Cancer Research UK, the University of Southampton and Touchlight Genetics, a London based biotechnology company, today (Wednesday) announce a new clinical development partnership to progress a therapeutic DNA vaccine, TGL-100, into an early phase clinical trial targeting head and neck squamous cell carcinoma (HNSCC).

HNSCC is the UK’s eighth most common cancer, but treatment options are limited and around 4,000 of those affected in the UK die each year. Whilst existing immunotherapies have a huge impact for a small number of cancer patients, it is hoped that targeted cancer vaccines could extend this benefit to many more people.

DNA cancer vaccines encode antigens from cancer cells that prime the immune system, waking up immune cells that can tackle cancer. These therapies have shown significant promise in clinical studies. However, to date, they have been based on circular plasmid DNA, which means their use is limited by slow and expensive manufacturing.

The newly designed DNA vaccine combines potent cancer antigens with Touchlight Genetics’ novel DNA vector – Doggybone DNA™ (dbDNA). Unlike plasmid DNA vectors, dbDNA is a double-stranded, linear, covalently closed molecule, which is an optimal vector for advanced therapies.

TGL-100 encodes two antigens overexpressed in HNSCC to induce an antigen-specific anti-tumor immune response in the body. This preclinical development was led by Dr Natalia Savelyeva at the Centre for Cancer Immunology at the University of Southampton in partnership with Dr Kue Peng Lim at Cancer Research Malaysia, and the clinical trial will be led by Professor Christian Ottensmeier.

TGL-100 emerged from a collaboration with the brilliant Christian Ottensmeier and his talented team at the University of Southampton. Partnering with Cancer Research UK will provide the regulatory know-how, clinical expertise and operational capability to help translate this potentially transformative class of personalized therapies into patient benefit.”

Jonny Ohlson, CEO of Touchlight Genetics

Under the terms of the agreement, Cancer Research UK’s Centre for Drug Development will sponsor and manage the Phase I/II trial to test TGL-100 in HNSCC patients with recurrent metastatic disease.

We’re delighted to be working with Touchlight Genetics and the University of Southampton at the forefront of oncology innovation. Through our collaboration we’ve been able to accelerate the development of this promising experimental vaccine and hope to see benefit for patients with HNSCC, a cancer that is hard to treat.”

Dr Nigel Blackburn, Cancer Research UK’s Director of Drug Development

The proposed clinical trial will test a new combination strategy of vaccination alongside a currently available PD-1 checkpoint inhibitor. This combination could markedly improve a HNSCC patient’s response to the checkpoint inhibitor and could lead to patients living longer.

Professor Christian Ottensmeier, Chief Clinical Investigator at the University of Southampton, said: “We hope this new DNA cancer vaccine will wake up immune cells already present at the tumor site and train new T cells to travel to the cancer tissue so they can fight the cancer.

“We expect that this trial will deliver fundamental insights into how we can use cancer vaccines in the most optimal way so we can boost survival for people with head and neck cancer.”

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