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A digital version of the NHS Health Check for 40- to 74-year-olds is to be piloted by the government as a way to lessen pressure on the nation’s GP services.

The NHS Health Check is designed to identify early signs and symptoms of stroke, kidney disease, and heart disease, as well as type 2 diabetes and some forms of dementia. Dubbed the ‘midlife health check’, it looks for some of the most common conditions that affect people as they age.

Based in Cornwall for now, instead of a face-to-face visit the digital check will include patients undergoing an online questionnaire, as well as being given a kit for taking a blood sample at home, and blood pressure checks will take place at either a local pharmacy or in the GP waiting room. Those who have results suggesting an underlying health condition will be followed up with within the GP practice setting.

Free to those over 50, the NHS Health Check is available to approximately 15 million people in England, according to the Department of Health and Social Care (DHSC). Prompted by the digitisation of healthcare during the pandemic, more than 2,000 people across three GP surgeries in Cornwall are to be invited to take part in the study.

Minister for Public Health, Neil O’Brien stated that the trial would help understand what a new digital NHS Health Check could look like in the coming years.

O’Brien also commented that the “health check is crucial in preventing and identifying potentially life-threatening conditions, and this digital version will do just that, while making patients’ lives easier and reducing pressure on frontline services.”

Managing director of NHS Cornwall’s North and East Integrated Care Area, Dr Andy Sant, said: “Much has been achieved in our county around digital inclusion, and the preventative value of health checks is already proven. So, we are delighted that patients in Cornwall are being given the first opportunity to access a digital version through this innovative trial.”

Chair of the Royal College of GPs (RCGP), Professor Kamila Hawthorne highlighted the importance of health checks for prevention and early diagnosis, and how digital health checks will encourage people to take a more active role in managing their personal health, but also noted that their efficacy for patients must be evidenced.

“Offering patients the opportunity to carry out health checks, or some aspects of health checks, for themselves at home has merit […] so is worth exploring,” she reasoned. For example, sexual health services. However, she cautioned that there needs to be “robust evaluation of this initiative”.

“It also needs to address concerns around the potential for causing unnecessary worry for patients who may not know how to interpret their findings, practice staffing implications regarding the running, interpretation, and explanation of tests, and additions to GP workload,” Professor Hawthorne explained.

Caroline Abrahams, charity director at Age UK, said: “DIY digitally enabled health checks will be fine for some people, but won’t work for everyone, especially if they are not online. Therefore, it’s important that anyone who wants a face-to-face appointment with a practice nurse or other clinician for this purpose is still able to get one.”

The digitalisation of the NHS Health Check follows news last month that NHS Digital and NHSX were to be folded into NHS England’s new Transformation Directorate, formed earlier this year with the aim of bringing together digital and operational improvement teams within the NHS and building on changes implemented as a result of the pandemic.

Novartis has a second positive phase 3 trial in the bag for its targeted factor B inhibitor iptacopan, vying to become an oral alternative to injectable therapies for ultra-rare blood disorder paroxysmal nocturnal haemoglobinuria (PNH).

The Swiss pharma group said this morning that the top-line results of the APPOINT-PNH trial showed that iptacopan provided “clinically meaningful” increases in haemoglobin levels in patients with PNH who had not previously been treated with injectable complement C5 inhibitors like AstraZeneca/Alexion’s Soliris (eculizumab) and Ultomiris (ravulizumab).

In the trial, a significant proportion of patients treated with iptacopan (200 mg twice daily) achieved clinically meaningful haemoglobin-level increases of 2 g/dL or more from baseline without the need for blood transfusions at 24 weeks.

The earlier APPLY-PNH study – reported in October – was carried patients who were still experiencing residual anaemia despite prior treatment with anti-C5 antibodies and showed that iptacopan was more effective than the C5 inhibitors at helping them to meet target haemoglobin levels.

Armed with both trial results, Novartis says it now intends to press ahead with plans to file for regulatory approval of iptacopan next year.

