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New vaccine trial for head and neck cancer patients

Written by Louise Stanley on . Posted in Cancer outcomes, Clinical trials, Experimental medicine.

Patients in Birmingham who have advanced head and neck cancers may be eligible to take part in a new clinical trial of a potential cancer vaccine, supported by the NHS Cancer Vaccine Launch Pad (CVLP).

Queen Elizabeth Hospital Birmingham, part of BHP founder-members University Hospitals Birmingham NHS Foundation Trust (UHB), is one of 15 sites across the country aiming to recruit more than 100 patients over the next year.

The investigational cancer vaccine in this latest trial on the platform uses mRNA technology to help the immune system recognise and kill cancer cells which express human papillomavirus (HPV) proteins.

The first head and neck cancer patients in England have received the investigational mRNA cancer vaccine in the clinical trial, known as AHEAD-MERIT (BNT113-01), with more patients to soon be enrolled at their nearest NHS hospital. 

More than 11,000 new head and neck cancer cases are diagnosed in England every year, with cancers typically developing in the mouth, throat or voice box.  

Despite advances in care for patients with head and neck cancer, the advanced form of the disease is difficult to treat and has high rates of recurrence, with two-year survival rates at under 50%.

The investigational cancer vaccine is designed to encode two proteins that are frequently found in head and neck squamous cell cancers associated with human papillomavirus (HPV-16). This is the most common type of head and neck cancer, accounting for 95% of these types of cancers, and the vaccine aims to train the immune system to fight the cancer.

NHS England is partnering with life sciences company BioNTech to help identify potentially eligible patients to refer to NHS hospitals running the clinical trial.

Dr Paul Sanghera, Consultant Oncologist and Principal Investigator of the trial at Queen Elizabeth Hospital Birmingham, said: “This clinical trial marks an important step forward in the search for better treatments for advanced head and neck cancers, which remain a significant challenge in oncology.

“These cancers are notoriously difficult to treat, and access to this investigational vaccine could offer patients a potential new option in their treatment journey. While we are still in the early stages, the hope is that this trial will pave the way for improved outcomes for those living with these challenging conditions.”

Matthew Metcalfe, Hospital Executive Director at Queen Elizabeth Hospital Birmingham, said: “We are incredibly proud to be one of the 15 sites across the country taking part in this important clinical trial. It reflects our ongoing commitment to driving forward research aimed at improving outcomes for patients in Birmingham and beyond, offering new hope to those facing these challenging diagnoses.”

Dr Iain Foulkes, Executive Director of Research and Innovation at Cancer Research UK, said: “It’s great to see more clinical trials of vaccines for head and neck cancer supported by the Cancer Research UK-funded Southampton Clinical Trials Unit.

“Research into personalised cancer treatments is vital. There are over 200 different types of cancer and it’s unlikely there will ever be a single cure that works for everyone. That’s why it’s vital that we support a wide range of research, so that more people can live longer, better lives, free from the fear of cancer.”

More cancer vaccines news from across BHP

Adding dendritic cell vaccine to liver cancer therapy slows disease progression

Written by Louise Stanley on . Posted in Clinical trials, Experimental medicine.

Patients with intermediate-stage primary liver cancer who received a vaccine of dendritic cells (DC) alongside their cancer therapy saw a longer time without tumour progression in response to standard treatment – found a study by BHP founding-member the University of Birmingham, funded by the National Institute for Health and Care Research (NIHR).

The results of the ImmunoTACE trial, the first clinical trial of its kind, published in Clinical Cancer Research, found improved progression-free survival (PFS) for patients with hepatocellular carcinoma (HCC) who received the cell-based vaccine expanded from their own white blood cells. The vaccine was administered alongside usual treatment with tumour chemoembolisation, a treatment for blood vessels that feed the tumour, plus chemotherapy.

The collaborative trial between the University of Birmingham, fellow BHP members University Hospitals Birmingham, Nottingham University Hospitals NHS Trust and Aintree University Hospital and Clatterbridge saw 48 patients recruited to receive either standard treatment alone or standard treatment plus a cellular vaccine using dendritic cells loaded with cancer antigens to stimulate immune responses against the cancer.

