June 5, 2017 / 9:42 PM / 3 months ago

UPDATE 1-Kite to launch mid-stage leukemia trial in fourth quarter 2017

(Add details of Juno trial, share prices)

By Deena Beasley

CHICAGO, June 5 (Reuters) - Kite Pharma Inc and Juno Therapeutics Inc on Monday presented new data for their experimental T-cell therapies, but investors were not overly impressed and shares of Juno fell nearly 11 percent.

Both companies are developing drugs in a new class called chimeric antigen receptor T-cells (CAR-T) using a complicated process of extracting immune system T-cells from an individual patient, altering their DNA to sharpen their ability to spot and kill cancer cells, and infusing them back into the patient.

Both Juno and Kite are developing CAR-Ts that target a protein called CD19 found on cancerous blood cells.

Juno, which earlier this year gave up on developing CAR-T candidate JCAR015 for acute lymphoblastic leukemia after toxicities and patient deaths, presented early trial results at a meeting in Chicago of the American Society for Clinical Oncology for another candidate, JCAR017, as a treatment for non-Hodgkin lymphoma (NHL).

Juno said that of 32 evaluated trial patients, 66 percent responded to the drug. But 18 percent suffered severe neurotoxicity and one patient died, although the company said the death was not attributed to the CAR-T treatment.

"They needed to hit a grand slam home run given how far behind they are in NHL and I don't think this data did that," said Brad Loncar, manager of the Loncar Cancer Immunotherapy ETF .

Kite's CAR-T, called axi-cel, is already under review by the U.S. Food and Drug Administration for treatment of advanced NHL.

Shares of Juno fell nearly 11 percent to close at $23.40 on the Nasdaq exchange, while shares of Kite fell 2.5 percent to close at $73.61.

Kite presented data showing that axi-cel induced remission in 73 percent of 11 evaluated patients with relapsed acute lymphoblastic leukemia (ALL) and said it plans to launch a Phase 2 trial in the fourth quarter of this year, possibly at a lower dose than is currently being tested.

In the current trial, Kite said 27 percent of patients had severe cytokine release syndrome (CRS), a potentially life-threatening inflammatory condition, and 55 percent suffered serious neurological problems.

As previously reported, one patient died due to CRS.

Kite said that to improve safety, more patients would be given the anti-inflammatory drug Actemra after their infusions, and it would test a lower 500,0000-cells-per-kilogram dose of the CAR-T cells.

In the current ALL trial, patients are given either 2 million- or 1 million-cells-per-kg of body weight.

"Our assessment is that there isn't much difference between those two - no loss of efficacy, so we decided to look at one more dose of 500,000 cells per kg," Kite Chief Executive Officer David Chang said.

Reporting by Deena Beasley; Editing by Peter Cooney and Dan Grebler

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