Analysts at Jefferies have previously said that iptacopan could hit $3.6 billion in peak annual sales if it gets approved for all its target indications, which along with PNH, include atypical haemolytic uraemic syndrome (aHUS) and rare kidney diseases C3 glomerulopathy (C3G) and idiopathic membranous nephropathy (IMN).

In PNH, the body’s complement system destroys red blood cells leading to anaemia, fatigued and in some cases needing blood transfusions. It is estimated that approximately 10-20 people per million worldwide live with PNH. It can develop at any age, though is often diagnosed in people between 30-40 years old.

Between 20% and 50% of PNH patients treated with Soliris or other drugs in the C5 inhibitor class can’t get symptoms under control and require blood transfusions, so there’s a clear need for new treatment options.

In PNH and aHUS, iptacopan will compete with Soliris and Ultomiris, but it could become the first treatment for C3G and IMN if approved.

ImmunoGen entered into a clinical collaboration deal with Gilead Sciences Friday to evaluate the safety and efficacy of two drugs that, when used in concert, have the potential to treat AML, a blood disorder biopharma has found challenging to target. 

Though both companies bring their share of speckled pasts in oncology to the deal, the companies’ officials hope the agreement with spark a breakthrough in notoriously intractable acute myeloid leukemia (AML).

A leader in antibody-drug conjugates–used to treat various malignancies –Immunogen plans to work with Gilead to assess the benefits of pivekimab sunirine in combination with Gilead’s magrolimab, a potential, first-in-class CD47 inhibitor in patients with relapsed or refractory (R/R) CD123.

Immunogen has a speckled history with few success stories. The company only recently gained its first regulatory approval with Elahere — 41 years after its founding.

Given the complementary profile of the two drugs and “limited overlap” in safety profiles, we hope to explore this therapy in the R/R patient population, where few treatments exist, said Anna Berkenblit, MD, senior vice president and chief medical officer of ImmunoGen in a statement regarding the partnership. 

Magrolimab targets CD47, a “do not eat me” signal that allows cancer cells to avoid destruction, thereby permitting the patient’s innate immune system to engulf and eradicate those cancer cells, according to Gilead.

Though the potential for an efficacious treatment for AML is much sought after, ImmunoGen and Gilead may make strange bedfellows. 

Besides ImmunoGen’s single win with Elahere, a therapeutic designed to treat ovarian cancer, Gilead, too, brings some historical baggage to the partnership.

Gilead’s magrolimab comes from its buyout of Forty-Seven in 2020. Safety concerns since the buyout have dinged this CD47 therapy.

Since the buyout, safety concerns over the novel therapeutic prompted an abrupt pause in magrolimab trials in April 2022, according to the American Association for Cancer Research.

The FDA lifted the partial hold later that month, allowing Gilead to evaluate magrolimab in combination with azacytidine across a variety of liquid tumors.

Nonetheless, the collaboration ought to begin in 2023 with a new patient group of ImmoGen’s current 802 study to evaluate pivekimab and magrolimab when used in combination, according to the companies. 

The collaboration will be a new cohort in the 802 study and will evaluate 42 patients with R/R CD123-positive AML.

Immunogen’s stock was up nearly 6% in pre-marketing trading Friday as investors reacted to the deal.

The microneedle system, along with an mRNA vaccine candidate, showed enhanced humoral immunity in animal models.

The US Food and Drug Administration (FDA) has granted clearance to Sorrento Therapeutics to commence clinical trials of the messenger ribonucleic acid (mRNA) vaccine STI-1557. 

Targeting the Omicron variants of the SARS-CoV-2 virus, the vaccine incorporates a mutation in the furin cleavage site that prevents the S1 subunit cleavage from the spike protein from attaching to the muscle cell membrane. 

This variation was introduced to prevent S1 subunit leakage from the expressed spike protein (S protein) into the bloodstream. 

S1 subunit leakage is claimed to possibly cause unwanted side effects in tissues of vital organs, following dosing with mRNA vaccines approved by the FDA at present. 

For protecting mRNAs from degradation, they are encased in a Sorrento lipid nanoparticle formulation (LNP) and facilitate the S protein’s translation in host cells, following intramuscular (IM) dosing, thereby eliciting an adaptive immune response.

