Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
Wuh - sure 050221, as per link below:
hxxps://www.clinicaltrials.gov/ct2/show/NCT04740320?term=hvivo&draw=2&rank=1
It's the first stage of the full study, as I've explained below.
Ear – I’m struggling to find any verifiable evidence\links to substantiate any of your questions\suggestions below. In fact, contrary to what you have posted, I only appear to have found a number of links suggesting that UK ethics approval is substantially on track as planned (please see my previous posts).
For example:
1. https://www.gov.uk/government/news/expert-partnership-to-explore-and-establish-human-challenge-studies-of-covid-19-in-the-uk
2. 'Stages of Research
A human infection vaccine challenge study for COVID-19 would consist of several stages. The first part is to screen volunteers to select people who meet the specific criteria set out in the study protocol...
....Each of these phases will need a favourable ethics opinion before it can proceed.'
https://www.hra.nhs.uk/about-us/news-updates/covid-19-human-infection-challenge-vaccine-studies/
We know that this has already started, as per link below:
hxxps://www.clinicaltrials.gov/ct2/show/NCT04740320?term=hvivo&draw=2&rank=1
So we can safely conclude from this evidence, that ethical approval has been given by the Ethics Committee for this stage of the process.
I can't find any other evidence to suggest, why this ongoing ethical approval will not continue to be given for the full study.
Please could you provide some research or evidence to support your assertions?
Thanks
‘Controlled Human Infection (CHI) models have been increasingly utilized to support vaccine R&D efforts. They have now been introduced to endemic regions where diseases are prevalent or other low- and middle-income countries as well. There have been discussions on the use of CHI to address the pressing COVID-19 R&D issues and these are currently planned in the UK. CHI models have been used as alternative approaches to shorten vaccine development timeline and reduce development cost, and to carry out basic vaccinology and immunology research. This plenary will present several CHI use cases to illustrate the utility of the models, and highlight scientific, regulatory, and ethical challenges and opportunities for vaccine R&D communities.’
https://gvirf.org/wp-content/uploads/2021/02/GVIRF-2021-Detailed-Agenda-4.pdf
Another high level international CHIM discussion next week, with some important UK scientist’s in attendance (Dr Chui & Prof Pollard).
Also includes some heavy hitter key note speakers, including Bill Gates & Anthony Fauci.
For me, this demonstrates the huge global interest and potential for CHIM’s over the short to long term.
ORPH’s services are central to this market and will be in a ‘hot sector’, for many years to come.
IMHO
Prof Nir Eyal, Rutgers Center for Population-Level Bioethics
Wednesday, 10 March 2021, 2.30pm to 4pm
'The talk will review the case for-, and the arguments that were made against- challenge trials for efficacy testing of COVID vaccines.'
Note the past tense ‘were made’. Has he got some inside info from the Ethics Committee?
https://www.weh.ox.ac.uk/upcoming-events/the-ethics-of-challenge-trials-for-sars-cov-2-vaccines
ExT - thanks for the post.
Interesting read & cross over with Imperial College and the Wellcome Trust.
I agree that this project can potentially be joined up with hVIVO via the Wellcome Trust consortium at some stage.
Interesting new paper published a couple of days ago, in relation to LMIC’s who are seeking to implement CHIM’s.
‘Engagement of ethics and regulatory authorities on human infection studies: Proceedings of an engagement workshop in Zambia’
https://wellcomeopenresearch.org/articles/6-31
The Wellcome Trust was represented at this LMIC meeting and the initial countries involved in the CHIM discussions to date are:
Malawi, India, Uganda, Zambia, Vietnam & Kenya (See table 1)
hVIVO is leading the HIC-Vac & Wellcome Trust Consortium, as per below:
‘hVIVO is leading 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).’
https://hvivo.com/aboutus/clinical-trial-consortium/
Cathal mentioned this (when questioned about the Wellcome Trust) in the latest webinar, stating:
“We’re the only people in the world that has got not one, but two GMP manufacturing facilities manufacturing CHIM agents…..it’s nice that people have to come to us if you want a challenge agent”.
https://www.openorphan.com/investor-webinar-9-february-2021
The total list of potential LMIC CHIM countries is huge, as per below link:
https://wellcome.org/grant-funding/guidance/low-and-middle-income-countries
As Cathal has previously stated - ‘we don’t do anything for free’.
