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A UK vision to unleash the full potential of clinical research delivery to tackle health inequalities, bolster economic recovery and to improve the lives of people across the UK.
‘As we look to the future, we must use?these lessons from COVID-19 as a springboard to build back better. Because we stand at an inflection point for global healthcare. Driven by data and analytics, cutting-edge technologies and treatments, including precision medicines and artificial intelligence, are transforming the way we treat patients.
And this is just the tip of the iceberg. The coming years will see an explosion?in breakthrough technologies which will pave the way to tackle the most pressing population health burdens and provide fresh hope to patients.???
We must seize the opportunity to put the UK at the forefront of this healthcare revolution and clinical research will be the backbone of our efforts. Because research is the single most important way in which we improve our healthcare – by identifying new means to prevent, diagnose and treat disease.
Therefore we, the UK government and devolved administrations, are setting out a bold and ambitious vision for the future of clinical research delivery, which capitalises on innovation, is resilient in the face of future healthcare challenges and improves the lives of patients all over the UK and around the world.
This means embedding clinical research at the heart of patient care across the NHS, making participation as easy as possible and ensuring all health and care staff feel empowered to support research. And it means capitalising on our strengths in health data and creating new digital infrastructure to make study set-up and delivery faster, more efficient and more innovative, so that the UK remains one of the best places in the world to deliver cutting-edge research.’
https://www.gov.uk/government/publications/the-future-of-uk-clinical-research-delivery/saving-and-improving-lives-the-future-of-uk-clinical-research-delivery
This new UK Gov policy seems to fit in very well with ORPH’s current & future activities.
I can’t think of any other AIM company, that is better positioned to take advantage of this hot sector, coupled with the UK Gov infrastructure and policy, in full support of it.
The future for ORPH is looking very bright, secure & profitable.
IMHO
Cathal stated on his recent presentation:-
~9 min 50 sec
“In the very close future well be signing quite a few Covid 19 antivirals, quite a few Covid vaccination trials and as soon as they’re signed you’ll see the announcements and most of those trials will be north of £10 million….these are premium products and this is the only place in the world you can get them done.”
https://www.youtube.com/watch?v=qIQpEiS1ZmE&ab_channel=Proactive
“A few” = 3 or more, so a minimum of six in total (antivirals & vaccine testing)?
So that will be £60 million plus of contracts ‘in the very close future’, in addition to everything else we’re expecting!
Not bad for the initial batch of Covid CHIM contracts!
GLA LTH’s
Open Orphan: My pick for this year’s ISA allowance
https://masterinvestor.co.uk/equities/open-orphan-my-pick-for-this-years-isa-allowance/
1. Why would anyone volunteer to be deliberately infected with coronavirus?
https://www.facebook.com/watch/?v=727419827923426
2. Cross reference with the UK Vaccine Task Force Strategy (which we already know ORPH are partners in):
https://hvivo.com/the-human-challenge-programme/
Make provision for international distribution of vaccines
‘The UK Government is leading global efforts to ensure that everyone at risk, anywhere in the world, has access to a safe and effective vaccine, irrespective of their ability to pay. The COVID-19 Vaccines Global Access facility (COVAX), to which the UK has committed up to £548 million, will provide access to vaccines for low, middle and high income countries – initially two billion doses for one billion people worldwide. As well as helping to shape the COVAX facility, the VTF has shared its expertise and people with COVAX to support their global efforts.
The biggest challenge facing the world is to establish a fair global pooling facility for buying, manufacturing, and distributing pandemic vaccines to all those people at risk around the world, since national solutions will not control the pandemic alone. COVAX’s global access vaccine facility, led by GAVI, the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organisation (WHO) is making progress, but it may still take 18- 24 months from the initial identification of the SARS-CoV-2 virus before safe, effective vaccines are available to most countries, whether high, middle or low income.’
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/944308/VTF_Interim_report_-_5th_publication.pdf
3. ‘As part of its mission to save lives, reduce poverty and protect the world against the threat of epidemics, GAVI has helped vaccinate more than 822 million children in the world’s poorest countries, preventing more than 14 million future deaths’
https://www.gavi.org/our-alliance/about
Rarely in investing, can you expect significant returns and simultaneously make the world a bit better. For me, I believe ORPH ticks both boxes.
IMHO
Live online event 11am Friday 190321
‘Scientists around the world have played a central role in the last year, informing policy makers and the public throughout the pandemic. Under pressure they have adapted new ways of working, while the creation and deployment of vaccines could have far-reaching consequences for global scientific collaboration. At this event, we will discuss the early lessons the science community should draw from the crisis.’
https://www.instituteforgovernment.org.uk/events/science-after-coronavirus
Both Dr Peter Openshaw & the Wellcome Trust have been keen advocates of Covid CHIM’s, so maybe worth a watch!