In the experimental arm of the trial the average time to progression of the tumour was 18 months compared with only 10 months in the group who only received standard treatment.

Professor David Adams, Chief Investigator of the study, Emeritus Professor of Hepatology at the University of Birmingham and past Director of BHP, said: “The results from this phase 2 trial are very promising and offer a potential new treatment option for patients with primary liver cancer, one of the highest causes of cancer-related death worldwide.

“As far as we know, ImmunoTACE is the first controlled clinical trial to show that a cell-based vaccine using lab-grown dendritic cells can improve patient outcomes with liver cancer. The results warrant further investigation and could in future offer much needed hope and a better treatment option for patients.”

The vaccine is made with dendritic cells (DC) which help orchestrate the immune system’s response to diseases including cancer by activating immune killer cells to recognise and destroy cancer cells.

The dendritic cells used in the study were expanded from the patients’ own white blood cells by growing them in a purpose-built laboratory for eight days with proteins taken from cancer cells. The cells allow the immune system to see these proteins and then to mount an immune attack on the cancer cells that bear them.

Patients received the DC vaccine at the same time as standard treatment with chemo-embolisation and then monthly for a further three months.

While dendritic cells are produced naturally in the body, studies have shown that in patients with cancer they can become “exhausted” and get stuck within the tumour rather than carrying cellular information back to the lymph nodes where they can activate immune killer cells. The idea of DC vaccine is to restore and uncover immune responses to the cancer. The current trial design reports that this therapy can be both affordable and effective.

Dr Yuk Ting Ma, lead author of the study and Associate Clinical Professor at the University of Birmingham, and an Honorary Consultant in Hepatobiliary Oncology at the University Hospitals Birmingham NHS Foundation Trust said: “These are very promising findings that demonstrate the potential use of dendritic cell vaccines in a widely prevalent and hard to treat cancer. With our approach to developing the vaccine, focusing on stimulation with multiple tumour antigens, we have shown a strong signal that we believe warrants testing in larger trials in patients with liver cancer.

“Dendritic cell vaccines also represent a potential additional immune therapy to add to current checkpoint inhibitors. Future studies will look at whether adding DC vaccination to standard immunotherapy can derive better outcomes for patient with HCC who show only modest responses to current checkpoint inhibitor drugs.”

Possible new disease targets for children with arthritis revealed by first-of-its-kind study

Written by Louise Stanley on . Posted in Experimental medicine, Inflammation and chronic disease.

Groundbreaking research by a team from BHP’s Birmingham Children’s Hospital and the University of Birmingham – working with UCL and Great Ormond Street Hospital – has revealed important clues into what is driving disease in children with arthritis.

Cutting-edge techniques have allowed scientists to uncover the unique architecture of cells and signals inside the joint as inflammation takes hold, for the first time.

Published in Science Translational Medicine, the study investigated juvenile idiopathic arthritis in children – caused by the immune system mistakenly attacking joints – which affects more than 10,000 children in the UK. It causes swelling, stiffness and pain in the joints over years or decades, leading to damage of the joints and long-term disability. While there are pain management treatments available, which in some cases achieve remission, there is no cure – and it can take time to find which treatment works for each person. Treatments don’t work in the same way for every child, suggesting there are hidden differences between individuals that we are yet to fully understand.

Deepening the scientific and clinical community’s understanding of the condition is vital if more effective treatments are to be found, and undertaking biopsies in young children provides a new way forward. The study’s potential has been advocated for by families of children with arthritis, who agreed that the procedure would be acceptable to families, especially compared to living with a chronic inflammatory disease.

In a world first, tiny tissue samples were collected from the joint lining when children were having medicine injected into the joint, which were then analysed with advanced imaging and gene-profiling technologies. The fine resolution maps of the joints revealed differences between children of different ages and cell changes in those with more severe disease – creating unique cellular ‘fingerprints’ which may help researchers understand why some drugs work better for some children, and not others. The joints of children with arthritis also looked significantly different to those with adults, demonstrating the need to understand arthritis in children better.