Using the Sofusa MuVaxx lymphatic delivery system, the company intends to seek more sophisticated mRNA vaccine approaches in the future. 

The microneedle system facilitates the intradermal delivery of the vaccines.

Along with an mRNA vaccine candidate, this system showed enhanced humoral immunity and increased cellular immunity using one tenth of the IM dose in animal models. 

In addition, following MuVaxx administered inoculation, a four-fold rise in T cell response was seen versus IM delivery. 

In August this year, Sorrento announced plans to begin a Phase I clinical trial of its oral therapy, STI-1558, for Covid-19 in China.

The move comes after the company obtained the China National Medical Products Administration (NMPA) approval for its IND application for STI-1558.

The trial will assess the combination of Phanes’ PT199 and BeiGene’s tislelizumab to treat advanced solid tumours.

Phanes Therapeutics has signed a clinical supply agreement with BeiGene for assessing a PT199 and tislelizumab combination in a Phase I clinical trial for multiple advanced solid tumours.

The multi-centre Phase I clinical trial has been designed to assess the pharmacodynamics, pharmacokinetics, tolerability, safety, and preliminary efficacy of Phanes ’ PT199 alone, as well as in combination with BeiGene’s tislelizumab.

It will be conducted in locally advanced or metastatic solid tumour patients, whose disease has progressed following all available standard therapy or whose condition is intolerable, ineffective, or inappropriate for standard therapy.

Phanes Therapeutics founder and CEO Dr Ming Wang said: “We are excited about the opportunity to evaluate PT199 in combination with tislelizumab for the treatment of solid tumours.

“PT199 is an anti-CD73 monoclonal antibody with a differentiated mechanism of action to counter the immunosuppressive tumour microenvironment in cancer patients.

“The combination of PT199 with tislelizumab provides a new opportunity to assess the strategy to enhance antitumor immune response in patients with advanced or metastatic cancer refractory to previous treatments.”

The differentiated anti-CD73 monoclonal antibody PT199 has been designed to counter the adenosine-mediated immunosuppressive tumour microenvironment (TME).

It completely hinders the enzyme activities of soluble and membrane-bound CD73.

The humanised IgG4 anti-PD-1 monoclonal antibody tislelizumab has been specifically designed to lower the Fc-gamma (Fcγ) receptors binding on macrophages.

This helps the immune cells in the body to detect and fight tumours.

The anti-PD-1 antibody is currently being assessed as a monotherapy and in combination for the treatment of hematologic malignancies and solid tumour.

In October this year, Phanes received approval from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to commence the Phase I clinical trials of antibody PT217 to treat small cell lung cancer (SCLC ), as well as other neuroendocrine cancer patients.

Assessing the safety and tolerability of varying doses of QRL-201 in ALS patients is the primary objective of the trial.

Health Canada has granted authorisation for the clinical trial application (CTA ) of QurAlis for the Phase I ANQUR trial of its therapy, QRL-201, for amyotrophic lateral sclerosis (ALS ). 

The international, randomised, multicentre, double-blind, placebo-controlled, multiple-ascending dose trial will assess the safety, tolerability, and pharmacokinetics (PK) of QRL-201 compared to a placebo.

Anticipated to commence in the country early next year, the trial will enrol 64 ALS patients across sites in Canada, the US, UK, Belgium, Italy, the Netherlands, Ireland, and Germany.

Determining the safety and tolerability of varying doses of QRL-201 in ALS patients is the primary objective of the trial.

A therapeutic product candidate, QRL-201 can potentially restore STATHMIN-2 protein expression in individuals with ALS. 

STATHMIN-2 is vital for neural repair and stability of axons and its expression is reduced in almost all patients with ALS. 

The latest clearance from the Canadian health agency is the first part of the international regulatory approach of the company for QRL-201’s clinical development.

Additional approvals across various jurisdictions are expected soon.