OS2 – frankly, I’m not bothered if it’s in the next few of weeks or months! The spin offs will happen whenever they’re ready and I’m in no rush.
This is a long term high conviction hold for me and any short term spin off’s, are just large bonus's along the way.
If anything, I think we may not get the opportunity to benefit from all of the non core assets, pending the inevitable takeover (which I anticipate will be multiple times of the current market cap).
IMHO
Including:
‘Compressing vaccine development timelines to 100 days
In response to COVID-19, the scientific community developed a safe and effective COVID-19 vaccine in just over 300 days—a record time.
Had the world been able to compress this timeline to 100 days:
- Millions of lives could have been saved
- Trillions of dollars in economic damage could have been averted
- Massive societal disruption could have been avoided
The 100-day vaccine development is an ambitious, but achievable, objective.
One that we must achieve if we are to break the cycle of epidemics and pandemics stalking humanity.’
‘Shortening emergency vaccine development timelines to this extent will require substantial prior investment in the development and testing of vaccine candidates.’
https://endpandemics.cepi.net/
https://cepi.net/wp-content/uploads/2021/03/CEPI_3.5_billion_investment_case_10032021.pdf
Anyone know a company that can make vaccine development timelines a lot quicker (for a large fee)?
‘Actions towards the development of a SARS-CoV-2 CHI model would represent a broad and sustained research effort toward understanding coronavirus biology and mitigating the current and potentially also future pandemics.’
https://www.frontiersin.org/articles/10.3389/fimmu.2021.658783/full
International peer reviewed scientific article in support of Covid CHIM’s (worth noting the authors are based in Belgium & Switzerland).
(Frontiers in Immunology is a leading journal in its field, publishing rigorously peer-reviewed research across basic, translational and clinical immunology.)
https://www.frontiersin.org/journals/immunology#about
These papers & articles are reminiscent of the debates in the UK last year, just prior to Covid CHIM’s being started.
This also links in with Dr Openshaw’s comments about other countries planning to conduct Covid CHIM’s.
https://www.webmd.com/coronavirus-in-context/video/peter-openshaw
IMHO
Open Orphan
Open Orphan (LSE:ORPH) is a popular healthcare stock: not a biotech but a pharmaceutical services business. That means it doesn’t engage in the risky and costly R&D of drug development. Instead it provides all the background data management and clinical trial services for vaccine and antiviral giants worldwide. Its clients include the likes of Pfizer and Johnson & Johnson.
It is most famous for helping to run the world’s first Covid-19 human challenge trials, winning a £46m UK government contract in October 2020. It also plans to spin off at least four major assets into separate companies. These include selling its novel disease data platform Disease in Motion to wearables giants like Google and Fitbit. Because I already own ORPH, I’ll get shares in each of these new companies in my Stocks and Shares ISA when that happens.
Because it is listed on AIM, it’s a relatively riskier buy than a company on the FTSE 250 or FTSE 100. Companies on this market have less stringent financial reporting requirements than on the higher tier.
Executive Chair Cathal Friel recently put a $1bn (£720m) valuation target on Open Orphan. That would give the business a share price of around £1.10, 266% higher than today’s 30p price.
https://www.fool.co.uk/investing/2021/03/16/2-fast-growth-uk-shares-for-my-stocks-and-shares-isa-in-april/
Are COVID-19 Human Infection Trials Ethical?
JOHN WHYTE: Other than the UK, are these trials being conducted anywhere else around the world?
PETER OPENSHAW: We are the first country in the world to give ethical approval for these trials. They are being planned in a number of other countries. The Netherlands in particular is also a world leader in human infection challenge studies and they are certainly planning to do these studies, but they don't yet have ethical approval.
https://www.webmd.com/coronavirus-in-context/video/peter-openshaw
Interesting answer from Dr Openshaw ref Covid CHIM’s stating “They are being planned in a number of countries”.
(Leiden University in the Netherlands are already part of the Hiv-Vac Consortium led by Hvivo)
https://hvivo.com/aboutus/clinical-trial-consortium/
‘Other countries’ could be China?, USA? etc – meaning more potential licensing opportunities for ORPH?
Scalable International Covid CHIM’s could lead to a massive recurring revenue model and an even more attractive takeover target from a large CRO?
IMHO
N.B. WebMD's network of websites reached more unique visitors each month than any other leading private or government healthcare website, making it the leading health publisher in the United States. In the fourth quarter of 2016, WebMD recorded an average of 179.5 million unique users per month, and 3.63 billion page views per quarter. In the first quarter of 2020, WebMD received approximately 127 million unique users viewing over 229 million page views per month.
