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Partnership Creates Region’s Largest Biotech CRO Platform to Meet Demand for Clinical Trials in Asia-Pacific

SYDNEY, and SHANGHAI, 4 December 2019 – Novotech and PPC Group (PPC), two leading, Asia-Pacific contract research organisations (CROs), announced today that they have formed a strategic partnership to meet growing demand for clinical trials in the region. The partnership creates the largest biotech specialist CRO platform in the Asia-Pacific, bringing together approximately 1,200 staff with significant scale and synergies across countries, research institutions, trial phases, therapeutic areas and functional specialities.

Novotech and PPC are majority owned by TPG Capital Asia and have already been working closely over the last two years collaborating on delivering biotech clinical trials in the region. Under the partnership, the companies will share an integrated governance structure as well as aligned systems and processes. The structure creates a scalable, regional platform, whereby both companies will continue to retain their own management teams, office locations and brands.

Globally, biotech clinical research activity has increased by 10 per cent each year over the past few years. In the Asia region, the increase has been over 25 per cent per year.[1]

TPG Capital Asia’s Head of Australia and New Zealand Joel Thickins said of the partnership:

“The combined group’s presence as the largest biotech specialist CRO in the Asia Pacific region presents significant growth opportunities and a greater ability to service a fast-growing market with attractive industry fundamentals.”

Novotech CEO Dr John Moller said:

“Strengthening our relationship with PPC will allow us to provide a seamless service to our biotech clients, particularly with access to PPC’s more than 350 Clinical and Operations staff across 28 cities in mainland China. Our increased scale will allow us to further invest in quality. This is a good thing for our clients, for institutions and for patients.”

PPC Group CEO Michael Stibilj said:

“PPC and Novotech have a strong record of working together. The complementary nature of Novotech’s position in the region and PPC’s particularly strong presence in mainland China, will be extremely attractive to current and future clients. Importantly, it positions us well to meet the significant and growing biotech demand in the Asia-Pacific market.”

Jason Zhu, PPC China, CEO added:

“Biotech companies in China are significantly expanding their investment in Multi-Regional Clinical Trials to accelerate product development. They select PPC as we are an agile partner focused on providing strong medical and technical capabilities to enhance their development strategy. The strengthening of the partnership between PPC and Novotech will further expand our ability to offer our customers a flexible and effective clinical development solution.”

Johnson & Johnson paused the clinical trial of its COVID-19 vaccine due to “an unexplained illness in a study participant.”

The company began its Phase III trial of JNJ-78436735 on September 23. The vaccine was developed by J&J’s Janssen Pharmaceutical Companies using its AdVac technology platform, which was also used to develop Janssen’s Ebola vaccine that was approved in Europe and to develop its Zika, RSV, and HIV vaccine candidates. The Phase III ENSEMBLE trial will evaluate the vaccine’s safety and efficacy compared to placebo in up to 60,000 adults ages 18 and older. It is enrolling volunteers in the U.S., Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.

J&J did not disclose much information about the unexplained illness, stating, “We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”

The company also emphasized that adverse events are part of most clinical trials and that this is a “study pause” instead of a “clinical hold,” which is a formal regulatory action. A “clinical hold” can last much longer than a “study pause.” Normally, J&J indicated they would not announce study pauses to the public, but due to the overwhelming interest in the study and the urgency involved because of the COVID-19 pandemic, felt the need to release the information.

Nor is it particularly surprising. The ENSEMBLE study is in 60,000 people, the size of some small cities, and in any population that size, numerous medical events occur on a regular basis.

The COVID-19 vaccine study being conducted by AstraZeneca and the University of Oxford was placed on clinical hold on September 8 after a potential adverse reaction in a UK patient. The patient was believed to have had transverse myelitis, a severe inflammation of the spinal cord. The study has since restarted in the UK and elsewhere, but is still on hold in the U.S.

J&J stated, “Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians.”

The company statement added, “Based on our strong commitment to safety, all clinical studies conducted by the Janssen Pharmaceutical Companies of Johnson & Johnson have prespecified guidelines. These ensure our studies may be paused if an unexpected serious adverse event (SAE) that might be related to a vaccine or study drug is reported, so there can be a careful review of all of the medical information before deciding whether to restart the study.”

Ashish Jha, the dean of the Brown University School of Public Health, told CNN, “This is completely expected, and it’s just a reminder how ridiculous it is to try and meet a political timeline of having a vaccine before Nov. 3. The Johnson & Johnson trial is the biggest trial of the vaccine that I know of—60,000 people. Within that trial you’d expect a few pauses.”

