TC BioPharm (TCB) said today it has won a €4 million ($4.7 million) grant from the European Union's Horizon 2020 (H2020) research and innovation program to advance its gamma-delta T (GDT) cell therapy for cancer.
TCB said the H2020 grant will allow it to develop a next-generation GDT cell therapy, OmnImmune®, using an allogeneic approach, in which treatments can be manufactured using existing donor cells stored in a biobank.
The company reasons that an allogeneic “off-the-shelf” approach will be able to treat a larger target population of cancer sufferers than an autologous treatment, since an allogeneic treatment would be more reproducible product, having been “campaign-manufactured” in bulk to contain costs.
TCB said it plans to manufacture allogeneic cell banks during 2017–2018, with the goal of treating its first cancer patients with GDT early in 2019.
Plans call for TCB to couple the treatment with its proprietary chimeric antigen receptor (CAR) platform, through which GDT cells will be “supercharged” to attack specific tumor types.
TCB has developed a first-generation GDT cell product ImmuniCell®, an autologous cell therapy designed to treat patients with various tumors—including malignant melanoma, kidney, and lung cancer.
ImmuniCell is now the subject of a Phase II/III trial in patients with melanoma, non-small-cell lung cancer (NSCLC), and renal cell carcinoma. The adaptive, open-label trial is designed to identify an optimal, safe dose for future clinical trials, to identify a response signal from at least one of the cancers under investigation, as well as to confirm safety and efficacy.
Looking Beyond the U.K.
At present, TCB said, it is working with Clinical Centres of Excellence to treat cancer patients across the U.K. in Glasgow, Edinburgh, Oxford, Southampton, London, Leeds, Cardiff, Manchester, Sheffield, and Belfast. Plans call for the eventual clinical testing and treatment of patients with outside the U.K. as well.
“I look forward to developing our novel allogeneic GDT cell therapies with clinical partners at trial sites in Prague, Madrid, Paris, Amsterdam, and Brussels,” TCB chief executive Michael Leek, Ph.D., MBA, said in a statement.
Added TCB COO Angela Scott: “We are thrilled that H2020 funding has been awarded, allowing us to treat large numbers of cancer patients across the EU and in North America.”
Headquartered in Scotland at the Pentlands Science Park outside Edinburgh, TCB has raised more than €25 million ($29.6 million) in funding since it began operations in February 2014.
Back in January, TCB said it raised more than £6.25 million ($6.7 million) from investors toward advancing ImmuniCell. Funds came primarily from NIPRO Corp. of Osaka, Japan, and the Scottish Investment Bank, as well as several unnamed “family-based investment sources.”
The company employs more than 50 people at facilities in Glasgow, Edinburgh, and London.
The grant awarded to TCB is the largest such EU-award to any U.K. company for development of a therapeutic product. TCB said it was one of only 57 projects selected for funding out of 1514 applications to H2020’s small- and medium-enterprise (SME) funding instrument, where fewer than 4% of companies applying to Phase 2 are selected.
Companies are evaluated for SME funding on criteria that include scientific excellence, business impact, and implementation quality.