Hampton, London, Southampton, UK - 29 July 2020 - 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-tumour 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.
Jonny Ohlson, CEO of Touchlight Genetics said: “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 personalised therapies into patient benefit.”
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.***
Dr Nigel Blackburn, Cancer Research UK's Director of Drug Development, said: “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.”
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 tumour 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.”
* Touchlight’s novel cell-free manufacturing method doesn’t require fermentation, one of the challenges of plasmid DNA production, making dbDNA production significantly faster and more scalable. This, in turn, enables a simpler route to commercialisation and the potential for rapid, fully personalised vaccination strategies. The dbDNA vector also eliminates bacterial sequences and antibiotic resistance genes, conferring a safety advantage.
** Touchlight has developed, patented, and scaled the fully enzymatic means of large-scale DNA amplification. It can produce multi-gram batches in a 5-day, benchtop process in a facility with minimal requirements. Doggybone is manufactured at Touchlight Genetics’ GMP facility in Hampton, UK. The structure eliminates backbone sequences for improved safety and dosing. Cancer Research UK’s Centre for Drug Development and Touchlight have received advice from the MHRA regarding approval for the Doggybone construct.
*** Most pipeline agents target HPV-driven HNSCC. This study will recruit HNSCC patients identified by early preclinical studies in collaboration with the University of Southampton and Touchlight Genetics. The DNA vaccine may offer a strategy to boost immune response in non-HPV driven HNSCC. Upon trial completion, Touchlight Genetics retains the option to undertake further clinical development and commercialisation of the vaccination strategy. If Touchlight elects not to exercise its option, Cancer Research UK will have the rights to take the programme forward in all cancer indications.
About Cancer Research UK’s Centre for Drug Development
Cancer Research UK has an impressive record of developing novel treatments for cancer. The Cancer Research UK Centre for Drug Development has been pioneering the development of new cancer treatments for more than 25 years, taking over 160 potential new anti-cancer agents into clinical trials in patients. It currently has a portfolio of around 20 new anti-cancer agents in preclinical development, Phase I or early Phase II clinical trials. Six of these new agents have made it to market including temozolomide for brain cancer, abiraterone for prostate cancer and rucaparib for ovarian cancer. Two other drugs are in late development Phase III trials.
About Cancer Research UK’s Commercial Partnerships Team
Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research. Cancer Research UK’s specialist Commercial Partnerships Team works closely with leading international cancer scientists and their institutes to protect intellectual property arising from their research and to establish links with commercial partners. Cancer Research UK’s commercial activity operates through Cancer Research Technology Ltd., a wholly owned subsidiary of Cancer Research UK. It is the legal entity which pursues drug discovery research in themed alliance partnerships and delivers varied commercial partnering arrangements.
Potential partners interested in collaborating with Cancer Research’s Centre for Drug Development please contact firstname.lastname@example.org.
About Cancer Research UK
For further information about Cancer Research UK's work or to find out how to support the charity, please call 0300 123 1022 or visit www.cancerresearchuk.org. Follow us on Twitter and Facebook.
About Touchlight Genetics
Touchlight is a privately-owned biotechnology company based in London, U.K., focussed on the discovery and development of DNA-based genetic medicines, including DNA vaccines and gene therapies. Touchlight has developed a novel, synthetic DNA vector known as “doggybone” or dbDNA™.
dbDNA™ is a minimal, linear, covalently closed structure, that eliminates bacterial sequences. Touchlight’s revolutionary enzymatic production platform enables unprecedented speed, scale, and the ability to target genes with a size and complexity that is impossible with current technologies.
Touchlight is applying dbDNA across advanced therapeutic modalities, both in-house and with partners. The company also provides contract manufacturing capabilities to produce dbDNA as a critical starting material for advanced therapy production through its manufacturing arm, Touchlight DNA Services.
For more information, please visit our website, www.touchlight.com, or connect with us on LinkedIn.
About the University of Southampton
The University of Southampton drives original thinking, turns knowledge into action and impact, and creates solutions to the world’s challenges. We are among the top 100 institutions globally (QS World University Rankings 2019). Our academics are leaders in their fields, forging links with high-profile international businesses and organisations, and inspiring a 22,000-strong community of exceptional students, from over 135 countries worldwide. Through our high-quality education, the University helps students on a journey of discovery to realise their potential and join our global network of over 200,000 alumni. www.southampton.ac.uk
About Cancer Research Malaysia
Cancer Research Malaysia is a Malaysian charity dedicated to saving lives through research, focusing on Asians. Cancer Research Malaysia is reliant entirely on research grants and charitable donations from the public and corporates for its life-saving research. Cancer Research Malaysia has been at the heart of making sure that research does not miss Asians and its research includes the discovery of new therapies, the development of precision medicine for Asians and ensuring that there is access to life-saving therapies. Together with its partners and supporters, Cancer Research Malaysia’s vision is a future free of the fear of cancer. For more information, please visit www.cancerresearch.my or follow us on Facebook, Instagram, LinkedIn and Twitter.
For media enquiries contact Angharad Kolator Baldwin in the Cancer Research UK press office on 020 3469 8456 or, out of hours, on 07050 264 059.