Generally speaking, the Johnson & Johnson clinical trial was running about fourth in the U.S. efforts to get a vaccine against COVID-19 ready. Pfizer and Germany-based BioNTech appear to be leading the race, potentially having actionable data by the end of this month. Moderna appears to be next and has recently indicated it will likely be able to apply for emergency use authorization (EUA) with the U.S. Food and Drug Administration (FDA) in November or possibly December. As mentioned earlier, AstraZeneca and the University of Oxford appear to be running third, although it is on clinical hold in the U.S. The Johnson & Johnson program, even before this pause, was unlikely to be ready to apply for EUA sometimes in the first quarter of 2021. Whether they are still able to do so will depend on how long the pause lasts and the results of their investigation into the unexplained illness.

Moncef Slaoui, the head of the U.S. government’s Operation Warp Speed, which is overseeing U.S. vaccine production, recently indicated he thought the first EUA for a vaccine would probably be around Thanksgiving.

Bristol-Myers Squibb has said it will buy biotech MyoKardia in a $13.1 billion takeover that marks a step up in its development of cardiovascular drugs.

The all-cash deal is mainly about MyoKardia’s mavacamten drug that BMS thinks could be a first-in-class treatment for hypertrophic cardiomyopathy (HCM) – a form of heart disease – based on clinical data reported in the spring.

In the EXPLORER-HCM study, cardiac myosin inhibitor mavacamten improved exercise capacity, cardiovascular health scores like left ventricular outflow tract (LVOT) and overall health status in patients with obstructive HCM over placebo, setting up an FDA filing on the first quarter of next year.

HCM is a condition in which the heart becomes thickened without any obvious cause, and can lead to chest pain and shortness of breath, irregular heartbeats and even heart failure in severe cases.

BMS is a longstanding player in cardiovascular with drugs like Pfizer-partnered Eliquis (apixaban) and Sanofi-partnered Plavix (clopidogrel), but over the last few years has been directing its R&D dollars mainly towards oncology.

Its cancer franchise – headed by flagship immunotherapy Opdivo (nivolumab) – accounted for around 80% of BMS’ sales of $20 billion in the first half of 2020.

It does have a few cardiovascular candidates in clinical trials – cimlanod for heart failure and Johnson & Johnson-partnered factor XIa inhibitor BMS-986177 for thrombotic disorders in phase 2 trials for example – but its heart disease programmes are dwarfed by the dozens of candidates for blood cancers and solid tumours.

Adding mavacamten gives it a near-term product candidate with potential in additional indications like non-obstructive HCM, as well as other drugs in clinical development, including follow-up myosin inhibitors danicamtiv (MYK-491) for dilated cardiomyopathy and MYK-224 hypertrophic cardiomyopathy.

Cardiovascular diseases haven’t seen the dramatic strides forward in drug therapy that have transformed other illnesses like cancer in recent years, so MyoKardia’s programmes – which are both based on novel mechanisms of action – have been keenly anticipated by physicians and patients alike.

BMS has bought into MyoKardia’s cardiovascular pipeline around 18 months after the California-based biotech’s former partner Sanofi walked away from a partnership on those three drugs, reportedly because the biotech was reluctant to extend commercial rights covered by the deal.

It is paying $225 per share for MyoKardia – a 60% premium on its closing share price last week – and shows clearly that BMS chief executive Giovanni Caforio isn’t averse to pursuing further sizeable deals despite its $74 billion takeover of Celgene last year that has left it with a sizeable debt burden of around $47 billion.

“We are further strengthening our outstanding cardiovascular franchise through the addition of mavacamten, a promising medicine with the potential to address a significant unmet medical need in patients with cardiovascular disease,” said Caforio.

He added: “We have long admired MyoKardia and what they have done to revolutionise cardiovascular treatments through a precision medicine approach.”

After the EXPLORER-HCM readout, analysts at Cantor Fitzgerald suggested that mavacamten could make $2 billion or more in sales in obstructive HCM, with another $600 million or more from the non-obstructive HCM category if approved.

Eli Lilly’s Olumiant (baricitinib) has a significant effect on recovery from COVID-19 when combined with Gilead Veklury (remdesivir), according to a large trial backed by funding from the US government.

The findings came from additional safety and efficacy data harvested from the US National Institute of Allergy and Infectious Diseases’ (NIAID) ACCT-2 trial.

