Adaptimmune begins in-house T-cell therapy manufacture at PA plant
The company’s unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer, including solid tumors. Adaptimmune is currently conducting clinical trials with SPEAR T-cells targeting MAGE-A4, MAGE-A10, and AFP across several solid tumor indications.
Adaptimmune CEO James Noble told Biopharma-Reporter that he was confident that the Philadelphia-based Navy Yard facility would be able to cope with the company’s future manufacturing needs through clinical trials and potentially commercialisation.
However, Noble cautioned that should the company’s MAGE-A4 product demonstrate a strong safety and efficacy profile there may be increased interest in enrolling in the company’s future clinical trials, which may mean increased demand for these T-cell therapies. Despite this, he remained confident in the capacity of the Navy Yard facility to deliver enough T-cell therapies to cope with demand.
The site was chosen for Adaptimmune’s US HQ and manufacturing operations in 2015 and the facility opened in March last year.
Scaling up: 1000 T-cell therapies a year?
At this stage in time the company can produce three T-cell therapies a month at full dose, said Noble. However, this will have expanded to 10 per month by June, he said.
The 10 therapy a month figure is the current output of the company’s current manufacturing partner, PCT ( a subsidiary of Hitatchi Chemical Advanced Therapeutic Solutions), which will continue to manufacture therapies for Adaptimmune for the time being, giving the company a total capacity to manufacture 20 T-cell therapies per month.
However, Navy Yard has the potential to be expanded to allow the manufacturing of 300 T-cell therapies per year should the need arise, with the demonstration of safety and efficacy of the SPEAR-T cell platform.
Noble noted that the facility is modular and at this point in time, half of the building is empty. Should the company progress to commercial manufacturing requirements with marketed products, it could manufacture 1000 TCR T-cell therapies per year. Significant responses in clinical trials would trigger the company to invest in the expansion of the facility, said Noble.
The company has announced over a cash position of over $200m which it has obtained through equity raises and its licensing deal with British pharma giant, GlaxoSmithKline, who exercised its option to license, develop and commercialize Adaptimmune’s NY-ESO-1 T-cell therapy last September. Noble noted that the company’s current cash burn would take the company beyond 2020 past pivotal trials for its MAGE-A10 and MAGE-A4 products across multiple tumour types.
Adaptimmune announced in January positive safety data from its pilot study of MAGE-A10 SPEAR T-cells. Noble noted that this was a major step forward for the company, with there being several concerns regarding neurotoxicity for Juno Therapeutics’ CAR-T JCAR015 product in recent months. The positive safety data will allow the company to escalate the dose to 1 billion cells, with the first patient already dosed at this level.
The company has also recently announced an agreement with Cell and Gene Therapy Catapult, enabling the company to have its own dedicated vector manufacturing space in the UK, ensuring supply production beyond 2020 for ongoing studies.