[This report has been updated from an earlier edition, to include comment from a Juno spokesman.]
Juno Therapeutics said today it will lease a Bothell, WA, facility as a manufacturing site for its cell therapy products.
The facility, set to begin operation “in early 2016” according to the company, will be designed to support Juno’s planned JCAR015 multi-center clinical trial, additional clinical programs in Juno’s pipeline, and the company’s first commercial products.
JCAR015 is Juno’s chimeric antigen receptor product candidate indicated for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia. JCAR015 is the subject of a Phase I trial for which researchers at Juno co-founder Memorial Sloan-Kettering Cancer Center (MSKCC) are recruiting patients. The trial is designed to determine the safety and appropriate dose of modified T cells in patients with ALL.
JCAR015 is one of three Juno CAR-T cell product candidates based on chimeric antigen receptor technology that employs the body’s immune system to attack cancer cells. JCAR017 is being tested at Seattle Children’s Hospital for relapsed/refractory CD19-positive pediatric leukemia.JCAR014 is being tested for refractory chronic lymphocytic leukemia, non-Hodgkin’s lymphoma and acute lymphoblastic leukemia at the Fred Hutchinson Cancer Research Center.
“The Bothell manufacturing facility is an important milestone for Juno,” said Hans Bishop, CEO and president of Juno. “The manufacturing expertise we are developing is key to our long term success, increasing our ability to run multiple clinical trials and commercialize our pipeline, and as a platform to introduce the various innovations we are investing in to optimize patient outcomes.”
Juno added that it will continue to work with its existing contract manufacturing partners to augment its manufacturing capabilities: “Among other advantages, this will enhance flexibility, provide redundancy, and increase capacity in a cost effective manner.”
A company spokesman, Andreas Marathovouniotis, told GEN that Juno's facility will be 67,799 square feet and was not the site being shut down by Amgen.
Last year, Amgen said it would close down its Bothell manufacturing site as well as its Seattle R&D campus overlooking Elliott Bay, as part of a restructuring announced in July. Amgen’s retreat jolted Washington state biopharma leaders, though they noted that the Seattle region had many advantages for the industry, from an experienced workforce to the presence of institutional employers and even numerous companies.
In its announcement today, Juno included a quote from Washington state Gov. Jay Inslee (D): “We are thrilled to have Juno as a part of our life science ecosystem and look forward to supporting the growth of this industry. The expansion of Juno Therapeutics' manufacturing presence in Washington state will increase Juno's ability to provide their potentially lifesaving treatments to more patients across the country and will produce high wage jobs in the region.”
Juno is a spinout of the Fred Hutchinson Cancer Research Center, having been launched in December 2013 by Fred Hutch, as well as MSKCC, and Seattle Children’s Research Institute.
In December 2014, Juno successfully closed on an initial public offering, raising about $265 million through the sale of 12.7 million shares of common stock at $24 per share, less discounts. That included 1.7 million additional shares of common stock issued upon the exercise in full by the IPO underwriters of their option to purchase additional shares at the public offering price.
Juno shares began trading under the symbol “JUNO” on The NASDAQ Global Select Market on December 19, 2014. Before the IPO, the company had privately raised more than $300 million from investors that include Amazon.com founder Jeff Bezos.
Also in December, Juno agreed to obtain a license from Opus Bio (formerly Lentigen) for a CAR-T cell product candidate targeting CD22—a protein expressed on most B cell leukemias and lymphomas. CD22 complements Juno’s existing CD19 directed portfolio.
In collaboration with Opus Bio, the National Cancer Institute (NCI) has already initiated enrollment in a Phase I trial evaluating the candidate in children and adolescents with relapsed/refractory acute lymphoblastic leukemia or non-Hodgkin’s lymphoma. The NCI-sponsored trial is designed to enroll patients with CD22 positive cancers, with both CD19 positive and CD19 negative patients eligible for treatment.