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Author: Louise Stanley

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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Birmingham Health Partners Centre for Regulatory Science and Innovation director appointed

Written by Louise Stanley on . Posted in Birmingham Health Partners.

Leading AI healthcare expert Professor Alastair Denniston has been appointed Director of the Birmingham Health Partners Centre for Regulatory Science and Innovation (BHP-CRSI).

Professor Denniston, who is Professor of Regulatory Science and Innovation at BHP founder-member the University of Birmingham brings a wealth of experience and expertise to his new role, having established himself as a leader in digital health and artificial intelligence-enabled medical technologies.

His team’s pioneering research in medical imaging and artificial intelligence (AI) applications in healthcare has attracted international acclaim, positioning him at the forefront of medical innovation.

Professor Neil Hanley, Head of the College of Medicine and Health at the University of Birmingham and Executive Director of Birmingham Health Partners said: “We are delighted to welcome Professor Denniston as the Director of BHP-CRSI. His vision and leadership will be instrumental in driving forward our agenda to drive innovation in regulatory science to promote efficient, safe and cost-effective implementation of new therapies, for the benefit of patients and society.”

Established in 2020 under the leadership of Professor Mel Calvert, BHP-CRSI serves as a collaborative hub for regulatory science and innovation, bringing together academia, industry, regulators, healthcare providers and patients. BHP-CRSI experts work with UK and international health regulators, using scientific and analytical skills to help optimise the regulatory process itself and accelerate innovation that can improve patient care.

The Centre’s activity is broadly grouped into three pillars: policy development; research and innovation; and capacity building and education. This helps ensure that innovation can be both effective and efficient, ensuring patient safety whilst also ensuring that patients can benefit from the best medicines and health technologies. The Centre has internationally-recognised expertise in critical areas such as AI, patient-reported outcomes, diagnostic tests, real world evidence and clinical trials.

Alastair Denniston

Professor Alastair Denniston, Professor of Regulatory Science and Innovation at the University of Birmingham and Honorary Consultant Ophthalmologist at BHP founder-members University Hospitals Birmingham (UHB) said: “I am honoured to lead BHP-CRSI and contribute to Birmingham Health Partners’ mission of improving patient outcomes through innovation. Together with our partners across the healthcare ecosystem, we will strive to create a supportive environment for regulatory science research and innovation, ultimately benefiting patients locally and globally.”

Prof Denniston’s appointment comes at an exciting time for the BHP-CRSI, with a number of its experts having been awarded UK Government funding to explore the creation of national Regulatory Science and Innovation Networks in high priority areas, including in AI and Digital HealthTech (led by Associate Professor Xiaoxuan Liu and Prof Denniston) and Advanced Therapies (led by Dr Olalekan Lee Aiyegbusi and Prof Mel Calvert, working with the Cell & Gene Therapy Catapult Ltd).

Prior to being appointed Director, Professor Denniston was the AI Theme Lead for BHP-CRSI and Director of the INSIGHT Health Data Hub for Eye Health, spearheading initiatives that continue to transform healthcare policies in data, digital health and artificial intelligence. He continues in his role as Member of the Regulatory Horizons Council to the UK Government, and as an NHS clinician at UHB.

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BHP welcomes Birmingham Community Healthcare to strategic research alliance

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

Birmingham Community Healthcare NHS Foundation Trust (BCHC) has become the sixth NHS member of Birmingham Health Partners – and its ninth overall – adding crucial community care to the city’s strategic health research alliance for the first time.

BCHC provides more than 100 core NHS community services for the 1.1m people in Birmingham, as well as specialist rehabilitation and dental services for the wider West Midlands population of 6.5m. Its vision is to provide the best care possible to support the people who use its services, many of whom are among the most vulnerable in our society, to live well in healthy communities.

The Trust is active in research, with live projects including the EPIC Neck Study – evaluating a new approach to exercise for people with persistent neck pain – and Move More, which is testing the feasibility of an app to help people with long-term disabilities to increase their activity levels. Both of these studies are being delivered collaboratively with BHP founding member the University of Birmingham, with whom BCHC also works closely at Birmingham Dental Hospital.

