Cell Therapy production across the world has made some significant advances in recent months, with investment in manufacture announced and exciting research suggesting new applications.
The industry in the UK has taken a step forward with confirmation that a new plant is to be built in Hertfordshire. Stevenage Borough Council has granted planning permission to The Cell Therapy Catapult to construct the £55 million large-scale manufacturing centre.The 7200m2 centre, which is expected to open in 2017, will be managed by the Cell Therapy Catapult and be used for manufacture of products for late phase clinical trials and for the commercial supply of advanced therapeutic medicinal products including cell and gene therapies.The facility is expected to create up to 150 jobs and its position on the Stevenage Bioscience Catalyst campus will provide additional inward investment from global companies.
Keith Thompson, CEO of the Cell Therapy Catapult, said: “I am delighted that Stevenage Borough Council has granted permission to create a centre that will advance the industry into becoming a world leader in advanced therapy development and commercialisation.“The large-scale GMP manufacturing centre will provide global scientific and medical communities with the assistance they need to turn research into products that have the potential to address many unmet medical needs.”The centre comes after the company’s 2013 survey of the UK’s manufacturing capability identified limitations in manufacturing and the supply chain as one of the barriers to the translation of research into commercially viable products.
The Cell Therapy Catapult was established in 2012 as an independent centre of excellence to advance the growth of the UK cell and gene therapy industry, by bridging the gap between scientific research and full-scale commercialisation. It has more than 100 employees focusing on cell and gene therapy technologies.In another development, The Cell Therapy Catapult has awarded a manufacturing contract to Manchester-based company Cellular Therapeutics Limited (CTL) to help develop an engineered T cell treatment for blood cancers such as acute myeloid leukaemia and myelodysplastic syndrome.The contract will support Phase I and II trials already under way, which involve the genetic modification of patients T cells so that they recognise and destroy WT1-expressing cancer cells when infused back into the body.CTL’s work will complements research being carried out in collaboration with Imperial College London, University College London and Great Ormond Street Hospital, led by Prof Hans Stauss and Dr Emma Morris, and originally funded by the charity Leukaemia & Lymphoma Research.According to The Cell Therapy Catapult, demand for immune cell therapy manufacturing is rapidly expanding globally and Keith Thompson said: “This contract will greatly enhance our WT1 clinical programme and accelerate this research intended to benefit patients with these life-threatening disorders.”
American research produces encouraging results
In America, clinical trials have offered another cause for optimism for the field. US biopharmaceutical firm Adaptimmune Therapeutics has announced encouraging results for its T-cell receptor (TCR) therapeutic targeting the NY-ESO-1 cancer antigen in patients with multiple myeloma.Multiple myeloma is a cancer formed by malignant plasma cells. Normal plasma cells are found in the bone marrow and are an important part of the immune system, which is made up of several types of cells that work together to fight infections and other diseases. Multiple myeloma is characterised by low blood counts, bone and calcium problems, infections and kidney problems.Encouraging clinical responses were observed in 16 patients (80 per cent) in the study: Of the 20 patients, 14 patients (70 per cent) had a near complete response or complete response, and another two had a very good partial response three months after treatment.
Dr Rafael Amado, Adaptimmune’s Chief Medical Officer, said: “We believe these are significant data for Adaptimmune and for the cancer gene therapy field.“The trial showed that autologous transduced cells can be safely administered to patients with advanced myeloma in the context of stem cell transplantation, and that the transduced cells persist for a prolonged period of time. There was also encouraging evidence of anti-tumour effect which supports further investigation of cell and gene therapy in myeloma.”Aaron P. Rapoport, MD, the Gary Jobson Professor in Medical Oncology at the University of Maryland School of Medicine and the Director of the Blood and Marrow Transplant Program at the University of Maryland Marlene and Stewart Greenebaum Cancer Center, said: “This study establishes a strong foundation for further research in cellular immunotherapy of myeloma.
“We hope to investigate additional combination approaches to boost the durability and function of the engineered T-cells to achieve even longer and deeper clinical responses.”
Japan offers great potential for cell therapy manufacture
A further boost to the field came when Lonza, the world’s leading developer and manufacturer of cells for regenerative medicine therapeutics, and Nikon Corporation announced an exclusive collaboration in the field of cell and gene therapy manufacturing in Japan.Japan has become an attractive location for the future of regenerative medicine since the induction of the Revised Pharmaceutical Affairs Act, which became effective in November 2014. The act states that conditional product approval may be granted in Japan if clinical safety and an indication of efficacy of a regenerative medicine product are demonstrated.Under the agreement, Nikon will acquire the technical know-how to differentiate and manufacture cells, including somatic stem cells and Andreas Weiler, Head of Emerging Technologies, Lonza Pharma&Biotech. said: “This collaboration will contribute greatly to the growth of the global cell and gene therapy market.”