Cellular Therapeutics bags immune cell production contract

Specialist manufacturer Cellular Therapeutics has been awarded a contract from the UK Cell Therapy Catapult to produce a new cell-based cancer therapy.

The immuno-oncology therapy is based on T lymphocytes harvested from patients with blood cancer such as acute myeloid leukaemia and myelodysplastic syndrome. The T cells are genetically modified to recognise and bind to tumour cells which express a cell surface protein called WT1.

Manchester-based Cellular Therapeutics was one of four contract manufacturing organisations (CMOs) bidding for the contract, which was open to companies across Europe, said a spokesman for the CTC.

The CMO will manufacture the engineered cells for the CTC over a two- to three-year period, providing enough clinical material for ongoing Phase I and II trials, which are due to complete recruitment in 2017, he added.

Preliminary manufacture was carried out at the UCL Institute of Child Health/Great Ormond Street Hospital cell therapy production unit, which allowed the first patient to be enrolled into the trial last December, but additional capacity will accelerate the project, according to the CTC.

Manufacturing boost

The CTC was set up in 2012 to advance the growth of the UK cell and gene therapy industry, acting as an intermediary to help bring academic discoveries through development and onto the market. It is one of several Catapults run by the UK government and was the only one in the life sciences prior to the formation of the Precision Medicine Catapult that launched in Cambridge last month.

A key part of the CTC initiative is the construction of a large-scale manufacturing facility for late-stage testing of these novel therapies, which is due to open in 2017 and will be located in Stevenage, at the heart of the biotech 'Golden Triangle' in the UK which extends between London, Oxford and Cambridge.

"One of the barriers to industry success is the ability to grow cells reliably at scale" said the CTC spokesman, who noted the organisation will publish its annual review into manufacturing capacity in the UK next week.

For earlier-stage projects that require smaller-scale production it is more cost-effective to deploy outsourcing partners, and last year the CTC kicked off a project to develop a network of up to six suppliers that were able to provide not only immune cell therapies but also treatments based on stem cells and somatic cells.

"We believe the UK is the place to do translational research and commercialise products for the benefit of patients," said the spokesman.

"The regulatory environment is very positive with highly engaged regulators and this is supported by the number of clinical trials being carried in the UK," he added.

Viral vector deal

Meanwhile, the CTC has also signed an agreement to work with King’s College London and Guy's and St Thomas' NHS Foundation Trust to on commercial-scale production of viral vectors that are used to genetically engineer cells or as gene therapies.

The organisation said it was "responding to concerns that scale-up of the manufacturing processes used for some viral vectors is a barrier to their use in larger scale and late-phase clinical trials and in commercial supply."

Keith Thompson, the CTC's chief executive, said the project could "help unlock a rich pipeline of new therapies," adding "our first aim is to double the output of gammaretrovirus and increase the number of clinical trials that can be carried out."

He noted the industrialisation project – which will get underway later this year – complements the CTC's ongoing work on the Stevenage manufacturing facility.