Novartis move damages CAR-T confidence

Novartis is to disband its cell and gene therapy unit, which is developing revolutionary CAR-T cancer immunotherapies, the move denting confidence in the potential next generation of treatments in this field.

The Swiss company is seen as a frontrunner in CAR-T with the research the unit, and around 400 jobs have been affected, although most staff are to be redeployed, according to reports.

The Swiss firm has been working with the University of Pennsylvania and has advanced one CAR-T therapy, CTL019, to the point where it plans filings for paediatric acute lymphoblastic leukaemia in the US and EU next year.

Marketed immunotherapies such as Bristol-Myers Squibb's Opdivo (nivolumab) flip biochemical switches to instruct T-cells to attack cancers.

CAR-T (Chimeric Antigen Receptor T-cells) takes this approach one step further by genetically modifying the patient's T-cells to attack the cancers.

Confidence in other companies in the field has also taken a knock, with shares in Juno Therapeutics and Kite Pharma falling after critical assessments of their prospects by analysts BTIG earlier this week.

Juno's research has run into trouble recently, where a phase 2 trial was put on hold due to three patient deaths. This was attributed to a pre-conditioning drug and the trial of JCAR015 has been restarted with a new protocol omitting use of fludarabine.

There are concerns about the side-effects of CAR-T, which can cause a “cytokine storm”, an extreme immune reaction in patients, with potentially lethal consequences.

But Juno's trial continues and Novartis said organisational shake-up will not affect plans, to file CTL019.

Celgene signed a 10-year deal Juno to develop CAR-T therapies last year, and new CEO Mark Alles told pharmaphorum in an interview earlier this year that these therapies could be as effective as a “surgical intervention” in some cancers.

With its new leader speaking so positively about the potential of CAR-T, it seems unlikely that Celgene will give up on this area of research unless there is a major setback.

Cell therapy expert and blogger, Paul Rennert, tweeted that Novartis' departure from CAR-T had been “common coffee shop knowledge for six months or more.”

https://twitter.com/PDRennert/status/770953746926956544

Rennert is clearly a man in the know – but the news was enough to start speculation about whether there were issues with Novartis' research and about Kite, which is expected to announce progress in investor conference calls this month.