Professor Lorraine Harper, Managing Director of BHP, commented: “BCHC provides vital services to adults and children across the city and beyond. Being responsible for the healthy management of long-term conditions and chronic illnesses, and a strategic focus on promoting equity and reducing health inequalities, their values align perfectly with BHP’s strategic objectives. We are excited to extend our collaborations with BCHC across our membership for the benefit of the patients and communities we serve.”

Dr Robbie Dedi, Chief Medical Officer at BCHC commented: “We are on a challenging journey to improve the health of our communities whilst ensuring equitable access and outcomes. Joining with BHP provides a really exciting opportunity to expand the research and evidence base across this field and translate this into practice. We look forward to BHP supporting research capability of our teams so they can make a lasting impact on patient care within their fields.”

‘Symptom triggered’ test can detect early-stage aggressive ovarian cancer in 1 in 4 cases

Written by Louise Stanley on . Posted in Cancer outcomes, Early diagnosis and detection.

Symptom triggered testing, prompted by symptoms such as pain, abdominal bloating/swelling, and feeling full soon after starting to eat, can pick up early-stage aggressive ovarian cancer in 1 in 4 of those affected, according to new research.

A study published in the International Journal of Gynaecological Cancer and funded by the National Institute for Health and Care Research found that the UK’s protocol for picking up early-stage disease in women with high grade serous ovarian cancer—the most common, aggressive, and lethal form of the disease— is an effective way to diagnose even early-stage ovarian cancer.

The findings also show that complete surgical removal of the cancerous tissue is possible even in more advanced disease, providing that women with suspicious symptoms are expedited for investigation and treatment, they add.

A team of researchers led by BHP founding member the University of Birmingham analysed data for 1741 women taking part in the Refining Ovarian Cancer Test accuracy Scores (ROCkeTS) study, which involves 24 UK hospitals. The women had all been fast tracked for treatment under the symptom-triggered testing rapid access pathway.

Sudha Sundar, Professor of Gynaecological Cancer at the University of Birmingham and the Pan Birmingham Gynaecological Cancer Centre at BHP member Sandwell and West Birmingham Hospital NHS Trust said:

“Our figures demonstrate that in a real-world setting, symptom-based testing can potentially lead to diagnosis of high grade serous ovarian cancer with low disease spread and results in a high proportion of complete surgical removal of the cancer.”

“These findings challenge the assumption that the disease should always be considered to be in its advanced stages in women once they develop symptoms.

“More importantly, our findings emphasise the importance of increasing an awareness of ovarian cancer symptoms to facilitate earlier diagnosis via referral through the fast-track pathway to improve patient outcomes.”

Key findings

  • Among participants in the study, 119 (7%) were diagnosed with high grade serous ovarian cancer with an average age of 63, and 90% had gone through the menopause.
  • In most of these women (112; 94%) cancer didn’t hugely interfere with their daily lives, as they were classified with a performance status of 0 or 1, meaning they either were fully active, or were able to do everything but strenuous activities.
  • One in four (30; 25%) had early stage I or II disease.
  • Visible cancerous tissue was completely removed in 73 (61%) and almost completely removed in 18 (15%). The disease was only deemed to be inoperable in 9 (8%).
  • The extent of cancer was low in 43 of the 119 (36%), meaning that it was localised in the pelvis; moderate in 34 (29%), meaning that it had spread to the lower abdomen; and high in 32 (27%), meaning that it had spread up to any of the liver, pancreas, diaphragm or spleen. Information on disease extent wasn’t available for 10 (8.5%) women.
  • Surgery to remove as much of the tumour as possible, which is associated with longer survival, was carried out in more than three in four women (93 ,78%), with almost two thirds receiving surgery ahead of chemotherapy (78, 65%,). 36 (30%) were given chemotherapy to shrink the tumour ahead of surgery; 5 (4%) women didn’t have surgery, information on this was not available for 17 (14%) women.

The UK adopted symptom-triggered testing for ovarian cancer in 2011. Women, especially those over 50 years with these symptoms are tested for levels of the tell-tale protein CA125 in their blood and given an ultrasound scan. Abnormal results prompt a fast-track referral for hospital review by a gynaecologist within 2 weeks.

Ovarian cancer is the seventh most common cancer amongst women worldwide, and the sixth most common cause of cancer death in the UK. While most (93%) women diagnosed with early-stage disease (I or II) survive for more than 5 years, only 13% of those diagnosed with advanced disease (stages III or IV) do so.

