TC BIOPHARM has been handed the right to become the only biotechnology company outside Japan to trial immunotherapy to treat patients with cancer.


The company has received a licence from the Medicines Healthcare Products Regulatory Agency (MHRA) to produce human cell therapy products at its clinical manufacturing facility in Lanarkshire.

The process is understood to be vital in the fight against cancer, and has already been trialled safely in Japan by Medinet, the Tokyo-listed immuno-cell therapy company.

Medinet holds 50 per cent of the shares in TCB and last year the two signed a strategic partnership which will see the Scottish firm clinically develop the process in the UK and Europe.

In simple terms, the process involves cultivating patients' Gamma Delta or T cells which help the body fight cancer and serious viral infections.

In the case of cancer, cells transformed by the disease divide more quickly and aggressively than the rate at which the body can make T cells. The treatment involves boosting patients' immune systems of patients by adding large numbers of T cells.

It is designed to complement other cancer treatments, chemotherapy, radio therapy and the latest anti-cancer drugs, including a treatment for melanoma which dampens the cancer's ability to attack the immune system.

With the licence from the MHRA in place, TCB is now focused on devising a clinical trial protocol, which will list the patients who will be treated and how they will be treated.

The trial will focus on patients with three types of cancer - melanoma, kidney and lung - with TCB hoping to begin treating patients in the middle of this year.

The treatment will take place under the guidance of principal investigator professor Jeff Evans of the University of Glasgow, and will work alongside cancer clinics around Scotland.

Dr Michael Leek, chief executive of TCB, said the company's 13-strong team of cancer specialists are eager to get the trial underway.

He said: "We are terribly excited about the prospect of treating patients later this year. Almost everything has been leading up to this moment.

"It's what we are all trained to do and we have got a group of highly experienced staff who are basically chomping at the bit to get product into patients in a way that is regulated, controlled and safe."

The treatment will take place at the company's state of the art facility at Maxim Park, based in the Eurocentral business site. The site, which took 12 weeks to build and a further 12 to commission, train staff and install equipment, has accounted for a large proportion of the £3 million raised by the company since it was set up in late 2013.

Dr Leek said about half of the funding has come from private equity, with sources including Medinet, high net worth individuals and people connected to the firm, and public sector grants.

Medinet is the single biggest shareholder in the Penicuik registered business, owning precisely half of the shares. The remaining 50 per cent are owned by individual investors, including operations director Angela Scott and Dr Leek.

He praised the "immense" support received from Scottish Enterprise, without which he said the business would not have been able to grow as quickly in the last year.

And he revealed the long term goal is to either be by a larger company to commercialise the technique, or stage an IPO (initial public offer) to raise funds.

TCB' said its Maxim Park facility is poised to become a hub for immune-cell therapy research, with its work bringing benefits to patients in the UK and Europe.

The site includes two GMP cleanrooms, process development laboratories and a quality control suite that allows in-house environmental monitoring, product testing and release.

In addition to cultivating cells to treat cancer, TCB plans to treat early diagnosis HIV patients at its facility, which also has the capacity and flexibility to treat cancer patients and major viral infections.

The company said large number of patients can potentially benefit from its therapeutic platform.