Sawston Business Park becomes world-class facility producing NW Bio cancer vaccine
Linda Powers, CEO of Northwest Biotherapeutics (NW Bio), has paid tribute to the clinical development team at Sawston Business Park – and contractor Advent BioServices – after announcing a historic production milestone success on the site.
The Maryland-based biotechnology company has been developing personalised immunotherapy products designed to treat solid tumour cancers, with input from its R&D team at Sawston. These therapies, it says, are “designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both North America and Europe”.
This milestone follows approval by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of a license for manufacture of GMP (clinical grade) cell therapy products at the Sawston facility for compassionate use cases, plus approval by the Human Tissue Authority (HTA) of a license for collection and processing of human cells and tissues for medical purposes. Under this UK regulatory program, the vaccine is identified as ADCV (‘autologous dendritic cell vaccine’).
As previously reported, the MHRA license was received in December of 2021, following nearly two years of preparations.
NW Bio now has a broad platform technology for DCVax dendritic cell-based vaccines: the lead program is a 331-patient Phase III trial of DCVax-L for newly diagnosed glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an ‘orphan disease’ (affects fewer than 200,000 people in the US).
Production of the first NW Bio dendritic cell cancer vaccine for a compassionate use patient at the licensed production facility in Sawston has now commenced.
Ms Powers said: “We are very pleased to be commencing production at Sawston for compassionate use.
“It will result in a significant expansion of production capacity for our dendritic cell cancer vaccine for compassionate use and follows the December approval by the MHRA for the manufacture of GMP (clinical grade) cell therapy products for such use.
“That Northwest Biotherapeutics, together with our contractor Advent BioServices, have been able to achieve this milestone during a global pandemic is testament to the persistence, dedication and expertise of our highly skilled teams.”
Since the issuance of the MHRA licence, Advent Bioservices has been conducting the required post-approval re-validations and testing, and the facility is now ready to scale up the manufacture of cell therapy products for clinical use. The company anticipates that Phase 1A of the Sawston facility will have the capacity to produce cancer vaccines for 450-500 patients per year.
NW Bio plans to continue developing the Sawston facility in phases, both to calibrate the capital expenditures with the capacity needed and to leave room for implementation of new technologies such as the Flaskworks system which boosts volume and reduces production costs.
“We look forward to continued progress at Sawston in the coming months as we focus on the next phase of the build-out,” concluded Ms Powers.
Late stage (or phase 3) trial results are expected in the near future.
