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WSJ – Researchers Ready Lab-Grown Covid-19 Delta Variant for Human Trials
U.K. company is growing the highly contagious variant under tight lab controls for use in challenge studies
Scientists have coaxed the Delta strain to mature, said Andrew Catchpole, chief scientiic oficer of trial partner hVivo.
PHOTO: HVIVO SERVICES LIMITED
by Jenny Strasburg – Wall Street Journal
LONDON—While the rest of the world is trying to stamp out the Covid-19 Delta variant, British researchers are making progress growing a carefully controlled batch in a lab that they hope to use to infect volunteers in studies.
The effort marks a new phase in the U.K.’s human challenge trials, the only Covid-19 studies in the world intentionally exposing participants to the virus with the goal of developing new vaccines and treatments. Other researchers are also isolating and growing Covid variant specimens for study. U.S. government-funded scientists are producing variants for research, but not for use in humans, a National Institute of Allergy and Infectious Diseases official said.
Two Covid challenge trials sponsored by Imperial College London and the University of Oxford started earlier this year in the U.K. They so far have exposed more than 40 healthy, young volunteers under isolated medical supervision to the original Wuhan strain that circulated widely in 2020.
Since then, the highly transmissible Delta variant has come to dominate infections globally, rendering vaccines less effective and boosting case numbers across the U.K., U.S. and elsewhere. Delta’s fast rise led researchers and U.K. challenge-trial partner hVivo Services Ltd. to focus on trying to grow the variant in the lab.
Full article here
Open Orphan #ORPH – 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
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Open Orphan plc |
+353 (0)1 644 0007 |
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Cathal Friel, Executive Chairman |
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Arden Partners plc (Nominated Adviser and Joint Broker) |
+44 (0)20 7614 5900 |
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John Llewellyn-Lloyd / Benjamin Cryer / Dan Gee-Summons |
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finnCap plc (Joint Broker) |
+44 (0) 20 7220 500 |
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Geoff Nash / James Thompson / Richard Chambers |
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Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0)1 679 6363 |
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Anthony Farrell |
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Camarco (Financial PR) |
+44 (0)20 3757 4980 |
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Tom Huddart / Hugo Liddy |
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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.
Open Orphan #ORPH: The Times – Inside Story of coronavirus battlers. The Sun – We salute the unsung key workers.
Inside stories of coronavirus battlers Aerogen, Hibergene, Open Orphan and Nearform
Ireland was placed sixth last week in a list of nations ranked on their response to the Covid-19 crisis in terms of innovation. The league table was compiled by StartupBlink, a Swiss-Israeli company that collates data on start-ups; the United Nations-backed Health Innovation Index; the Moscow Agency of Innovations; and partners such as tech database provider Crunchbase.
While the Republic has punched above its weight largely because of multi- national medical device firms, Enterprise Ireland says more than 100 of its client companies are responding to the crisis. Here, we step inside four Irish businesses that are seeking to make a material contribution in the fight against the deadly spread of Covid-19.
Link here for the full story.
By Brian Carey and Conor McMahon
THE HOMES FRONT: We salute the unsung key workers who are keeping Britain going during lockdown – from binmen and bus drivers to teachers
Scientist
ANDREW Catchpole heads London’s hVIVO lab — pioneering testing of new Covid-19 vaccines.
The 44-year-old doctor said: “We have received a massive response from volunteers to take part in human testing with a non-deadly coronavirus.
“Normally 200 would respond on our website in a week. This time we had 20,000 in a few days. People want to help.
“We are trying to find a model that will speed up vaccine testing.
“At the moment we are setting up the trial and testing the virus to ensure it is safe, before we put it into people. We will take healthy volunteers and inoculate them with a virus, making them sick but in a very controlled setting.
“We are putting in lots of hours to get this running.”
By Grant Rollings, Kate Ferguson, Ben Leo
Link here for the full story.
Open Orphan #ORPH – Development of the World’s First Human Coronavirus Challenge Study Model
Open Orphan, the rapidly growing specialist Clinical Research Organisation (“CRO”) pharmaceutical services company whose London-based subsidiary hVIVO is the world leader in the provision of virology and vaccine challenge study services, is pleased to announce that it has commenced the development of the world’s first commercial human coronavirus challenge study model, also known as a Controlled Human Infection Model (CHIM). The Company has Europe’s only 24-bedroom quarantine clinic with onsite virology lab where the challenge model will be developed and used. The development of this coronavirus human challenge study model is being led by hVIVO’s Chief Scientist Andrew Catchpole and his team in conjunction with Open Orphan’s Scientific Advisory Board, which is led by world-renowned virologist Prof John Oxford, and builds upon work by hVIVO to potentially develop a Coronavirus challenge study model several years ago and hVIVO’s extensive knowledge in developing human challenge models.
The Company is in early discussions with King & Wood Mallesons, acting on behalf of selected Chinese pharmaceutical and life science clients, to secure funding for the further development of this Coronavirus challenge study. It is intended that the major cost of developing this Coronavirus human challenge model will be primarily funded by new Chinese pharmaceutical partner companies who will get a return on their investment from royalties on the sale of this particular challenge study model.
Open Orphan will utilise common coronavirus strains such as OC43 and 229E which are from the same family of viruses as the newly emerging Covid-19 virus but unlike Covid-19 these common coronaviruses have been widespread in the community for many years and cause only a mild cold-like respiratory illness. Consequently, these common coronaviruses, while closely related to the Covid-19 strain can safely be administered to volunteers in hVIVO’s highly controlled quarantine clinic, staffed by a highly experienced medical and scientific team who to date have already safely inoculated over 3,000 volunteers in hVIVO’s current range of respiratory virus challenge models.