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Birmingham launches pioneering trial to improve pregnancy outcomes for severe haemolytic disease

Written by Louise Stanley on . Posted in Clinical trials, Maternal health.

A pioneering study that took place at Birmingham Women’s Hospital has found an antibody that can improve the survival rate of unborn babies with rare, early-onset fetal anaemia, as a result of haemolytic disease of the fetus and newborn (EOS-HDFN).

Pregnant mothers have taken part in the UNITY trial, which has found that nipocalimab, an investigational, fully human, monoclonal antibody, has the potential to improve the survival rate of these babies.

BHP members the University of Birmingham (UoB) and Birmingham Women’s and Children’s NHS Foundation Trust (BWC) were a study site for a global, multicentre, open-label trial, in which nipocalimab was given for the treatment of pregnancies at high risk of severe EOS-HDFN, and evaluated safety, efficacy and the maternal metabolism of the monoclonal antibody.

Site investigator Mark Kilby, Emeritus Professor of Fetal Medicine at UoB and Honorary Consultant of Fetal Medicine at BWC said: “For mothers with severe HDFN the outcome not only of the condition but of the treatment, can be devastating. This is why the search for therapies to reduce the consequences of the maternal immune response has been focused on this cohort of women. The clinical study has found that nipocalimab is well tolerated and greatly increases the chance of unborn babies surviving severe EOS-HDFN, requiring less in-utero transfusion therapy.”

Haemolytic disease of the fetus newborn (HDFN), which is also sometimes referred to as Rhesus disease, is caused by a system of red blood cell antigens (most commonly of Rhesus D type) which raises the pathological antibody response in a pregnant person. These ‘pathological antibodies’ or alloantibodies can cross the placenta to the fetus and destroy its red cells, leading to progressive fetal anaemia and – if untreated – death of the fetus. 

Professor Kilby added: “These are fantastic results. In this group of pregnant women with severe HDFN, the medical management with nipocalimab has significantly reduced the need for early-onset in-utero fetal transfusion and improved the survival of these babies, reducing risks of miscarriage and stillbirth. Furthermore, and very importantly, nipocalimab seems to be well tolerated and safe for the mother and her unborn/newborn baby.   

“This research is a huge step forward for mothers who experience severe HDFN, as well as their partners, extended families, and of course, their children.”

Rosemary and Darren from Ireland were expecting baby Nessa when they took part in the clinical trial. Rosemary had had a previous in-utero transfusion for HDFN, and the couple had a child following treatment. Sadly, the couple lost a second baby after another in-utero transfusion. 

She was desperate to avoid another in-utero transfusion and was referred to the Fetal Medicine Centre at Birmingham Women’s Hospital eight weeks into her pregnancy after seeing news of the trial online and contacting her doctors at Dublin’s Rotunda Hospital. She had cell-free fetal DNA testing to confirm the baby was ‘suspectable’ to the antibodies she had produced. Rosemary then had maternal infusions of nipocalimab intravenously at weekly intervals from 14 to 35 weeks. 

Baby Nessa was born at 36 weeks weighing six pounds and 13 ounces and without the need for any IUTs.

Rosemary said: “When we were accepted onto the trial, we were both relieved and excited. Following the loss of our little girl Liliana, we were advised not to have any further pregnancies and we were devastated. This trial gave us hope of having another baby.”

“We were pregnant during the COVID lockdowns and as I was commuting from Ireland to Birmingham, it was a big worry but throughout our involvement in the trial, we felt supported, informed, understood and safe. We are forever grateful, the level of professionalism, compassion and empathy shown towards us is something we will never forget.” 

“Our two sons, Ollie and Joey now have a little sister, Nessa, who is a bubbly happy healthy four-year-old, full of mischief, giggles, and fun. To think the trial has given us what we believed was impossible, is a dream come true. To hear the trial has also given others living healthy children is fantastic. In a situation where we, like so many others felt was hopeless, to now know there is a treatment is like a miracle.”

New funding supports West Midlands healthcare and social work students into research

Written by Louise Stanley on . Posted in Birmingham Health Partners.

