"Have you ever seen a race car that looks like it is competing with leaders up front but in reality is a lap down? That's Juno right now." -- Brad Loncar.
Loncar, a healthcare investor and manager of a cancer immunotherapy fund, found a perfect analogy to describe the problems weighing on Juno Therapeutics (JUNO) as it struggles to compete against Kite Pharma (KITE) and Novartis (NVS) to develop engineered T cell therapies known as chimeric antigen receptor T cells, or CAR-T.
On Saturday at the American Society of Hematology (ASH) annual meeting, Novartis showcased a 60% complete response rate at six months from a pivotal clinical trial of CAR-T CTL019 in children and young adults with B-cell acute lymphoblastic leukemia.
An approval filing for CTL019 with the U.S. Food and Drug Administration is targeted for early 2017, Novartis said.
That timeline puts Novartis on an equal footing with Kite Pharma, which has already announced FDA filing plans for its CAR-T KTE-C19 in the first quarter 2017. KTE-C19's initial marketing application will target treatment of several forms of aggressive lymphoma.
Juno spent the weekend at the ASH meeting trying to defend its CAR-T pipeline from documented reports of patient deaths and neurotoxicity that forced lead product JCAR015 into a second clinical hold.
The company now finds itself one year, if not two years or more, behind Novartis and Kite.
In an interview at the ASH meeting on Saturday, Steve Harr, Juno's chief financial officer and head of corporate development, said JCAR015 remains on clinical hold while the company seeks to determine if JCAR015 caused two new cases of fatal brain swelling in adults with acute lymphoblastic leukemia. Three other leukemia patients treated with JCAR015 died from toxic side effects in July.
JCAR015 might be shelved permanently if the safety risk to patients, even for those with no other treatment options, is found to be unacceptable, Harr said. Juno might also try to get JCAR015 off clinical hold and start treating patients again if changes to the CAR-T or the way it is administered can be made, he added.
Juno is holding an investor and analyst meeting on Monday night but there won't be any announcement about the final fate of JCAR015, Harr said.
It might be a moot point because investors have largely written off the troubled product, believing Juno will have no choice but to discontinue development and move on to other CAR-Ts in its pipeline.
Juno shares are down 53% year to date and trade near an all-time low.