Open Orphan PLC
ORPH]

Pharmaceutical companies worldwide are joining global efforts to combat, diagnose, treat, and prevent infections from COVID-19. As we have seen, the search for vaccines and possible treatment to curb the transmission and reduce the mortality and morbidity caused by the novel coronavirus is in overdrive. However, numerous concerns stem from the fact that drug development is traditionally a complex, highly expensive, and time-consuming endeavour, entrenched with a high degree of uncertainty. Needless to say, these challenging times also serve as an opportunity for pharmaceutical companies to set a precedent in how quickly they can make a vaccine available to protect the population from the devasting health and economic effects of this newly emerged pandemic virus.

Many of these pharmaceutical companies could speed vaccine development through novel study models, such as human challenge. If there is one organisation that truly warrants credit for the advancement of human challenge clinical trials, it is Open Orphan. A rapidly growing niche CRO pharmaceutical services company, Open Orphan is setting a gold standard as a world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. With its two-commercial specialist CRO services businesses—hVIVO and Venn Life Sciences—Open Orphan is uniquely positioned to help scientists and medics assess the effectiveness of vaccines or treatments against the disease and identify any side effects.

“At a time when big pharma companies are making increased investments in vaccine development programmes, we believe we are lucky to be in the right place at the right time,” says Cathal Friel, co-founder and executive chairman, Open Orphan.

Led by a highly experienced Board and management team with deep industry and financial experience and a track record of delivering shareholder value, Open Orphan brings a rich history of commercial human challenge studies to the table. “A huge amount of phase III vaccines hasn’t worked in the last two decades. This is where human challenge studies—a very small niche within the pharmaceutical CRO business—are now creating opportunities. This study model is an effective way of getting early efficacy data for products in phase II(a) and II(b) clinical trial. At Open Orphan, we are consistently pushing the envelope of human challenge studies,” adds Friel.

Open Orphan takes immense pride in having commenced the development of the world’s first human Coronavirus challenge study model in March 2020. Recently, the company announced it had joined a UK government-supported partnership, along with Imperial College London and the Royal Free London NHS Foundation Trust.

Open Orphan was born from a unique idea of combining a preclinical pharma consulting company, Venn Life Sciences with offices in Paris and Breda, the Netherlands for almost 30 years and a clinical trial company, hVIVO, founded in 1989, with a vision to make vaccine development better and faster. hVIVO— the world leader in the testing of vaccines and antivirals using human challenge study models—is a trusted partner and industry-leading clinical development services business pioneering human disease models based upon viral challenge.

Run from Europe’s only 24-bedroom quarantine clinic with an onsite virology lab in London, hVIVO uses human challenge studies to establish early proof-of-concept and its clinical trial platform to accelerate drug and vaccine development in respiratory and infectious disease. The company supports product development for customers developing antivirals, vaccines, and respiratory therapeutics. With an unmatched portfolio in business, hVIVO leads with its portfolio of eight viral challenge study models, two for ‘flu, two for respiratory syncytial virus (RSV), one for human rhinovirus (HRV), one for asthma, one for cough and one for chronic obstructive pulmonary disease (COPD).

At Open Orphan, we are consistently pushing the envelope of human challenge studies

Venn Life Sciences has been active for more than 30 years, providing services to some of Europe’s leading pharmaceutical companies, while hVIVO has more than 20 years of experience running clinical trials of vaccines with partnership ofthe world’s leading pharma companies and governments.

Talking more about the rise of human change studies, Friel reveals that challenge study models can potentially speed up vaccine development and approval by two to three years by testing the efficacy on human volunteers over a short period of time in a quarantine clinic. He cites the example of the coronavirus vaccine developed by Astrazeneca and Oxford University. Thirty thousand people across Britain and South America were inoculated to test the vaccine. The researchers are hoping that once 150 of those 30,000 volunteers get COVID, they can unlock the data and do an interim review.

“It’s a lot of volunteers to inoculate just to get 150 infections. Instead, at Open Orphan we can use a challenge study to determine vaccine efficacy with as little as 100 volunteers, of which 50 percent will get a placebo, and 50 percent will get the target vaccine,” says Friel. “Post inoculating the volunteers with the vaccine, they can be sent home for four weeks, until the vaccine takes effect, ready to then test if the elicited immune response is able to protect from disease on challenge with the virus.”

The virus challenge phase is conducted in a viral challenge unit such as Open Orphan’s London-based quarantine unit and screening centre that has 24-en-suite isolated rooms with onsite specialist virology laboratory, which offers highly specialised virology and immunology laboratory services to support pre-clinical and clinical respiratory drug, antiviral, and vaccine discovery and development. Volunteers need to remain quarantined in this facility for about two weeks, where they get access to all their personal mobile devices and unlimited access to TV streaming services for their convenience. High infection rates are ensured during challenge studies by pre-screening the volunteers for the presence of antibodies against the challenge virus and excluding all whom demonstrate antibody levels indicative of protective immunity. “By direct inoculation of volunteers with low or no pre-existing immunity to the virus we can ensure that sufficient volunteers get infected with the virus to inform the vaccine development companies if their vaccine is effective or not. It’s very binary and a great way of guaranteeing efficacy determination within a couple of months and saving both overall costs and time,” he adds.

Volunteers are recruited for trials through hVIVO’s FluCamp website, before they enter hVIVO’s challenge unit wherein they stay under expert supervision in a safe, controlled, clinical environment to advance medical research and help understand respiratory illnesses.

Harness the Power of an Extensive Database

hVIVO has the most extensive challenge model database in the world having safely inoculated over 3000 volunteers in challenge studies. This is crucial, as it facilitate the ability to accurately power the challenge studies for the chosen endpoint to ensure the study has the right number of volunteers to appropriately test the chosen efficacy endpoint. Retrospective analysis of the database also enables refinement of endpoints as well as identification of new improved endpoints better able to determine product efficacy efficiently.

When performing such clinical trials, huge amounts of medical data areaccrued, such as temperature, heartbeat, blood oxygen level as a disease progresses in a body. This makes the company a leading provider of the world’s largest database of infectious disease progression data. “We’ve got a huge database of what happens to the body when you inoculateit with a virus or any pathogen, very few companies have the ability to generate data as efficiently as hVIVO because we’re doing it every day of the week, every month of the year, every year. So, we’ve got data that are very valuable, in recent months we have had direct inbound enquiries from many of the worlds largest wearable companies and technology companies seeking ways to access this unique database that we now hold” states Friel.

With wearables on volunteers, data gets accumulated such that it can act as biomarkers for a few health ailments and diseases. “We’ve never monetised this data before. But going forward, I think that makes us very attractive,” he adds. Moving ahead, Open Orphan is planning to explore the efficiency of the human challenge studies in other regions like Australia and North America.