Open Orphan (ORPH ) has entered into a contract with a biotechnology firm to run a human viral challenge study for a respiratory syncytial virus (“RSV”) prophylactic and treatment. The contract value is £7.5m and the study is due to commence in 4Q21, with the majority of revenues being recognised in 2021.
Open said the ‘substantial and significant’ contract win is between its subsidiary, hVIVO, and an unnamed US biotechnology company, which is currently developing a product for the prevention and treatment of acute and chronic respiratory syncytial virus infections.
hVIVO will conduct this study on behalf of the biotechnology company ‘to demonstrate the efficacy of their lead candidate against RSV infection.’
The product is expected to have substantial advantages with respect to potency, safety, tolerability and convenience while fully maintaining efficacy versus other similar products.
RSV is a contagious virus affecting the respiratory tract of children and at-risk older adults; and in severe cases, it can cause pneumonia and other life-threatening breathing difficulties.
There is currently no prophylactic or specific treatment on the market for RSV which is known as one of the leading causes of hospitalisation of young children across the world.
RSV is a significant public health threat, particularly in at-risk older adults. In the current climate, 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.
Executive Chairman, Cathal Friel, said, “This is another substantial and significant contract win for hVIVO and Open Orphan. He highlighted that Open’s hVIVO division is “currently the only company worldwide that can facilitate RSV challenge studies”, adding that it is in advance negotiations with all the significant RSV vaccine and drug developers globally.
He added, “With the ongoing expansion of our clinical footprint, we can now provide any pharmaceutical company, anywhere in the world, rapid access to challenge study clinical trials to gather data on their product in a relatively short time period.
In the past, human challenge studies suffered from the perception that it was difficult to find a provider and that it may take a long period of time to complete, however, Open Orphan is transforming this view. We are delighted to see human challenge clinical trials now becoming an increasingly important part of pharmaceutical product testing and commercialisation.”
More positive news for investors, which complements a string of recent deals in 2021, and reinforces ORPHs position as the clear world leader in human challenge studies. There is currently no prophylactic or specific treatment on the market for RSV and hVIVO is currently the only company worldwide that can facilitate RSV challenge studies so investors can expect more positive Newsflow as the Company advances negotiations with all the significant RSV vaccine and drug developers globally.
Today’s news follows yesterday’s announcement that the first cohort of volunteers from the group’s COVID-19 human challenge characterisation study - a global first - had successfully completed the quarantine phase of their participation ‘with no safety concerns presented.’ Open expects to release the study’s results in ‘due course’ and move forward with vaccine challenge studies later this year which will be an important step for vaccine development.
Shares in Open Orphan have increased by over 25% in value since the beginning of the year, with the stock demonstrating a more than four-fold increase since the start of April 2020.
Reasons to ORPH
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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