Results in hospitalised adults with COVID-19 infection also showed a numerical decrease in death – 35% – in patients treated with the combination therapy, which was more pronounced in patients receiving oxygen.

Lilly said that mortality rate seen on the combination was 5.1%, compared with 7.8% in patients treated with remdesivir alone.

In patients receiving oxygen the combination reduced mortality rate by 60% at day 29, was 43% in certain subgroups.

No new safety signals were observed for patients treated with Olumiant and results will be peer reviewed soon, the company added.

Lilly is continuing talks with the FDA around the potential for an Emergency Use Authorisation for Olumiant, which has been approved since 2018 in the US to treat rheumatoid arthritis.

However because of the well-known side effects associated with Olumiant, which may increase the risk of blood clots that can cause deep vein thrombosis and pulmonary embolism, it’s likely that the drug will be reserved for use in only very sick COVID-19 patients.

The drug works by inhibiting janus kinase (JAK1 and JAK2), which has the effect of reducing the activity of the immune system.

This is important because the more extreme symptoms seen in serious cases of COVID-19 are caused when the virus causes the body’s immune system to over-react.

Several drugs have been trialled to counter the inflammation and damage to organs that this can cause, such as dexamethasone, a cheap steroid that was found to work against COVID-19 in the UK’s large RECOVERY trial.

Regeneron has followed Eli Lilly in asking the FDA for emergency approval of its COVID-19 antibody therapy, shortly after the drug was thrust into the spotlight by being used to treat President Trump.

The request for emergency use authorization (EUA) for REGN-COV2 comes amid a spike in interest about antibodies against the SARS-CoV-2 coronavirus, driven by Trump’s assertions that the drug was instrumental in his apparently swift recovery from the infection and is a “cure” for COVID-19.

That rise in demand is however already forcing a reality check about how many patients may be able to get REGN-COV2 treatment. In its statement on the EUA request, Regeneron says it has supplies available to treat 50,000 patients, adding that should rise to 300,000 “within the next few months.”

That’s far from what will be needed, points out former FDA Commissioner Scott Gottlieb in a tweet suggesting demand could be more than 7,500 patients per day.

The US has had more than 7.5 million cases of COVID-19 and 213,000 deaths to date, with around 50,000 new cases every day.

Regeneron has been working on ramping up manufacturing capacity for REGN-COV2, with the help of $450 million in funding from the US government, and recently enlistedthe aid of Roche to expand capacity. The US has rights to the first 300,000 doses under that funding agreement.

Shares in Regeneron continued their inexorable rise on the news, with another surge after Trump’s comments, and the stock is now trading at twice their value from a year ago at close to $600.

The cocktail of two antibodies targets two components in the spike protein on SARS-CoV-2 with the aim of preventing attachment of the virus to host cells and interrupting infection.

The clinical data behind the EUA comes from a study in 275 patients, and looks promising. The latest readout from the trial showed the drug reduced both viral load and the time to alleviation of symptoms in non-hospitalised patients with COVID-19.

The greatest benefit was seen in patients who had not mounted their own immune response against the virus, according to trial investigators. Results in hospitalised COVID-19 patients are due later this year, and the antibody drug is also being tested for prophylaxis of SARS-CoV-2 infection.

There are still plenty of dissenting voices about REGN-COV2 however, suggesting that it’s far too early to make a judgment on how well it works.

One US physician pointed out that Trump was also treated with dexamethasone – a potent steroid shown clinically to improve survival in COVID-19 – that can make patients feel “20 years younger” – an effect reported by Trump.

The President was also treated with Gilead Sciences’ Veklury (remdesivir) – also shown to reduce the duration of symptoms in trials – as well as various other remedies including zinc and vitamin D supplements, the heartburn drug famotidine, melatonin and aspirin.

Regeneron’s request came hard on the heels of Lilly’s EUA filing for its antibody cocktail LY-CoV555 for use in higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19. The company has said it could be able to produce up to a million doses of the drug.

Meanwhile, other companies including AstraZeneca and GlaxoSmithKline/Vir are also working on antibody-based therapies for the disease. It’s clear however that if approved, these drugs will have to be used thoughtfully and sparingly to eke out limited supplies.

Cytokinetics‘ stocks plummeted Thursday after they released topline results from their Phase III cardiovascular clinical trial with partners Amgen and Servier. While primary endpoints were met, the secondary endpoint to prove potential to save lives failed. 