Another great presentation from CF last week. confirming all of the expected multiple revenue streams\spin offs etc that are in progress and CHIM contracts pending (in the short term).
I’ve noticed that Cathal tends to drop some hints in his presentations, of significant new work streams in progress. A number of linked comments made by CF (which seemed to stand out to me), were: working on monoclonal antibodies; CHIM vaccine testing; working with the Vaccine Task Force & the new MHRA CHIM approval process.
https://www.proactiveinvestors.co.uk/companies/news/943709/open-orphan-lonorph-presenting-at-the-proactive-one2one-virtual-forum-943709.html
So, I’ve started to join up some dots, as per below:
1. The new MHRA vaccine testing and approvals ACCESS process, effectively writes in CHIM’s within the Uk Gov’s next generation testing vaccine infrastructure program.
(This was also confirmed & described in Dr Chiu’s presentation this last week – ‘Accelerating pathways for vaccine licensure’).
https://www.gov.uk/government/publications/access-consortium-guidance-on-strain-changes-in-authorised-covid-19-vaccines/guidance-on-strain-changes-in-authorised-covid-19-vaccines
2. GSK has recently announced success in working with monoclonal antibodies and are also working with CureVac, & the UK Gov’s Vaccine Taskforce, in developing the next generation of Covid vaccines:
‘In February, CureVac then signed a deal with British drug maker GlaxoSmithKline (GSK) to develop the next generation of mRNA-based COVID-19 vaccines (50-200 million doses 2021-22).
The GSK/CureVac deal will focus on developing a novel mRNA-based COVID-19 vaccine candidate….
…..The UK Vaccines Taskforce is also working with CureVac to assess multiple variants of the SARS-CoV-2 virus that causes COVID-19, and will seek to generate vaccine candidates against selected strains.
In a statement, the UK government said that ‘almost all vaccines’ developed as part of the CureVac partnership will be variants of the German company’s existing vaccine, CVnCoV.’
http://www.pmlive.com/pharma_news/curevac_signs_manufacturing_agreement_with_novartis_for_covid-19_vaccine_candidate_1364625?SQ_DESIGN_NAME=2
3. CureVac’s vaccine development lead (Peter Kremsner) is very much in favour of CHIM’s and likely to partner with ORPH on Covid vaccine variant testing (please see my previous post ref CureVac & ORPH).
https://www.deutschlandfunkkultur.de/tropenmediziner-zu-human-challenge-studien-tausendmal.1008.de.html?dram:article_id=493832
So, putting all of these overlapping elements, connections and partnerships together, I am convinced that ORPH is virtually guaranteed to be involved in ‘‘almost all vaccines developed as part of the CureVac (UK Gov) partnership’.
Time will tell, but I believe a number of future £xx million ORPH CHIM contracts, will involve GSK & CureVac, in addition to a large percentage of the other international next generation Covid vacci
Join Cathal Friel graduate of Ulster University and Co-founder & Executive Chairman at Open Orphan plc in a fireside chat with our moderator Sarah Travers as he talks about his latest vaccine venture and the highs and lows of growing companies in unprecedented times.
31 March 2021 12:00PM - 1:00PM
https://www.ulster.ac.uk/alumniandsupporters/events/virtual-events
Preparing for pandemics - Scientists look to the future
‘Catchpole says SARS-COV-2, the virus that causes COVID-19, caught many in the medical and scientific community by surprise because other coronaviruses had not been unknowingly transmitted from person to person.
"It wasn't clear whether it had true pandemic potential, most of us virologists believed that they did because even before SARS 1 we have been living with coronaviruses actually for many decades they just caused common colds so people don't even know their name, don't even realise they're having them because the disease they cause is so mild.
So any virus which causes a disease like that and transmits, and is with us all the time, the family of viruses always have then pandemic if there are related viruses in animals and indeed with coronaviruses there are," says Catchpole.
In some locations protestors are demanding a return to a life they find more easily recognisable.
