Oncology centres in Glasgow and Edinburgh commence recruitment of skin, lung and kidney cancer patients : Novel therapy ‘ImmuniCell’ uses ‘killer cells’ to target the tumour
Biotechnology company TC BioPharm Ltd (TCB) has today announced its MHRA-approved (Medicines and Healthcare Regulatory Agency) clinical study has commenced, treating patients suffering from several different tumour types including melanoma, lung and kidney cancer.
TCB’s lead product, ImmuniCell, is an innovative immunotherapy which uses T lymphocytes (a type of white blood cell) that have been grown in culture and specifically activated to target and kill cancerous tissue. Manufactured at TCB’s state-of-the-art GMP* cleanroom facility outside Glasgow, ImmuniCell provides UK patients with access to a promising new treatment for cancer.
In designing an adaptive phase II/III clinical trial, TCB worked closely with UK regulators MHRA (Medicines and Healthcare products Regulatory Agency) to establish a pragmatic treatment framework which maximises potential for an effective outcome. The first part of TCB’s clinical study will evaluate the usefulness of ImmuniCell in three different disease indications – specifically late-stage patients with advanced melanoma, lung and kidney cancer. As data emerges from the trial, the treatment focus will shift towards the tumour types which respond best to TCB’s novel cell therapy.
Patients enrolled into the clinical study will receive six doses of ImmuniCell over a three month period, and will be monitored for a further twelve months using established measures for evidence of responses to treatment such as tumour remission, and progression-free disease. In addition to manufacturing the cell-based product internally, TCB has retained control of the clinical study by building an experienced in-house clinical research team, employing highly specialised staff to facilitate patient recruitment, project manage the study, monitor therapeutic effects and expand treatment outreach to cancer centres of excellence elsewhere in the UK and EU.
Director of Clinical Studies at TC BioPharm Ltd, Dr Karen Williams commented: “This is a major milestone for TCB; we are delighted to be working closely with cancer centres in Glasgow and Edinburgh using ImmuniCell to treat a wide variety of different tumour types.”
The first cancer patients will be treated in Glasgow under the expert guidance of chief investigator, Professor Jeff Evans (Beatson West of Scotland Cancer Centre), in Edinburgh by Dr Sally Clive with Dr Stefan Symeonides (Edinburgh Cancer Centre, Western General Hospital) and in Southampton by Professor Christian Ottensmeier with Dr Ioannis Karydis (Experimental Cancer Medicine Centre, Southampton). Additional confirmed trial centres include Oxford, Newcastle, Royal Marsden, Leeds and Nottingham; with EU and US sites to follow later during 2016.
Commenting on the clinical study, Professor Evans said: "Harnessing the immune system to eradicate cancer cells is a very exciting area of research. During this trial we will explore a novel approach to exploiting the immune system to target cancer."
Commencing initial operations during 2014, TC BioPharm has progressed rapidly to late-stage clinical trials. Such rapid progress was assisted by TCB’s strategic partner, Medinet (Yokohama), which has established a safe history of use in Japan, and facilitated transfer of a proven cell therapy from its Shin-Yokohama facility to TCB’s cleanrooms in Scotland.
Mr Yoshiji Kimura, President and CEO of Medinet said: “Medinet is delighted to be partnering with TCB to deliver this novel cell therapy worldwide. The unprecedented pace of TCB’s clinical trial has resulted from extensive efforts and enthusiasm for cancer treatments by Dr Leek and his colleagues. We believe that initiating this trial represents a critical leap forward in being able to rapidly commercialise ImmuniCell which has the potential to open up a whole new approach to cancer treatment.”
Dr Michael Leek, TCB’s chief executive, said: “Forecasts show that approximately 60,000 UK patients will be diagnosed with melanoma, non-small cell lung cancer or renal cell carcinoma during 2019 when ImmuniCell is due to launch; TC BioPharm’s aim is to bring this innovative immunotherapy to market, significantly improving these individuals’ survival rate and quality of life.”
ImmuniCell is manufactured by TCB at its multi-million pound cleanrooms just outside Glasgow, Scotland. The GMP-compliant facility at Maxim Park houses TCB’s thirty staff, and is rapidly becoming a hub for immuno-cell therapy, benefitting cancer patients in the UK, Europe and North America. The facility has flexibility and capacity to treat both individuals with cancer and also those with major viral infections, potentially allowing large patient numbers to benefit from TCB’s versatile therapeutic platform.
Headquartered at the Pentlands Science Park outside Edinburgh, TCB is registered in Scotland (SC 453579). Becoming operational from February 2014, the Company is developing ImmuniCell an autologous anti-cancer immunotherapy which involves expansion of γδ T cells over several weeks - formulating a treatment for a wide-variety of different tumour types. The technology was initially developed and commercialised by Medinet, who have successfully treated numerous cancer patients in Japan. Publicly listed on the Tokyo Stock Exchange, Medinet was founded in 1995, and is a lead contract development manufacturing organisation offering a full range of cell and tissue products in Japan. Medinet has conducted collaborative worldwide research with universities, medical/academic institutions, and other companies in Japan, US and Europe.
In January 2015, TCB was awarded a Manufacturer's Authorisation for Investigational Medicinal Products MIA (IMP) which permits manufacture and release of Advanced Therapy Medicinal Products (ATMPs) for use in clinical trials. Further to obtaining an MHRA manufacturing license, TCB was granted a Clinical Trial Authorisation (CTA) by the MHRA in September 2016.