The trial, GALACTIC-HF, was intended to show that treatment with their cardiac myosin activator, omecamtiv mecarbil, would drastically improve odds for heart failure patients with reduced ejection fraction (HFrEF). The 8,256 person study did show a significant 8% reduction in the odds of hospitalization or other urgent care visits for heart failure. But it failed in the key marker – helping high risk patients live longer. 

“Trial technically worked,” Mizuho’s Salim Syed wrote to investors, “but failed on what was really needed here to be a foundational medicine, in my view, which is CV death.” 

In patients with HFrEF, the muscle of their left ventricle is not contracting enough to squeeze out the amount of blood it should to supply the body. The drug on trial is intended to activate myosin, the motor protein with a strong role in muscle contraction, to help the heart contract and pump as it should.  

The trial had incredibly high hopes after a similar product by MyoKardia delivered big on its Phase III trial ending in May. MyoKardia’s drug, mavacamten, also targeted myosin but in the opposite way, by inhibiting it to treat obstructive hypertrophic cardiomyopathy, where the heart is contracting too vigorously leading to obstructed blood flow. In fact, the trial went so well that Bristol Myers Squibb announced this week that it is buying MyoKardia for a cool $13.1 billion by the end of the year.  

After MyoKardia’s success, the failure of GALACTIC-HF to meet its secondary endpoint of extending life expectancy was a tough blow. Heart failure is the leading cause of hospitalization in people 65 and older. Nearly 5 million Americans are currently living with heart failure and more than half of those diagnosed will die within 5 years of diagnosis. Approximately 550,000 new cases are diagnosed each year.  

However, there is always something to be learned when expectations for a trial are not met. David M. Reese, M.D., executive vice president of R&D at Amgen promised to keep his hand to the plow and said, “The outcomes observed in GALACTIC-HF further the understanding of treating heart failure. At Amgen, we remain committed to developing and delivering transformative medicines that improve the lives of patients with cardiovascular disease.” 

This trial was one of the largest heart failure trials ever conducted and will provide valuable insight into the effects associated with targeting cardiac muscle contractility. The full results will be presented after further analyses at the American Heart Association Scientific Sessions 2020. 

An additional trial for the same drug is currently in process to assess its effect on exercise capacity in subjects with HFrEF. The study began in April 2019 and is expected to be completed by November 2021.

Pfizer’s Phase III study assessing Ibrance as a potential treatment for early breast cancer patients who have residual invasive disease following neoadjuvant chemotherapy failed to meet its primary endpoint.

This morning, the pharma giant announced the PENELOPE-B study failed to hit the mark of improved invasive disease-free survival (iDFS). The study was particularly looking at women with hormone receptor-positive (HR+), human epidermal growth factor-negative (HER2-) early breast cancer (eBC) who have residual invasive disease after completing neoadjuvant chemotherapy. The PENELOPE-B study compared one year of Ibrance plus at least five years of standard adjuvant endocrine therapy to placebo plus at least five years of standard adjuvant endocrine therapy in 1,250 women with HR+, HER2- eBC at high risk of recurrence who have residual invasive disease after completing neoadjuvant chemotherapy.

Chris Boshoff, chief development officer in oncology for Pfizer Global Product Development, said the failure to meet the endpoint of the study is disappointing. However, he noted that a continued examination of the data could yield positive information about certain subgroups who participated in the study. Understanding that data could help inform the development of next-generation CDK inhibitors in early breast cancer, he said.

“This is the first randomized Phase III study to establish mature iDFS results for a CDK4/6 inhibitor as part of the adjuvant treatment for early breast cancer,” Boshoff said in a statement.

Detailed results from the study will be presented at an upcoming medical conference.

Ibrance (palbociclib) is an oral inhibitor of CDKs 4 and 6, which are key regulators of the cell cycle that trigger cellular progression. Ibrance was first approved by the U.S. Food and Drug Administration in 2015. The drug is indicated for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or men. Ibrance was also approved in combination with fulvestrant in patients with disease progression following endocrine therapy.

“We are proud of the transformative impact IBRANCE has had on the treatment of HR+, HER2- metastatic breast cancer – a vastly different treatment setting than early breast cancer. Our commitment to the metastatic patient community is as strong as ever as we continue to generate new data, including the most extensive body of real-world evidence for a CDK 4/6 inhibitor,” Boshoff added.

