July 14, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Despite a recent bad news/good news situation with Seattle’s Juno Therapeutics , or maybe because of it, the company has increased its staff by almost 50 percent this year, jumping from 307 in December to its current headcount of 450.
As for the good news/bad news, on July 7, the U.S. Food and Drug Administration (FDA) placed a clinical hold on the company’s Phase II clinical trial of JCAR015, a CAR-T therapy for patients with relapsed or refractory B cell acute lymphoblastic leukemia. This was the result of three patients deaths apparently connected to a chance in the company’s trial protocol.
JCAR015 involves taking T-cells from the patient, genetically engineering them to attack the patient’s cancer cells, and infusing them back into the patient. In order for that to work, patients are first given a cocktail of chemotherapy drugs before the infusion to wipe out their existing T-cells. During the earlier parts of the, the cocktail was primarily made up of cytoxan. Because the company noted improvements in the new T-cells gaining a foothold when they added fludarabine to the cocktail, that was added to the cocktail.
However, all three deaths, which were caused by cerebral edema, or swelling in the brain caused by excess fluid, were linked to the addition of fludarabine.
Juno provided more data to the FDA and requested the hold be lifted if they take the fludarabine out of the protocol. On July 13, the FDA agreed.
Juno has two ongoing clinical trials, one for JCAR015, and the other for JCAR017. There are also 10 other trials in play with other companies that utilize Juno therapies.
In addition, the company has plenty of cash. Last year it inked a deal with Celgene , resulting in Juno wrapping 2015 with $1.22 billion in cash. That collaboration will last 10 years, involved an upfront payment of $150 million in cash, and Celgene acquired 9,137,672 shares of Juno common stock for $93 per share.
In January, Juno acquired a Harvard spinout, AbVitro, for $125 million in cash and stock. That didn’t take much of a bite out of its war chest.
AbVitro offers technology that can sequence single T-cells and B-cells, which would be in total alignment with Juno’s focus.
Most of the new jobs have been scientific jobs. The Puget Sound Business Journal also points out that Bothel, Washington-based Seattle Genetics is also adding 100 staffers in the U.S., and about 20 in Switzerland. Those staffers will primarily be in operations, as opposed to research. Clay Siegall, Seattle Genetics’ chief executive officer, said that they have hired approximately 100 people each year for the last five years.
Seattle Genetics recently announced its drug, Adcetris, to treat adult patients with CD30+ Hodgkin lymphoma, had received marketing authorization by the European Commission. Adcetris was developed in collaboration with Takeda Pharmaceutical Company .
