Open Orphan (ORPH ) shares rose 4% this morning after the company announced its clinical laboratories in Queen Mary's Bioenterprise Centre and Plumbers Row ("hLab") have been awarded accreditation by the College of American Pathologists (CAP).
CAP is the world's leading provider of laboratory accreditation and proficiency testing programmes. The accreditation "supports laboratories performing testing on specimens from human, using methodologies and clinical application within the expertise of the program". The nod from CAP builds on Open Orphan's existing GCLP accreditation from the Medicines and Healthcare products Regulatory Agency.
With this additional tool, Open Orphan can provide even greater quality assurance to its clients, particularly in the US, and fully conform to requirements by the US FDA.
The company's clinical labs ("hLab") are specialised virology and immunology facilities, offering a suite of services to support pre-clinical and clinical respiratory drug and vaccine discovery and development. hLab now provides services beyond Open Orphan's in-house human challenge trials, offering clients a standalone service to support vaccine and drug development from pre-clinical studies through Phases I-III clinical trials.
Brandon Londt, Development Operations Director, commented: "We are proud to have received the CAP accreditation, which is recognition of the quality of our laboratory and further demonstrates our commitment to maintaining the highest standards of excellence and ensuring that our work practices meet the rigorous CAP assessment standards. This accreditation will provide current and future clients a further degree of confidence in the quality of work performed in our laboratory and assurances of the results we produce."
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The CAP accreditation follows last week's news of Open Orphan subsidiary hVIVO signing a £10.4m full-service contract with an existing "top 5" global pharma client. Open Orphan will manufacture an H1N1 influenza challenge virus for the client, leveraging an existing in-house model, in order to conduct a human challenge trial and test the client's antiviral product.
This is the third human challenge contract Open Orphan has signed with this client. The majority of revenue from the contract is expected to be recognised in 2023.
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, commented: "This contract is a strong example of where human challenge studies can provide significant value. These studies can quickly and cost-effectively generate efficacy data for our clients in specific viral subtypes. As illustrated with this contract, our world-class manufacturing capabilities can produce a challenge agent for subtypes that pose a particular global health risk or are already circulating in the population. The resulting data can then indicate whether the candidate is viable for Phase II/III studies, providing substantial time and financial savings compared to traditional field-based studies."
Since the COVID-19 pandemic, Open Orphan has seen an increase in the number of clients looking to test vaccines and antivirals against specific subtypes of viruses that have the potential to be widely spread. As a result, there is greater interest in end-to-end human challenge contracts:
In addition to last week's £10.4m contract, hVIVO earlier signed a £6.2m contract in August with a US-based biotechnology company, to test its antiviral candidate using the hVIVO Influenza A human challenge study model.
And in June hVIVO signed a £7.2m RSV contract with the same top 5 global pharma client, as well as a £14.7m influenza contract with another large existing client. That followed a £5m RSV contract with a European biotech company signed in March.
Based on this string of large contract wins for hVIVO, it is clear that industry attention is shifting to potential future outbreaks of influenza. The disease is a significant global health threat, with an estimated 1 billion cases per year, including 3-5 million severe cases. "With this increasing demand in mind, we expect to continue to see our work coming from a broad range of infectious and respiratory diseases, and from companies ranging from smaller innovative biotechs to Big Pharma." CEO of Open Orphan Yamin Khan has said.
While hVIVO has been busy with influenza studies, the company also announced in June 2022 that it is developing the world's first SARS-CoV-2 Omicron human challenge model. More exciting news from Open Orphan therefore looks likely, as the infectious disease clinical trial market continues to grow to an estimated US$5.5b by 2027. Make sure to Open Orphan so you do not miss out on future news.