Sibylle Loibl, chair of the German Breast Group, which co-sponsored the PENELOPE-B study, added her belief that key findings will emerge from the “large number of biomarkers being analyzed from collected tumor tissue, which will help inform future breast cancer research.”

No new safety signals were observed in this Phase III study, Pfizer said.

HOUSTON, Sept. 23, 2020 /PRNewswire/ — Pharm-Olam International, a global mid-sized clinical research organization (CRO), has been selected by the U.S. Department of Defense (DOD) to build capability at military treatment facilities in order to support Phase III clinical trials of one or more lead COVID-19 vaccine candidates being developed under Operation Warp Speed. The CRO will provide project management, contract management, and clinical trial site support to participating military treatment facility investigative sites. Pharm-Olam will be partnering with The Geneva Foundation (Geneva), which is dedicated to serving military medical researchers with the on-site support needed to operationalize clinical trials.

“Pharm-Olam is pleased to have been selected for this important project and look forward to working with DOD, Geneva, and other involved parties supporting the rapid development of COVID-19 vaccines. It has always been our mission to help create a healthier world and joining the fight against COVID-19 is an important part of that effort,” said Jason Ezzelle, the CRO’s chief commercial and government contracts officer. “Our team has supported more than 50% of the new chemical entity antibiotics approved by the Food and Drug Administration (FDA) since 2013, and we are excited to leverage that collective expertise to reinforce the OWS endeavor.”

The CRO has worked with and augmented the efforts of a variety of government entities, including divisions of the U.S. Department of Health and Human Services: the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response; the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) as well as the DOD and several non-governmental organizations. Pharm-Olam also holds memberships in the Medical CBRN Defense Consortium and has a strong history of drug development related to medical countermeasures.

ABOUT PHARM-OLAM LLC

Pharm-Olam is a global clinical research organization that delivers right-sized trial services to pharmaceutical, biotechnology, government, and public health organizations around the world. They specialize in small molecule therapies and biologics in oncology-hematology, rare disease, allergy, autoimmune, infectious disease, and vaccines. Founded in 1994, with operations in 60 countries, this CRO goes the distance to create a healthier world through agile, innovative, and customized CRO solutions for Phase I-IV research. Learn how Pharm-Olam helps studies succeed at www.pharm-olam.com.

ABOUT THE GENEVA FOUNDATION

The Geneva Foundation is a 501(c)(3) non-profit organization that advances military medicine through innovative scientific research, exceptional program management, and a dedication to U.S. service members and veterans, their families, and the global community. Geneva is proud to have over 25 years of experience in delivering full-spectrum scientific, technical, and program management expertise in the areas of federal grants, federal contracts, industry-sponsored clinical trials, and educational services. http://www.genevaUSA.org

In the U.S., most of the attention to the COVID-19 vaccine race has been on Moderna, Pfizer and BioNTech, and AstraZeneca and the University of Oxford, which are leading the way. There are a number of other major biopharma companies also working to advance their vaccine candidates, and today, Johnson & Johnson announced a major milestone. It is launching its large-scale, international Phase III trial for its vaccine candidate, JNJ-78436735.

The vaccine was developed by J&J’s Janssen Pharmaceutical Companies using its AdVac technology platform, which was also used to develop Janssen’s Ebola vaccine that was approved in Europe and to develop its Zika, RSV, and HIV vaccine candidates.

If approved, the vaccine would have a few advantages over some of the other vaccines in development. First, the J&J vaccine is believed to remain stable for two years at -20 degrees C and at least three months at 2-8 degrees C. Some of the other candidate vaccines require storage at -80 degrees C, with others -60 degrees C. This creates significant logistical problems in terms of distribution.

A second advantage, and a likely important one, is the J&J vaccine appears to require only a single dose. Several of the other candidate vaccines require two doses about 28 days apart.

J&J’s Phase III ENSEMBLE trial will evaluate the safety and efficacy of a single dose compared to placebo in up to 60,000 adults ages 18 years and older, with “significant representation from those that are over age 60.” It expects to enroll volunteers in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the U.S. It also expects to include people with and without comorbidities linked to increased risk for progression to severe disease. In the U.S., it will include significant representation of Black, Hispanic/Latinx, American Indian and Alaskan Native volunteers.

