The first volunteer has been dosed with a COVID-19 vaccine as part of hVIVO’s phase 1 clinical trial of COVI-VAC.
Following on from its announcement in July last year, the CRO, part of Open Orphan (LSE: ORPH), has begun its randomised, double-blinded, placebo-controlled dose-escalation study in collaboration with US biotech Codagenix.
The study will evaluate the safety and tolerability of the live attenuated COVI-VAC vaccine in 48 volunteers at the company’s quarantine facility in London, while also testing the vaccine’s ability to bring about an immune response to SARS-CoV-2.
Open Orphan’s 24-bedroom clinic at The Royal Free Hospital’s specialist unit will be continually in use for the challenge study – sponsored by Imperial College London – with the facility booked to full capacity until Summer 2021.
COVI-VAC is a single-dose, intranasally delivered vaccine. It will not require a needle and syringe to be administered and will not need to be stored in ultra-low temperatures, but it can be manufactured on a large scale.
hVIVO and Codagenix believe the vaccine has the potential to address several key logistical challenges in the immunisation push for the pandemic, and will publish the results of the testing in mid-2021.
Cathal Friel, Executive Chairman of Open Orphan, described the work as part of “the next generation of COVID-19 vaccines”.
“In our opinion, because it is a live attenuated virus vaccine, COVI-VAC has the potential to give much longer-lasting cellular immunity against COVID-19 than many of the first-generation vaccines.”
This is not the first time Open Orphan has been involved in the response to COVID-19. In April 2020, the company began testing an antiviral drug using hVIVO’s virology expertise and laboratory. The drug has potential utility for treating the global virus, providing both anti-viral and anti-inflammatory activity to decrease the its infectivity and severity.
Then, in May, Open Orphan partnered with Quotient Limited for COVID-19 antibody testing using hVIVO’s laboratory. MosaiQ system’s best-in-class COVID-19 antibody testing performance was added to the virology lab in London, bringing fast and accurate antibody testing to the UK.
Soon after, hVIVO launched Covid Clear, an offering to employers in the UK to help protect staff and customers from COVID-19 outbreaks via a full range of tests.
The market for vaccine development and CROs has boomed in response to the pandemic. It’s expected that governments and big pharma will make huge catch-up investments in vaccine development to ensure the effects of any future outbreaks can be mitigated.
Open Orphan’s stock value has increased by over 300% since the start of the pandemic, and by 10% in the last two weeks.