Subsequently, I think we can foresee yet another series of lucrative recurring revenue streams being created via LMIC’s i.e. in the consulting & licensing of human challenge studies, as well as the supply of CHIM agents in the short to long term.
ORPH really is the ‘gift that keeps on giving’. ??????????
IMHO
Prioritizing between second-generation SARS-CoV-2 vaccines through low-dosage challenge studies
‘By enabling control of the timing of infection, challenge studies excel at demonstrating vaccine efficacy against asymptomatic infection and transmission, as well as the duration of vaccine protection, and generating other information for improved control measures (Douglas and Hill, 2020; Levine et al., 2020; Eyal et al., 2021). Challenge studies may also help to refine dosing regimens of existing vaccines and determine the degree of protection against particular viral variants…..
Conclusion
…… The disadvantages of low-dosage challenge studies over conventional challenge studies for triaging vaccine candidates may be less significant than they appear. Therefore, low-dosage challenges may be a useful tool in expediting second-generation SARS-CoV-2 vaccine testing, and specifically in providing estimates of candidate vaccine impacts on infection to select promising candidates for further investigation’.
hxxps://www.ijidonline.com/article/S1201-9712(21)00124-7/fulltext
Great new paper which validates and corroborates ORPH’s approach, to the imminent Covid Characterisation & CHIM studies.
https://www.clinicaltrials.gov/ct2/show/NCT04752644?term=hvivo&draw=2&rank=16
https://www.bavarian-nordic.com/what-we-do/infectious-diseases/rsv.aspx
Interesting new video covering: current vaccine and variant investigation; covid therapy development; current and future covid\influenza vaccine development.
A great quote from Prof Wendy Barclay:
~57 mins
“The whole field a vaccinonolgy is completely opened up and it’s like a revolution. I think the next few years will really change the ways we use these vaccines”
https://www.youtube.com/watch?v=pEPAz5mMXXk&ab_channel=ImperialCollegeLondon
The discussion involves some of the UK’s top scientists and interestingly corroborate Cathal’s view, of how much vaccine development will significantly increase in the coming years.
Well worth a watch for those who are interested.
‘A consortium has been established among Imperial College London, the Royal Free Hospital, and the hVIVO company, supported by the UK Vaccines taskforce, for the implementation of COVID-19 human challenge studies. The UK will be working with scientific and specialist groups, including the Health Research Authority (HRA) and regulators to ensure the ethical safety of volunteers are prioritized and maintained.
The Oxford group reported that they will be conducting their study in parallel with Imperial London College and intend to use their human challenge model to understand the definition of protective immunity focusing on susceptibility to re-infection through people previously infected with SARS-CoV-2 and investigate how they are resistant to re-infection, compared to a naïve control group. The study will be using the same GMP virus stock, protocol endpoints and DSMB as the Imperial London College group, thus allowing direct comparison of data across the two studies.’
https://www.who.int/publications/m/item/report-of-the-who-ag-on-human-challenge-studies
Interesting historical (071220) WHO document which has been released, discussing guidelines around implementing Covid CHIM’s.
The meeting was attended by UK experts: Dr Andrew Cathchpole, Dr Chiu, Prof Pollard and Prof Openshaw.
Clearly matters have moved on now since December, as the covid characterisation study has been started and they are currently recruiting volunteers, prior to implementing the full Covid CHIM study.
A significant point of interest for me, is that Imperial College is clearly working in tandem with Oxford University, utilising CHIM’s. Clearly the hVIVO CHIM’s are an integral part of the UK Gov’s strategy to not only test and compare new vaccine efficacy, but also to test immunity against re infection (brilliant news).
This also ties in with Matt Han****’s statement in parliament yesterday that:
“We don’t rule out challenge studies at all and we’re working with Oxford University on such an approach. More broadly, I am up for considering anything that can safely be brought to bear and support the effort as fast as possible”.
https://www.bbc.co.uk/iplayer/live/bbcparliament
I still find it unbelievable that a small undervalued CRO company like ORPH, is central to the UK Gov’s Covid vaccination testing strategy.
UK Gov today, China State tomorrow and next week ….?