Mapping out the networks of cells in the joint revealed a barrier layer (pink), with immune cells (navy) flooding in through blood vessels (light blue), which increase in number as the disease continues

Professor Adam Croft, Versus Arthritis Professor of Rheumatology at the University of Birmingham and chief investigator of the study, said: “We know how frustrating it can be for families and young people to find a drug that best works for their arthritis. Finding ways to better predict which medicines will be beneficial for a particular child would mean we were able to treat the disease more rapidly and effectively. To achieve this goal, we first needed to understand what cells make-up the lining of the joint where the inflammation occurs. Equipped with that knowledge, we can now start to tackle the next challenge, determining how these cellular fingerprints within the joint tissue can help us predict which drug will work best, ensuring we give the right drug, to the right child, at the right stage of their disease.”

Professor Lucy Wedderburn, University College London Great Ormond Street Institute of Child Health and Consultant of Paediatric Rheumatology at Great Ormond Street Hospital said: “This study represents a real step change in our work with children and young people who live with arthritis, and has been a huge team effort. Rather than having to rely on blood tests which often do not tell us accurately what is happening in the joint, we can now directly analyse the joint lining, across different types of childhood arthritis and different ages. Our findings show that younger children have different types of immune cells invading their joints compared to older children. Samples from children with arthritis looked different to adult samples, with a different make up of immune cells, blood vessels and distinct connective tissue cells. This suggests that treatments may need to vary depending on age and shows why we can’t just extend studies from adult studies to understand arthritis in children.”

The study was funded by the Medical Research Council, Versus Arthritis, National Institute of Health and Care Research, Great Ormond Street Hospital Charity, amongst others, and delivered through the National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre (BRC).

Instrumental to driving this research forward was Dr Eslam Al-Abadi, a study investigator from the Birmingham Women’s and Children’s Hospital NHS Foundation Trust, who sadly passed away before publication. His incredible efforts in seeking to improve the care of children with this disease are gratefully acknowledged.

New UK network to strengthen regulatory environment for advanced therapies

Written by Louise Stanley on . Posted in Birmingham Health Partners, Experimental medicine.

A new network has been established to foster collaboration among regulators, industry, and researchers to ensure there is a world-leading regulatory environment in the UK for advanced therapies that supports companies in the development, trial, and launch of these innovative treatments.

The network has been established by the Cell and Gene Therapy Catapult (CGT Catapult), an independent innovation and technology organisation specialising in the advancement of the cell and gene therapy industry, and the Birmingham Health Partners Centre for Regulatory Science and Innovation (CRSI), funded by Innovate UK and support from the MHRA.

The effective regulation of advanced therapies is vital to ensure that patients can access these transformative treatments promptly, to prepare the healthcare sector for the large-scale deployment of these therapies, and to ensure patient safety.

To help achieve this, the network will work with the UK regulators, predominately the MHRA, to identify effective and efficient regulatory strategies that address the unique challenges of these therapies. By sharing its recommendations with therapy developers and regulatory and healthcare stakeholders, it will support the UK to build a first-in-class regulatory ecosystem that welcomes and encourages healthcare innovation. This aims to enable the timely development of, and improved access to, safe and effective advanced therapies.

The network is one of seven new Centres of Excellence in Regulatory Science and Innovation established by Innovate UK to help shape the development and approval of medical innovations in the UK.

Matthew Durdy, Chief Executive of the CGT Catapult, said: “Advanced therapies are both an opportunity for patients and an opportunity for the UK. This initiative is part of a drive to keep the UK as a leader in this field.”

Melanie Calvert, Deputy Director of the Birmingham Health Partners Centre for Regulatory Science and Innovation, Director of the Centre for Patient Reported Outcomes Research, Professor of Outcomes Methodology at the University of Birmingham, NIHR Senior Investigator and co-lead of the NIHR Birmingham Biomedical Research Centre’s Patient Reported Outcomes research theme, said: “As the number of advanced therapies requiring regulatory approval increases, it is essential that regulatory frameworks are developed that are fit-for-purpose. Our focus at Birmingham is understanding how the patient voice can help shape regulatory decision making and ensuring that we understand the risks and benefits of treatment from the patient perspective. I am excited to leverage our extensive expertise in the field and work with our partners to provide patients with timely access to transformative treatments.”

