Juno takes the manufacturing plunge in a high-stakes CAR-T race

Depiction of CAR-T cell--Courtesy of Juno

High-profile cancer startup Juno Therapeutics ($JUNO) is spending money on a manufacturing facility of its own, leasing a Washington plant to produce its complex cell therapies for clinical trials and keep pace with rival Novartis ($NVS).

The Seattle company has largely relied on contract manufacturers to supply its early-stage trials, but, with its breakthrough-designated lead candidate headed for a multicenter study, Juno wants to vertically integrate. The new facility is slated to come online in 2016, the biotech said, in time to churn out doses of the blood cancer-treating JCAR015.

Juno, a 2014 Fierce 15 honoree, is a leader among companies developing treatments that promise to change the standard of care for blood cancers. The biotech's candidates are CAR-T immunotherapies, made through a process in which scientists remove T cells from a patient's blood and equip them with targeting mechanisms called chimeric antigen receptors (CARs), which seek out and bind to proteins expressed by cancer cells. The resulting cells are reinjected into the patient, at which point they track down malignancies and attack them as they would any commonplace infection.

The complexity of that process makes manufacturing a particularly important aspect of Juno's mission, and the biotech's plan to take a slew of candidates through clinical development will depend on its ability to reliably generate modified T cells. Beyond JCAR015, Juno has ambitious plans to get 10 therapies into the clinic over the next year, and establishing a manufacturing foothold will help the fledging company grow into its potential, CEO Hans Bishop said.

"The Bothell manufacturing facility is an important milestone for Juno," Bishop said in a statement. "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."

The company is in a race with Novartis, which is developing a similarly promising Phase I CAR-T therapy alongside the University of Pennsylvania. The fast-crowding space also includes Kite Pharma ($KITE), which grossed more than $140 million in a 2014 IPO on the strength of its approach to T cell modification, and Bellicum Pharmaceutials ($BLCM), which went public last year with a proprietary spin on the technology. Heavyweights including Celgene ($CELG), Johnson & Johnson ($JNJ) and Pfizer ($PFE) have also made their way into the space with biotech partnerships over the last two years.

- read the statement

Special Report: FierceBiotech's 2014 Fierce 15 - Juno Therapeutics

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