terry, Breaking News Staff


Seattle Genetics (SGEN) announced that Karen Walker will be joining the company as vice president of Global Quality in mid-April. She was formerly vice president Global Head Cell and Gene Therapies Technical Development and Manufacturing at Novartis (NVS)

Particularly notable is that Walker is one of several recent high-profile defections from Novartis’s CAR-T operations. Walker is one of three senior executives who headed Novartis’ CAR-T initiative after, as John Carroll, writing for EndPoints News says, “a bruising restructuring over the summer in which the unit was chopped up and absorbed inside a huge R&D organization.”

The other two were Samuele Butera, who heads the commercial/business role, and David Lebwohl, who oversaw clinical operations.

On January 4, 2017, Alessandro Riva, Head, Global Oncology Development for Novartis Oncology (NVS), left the company to join Gilead Sciences (GILD) as senior vice president, Hematology and Oncology Therapeutic Area Head. Last summer, Usman ‘Oz’ Azam, the top executive in Novartis’ CAR-T division, left the company. That occurred around the same time as the reorganization, and approximately 120 staffers were laid off as well.

This news comes almost simultaneously with this week’s announcement that the U.S. Food and Drug Administration (FDA) had accepted Novartis’ Biologics License Application (BLA) filing and granted priority review for CTL019 (tisangenlecleucel-T), the company’s CAR-T product.

For some time, Novartis, Juno Therapeutics (JUNO) and Kite Pharma (KITE) were neck-and-neck in a race to be the first to get a CAR-T product to market. Juno was the leader for a while until a series of five high-profile deaths in its program last year slowed its progress. Then, as of this week, Juno abandoned its problematic JCAR016 program to focus on another CAR-T program, JCAR017 for diffuse large B cell lymphoma.

Kite’s focus is on non-Hodgkin’s lymphoma. It plans a submission for its own BLA soon.

Carroll notes, “Manufacturing in this field is critical. To make this therapy, physicians extract cells from cancer patients and then reengineer them with a chimeric antigen receptor to guide them to attack cancer cells. The revised cells are then injected back into patients. To be competitive, a company has to prove not only that they know how to make the therapy, they also have to be able to turn it around quickly to use.”

It’s a logistical issue, tracking the patient cells, engineering them, returning them, all while providing high-level quality control and assuring the correct cells are returned to the correct patient.

CAR-T appears to be very effective in certain types of cancers—particularly blood cancers. The most common, and potentially lethal, side effect to CAR-T therapies is cytokine release syndrome (CRS). The most severe cases are called cytokine storms. They result in a systemic inflammatory response similar to those seen in severe infections, basically behaving like a non-infective fever, and can cause pulmonary edema, which is what killed most of the patients in Juno’s trial fatalities.

Novartis seems to have avoided that problem. Although it noted that 48 percent of the patients in its ELIANA clinical trial had grade 3 or 4 cytokine release syndrome, there were no fatalities. The company stated, “CRS was managed per protocol on a global scale using prior site education with implementation of the CRS treatment algorithm. There were no deaths due to CRS.”



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