Walmart has become the latest big pharmacy chain in the US to put forward a settlement to resolve claims it contributed to the national opioid crisis by failing to regulate prescriptions at its outlets.

The retail giant has confirmed it has offered $3.1 billion to settle thousands of outstanding lawsuits from state local and tribal governments, adding to nearly $10 billion pledged by rival pharmacy chains CVS Health and Walgreens a few weeks ago. The finer details of that earlier offer are still being discussed.

Along with its peers, Walmart refutes any allegations that it was culpable in driving the opioid epidemic, which continues to claim lives with 108,000 drug overdose-related deaths in the US in 2021, according to data from the Centres of Disease Control and Prevention (CDC).

In a statement, Walmart said it “will provide significant aid to communities across the country in the fight against the opioid crisis,” adding that its deal will see “aid reaching state and local governments faster than any other nationwide opioid settlement to date” if all the settlement requirements are met.

Its programme is aimed at educating pharmacists and the public about opioid misuse, reducing the amount of opioids dispensed, taking measure to prevent diversion and theft, and increasing access to overdose reversal drugs.

“Pharmacies such as Walmart played an undeniable role in perpetuating opioids’ destruction, and my fellow attorneys general and I are holding them accountable,” said New York Attorney General, Letitia James.

She added that the settlement will include “broad, court-ordered requirements Walmart must comply with, such as robust oversight to prevent fraudulent prescriptions and flag suspicious prescriptions.”

The deal still needs to gain support from the required US 43 states by the end of 2022, which would then allow local governments to join the deal during the first quarter of 2023.

The pharmacy chains are following in the footsteps of the big three US wholesaler distributors – McKesson, Cardinal Health, and AmerisourceBergen – who agreed a $21 billion settlement earlier this year.

Meanwhile, pharma manufacturers have also negotiated multibillion-dollar settlements, including $5 billion for Johnson & Johnson, around $4.3 billion for Teva Pharmaceutical, $2.4 billion for AbbVie, $1.7 billion for Mallinckrodt, and $450 million for Endo Pharma.

Purdue Pharma is also trying to agree its own $6 billion deal, although that has stalled, as some plaintiffs are reluctant to agree to a settlement that provides immunity to the Sackler family that controls the company.

The trial is designed to evaluate the efficacy, safety, and tolerability of PrimeC in ALS patients.

The US Food and Drug Administration (FDA) has granted clearance for NeuroSense Therapeutics’ Investigational New Drug (IND) application to enrol patients in the country in its Phase IIb PARADIGM clinical trial of its PrimeC drug candidate to treat amyotrophic lateral sclerosis (ALS).

The company anticipates enrolling and dosing the first US subjects at ALS centres soon.

At present, the trial is enrolling subjects in Israel, and the company anticipates launching trial sites for participant recruitment in the European Union soon.

The placebo-controlled, double-blind, multinational trial is designed to evaluate the efficacy, safety, and tolerability of PrimeC in ALS patients.

It is enrolling and randomising 69 ALS patients into a 2:1 ratio to receive either PrimeC or a placebo.

The participants will also be allowed to take standard-of-care (SOC) treatment using approved products.

Evaluating ALS-biomarkers, clinical efficacy, and improvement in quality of life are included as the primary and secondary endpoints of the trial.

The findings from the trial are anticipated during mid-next year.

A lead drug candidate of the company, PrimeC is a fixed-dose combination of two drugs, ciprofloxacin and celecoxib, which are approved by the FDA.

The extended-release oral formulation can act on various crucial ALS mechanisms that lead to motor neuron degeneration, inflammation, the build-up of iron, and impaired ribonucleic acid (RNA) regulation to hinder disease progression.

According to data from a concluded Phase IIa trial, PrimeC met the safety and efficacy endpoints, including lowering functional and respiratory decline.

It also offered statistically significant changes in ALS-associated biological markers, indicating the biological activity of PrimeC.

NeuroSense CEO Alon Ben-Noon said: “[The] FDA’s acceptance of our IND paves the way for NeuroSense to commence patient enrolment in the US and is another significant milestone achieved in our drug development plan.