For the purposes of the human challenge study model, the common coronavirus strains such as OC43 and 229E, will provide an effective tool to obtain fast proof-of-concept data against this important family of viruses. It can be used to test the efficacy of both new novel and existing vaccines and anti-virals. This will allow the effective selection of the best candidates and the effective products to be fast-tracked for subsequent field testing against Covid-19. All of the human challenge studies can be run out of hVIVO’s quarantine clinic with onsite virology lab in London. Once developed, hVIVO will offer its coronavirus challenge study model as both a standalone service to customers or as part of a combined Phase 1 and human challenge study that can both be run out of its London quarantine clinic. Furthermore, hVIVO can also offer services in early phase vaccine development.
This news follows an announcement on Friday 6 March that the Company had signed a contract with a new client, which is a European Biotech company, for the provision of an RSV human challenge study. This study is projected to deliver 3.2m in revenue, all of which is expected to be recognised in 2020. Furthermore, if that study is successful it is anticipated that an additional follow-on larger pivotal challenge study will commence end Q4 2020, delivering significant further revenue which is expected to be a minimum of £7m. This contract is significant as it the first that utilises the complementary in-house CRO services of both hVIVO and another of the Company’s subsidiaries, Venn Life Sciences, following the completion of the Company’s merger with hVIVO in late January and demonstrates the Company effectively converting its pipeline.
Cathal Friel, Executive Chairman of Open Orphan, commented:
“This is an important milestone in the development and evolution of Open Orphan and particularly the Company’s subsidiary hVIVO which is based in London, UK. We are very happy to be able to try and assist in the battle against Covid-19. Our hVIVO scientists and virologists, and especially hVIVO’s founder and the now Chairman of our Scientific Advisory Board Prof John Oxford, have a long history and experience of successfully developing challenge studies.
This development also reinforces the strength of hVIVO’s reputation as a world leader in providing services to global vaccine and anti-viral production companies and is another example of the growth potential for Open Orphan. A considerable amount of the work around this project has already been carried out and the project takes advantage of the significant knowledge and experience gained from hVIVO’s previous challenge virus manufacturing campaigns. We are delighted to be working with Mike Wang of the international law firm King & Wood Mallesons who is working with us to secure funders for this project from his network of Chinese pharmaceutical and life science companies. “
Professor John Oxford, Chairman of Open Orphan’s Scientific Advisory Board, commented:
“After almost 5 years’ of absence from hVIVO, I’m delighted to be more involved again and particularly to be back involved as Chairman of the Scientific Advisory Board. Over the years, I have had extensive experience in dealing with novel and threatening viruses and in 2009 I was the first person, in conjunction with the hVIVO laboratory, to get permission from the government to bring the SARS virus into the country in order to analyse it as part of seeking a solution to the outbreak.
A couple of years ago, the hVIVO Scientific team started a project to potentially develop a Coronavirus challenge study model but after a certain amount of work and effort they suspended this project because they didn’t see sufficient market demand for a Coronavirus challenge study model. However, in recent weeks, the hVIVO scientific team led by their Chief Scientist Andrew Catchpole have reopened their Coronavirus challenge study project and work files. Given the unfortunate circumstances of Covid-19 now spreading around the world they and I felt that there was an obligation on us to reactivate the project and to do our best to now swiftly and effectively make a Coronavirus challenge study model available to the market as soon as possible.
I’m looking forward to working with the team in the days and weeks ahead to do our best to make the world’s first Coronavirus challenge study model available as soon as possible.”
For further information please contact
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Open Orphan plc Cathal Friel, Executive Chairman Trevor Phillips, Chief Executive Officer |
+353 (0)1 644 0007 +44 (0)20 7347 5350 |
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Arden Partners plc (Nominated Adviser and Joint Broker) John Llewellyn-Lloyd / Benjamin Cryer |
+44 (0)20 7614 5900 |
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Davy (Euronext Growth Adviser and Joint Broker) Anthony Farrell |
+353 (0)1 679 6363 |
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Camarco (Financial PR) |
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Tom Huddart / Daniel Sherwen |
+44 (0)20 3757 4980 |
Notes to Editors:
Open Orphan is a rapidly growing specialist CRO pharmaceutical services company which has a focus on orphan drugs and is a world leader in the provision of virology and vaccine challenge study services and viral laboratory services. It has Europe’s only 24-bedroom quarantine clinic with onsite virology lab in London. hVIVO supports product development for customers developing antivirals, vaccines and respiratory therapeutics, all particularly relevant and topical in the environment of heightened awareness of the Coronavirus in 2020. The company also 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. No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each.
Open Orphan comprises of two commercial specialist CRO services businesses (Venn and hVIVO) and is developing an early stage orphan drug genomics data platform business. This platform captures valuable genetic data from patient populations with specific diseases with designated orphan drug status and incorporating AI tools. 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. Venn, as an integrated drug development consultancy, offers CMC (c hemistry, 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.
About Coronavirus
Coronaviruses are a family of viruses that can lead to respiratory illness, including Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). Coronaviruses are transmitted between animals and people and can evolve into strains not previously identified in humans. On January 7, 2020, a novel coronavirus (2019-nCoV) was identified as the cause of pneumonia cases in Wuhan City, Hubei Province of China, and additional cases have been found in a growing number of countries.1,2
1“Coronavirus.” World Health Organization, https://www.who.int/health-topics/coronavirus.
2“2019 Novel Coronavirus, Wuhan, China.” Centers for Disease Control and Prevention, https://www.cdc.gov/coronavirus/2019-nCoV/index.html.