Few biotech startups have burst onto the scene like Juno Therapeutics. The Seattle company secured $310 million in private financing in less than a year, budding out of cancer immunotherapy work at three of the nation’s premier cancer centers in New York and Seattle.
With that type of momentum, it was only a matter of time until Juno took itself public. And today Juno is showing it’s ready to take the plunge.
Juno filed for an IPO this morning, aiming to trade on the Nasdaq under the ticker symbol “JUNO.” The stock sale would help finance the work Juno’s doing to develop cell-based cancer immunotherapies—removing a sick patient’s own T cells, engineering them into better cancer killers, and infusing them back into a patient. Juno, for those unfamiliar, is doing this in two ways: chimeric-antigen receptor T-cell therapy, or CAR-T for short, and high-affinity T-cell receptors, or TCRs. The former strategy targets certain proteins on the surface of tumor cells; the latter, specific proteins inside or on the surface of those cells.
Juno has three drug candidates it is testing in clinical studies. They’re known as JCAR014, JCAR015, and JCAR017. Juno aims to start its first Phase 2 study by the end of next year, a study in relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) it believes could support a filing for accelerated approval from the FDA—as in, on a speeder timeline and on a thinner body of evidence than usual—assuming, of course, all goes well in that trial. The company is also planning Phase 1 trials in Non-Hodgkin’s lymphoma, and for “at least four different cancer-associated proteins” in blood cancers and solid tumors, according to its IPO prospectus.
So far, Juno has reported early data from two of its therapies. In an ongoing Phase 1 study, JCAR015 wiped out the cancer of 20 of the 22 evaluable patients with relapsed/refractory ALL And of six patients in the early portion of a Phase 1/2 study in pediatric ALL, five of them had complete remissions, or no trace of cancer in their blood. Juno will continue that study, and plans to start an additional Phase 1 study of JCAR017 in relapsed/refractor B cell non-Hodgkin’s lymphoma next year.
Juno hasn’t reported data from its third prospect, JCAR014, as of yet, though it’s testing the treatment in patients with a variety of B cell malignancies and expects to report data before the end of the year.
All three of these candidates are CAR-T therapies that target CD-19, a protein on the surface of tumor cells; Juno has yet to put its first TCR treatment into clinical trials, though it aims to by the end of 2015. It’ll use the IPO cash to fund its ongoing trials, expand its internal R&D efforts, and potentially to make acquisitions of its own.
Juno was formed by Arch Venture Partners and the Alaska Permanent Fund (the state of Alaska’s oil revenue fund) in December around technologies out of the Fred Hutchinson Cancer Center and Seattle Children’s Hospital in Washington, and Memorial Sloan-Kettering Cancer Center in New York. It closed a $176 million Series A round less than five months after it launched, and then added a $134 million Series B over the summer. At the time of its last round, Arch managing director and Juno co-founder Bob Nelsen told Xconomy that Juno had amassed the shareholder base “of a commercial operating company with a $50 billion market cap.” Some 10 public mutual funds and healthcare-focused funds participated in the round, which clearly set the stage for a looming IPO.
Juno is one of several entities in an arms race to harness the tantalizing potential of CAR-T treatments. Others include Carl June’s group at the University of Pennsylvania, which is collaborating with Novartis; Summit, NJ-based Celgene (NASDAQ: CELG), via a deal with Cambridge, MA-based gene therapy company Bluebird Bio (NASDAQ: BLUE); and Santa Monica, CA-based Kite Pharma (NASDAQ: KITE), which recently banked $128 million in one of the biggest biotech IPOs of the year. Pfizer also recently cut a deal with Paris-based Cellectis to tap into its CAR-T work. A new startup from Atlas Venture, Unum Therapeutics, is also trying its own approach to T-cell therapy for cancer as well.
Juno is also involved in a legal tussle with June’s group over IP in the CAR-T field. A trial is set to begin in April, filings show.
While the prospects of CAR-T and TCR are massive, it’ll be awhile before it’s actually proven that these procedures are safe and effective—not to mention affordable to scale to manufacture. CAR-T therapies have already had their hiccups, with patients in some studies experiencing cytokine release syndrome—a toxic immune response that can occur when a treatment essentially kicks the immune system into overdrive, triggering widespread, potentially life-threatening, inflammation. Juno’s IPO prospectus showed that in the JCAR015 study, 9 of the 23 adults with ALL experienced CRS. That’ll be closely watched moving forward.
Juno’s primary backers are CL Alaska and JT Line Partners, two funds that own 34.75 percent of the company combined. Arch (15.17 percent) and the Hutch (5.17 percent) also hold sizeable stakes. Juno had about $238 million in cash on hand as of Sept. 30.
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