“As COVID-19 continues to impact the daily lives of people around the world, our goal remains the same—leveraging the global reach and scientific innovation of our company to help bring an end to this pandemic,” said Alex Gorsky, chairman and chief executive officer of J&J. “As the world’s largest healthcare company, we are bringing to bear our best scientific minds, and rigorous standards of safety, in collaboration with regulators, to accelerate the fight against this pandemic. This pivotal milestone demonstrates our focused efforts toward a COVID-19 vaccine that are built on collaboration and deep commitment to a robust scientific process. We are committed to clinical trial transparency and to sharing information related to our study, including details of our study protocol.”

Because the pandemic has become increasingly politicized, and President Trump continues to insist a vaccine will be available before the November 3, 2020 presidential election despite statements by numerous experts and the companies themselves that this is unlikely, companies involved in vaccine development have pledged to adhere to the strictest scientific procedures. Many have also posted their trial protocols in order to provide more transparency. The J&J study protocol can be found here.

Reportedly, the U.S. Food and Drug Administration (FDA) is considering implementing a more stringent new standard for emergency use authorization (EUA) of a COVID-19 vaccine to assuage these concerns. This would also make it almost impossible for any vaccine to be cleared before the election. In that the highly politicized process has led to deep skepticism over the safety of the vaccine, some polls have suggested that as much as half of the U.S. population will refuse to get the vaccine.

In a statement about the J&J announcement, Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID), said, “Four COVID-19 vaccine candidates are in Phase III clinical testing in the United States just over eight months after SARS-CoV-2 was identified. This is an unprecedented feat for the scientific community made possible by decades of progress in vaccine technology and a coordinated, strategic approach across government, industry and academia.”

He went on to say, “It is likely that multiple COVID-19 vaccine regimens will be required to meet the global need. The Janssen candidate has showed promise in early-stage testing and may be especially useful in controlling the pandemic if shown to be protective after a single dose.”

J&J believes it will take six to eight weeks to enroll and dose 60,000 participants.

Maryland’s Novavax initiated a Phase III study of its COVID-19 vaccine candidate in the United Kingdom. The late-stage study is part of an agreementstruck between the company and the U.K. government last month that includes providing 60 million doses of the vaccine, should it be approved.

The first Phase III study of NVX-CoV2373, Novavax’s COVID-19 vaccine candidate, is being conducted in the United Kingdom in partnership with the U.K. Government’s Vaccines Taskforce. The trial is expected to enroll 10,000 patients between the ages of 18 to 84. Some of the patients who will be included in the trial will have relevant comorbidities that COVID-19 likes to target, including hypertension, obesity, diabetes and other pre-existing conditions. The patients are expected to be enrolled in the study over the next four to six weeks, the company announced Thursday.

The Phase III study in the U.K. is a randomized, placebo-controlled, observer-blinded study. Half the participants will receive two intramuscular injections of vaccine comprising 5 µg of protein antigen with 50 µg Matrix‑M adjuvant, administered 21 days apart, while half of the trial participants will receive placebo.

The trial is designed to enroll at least 25% of participants over the age of 65 as well as to prioritize groups that are most affected by COVID-19, including racial and ethnic minorities. Additionally, up to 400 participants will also receive a licensed seasonal influenza vaccine as part of a co-administration sub-study.

Gregory M. Glenn, president of Research and Development at Novavax, anticipates the trial enrolling quickly due to expected increases in infection rates in the United Kingdom. There are more than 416,000 confirmed cases of COVID-19 in the United Kingdom and, after a lull, the numbers have begun to rise again in the countries making up the U.K., according to reports.

“The data from this trial is expected to support regulatory submissions for licensure in the UK, EU and other countries. We are grateful for the support of the UK Government, including from its Department of Health and Social Care and National Institute for Health Research, to advance this important research,” Glenn said in a statement.

NVX‑CoV2373 consists of a stable, prefusion protein made using its proprietary nanoparticle technology and includes Novavax’ proprietary Matrix‑M adjuvant. Phase I data from a Phase I/II study showed that NVX‑CoV2373 produced antibodies in healthy patients, a sign the vaccine is working as intended. The vaccine was also well-tolerated in those patients, the company said. Novavax noted that its vaccine candidate has a favorable product profile that will allow handling in an unfrozen, liquid formulation, which will allow for distribution using standard vaccine channels. Some of the vaccine candidates against the novel coronavirus that are in development require the medication to be kept on dry ice until needed.

Novavax expanded its collaboration with FUJIFILM Diosynth Biotechnologies earlier this summer to manufacture the antigen component of NVX-CoV2373 from its Billingham, Stockton-on-Tees site in the U.K., in addition to its sites in North Carolina and Texas in the United States.