CAR-T

Gilead Sciences subsidiary Kite Pharma has announced plans to open a new CAR-T manufacturing facility in Frederick County, Maryland (US).

The new 20-acre site will extend the firm’s ability to manufacture various CAR-T therapies including Kite’s cancer treatment Yescarta.

Tim Moore, Executive VP of Technical Operations at Kite, explained: “This new facility in Frederick County builds on our substantial technical capabilities and rapid progress in making personalised CAR-T and TCR cell therapies for people with cancer.”

It’s bad news for Scottish patients living with aggressive forms of non-Hodgkin lymphoma (NHL) as it emerges that the Scottish Medicines Consortium has chosen to reject Gilead’s CAR-T therapy Yescarta (axicabtagene ciloleucel).

The decision means that patients who may have exhausted all other avenues of treatment will not be able to receive the treatment on the NHS in Scotland, with many not expected to survive longer than six months in these cases.

NICE has announced another momentous decision for lymphoma patients in England and Wales:, recommending Novartis’ chimeric antigen receptor T cell (CAR-T) therapy Kymriah (tisagenlecleucel) for the treatment of adults with relapsed or refractory diffuse large B-cell forms of the condition (DLBCL) who have not responded or have relapsed after two courses of chemotherapy.

It is estimated that 200 patients will be eligible to access the treatment each year in England and Wales.

Takeda has revealed that it is set to bolster its novel immuno-oncology portfolio with three new research collaborations. The Japanese pharmaceutical firm has struck an alliance with the Memorial Sloan Kettering Cancer Center (MSK) in New York City, while also expanding two existing partnerships.

The deal with MSK will focus on the discovery and development of CAR-T drug products to treat blood cancers and solid tumours, including multiple myeloma and acute myeloid leukaemia.

Gilead has gone head to head with Novartis at the American Society of Hematology (ASH) Annual Meeting 2018, meeting the latter’s reveal of data on rival Kymriah with study findings of its own CAR-T therapy Yescarta (Axicabtagene Ciloleucel).

The findings revealed that after a minimum follow-up of two years after a single Yescarta infusion – and a median follow-up of 27.1 months – 39% of participants achieved an ongoing response in the treatment of refractory large B-cell lymphoma; in this group, 93% of those experiencing response at 12 months went on to maintain a response after 24

NICE has announced its recommendation that Novartis’ CAR-T cell therapy Kymriah (tisagenlecleucel) be made available in the treatment of relapsed or refractory B-cell acute lymphoblastic leukaemia (ALL) for patients under the age of 25 via the Cancer Drugs Fund.

Eligible patients within this age range will have proven unresponsive to current treatment – blinatumomab or chemotherapy – or relapsed following stem cell transplant, so it has been estimated that around 25 to 30 people will benefit from the decision in England each year.

Image Credit: Novartis

The Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Medicines Agency (EMA) approve Novartis’ CAR-T therapy Kymriah (tisagenlecleucel, formerly CTL019).

The blood cancer treatment gained FDA approval in August 2017 having initially been developed by researchers at the University of Pennsylvania. Following a recommendation from the CHMP, the CAR-T cell therapy will now be reviewed by the EMA for approval in the European Union.

CAR-T is emerging as one of the most potentially exciting therapies in the industry, particularly as a beacon for the collective push towards personalised treatment, so it is unsurprising that many small biotechs are currently pursuing treatments within this space.

The expense and laborious process involved in bringing CAR-T therapies to patients was used a key reason for the high cost of the treatments; now, the next step in the field is to find a way to speed up this process, whoever gets there first will have a big advantage.

With this in mind, Gilead has signed a deal with Sangamo Therapeutics that could be worth over $3 billion for the latter company, in a bid to strengthen its acquisition of Kite to gain a position on the market.

It seems like 2018 may well be the year for M&A that everyone had expected, as two major deals on the same day announced that acquisitions were back with a bang.

First, Sanofi managed to achieve a long-held goal of making a sizeable addition to its business and now Celgene has made the plunge to acquire Juno Therapeutics in a $9 billion deal.