IMHO
https://www.youtube.com/watch?v=kPEw68m1oCI&ab_channel=SerpentTrading
Here’s my summary below following tonight’s webinar:-
I’m Buying More!
GLA LTH’s
Vas - great find.
The Parliament question was from MP Aaron Bell and was directly in relation to speeding up the new covid variant vaccines by using human challenge studies.
Matt Han**** replied :
“We don’t rule out challenge studies at all and we’re working with Oxford University on such an approach (I think he got mixed up and should have said Imperial College). More broadly, I am up for considering anything that can safely be brought to bear and support the effort as fast as possible”.
https://www.bbc.co.uk/iplayer/live/bbcparliament
Sounds to me like a continuing positive endorsement for Human Challenge Studies from UK Gov and he’s ‘up for it’!
IMHO
‘This is an exciting opportunity for a Research Nurse to join our team at our London site in E1 & NW3. As a Research Nurse you will support the Clinical Trial Centre with, day to day planning and execution of a clinical study screening.’
https://www.glassdoor.co.uk/job-listing/research-nurse-bank-hvivo-whitechapel-JV_IC2671300_KO0,19_KE20,37.htm?jl=3820254531
Nice to see confirmatory recruitment is ongoing for both sites, including the Covid CHIM’s @ the Royal Free Hospital, as well as the non Covid CHIM’s @ the new Whitechapel Clinic.
Just a quick update & refresher, for any new researchers & investors who may be interested:
A few key reasons to invest in ORPH, as follows:
- A world leader in testing vaccines via Controlled Human Infection Models (CHIMs)
- New ‘Disease in Motion’ platform with potential current market cap valuation of ~£200 million
- New Whitechapel Quarantine Clinic opened Feb’21 with expanded 19 bed capacity
- Enqs ongoing to locate a 4th clinic with potential 100+ bed capacity
- Potential huge Covid CHIM’s licensing deals or studies with the Chinese State
- Potential expansion of lab facilities with UK Gov, to cope with anticipated on going demand
- Near term large special dividends due from monetisation of Imutex, PrepBiopharm and Influenza Immune Modulator
- Confirmed ~£46 million contract for Covid CHIM’s with UK Government
- Confirmed Covid CHIM facilities expansion via UK Gov @ The Royal Free Hospital
- Multiple global vaccine co’s queuing up for future Covid CHIM slots ~£10m per contract
- Non Covid CHIM’s fully booked for next 18 months, ~£5 million plus per contract
- Huge & recurring future anticipated revenues from both Covid & Non Covid services
- Excellent CEO Cathal Friel and his team, who deliver on what they say they will do
- CEO with ‘skin in the game’, investing £2.5 million of his own cash (large % holder)
- Low risk ‘picks and shovel’ company, with a ‘large moat’ in a niche & hot sector
- Regular anticipated future annual normal dividends from surplus cash
- Multiple valuable assets i.e. 24 bed London clinic & lab, 8x challenge studies etc
- Cash generating & profitable (~£20 million cash), within a growing global market
- Commitment to no future placings from CEO, who is ‘locked in’ until mid 2022
- Future new CHIMagents challenge studies i.e.malaria, bacterial infections & Pneumococcus
- International consortium lead to assist Low & Middle Income Countries via The Wellcome Trust
- Future new strategic International Data Management & Technology Monetisation
- Future strategic Global Licensing Expansion of a full vaccine & antiviral services company
- Probable future takeover bid from large pharma service’s company
- Low market cap, relative to likely future revenues, assets and high growth prospects
For further research, any new investors may wish to view some video presentations, from our CEO Cathal Friel, as per link below:
https://www.openorphan.com/news-and-media/video-library
Additionally, there are numerous posts from knowledgeable and experienced investors on this board, with associated links and rationale.
Hopefully this may assist.
N.B. I’ve probably missed a few more key reason’s but please feel free to add or comment.
GLA LTH’s
Intelligent Wearable Technologies and Clinical Applications in Low- and Middle-income Countries (LMIC)
'The webinar will discuss the growing medical applications of wearable technologies for healthcare, and potential roles in guiding clinical and public health decision-making. Ongoing work between Imperial College Centre for BioInspired Technology and Oxford University Clinical Research Unit, Vietnam in development and clinical evaluation of these technologies for infectious diseases management will be introduced. This work forms part of a multi-national collaboration funded by the Wellcome Trust Flagships Award.'
hxxps://www.eventbrite.co.uk/e/intelligent-wearable-technologies-and-clinical-applications-tickets-136623754327
Note the references to LMIC’s, Imperial College and The Wellcome Trust.