“This clinical trial is evaluating our new and improved extended release formulation of PrimeC, which may provide a better outcome than already observed in our prior Phase IIa study.”

In April this year, the company dosed the first healthy subject in the pharmacokinetic study of PrimeC to treat ALS.

• Breast cancer is currently the most frequently diagnosed cancerTrusted Source in the United States, and globally it is the world’s most prevalent cancer.
• According to new phase 1 clinical trial data, a new plasmid DNA-based vaccine that is able to target a receptor in breast cancer appears safe.
• The non-randomized study showed an increased immune response after vaccination in people with advanced-stage ERBB2-positive breast cancer.

According to the World Health OrganizationTrusted Source, 2.3 million women were diagnosed with breast cancer in 2020, and there were over 7.8 million women alive who had been diagnosed with breast cancer in the previous 5 years.

Being female is the biggest risk factor for breast cancer, but around 1% of breast cancers do occur in men. The treatment of breast cancer follows the same principles for both sexes.

Speaking to Medical News Today Dr. Kotryna Temcinaite, senior research communications manager at Breast Cancer Now explained:

“Breast cancer is not a single disease, which makes it more difficult to treat. There are many types of breast cancer and treatments that work well for some people, may not work as well for others. That’s why we need to undertake further research into the disease, develop [k]inder and smarter treatments.”

Now, new research led by Dr. Mary (Nora) L. Disis, at the University of Washington Medicine Cancer Vaccine Institute on an experimental vaccine against breast cancer has shown it generates a strong immune response to ERBB2—formerly called HER2—a key tumorprotein.

The completed study was a single-armTrusted Source phase 1Trusted Source clinical trial that followed 66 people ages 34 – 77 years who had advanced-stage ERBB2-positive breast cancer. Researchers analyzed the data twice—from January 2012 to March 2013 and from July 2021 to August 2022.

Participants were vaccinated with either 10ug, 100ug, or 500ug doses of the plasmid DNA vaccineTrusted Source every month for three months. The researchers measured blood immunity and vaccine toxicity at set time points and assessed the DNA persistenceTrusted Source of the vaccine via biopsy samples taken from the vaccine site at 16 and 36 weeks.

The researchers noted the most common side effects associated with the injection, 33% recorded flu-like symptoms, and 36% fatigue.

Participants who received the higher vaccine doses of 100 μg and 500 μg demonstrated a stronger immune response than those who received the 10ug dose, but there was no significant difference between the immune responses to the 100ug and 500ug doses.

The research team also found DNA persistence at the injection site was greatest with the highest vaccine dose and that this DNA persistence was associated with more rapidly waning immunity.

Treating cancer with a vaccine

The study’s lead author Dr. Disis explained that the problem with current breast cancer treatments is “disease recurrence after optimal treatment.” She said the disease recurred because a small amount of cancer remained undetected.

“Ideally, it would be great to prevent all cancers before treatment is needed. We have already made way with some vaccines in cancer prevention such as the hepatitis B vaccines against hepatocellular carcinoma and HPV against cervical cancer,” said Dr. Bhavana Pathak, board certified hematologist and medical oncologist at MemorialCare Cancer Institute at Orange Coast Medical Center, California, who was not involved in the study.

Exciting potential

Dr. Temcinaite believes a vaccine has “exciting potential” for treating breast cancer. However, she said that “Scientists must investigate what to include in a vaccine, to trigger the right immune response.”

Breast Cancer Now is currently funding research to design a new cancer vaccine, specifically targeting the protein p53.

Dr. Parvin Peddi, medical oncologist and director of Breast Medical Oncology at Providence Saint John’s Health Center and associate professor of medical oncology at Saint John’s Cancer Institute, California further explained to MNT:

“[T]his is the first study in my knowledge to examine a HER2 specific vaccine for patients with HER2 positive metastatic breast cancer who are in remission. Although it’s an early study and it was not compared directly to patients not receiving the vaccine, the survival of patients seen in this study is much more than expected with observation.”

