Open Orphan (ORPH ) has told investors that the first three volunteers from the group’s COVID-19 human challenge characterisation study have now successfully completed the quarantine phase of their study participation ‘with no safety concerns presented.’
The study, which will now progress onto the next volunteers, is led by Open’s hVIVO division in partnership with the UK Government, Imperial College London, and the Royal Free Hospital in London as the world’s first COVID-19 human challenge characterisation study.
The study is conducted by hVIVO at the Royal Free Hospital, ‘under the scrutiny of highly trained scientists and medics’ while the virus being used in the study has been produced under hVIVO's supervision by a team at Great Ormond Street Hospital for Children NHS Foundation Trust in London, with support from virologists at Imperial College London.
hVIVO received approval from a specially convened Research Ethics Committee ("REC") enabling it to initiate the world's first COVID-19 characterisation study back in February.
The approval followed a contract signed by hVIVO back in October 2020 with the UK Government to develop a COVID-19 (SARS-CoV-2) human challenge study model.
The initial virus study intends to inoculate up to 90 volunteers, between the ages of 18 and 30 years old, in order to enable identification of the most appropriate dose of the virus needed to cause COVID-19 (SARS-CoV-2) infection in a safe and controlled environment.
The first cohort was inoculated with a low dose of COVID-19 via droplets in the nose, and ‘carefully monitored’ by clinical staff in a controlled environment over a two-week period.
Open said the first three volunteers will now continue their study participation with follow up visits and monitoring for a period of up to one year and as is normal practice during any clinical trial, none of the partners in the study will be identifying any of the volunteers.
Chief Scientific Officer at hVIVO, Dr Andrew Catchpole, said: "We are pleased to announce that the first three volunteers in this world's first study have now successfully completed the quarantine phase, these volunteers will continue to be monitored post-study for up to 1 year.”
He added, “We expect that this study will greatly assist our understanding of this disease and provide insights into its progression, natural immune response, and transmission.”
Dr Chris Chiu, Chief Investigator and Reader in Infectious Disease at Imperial College London said the first cohort of volunteers from the characterisation study remain “in good health” but added that it would be “premature” to discuss further details at this early stage.
Investors can now recognise ORPH’s potential in playing an important role in providing further data and information that will help the World continue to develop more vaccines to control the pandemic. 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. This morning, shares in the company were trading 0.31% higher at 32.2p following the news.
Reasons to Follow 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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