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Researchers at the Royal Orthopaedic Hospital secure funding to develop cancer-killing injectable paste for bone tumours

Written by Louise Stanley on . Posted in Cancer outcomes, Experimental medicine.

The Dubrowsky Lab at BHP member the Royal Orthopaedic Hospital (ROH) has secured a £110k grant from Orthopaedic Research UK to develop an injectable paste with anticancer and bone regenerative properties.

The project will see researchers at ROH work with BHP members Aston University to produce an injectable paste comprised of gallium-doped bioglass that, if proved effective, could be used to treat patients with primary and metastatic bone cancer.

Dr Lucas Souza, Research Lab Manager at the Dubrowsky Lab and Lead Researcher for this new project, comments: “Advances in treatment of bone cancer have reached a plateau over the past 40 years, in part due to a lack of research studies into treatments and the complexity and challenges that come with treating bone tumours. Innovative and effective therapeutic approaches are needed and this grant from Orthopaedic Research UK provides vital funds for us to continue our research into the use of gallium-doped bioglass in the treatment of bone cancer.”

Gallium is a metallic element that has cancer-killing properties. When combined with bioactive glass the material can kill cancer cells that remain when a tumour is removed and accelerate the regeneration of the bone defect. In addition, the material also prevents bacterial contamination in the surgical site. A recent study led by Aston University in collaboration with the ROH found that bioactive glasses doped with the metal have a 99 percent success rate of eliminating cancerous cells.

The injectable paste is to function as a drug delivery system for localised delivery of anticancer gallium ions (GaBG) and bisphosphonates whilst regenerating bone. The team hypothesise that the GaBG and bisphosphonates will promote rapid bone formation and will prevent cancer re-occurrence by killing residual cancer cells and regulating local osteoclastic activity.

The new therapeutic approach will be particularly useful in reducing cancer re-occurrence, implant site infections and implant failure rates in cases of bone tumours where large resections for complete tumour removal is either not possible, e.g. when tumours are located too close to vital organs, or not recommended, e.g. in the treatment of bone metastases and aggressive benign bone tumours (such as Giant-cell tumour of bone) when the harm inflicted by a large surgical procedure may be greater than its benefits. It could also be used in combination with minimally invasive intralesional therapies such as cryoablation or radiofrequency ablation for optimal management of metastatic bone lesions.

Dr Lucas Souza adds: “The proposed biomaterial has the potential to drastically improve treatment outcomes of bone tumour patients by reducing cancer re-occurrence, implant-site infection rates, and implant failure rates leading to reduced time in hospital beds, less use of antibiotics, and fewer revision surgeries. Taken together, these benefits could improve survival rates, functionality and quality of life of bone cancer patients.”

Dr Lucas Souza will be supported by Professor Adrian Gardner, Director of Research and Development at the Royal Orthopaedic Hospital and Professor of Clinical Orthopaedics at Aston University, as well as Mr Jonathan Stevenson, Orthopaedic Oncology and Arthroplasty Consultant. The project is also supported by collaborators Professor Richard Martin and Dr Eirini Theodosiou from Aston University and Professor Joao Lopes from the Brazilian Aeronautics Institute of Technology.

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Birmingham opens Europe’s first pancreatic cancer mRNA vaccine trial

Written by Louise Stanley on . Posted in Cancer outcomes, Clinical trials, Experimental medicine.

Researchers at BHP founding-members University Hospitals Birmingham NHS Foundation Trust (UHB) and the University of Birmingham have opened a trial to study how messenger RNA (mRNA) cancer vaccines may be used to prevent recurrence of pancreatic cancer. The Queen Elizabeth Hospital Birmingham (QEHB) is the first hospital in Europe to recruit into such a trial.

Pancreatic cancer is among the deadliest cancers globally, with a survival rate beyond 10 years of just 5% in England (2013-2017). It is often only when the cancer has reached an advanced stage that physical symptoms appear, at which point it becomes more difficult to treat.

