ORPH.L Regulatory News (ORPH)

REACH

19 November 2020

Open Orphan plc

("Open Orphan" or the "Company")

Collaboration Agreement with HIC-VAC and Wellcome Trust

Open Orphan, a rapidly growing specialist CRO pharmaceutical services company which is the world leader in the testing of vaccines and antivirals using human challenge clinical trials is pleased to announce that its subsidiary hVIVO has been selected to lead a consortium, on behalf of HIC-Vac, an international network of researchers who are developing human infection challenge (HIC) studies to accelerate the development of vaccines against pathogens, and the Wellcome Trust, to generate regulatory style guidelines on the manufacture of human challenge agents for subsequent use in controlled human infection studies (CHIM).

Highlights:

· This consortium aims to develop international standards that pertain to challenge agent manufacture and storage, extending the current general WHO guidelines relating to challenge studies.

· The consortium intends to create guidance fulfilling Good Manufacturing Practice (GMP) requirements to as much as is practically possible without necessarily being GMP certified, 'GMP-like' guidance. This will allow flexibility to manufacture challenge agents outside of GMP-certified premises, but with guidance to ensure safety, quality and consistency are maintained.

The guidance will be produced in consultation with a range of researchers currently working with different challenge agents as well as with input from regulatory experts and, where possible, regulatory or advisory bodies (such as the WHO). There will also be wider engagement beyond the core consortium members with the specific intent of aiming to ensure its' full applicability to all currently used challenge agents and its potential for wide adoption globally by local regulatory bodies and non-governmental institutions involved in the provision of guidance associated with CHIM studies. Learn more about the consortium at hvivo.com/aboutus/clinical-trial-consortium/

Cathal Friel, Executive Chairman of Open Orphan, said:

'We are proud to have been selected to work alongside HIC-Vac and the Wellcome Trust to lead the consortium on this important and much needed guideline. hVIVO is at the forefront of human challenge studies and has world leading capabilities, this collaboration is recognition of the work we do in the scientific community."

Andrew Catchpole, Chief Scientific Officer, hVIVO, said:

"We are delighted to be collaborating with the members of the international consortium with specific input from low-to-Middle income countries (LMIC's).

Today's announcement shows the continued commitment of the infectious disease community in progressing designs and capabilities for research into bacteria, parasites and viruses."

Footnote

CHIM - controlled human infection studies are when a well-characterised strain of an infectious agent is given to carefully selected adult volunteers in order to better understand human diseases, how they spread, and find new ways to prevent and treat them. These studies play a vital role in helping to develop vaccines for infectious diseases.

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

For further information please contact

Notes to Editors - Open Orphan:

Open Orphan is a rapidly growing niche CRO pharmaceutical services company which is the world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. Conducted from Europe's only 24-bedroom quarantine clinic with onsite virology providing individually isolated rooms and connected to our specialist laboratory facility. hVIVO's challenge studies require healthy volunteers to take part, volunteers are recruited through FluCamp, learn more at www.FluCamp.com. 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. Reliable laboratory analysis underpinned by scientific expertise is essential when processing and analysing clinical samples. Robust quality processes support our team of scientists in the delivery of submission ready data.

The Company 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, Open Orphan is rapidly advancing a number of Coronavirus challenge study models and expects to be helping many COVID-19 vaccine development companies to test their vaccines. No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each. hVIVO also works with companies in the UK and Ireland to provide COVID-19 testing to staff to protect staff and customers from a workplace COVID-19 outbreak through its COVID Clear offering.

Open Orphan comprises of two commercial specialist CRO services businesses, hVIVO and Venn Life Sciences and is also building out a valuable data platform business. hVIVO has built up one of the world's largest databases of infectious disease progression data and we are populating our Open Orphan Health Data platform with this historical hVIVO data. In our clinical trials going forward, we are also planning to collect data on volunteer's via wearables during clinical trials. Therefore, Open Orphan's data, which may yield valuable digital biomarkers, could be one of the more sought-after datasets by many of the large wearables /smart watch wearables providers around the world. In June 2019, Open Orphan acquired AIM-listed Venn Life Sciences Holdings plc in a reverse take-over and in January 2020 it completed the merger with hVIVO plc in January 2020. Venn is an integrated drug development consultancy firm which offers CMC (chemistry, manufacturing and controls), preclinical, Phase I & II clinical trials design and execution. The merger with hVIVO created a European full pharma services company broadening the Company's customer base and with complementary specialist CRO services, widened the range of the Company's service offerings.

Notes to Editors - HIC-Vac:

HIC-Vac is an international network of researchers who are developing human infection challenge (HIC) studies to accelerate the development of vaccines against pathogens of high global impact.

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