NorthWest Biotherapeutics Inc (NWBO)

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businessweekly.co.uk

17 February, 2022 - 23:32 By Tony Quested

Cancer vaccine production starts in Cambridge.

A world first cancer vaccination has started production in Cambridge. US biotech pioneer Northwest Biotherapeutics (NW Bio) is steering the historic breakthrough by developing DCVax® personalised immune therapies for solid tumour cancers.

Business Weekly reported in early February that production was set to get underway at the company’s Sawston facility. Now it has.

NW Bio, headquartered in Maryland, is producing its first dendritic cell cancer vaccine for a compassionate use patient. A dendritic cell is a special type of immune cell found in tissues, such as the skin, and boosts immune responses by showing antigens on its surface to other cells of the immune system.

The production milestone follows approval by the UK Medicines and Healthcare Products Regulatory Agency of a licence for manufacture of GMP (clinical grade) cell therapy products at Sawston for compassionate use cases and approval by the Human Tissue Authority for NW Bio to collect and process human cells and tissues for medical purposes.

The MHRA licence was received in December following nearly two years of preparations. This included hiring and training of technical staff, preparation of approximately 1,000 regulatory documents, validation of facilities, equipment and protocols and practice manufacturing cycles. This was followed by a review and detailed inspection by the MHRA.

Since the licence was issued, Advent Bioservices – NW Bio’s contract manufacturer in the UK – has been conducting the required post-approval re-validations and testing so that the facility is now ready for the manufacture of cell therapy products for clinical use.

The first vaccine production for compassionate use treatment is for a glioblastoma patient. Glioblastoma is an aggressive cancer that originates in cells called astrocytes that support nerve cells. It can form in the brain or spinal cord. It is anticipated 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.

Northwest Biotherapeutics is focused on developing personalised immunotherapy products 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.

https://www.businessweekly.co.uk/news/biomedtech/cancer-vaccine-production-starts-cambridge