Now compare this to ORPH’s RNS dated 191120:
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).
https://www.londonstockexchange.com/news-article/ORPH/collaboration-with-hic-vac-and-wellcome-trust/14761432
So I think we can safely assume there is yet another major ORPH project ongoing, in supplying infectious disease data to LMIC’s wearable technology.
Just look at the list of LMIC’s! (according to the Wellcome Trust) below:
hxxps://wellcome.org/grant-funding/guidance/low-and-middle-income-countries
Yesterday I thought the China CHIM link was huge!
Today I think half of the worlds population may benefit from ORPH’s wearable data – this underated company and it’s massive potential is just unbelievable!
IMHO
Sport – good spot.
Additionally, on ORPH’s website they state:
‘The first stage of this project will explore the feasibility of exposing healthy volunteers to COVID-19. In this initial phase, called the Virus Characterisation Study, the aim will be to discover the smallest amount of virus it takes to cause a person to develop COVID-19. The study will be sponsored by Imperial College London and conducted by hVIVO at the Royal Free Hospital’s specialist research unit in London, under the scrutiny of hVIVO’s highly trained scientists and medics. If the COVID-19 research is approved by regulators, it will begin early next year with results expected by May 2021.’
https://www.openorphan.com/human-challenge-model
Well we now know it has started on 050221 and they are recruiting, as per link below:
https://www.clinicaltrials.gov/ct2/show/record/NCT04740320?term=hvivo&draw=2&rank=1
So even though it’s not been RNS’d, clearly ethics approval has been given for this stage of the characterisation study.
1. Cathal has previously discussed China CHIM’s and also a potential licensing option for a very large sum.
“Friel is currently in talks over running challenge trials for a dozen COVID-19 vaccine developers in Europe, North America, and Asia, three of which are from China.”
hxxps://www.chinadaily.com.cn/a/202006/12/WS5ee2dbeda3108348172528b9_1.html
2. Professor Fuqiang Cui is a Professor and Head of Department of Laboratorial Science and Technology & Director of Vaccine Research Center, School of Public Health, Peking University. He used to be the Deputy Director of the National Immunization Programme, Chinese Center for Disease Control and Prevention, Manager of Ministry of Health/Global Alliance on Vaccines and Immunization.
hxxps://sph.pku.edu.cn/info/1411/4181.htm
On 13th Jan’21 he delivered a presentation and specifically covered CHIM’s and hVIVO on the slide deck (see page 57 & 58 below):
hxxps://apru.org/wp-content/uploads/2020/12/APRU-presentation-slides.pdf
He then immediately goes on to discuss population vaccination in China and what they need to evaluate, including ‘Effects of variation on vaccine efficacy’ (a key area in which CHIM’s can be utilised i.e. head 2 head studies).
3. Just three weeks later and Cathal is holding a conference call with seven of China’s largest CEO’s and China’s head regulator – a huge feat for a small CRO company!
It therefore appears to me that some dots are now been joined up!
If the UK gov will pay £46 million to Open Orphan for CHIM’s, with a population of ~67 million people, how much would China pay with a population of circa ~1,45 billion people!?!
IMHO
Spin – I think it’s a case of ‘you have to spend money to make money’
Finance Directors bring multiple skills to a business, see link below:
'The finance director is often viewed as the member of the board who creates a solid foundation upon which a business can grow.'
“Like a football team you need a good goalkeeper and you need a good goal scorer, and one can’t cope without the other” – Jerry Wales, former FD M&C Saatchi
https://www.iod.com/news/news/articles/role-of-the-Finance-Director
‘The Corporate Finance Director will be involved in all aspects of large and value-driving corporate and commercial transactions for the Open Orphan Group’
https://careers-hvivo.icims.com/jobs/2510/director%2c-corporate-finance/job
CF looking for some help in dealing with ORPH’s anticipated ‘large commercial transactions’!
Looking extremely good here.
IMHO