The trial aims to recruit patients undergoing surgery to remove pancreatic ductal adenocarcinoma (PDAC), an extremely aggressive disease that accounts for 90% of all pancreatic cancers.

Patients enrolled in the study will either receive an investigational cancer vaccine combined with chemotherapy (treatment group) or standard chemotherapy alone (control group).

In this investigational therapeutic cancer vaccine, mRNA is used to deliver the instructions for building several proteins (neoantigens) found in a person’s cancer. In doing so, the trial vaccine aims to train the immune system to recognise and attack the set of proteins (usually found on microscopic cancer cells) when it encounters it again.

Following surgery, samples of the patients’ tumour tissue and blood are sent to laboratories, to design and manufacture the investigational cancer vaccine. For the patients eligible for the trial, a mRNA-based cancer treatment is manufactured with mRNA specific to the proteins in that individual’s tumour.

This novel treatment approach is aimed at training the immune system to recognise and attack cancer cells, to potentially prevent cancer recurrence and increase the prospect of a patient being cured.

Dr Shivan Sivakumar, Principal Investigator of the trial, Associate Professor in Oncology at the University of Birmingham and Consultant Medical Oncologist at QEHB said: “We are incredibly proud that the Queen Elizabeth Hospital Birmingham is the first site in Europe to enrol a patient to this investigational pancreatic cancer vaccine trial. This achievement highlights Birmingham’s leading role in advancing cancer treatment, offering new hope for patients battling one of the most challenging cancers we face today.

“We recently also became the first site in Europe to open an immunotherapy study in cholangiocarcinoma (bile duct cancer), another deadly cancer. Birmingham is positioning itself to be a leading centre in Europe to test novel treatments for these hard-to-treat cancers and I find it humbling that patients in the Midlands have been able to enrol onto this trial, before anyone else in Europe.”

Professor Kiran Patel, Chief Medical Officer at UHB, which operates QEHB, added: “We are very fortunate to have exceptional infrastructure and world-class talent that positions us perfectly to lead in vital areas of cancer research.

“This trial showcases the expertise and dedication of our medical professionals, and the fantastic teams supporting them, who are at the leading edge of clinical research here in Birmingham.

“To be the first site to open in Europe, reaffirms our role as a national and international centre for cutting-edge oncology and highlights our commitment to improving patient outcomes through pioneering approaches.”

Jo Gray, Head of Research and Development Operations at UHB, said: “Through the National Institute for Health and Care Research (NIHR) Wellcome Trust Clinical Research Facility (CRF), we are able to provide expert care to patients receiving experimental therapies. Birmingham is the first site outside of North America to open and to enrol a patient onto this complex, early phase trial, that addresses an important need to identify better post-surgery treatments for pancreatic cancer.”

Professor Neil Hanley, Head of the College of Medical and Dental Sciences at the University of Birmingham, said: “This work epitomises why the University of Birmingham and its tremendous partnership with UHB is delivering life-changing impacts.

“Whilst such approaches were being investigated before 2020, we now know the power of mRNA vaccines from the COVID-19 pandemic; to tilt those discoveries from a time of tremendous challenge towards a much-needed world of new cancer treatments is inspiring for all of us.

“Birmingham is the ideal place to open this trial, with one of the leading pancreatic cancer units in the UK and serving a super diverse population. The chemistry between the university and hospitals is clear. By working as one team under the banner of Birmingham Health Partners, we are delivering the kind of cutting-edge research leading to transformational clinical care that befits Birmingham as an innovative city at the forefront of health and life sciences.”

Dr Chris Macdonald, Head of Research at Pancreatic Cancer UK, said: “For too long we have had so few treatment options for people with pancreatic cancer. Surgery is currently the only potential cure and yet, tragically, in 75% of cases the cancer reoccurs within a year. Finally, there is hope on the horizon.

“We are absolutely delighted that Queen Elizabeth Hospital Birmingham is the first site in Europe to enrol a patient to an individualised pancreatic cancer vaccine trial. We will be following the results with great interest, as the potential here cannot be understated. If this research proves successful, the vaccine could be a vital new weapon against the deadliest common cancer.”

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