The pandemic is far from over, even as vaccines are reaching some countries, others are experiencing a spike in infections. Even so scientists warn that COVID-19 may not be the last pandemic the world sees.’
https://www.youtube.com/watch?v=_72W-ZxXiSw&ab_channel=APArchive
(AP Archive - 3.74M subscribers)
I know who I'd nominate (again)!
https://twitter.com/EOYIreland/status/1370331663406919687
Human Infection Studies:
Considerations on manufacturing of challenge agents - viruses (SARS-CoV-2/COVID-19) and parasites as examples
https://www.iabs.org/documents/conferences/2021/human-infection-studies-webinar/1529-iabs-webinar-3-2021-chim-covid-agenda/file
‘You will work closely with internal Wellcome teams to manage the contract process. You will project manage funded projects, engage regularly with key stakeholders both internal and external such as awardees, contractors and those involved in the human infection study field e.g. experts, regulators and ethicists. Regular reporting to senior leadership on progress and delivery of the specific projects is also key part of the job too.’
https://www.vercida.com/uk/jobs/research-adviser-wellcome-london
Links in with todays RNS ref LMIC’s & Cross ref:-
https://www.londonstockexchange.com/news-article/ORPH/collaboration-with-hic-vac-and-wellcome-trust/14761432
I wonder what ‘contract process’ they are implementing in relation to CHIM’s?
Wolf - Well, guess what…..we’ll wait and see (beep, beep)?
Very interesting and informative presentation by Dr Chiu earlier this evening, particularly the ‘Accelerating pathways for vaccine licensure’ slide.
Dr Chiu’s comments and flowchart appeared to suggest (in conjunction with the new MHRA approval procedure), that future CHIM’s could be utilised as a potential replacement for Phase 3 trials.
This could have a massive impact on ORPH, who are currently the only company in the world, able to conduct Covid CHIM’s.
The average cost of a Phase 3 trial is $20 million and there are currently over 70 pre Phase 3 Covid vaccines in development.
https://www.sofpromed.com/how-much-does-a-clinical-trial-cost/
https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
If only 50% of the new vaccines make it through Phase 1 & 2, this could mean huge demand for ORPH’s CHIM’s and subsequently significantly higher fee’s to conduct them (supply & demand).
Dr Chiu also discussed all of the short, medium and long term uses for CHIM’s.
I am in no doubt that ORPH has years of lucrative work ahead and that demand will out strip supply, for the foreseeable future.
IMHO
This also links in with the recent MHRA policy in 'fast tracking' vaccines for Covid variants and allowing CHIM's to used, as per below:
Modified COVID-19 vaccines for variants to be fast-tracked, says MHRA and other regulators
https://www.gov.uk/government/news/modified-covid-19-vaccines-for-variants-to-be-fast-tracked-says-mhra-and-other-regulators
https://www.bbc.co.uk/news/health-56274293
Importantly for ORPH, the ACCESS Consortium has published guidance on strain changes in authorised Covid-19 vaccines and states the following:
Considerations on Human Challenge Studies
‘In an ongoing pandemic with multiple mutations occurring at different places in the world, Human Challenge Studies may be a valid additional or alternative way of studying (an) updated vaccine candidate(s). Human Challenge Studies have the advantage that the course of developing immunity, viral shedding, local suppression of SARS-CoV2 shedding in the upper respiratory tract and other parameters can be measured in a controlled setting. Important insights like which variant can evade pre-existing immunity better than others (thus having a higher likelihood to emerge as dominant variant) may be obtained by challenging subjects who were either vaccinated with the current vaccine or had COVID-19 as a natural disease. The latter scenario may be hampered by likely lack of knowledge on what variant caused disease in the first place. Human challenge studies may be more straight-forward in a scenario where vaccines and more effective treatments exist in order to protect study participants. A human challenge study is only possible if a model has been set up and is available with the new variant.’
https://www.gov.uk/government/publications/access-consortium-guidance-on-strain-changes-in-authorised-covid-19-vaccines/guidance-on-strain-changes-in-authorised-covid-19-vaccines
Tropical medicine specialists on human challenge studies
"A thousand times better than animal testing"
‘The Curevac vaccine would be on the market faster
Kremsner is currently leading the approval study for the vaccine from the Tübingen-based company Curevac. However, this is not intended as a controlled infection study, but as a classic clinical study.’
https://www.deutschlandfunkkultur.de/tropenmediziner-zu-human-challenge-studien-tausendmal.1008.de.html?dram:article_id=493832
Cross reference with the Uk Gov announcement below:
‘A new partnership between the UK government and vaccine manufacturer CureVac has been established to rapidly develop new vaccines in response to new COVID-19 variants if needed….
….Through the agreement announced today, the UK has placed an initial order for 50 million doses of new vaccines to be delivered later this year if they are required.’
https://www.gov.uk/government/news/new-vaccines-partnership-to-rapidly-respond-to-new-virus-variants
Kremsner is leading vaccine development at Curevac and is highly in favour of using CHIM’s.
Whilst Kremsner is currently utilising a classical study for the current Curevac vaccine, which company do you think he will use to test and ‘rapidly develop new vaccines in response to new COVID-19 variants’?
IMHO