Pfizer announces ‘successful’ data from OPEN ORPHAN’s hVIVO-sponsored RSV human challenge trial
Contract win with unnamed new customer
Back in August 2020,(ORPH ) secured a €4m contract to trial a new treatment for respiratory syncytial virus, which causes infections of the lungs and respiratory tract.
Addressing shareholders at the time, Open Orphan’s Chairman, Cathal Friel said: “This is another exciting new contract win with a new [and unnamed] customer for Open Orphan’s subsidiary hVivo as we convert the substantial pipeline that is building up within the company.”
RSV, a contagious virus that affects children and at-risk older adults, is considered a significant public health threat and a leading cause of hospitalisation of young children globally. In severe cases, it can cause pneumonia and life-threatening breathing difficulties.
‘RSV may also lower immunity and increase the risk of developing COVID-19, and where these infections occur together, it can worsen the severity of COVID-19 illness,’ the Company also explained at the time.
hVivo, which holds a quarantine facility in Whitechapel, is a clinical trial business that can accelerate drug and vaccine development, specialising in human challenge studies. The RSV trial forms part of Open Orphan’s wider expansion from one clinic to multiple clinics.
“hVIVO is currently the only company worldwide that can facilitate RSV challenge studies and we are in advanced negotiations with all the significant RSV vaccine and drug developers globally. Our multiple state-of-the-art East London quarantine facilities are well equipped to carry out this study in a safe and controlled clinical environment,” said Friel.
In a research note released in March 2021, analysts at Arden Partners commented: “There is currently no specific treatment on the market for RSV and Open says hVIVO division is “currently the only company worldwide” that can facilitate challenge studies for the virus.”
As a result, Open Orphan described the contract as ‘substantial and significant’ and said it is in advanced negotiations with all the significant RSV vaccine and drug developers globally. There are no existing effective licensed therapies generally available for RSV disease.
Pfizer announces RSV results during 2Q20 earnings call
Further analysis during an Q2 2021 earnings call
Pfizer last week cited the “successful” Phase 2a human challenge trial as a key highlight within its 2Q21 results.
Importantly for ORPH investors, Pfizer highlighted the RSV Adult Vaccine as part of its “First in Class Science Update.
Outlined within its quarterly report, Pfizer cited key data from the hVIVO-sponsored human challenge trial, which involved testing a vaccine candidate of respiratory syncytial virus (RSV).
Furthermore, results from the study yielded 100% efficacy against symptomatic disease in 18- to 50-year-olds.
Results from Phase 2, which is to be submitted for peer-reviewed publication soon, show the vaccine was 100% effective against mild-to-moderate symptomatic infection. The Group highlighted that most participants in the study experienced minimal to no side effects.
Meanwhile, as a performance benchmark, the Ad26.RSV preF vaccine showed 52% observed efficacy in the same human challenge model, the company outlined to investors.
In Pfizer's 2Q21 earnings conference call which occurred last Wednesday, Mikael Dolsten, President of Worldwide Research and Development and Medical noted that there remains much excitement about the trial’s data as well as the opportunity for an RSV adult vaccine.
Addressing Pfizer shareholders, he commented: “There are hundreds of thousands of cases, and they -- per year in the US, and they are particular, of course, difficult for -- in older adults above 60 or adults that have underlying conditions, whether chronic lung diseases or immunocompromised. Now, there are actually up to 15,000 deaths just in the US annually.”
Going forward, Phase 3 of the human challenge study which will be focused on RSV in adults is expected to commence in 3Q21 with a potential conclusion expected as early as 1Q22.
View from VOX
hVIVO is proving to be a world class asset for ORPH.
In addition to being selected by Pfizer for RSV as outlined above, it was recently chosen to work alongside the UK Government earlier this year as part of the of the characterisation study where researchers would aim to identify a dose of the COVID-19 virus that causes a safe and reliable infection in unvaccinated COVID-19 naïve volunteers. Last month, the UK Government said it had decided to expand the Human Challenge Programme to answer further questions that can help in the fight against COVID-19.
The study, which is being conducted by hVIVO at the Royal Free Hospital and funded by the UK Government who have commissioned Imperial College London as the study sponsor, will initiate as soon as appropriate regulatory approvals and clinical preparations are complete.
The Group said existing data from the characterisation study has already provided valuable insight into the biology of the virus which causes COVID-19 while further data is expected to improve the ability to manage the virus and deliver a range of treatment options in the future.
Also commenting on ORPH’s outlook, analysts at research firm Arden Partners said the group’s pipeline is ‘continuing to grow through interactions with key global pharma players with signed deals in 2021 already ahead of 2020, underpinning confidence in the outlook.’
Open Orphan is a rapidly growing Contract Research Organisation and world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials.
The Group comprises two commercial specialist CRO services businesses, hVIVO and Venn Life Sciences and is also building out a valuable data platform business. All businesses are now working closely together to offer upselling and cross selling opportunities.
World Class Facilities
Open has Europe's only 24-bedroom quarantine clinic with onsite virology providing individually isolated rooms and specialist laboratory facilities. The hVIVO facility offers highly specialised virology and immunology laboratory services to support pre-clinical and clinical respiratory drug, antiviral, and vaccine discovery and development.
Largest Test Portfolio
Open Orphan has a leading portfolio of 8 viral challenge study models, which are: 2 FLU, 2 RSV, 1 HRV, 1 Asthma, 1 cough and 1 COPD viral challenge models. As announced in early March 2020, it is rapidly advancing several COVID-19 challenge study models and expects to be helping many COVID-19 vaccine development companies to test their vaccines.
hVIVO works with UK and Irish companies to provide COVID-19 testing to staff to protect staff and customers from a workplace COVID-19 outbreak through its COVID Clear offering.
The company announced that its first volunteer had been dosed with the Codagenix needle free, intranasal COVID-19 vaccine, COVI-VAC as part of a Phase I clinical trial of COVI-VAC currently being carried out by hVIVO, at its facility in the UK.
Rapidly Expanding Market
The market for vaccine development and testing has grown rapidly over the past six months, largely due to the outbreak of Covid-19.
However, ORPH believes Governments and International pharmaceutical companies around the world will be making enormous ‘catch-up investments’ in all types of vaccine development to ensure the effects of any pandemic can be mitigated in the future, which it said should result in the hIVO facility being booked out for months, if not years, in advance going forward.
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