Vaccines against other cancers

Dr. Disis said she believes there is a “good chance” breast cancer vaccines will be in use in clinics in about 5 years.

“Clinical trials of breast cancer vaccines given alone or with other treatments have increased by about 25% in the last several years. There are many groups working on ‘next-gen’ vaccines with very effective delivery technologies and adjuvants,” she told MNT.

Dr. Pathak echoed similar thoughts. She called the current study a “building block showing an increase[d] immune response against specific targets for patients with cancer.”

“Once later phase trials are completed showing efficacy in addition to tolerability, we can potentially anticipate seeing vaccines in clinic,” she said.

But could similar vaccines be developed to treat other types of cancer? Dr. Disis said she believes that is where cancer treatment’s future is headed.

“[Yes.] At the UW Medicine Cancer Vaccine Institute we have programs in breast cancer, ovarian cancer, colon cancer, prostate cancer, and bladder cancer vaccines and ideas for others,” she elaborated.

Vaccines may not replace treatment yet

However, experts have also expressed caution about the trial’s early results.

Dr. Temcinaite said it was “too early to tell whether treatment vaccines for cancer could replace other existing treatments.”

Dr. Pathak also raised caution that this study has only been completed in people with breast cancer. “[M]ore studies will be needed to address the possibility of primary prevention,” she pointed out.

“In general, if the protein that is targeted by the vaccine is also found in [healthy] cells, it would be important to watch for autoimmune side effects. For example, heart muscle also has HER2 expression. Although no excess cardiac side effects were reported in this study, it would be important to watch that in larger studies,” Dr. Peddi added.

It is also important to understand how long the benefits of these vaccines may last. The immune response wanes after vaccination so, it would be interesting to understand if booster vaccines might be needed for some patients.

What’s next?

When asked about the next steps Dr. Disis told MNT that the remarkable results they got from the Phase I trial for the HER2 vaccine lays the ground for future studies.

“The next step is to formally test that observation. In the Phase II study, we will randomize HER2-low patients to receive the vaccine or an immune-stimulating agent. The endpoint will be whether we do prevent disease recurrence,” she said.

Dr. Temcinaite advised that these new vaccines might not work for everyone who receives a breast cancer diagnosis.

“[M]ore research to discover new ways to treat breast cancer and build our understanding of who will and who won’t benefit from particular treatments and why,” she said.

StudyTeam follows trial subjects through to enrolment and offers visibility to sponsors at each step of the enrolment process.

OneStudyTeam has signed a collaboration with Antidote Technologies to offer an integrated, end-to-end patient referral management approach to sites and sponsors to provide control in patient recruitment in clinical trials.

OneStudyTeam will merge patient recruitment solutions with StudyTeam, its Cloud-based technology platform, and works directly with research sites, sponsors, and technology partners to reduce the burden on site staff. 

An enrolment management solution, StudyTeam enables site personnel to log into a system to oversee enrolment across all patient sources and carry out trials effectively. 

StudyTeam follows trial subjects through to enrolment and offers visibility to sponsors at each step of the enrolment process. 

To identify the right patients for trials, Antidote merges technologies powered by data, digital capabilities, deep domain understanding, and a diversified partner network. 

For optimising site workflows and offering referrals and patient demographic data directly into the StudyTeam platform, Antidote is merged with the Referral Partner Interface (RPI) of StudyTeam, which features a new race and ethnicity feature.

This enables sites to receive enhanced quality referrals in StudyTeam. 

Sponsors can also obtain relevant enrolment information such as recruitment source traceability, patient source comparison, evaluate ROI on central advertising approaches, and understand the impact of recruitment on the diversity of patients.

OneStudyTeam CEO Ralph Passarella said: “Where OneStudyTeam provides visibility to measure and understand gaps in enrollment strategy, Antidote has mastered identifying those critical patients and matching them to the right trial. 

“This collaboration spans the recruitment and enrollment continuum to drive diversity, equity, inclusion, and representation among trial candidates.”

In February 2019, Antidote Technologies and PatientPoint collaborated to enhance trial recruitment, leveraging point-of-care patient engagement tools.