A collaboration between the NHS, social care and academic institutions across the West Midlands – including BHP’s Universities and NHS members – will inspire registered healthcare, social work and public health students to consider a range of research careers.

The National Institute of Health and Social Care Research (NIHR) has pledged £34.9m to encourage the regulated healthcare and social work professions into research roles as part of the new INSIGHT: Inspiring Students into Research scheme. This strategic move will accelerate the numbers of nurses, midwives, pharmacists, social workers and allied health professionals (AHPs) leading research and generating evidence to underpin care.

The West Midlands NIHR INSIGHT Consortium, led by BHP founding member the University of Birmingham, has been awarded £2.5m to provide fully funded research master’s courses to early career healthcare professionals and social workers. Working with local NHS trusts, students will be able to take the courses full or part time so they can continue their career pathways in healthcare. It is envisaged this initiative will provide the right start for the future research workforce and retain talent in the region.

For further information and to apply, visit the INSIGHT West Midlands Consortium page.

According to NIHR, the most recent headcount from 2017 showed that less than 0.1% of the nursing, midwifery and allied health professional workforce were involved with research. Yet it is well documented that research led by nurses, midwives, pharmacists, AHPs and other healthcare and social work professionals, and the contributions they can make as members of multidisciplinary research teams, can drive change to policy and patient care. Research is integral to high quality evidence-based care and has also been shown to increase job satisfaction for staff and improve retention, when conducted alongside delivering care.

The consortium sees seven universities and eight NHS trusts come together to accelerate the development and growth of future health and social work researchers. Suitable candidates will be allocated to higher education institutions and programmes according to discipline, personal and professional needs and student choice. The first cohort of places start from September 2024.

The programme will target those professions that don’t have much exposure to research during their professional training.

Professor Waljit Dhillo, Dean of the NIHR Academy, said: “We know how important early exposure to research is for building capacity within health and social care. The INSIGHT programme will offer over 300 funded research masters places per year and provide engagement activities that have the potential to excite and capture the imagination of students at an early stage in their career.

“I’m delighted that we can invest in our next generation of researchers in the West Midlands, and show students all of the benefits that research roles and careers have to offer.”

The West Midlands bid, put together with input from final year nursing students, patient ‘experts by experience’, early career clinical academics and research delivery staff from across our health and social care community, emphasised that research must reach out to all communities if it is to make a difference to the health and wellbeing of those living and working in the West Midlands. Collaborating institutions will seek to ensure that future practitioner researchers represent the communities they serve by ensuring access to funded postgraduate study.

Professor Liz Moores, deputy dean of Aston University College of Health and Life Sciences, said: “As a healthcare professional, having the knowledge and the ability to critically review others’ research and to meaningfully evaluate your own practice is a key part of improving healthcare for the future. This programme will help to support the workforce to develop those skills and Aston University is proud to be a partner in it.”

Dr Nikolaos Efstathiou, School of Nursing and Midwifery, University of Birmingham said: “We seek to provide a sustainable regional pipeline via which those motivated next generation researchers can acquire the skills and capabilities so they can have fulfilling careers delivering and leading research. With our many NHS, social care and research infrastructure partners we are fully committed to creating a positive place-based research and innovation environment for our talented graduates who aspire to be future clinical academics and research leaders.”

Professor Anne Topping, Professor of Nursing University Hospitals Birmingham NHS Foundation Trust and University of Birmingham said: “The programme is important for future-proofing our sustainable regional research workforce. Our programmes will produce those professionals, who are able to work collaboratively, generate, translate and implement best available science and evidence into real world interventions, ultimately bringing benefits to care, and the health and wellbeing of our communities.”

Led by the University of Birmingham, the programme is a partnership with (BHP members in bold): University of Keele, University of Warwick, Birmingham City University, Coventry University, Aston University, Staffordshire University, as well as Midlands Partnership NHS Foundation Trust, University Hospitals Coventry and Warwickshire NHS Trust, Birmingham Community Healthcare NHS Foundation Trust, University Hospitals Birmingham NHS Foundation Trust, Birmingham Women’s and Children’s NHS Foundation Trust, Sandwell and West Birmingham Hospitals NHS Trust, University Hospitals of North Midlands NHS Trust and Birmingham and Solihull Mental Health NHS Foundation Trust and other health and social care providers across the region.