Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
'You will join a talented group of clinical fellows, research nurses and scientists led by Dr Chris Chiu (www.imperial.ac.uk/people/c.chiu) in the Department of Infectious Disease, to characterise the response to SARS-CoV-2 during experimental human infection. This will enable investigation of COVID-19 pathogenesis and protection as well as permitting follow-on vaccine efficacy studies. In particular, you will focus on the biology of T cells generated during infection.'
https://www.imperial.ac.uk/jobs/description/MED02149/research-associate-respiratory-virus-vaccine-immunology
Note the ' follow on vaccine efficacy studies' , confirming several vaccines initially identified for future investigation.
All great confirmatory information, that the planned Covid CHIMs are progressing well.
GLA
‘We are looking for a highly motivated Research Associate to work on an innovative SARS-CoV-2 human infection challenge study, in the first instance. You will be part of a multi-disciplinary group focusing on human immunity against respiratory viral infections using exciting and unique studies of experimentally infection/vaccination of volunteers and hospitalised patients.’
https://www.imperial.ac.uk/jobs/description/MED02149/research-associate-respiratory-virus-vaccine-immunology
Interesting to see that the lead for the Oxford Astra vaccine, Prof Andrew Pollard, is not only a director for HIC Vac but has conducted human challenge studies himself:
‘His research includes the design, development and clinical evaluation of vaccines including those for meningococcal disease and enteric fever and leads studies using a human challenge model of (para)typhoid.’
https://www.hic-vac.org/members/members-profiles/professor-andrew-pollard
As someone in the global news spotlight at present, I’m sure his views and experience with CHIM’s, may well persuade other countries to consider conducting CHIM’s for both covid and non covid vaccines in the future.
IMHO
Slightly dated podcast (261020), but key comments include confirmation and reassurance that the UK Gov intend to utilise Covid CHIM’s for:
- First generation Post Phase 3 vaccine efficacy studies
- Head to head vaccine Covid CHIM’s
- Next generation vaccine Covid CHIM’s
- Regulatory framework & facilities all in place to progress Covid CHIM
Forward ~ 7 min 20 secs
‘In the short term you’ll see an announcement, we’ll have access to a third facility, we’ve so much work’
SGS RNS soon?
https://www.youtube.com/watch?v=n7IbXS1nbH0&feature=push-u-sub&attr_tag=HtpXx3xQgZBpQ9Hu%3A6
Cashed up, company expansion, poss buy out option Sping '21, wearables deal, Imutex, growing sector etc etc
Credit to toyin on advfn
Professer Andrew Pollard is the lead for the Oxford Astra Covid vaccine:
https://twitter.com/BBCNews/status/1330954133424238602
He is also the director of the HIC Vac network that aims to accelerate the development of vaccines globally utilising CHIM’s:
https://www.hic-vac.org/
ORPH’s recent RNS confirm’s collaboration with HicVac:
https://www.londonstockexchange.com/news-article/ORPH/collaboration-with-hic-vac-and-wellcome-trust/14761432
Based on the above, I would guess an Oxford vaccine CHIM study, would be highly likely in the New Year.
This would be great kudos for ORPH and likely to generate more head to head CHIM’s in the future.
IMHO
https://www.theguardian.com/uk-news/2020/nov/23/oxford-covid-vaccine-hit-90-success-rate-thanks-to-dosing-error?CMP=Share_iOSApp_Other
If a 90% success rate was achieved by a ‘dosing error’, how valuable would a human challenge trial be, in establishing correct dosages and timings for all the new Covid vaccines?
‘EMA is providing guidance to assist developers of potential COVID-19 medicines, to prepare for eventual applications for marketing authorisation.’
CHAG-COVID19-CA ChimAgents Challenge agent for human infection models Non-clinical phase
https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines-covid-19
Good to see ORPH liaising with the EMA, in order to progress the Covid CHIM challenge agent in Europe.
Subsequent EMA authorisation will be a step change for ORPH and enable it to potentially utilise the Covid CHIM at the third facility (presumed 45 bedroom CHIM unit at SGS in Belgium).
IMHO
Bar - full recording now on.
Pre-symptomatic detection of COVID-19 from smartwatch data
‘Consumer wearable devices that continuously measure vital signs have been used to monitor the onset of infectious disease. Here, we show that data from consumer smartwatches can be used for the pre-symptomatic detection of coronavirus disease 2019 (COVID-19)…
…..Data on reported respiratory rates and blood oxygen saturation are expected to be particularly useful in COVID-19 prediction28, although the disease is quite heterogeneous in its physiological presentation29,30, as observed in our study. At the time of writing, such data were not available to us; however, these data, especially when combined with machine learning approaches, as well as an increased number of study participants, will greatly improve diagnostics. Regardless, this continuous monitoring approach is expected to be powerful for early infectious illness detection and offers many advantages that may help increase disease detection during the current global pandemic. Specifically, wearable device-based disease detection does not require testing infrastructure, materials or personnel that can be overburdened by global supply chain shortages. In addition, real-time monitoring by smartwatches is a passive form of testing that does not burden patient schedules and can serve as a high-resolution continuous screening to inform follow-up testing and self-isolation. We hope that ongoing screening for COVID-19 risk using wearable devices can provide a scalable solution to help overcome current barriers with testing, and inform early diagnosis and treatment to mitigate the spread of the disease. Such information will inform patients for self-isolation, diagnosis confirmation and early treatment.’
https://www.nature.com/articles/s41551-020-00640-6
Great paper, confirming to the global wearable & tech companies, of the vast & scalable potential in detecting Covid 19 (and other infectious diseases), through their respective technologies.
Interesting to see that Fitbit, Apple and Garmin devices were predominantly utilised in the study. Might be the trigger needed, for some contract offers to start coming in?
All they need now is the:
Data for Covid 19 ‘respiratory rates and blood oxygen saturation’ = ORPH data!
IMHO
https://www.theguardian.com/world/2020/nov/22/why-the-race-to-find-covid-19-vaccines-is-far-from-over
Small mention of challenge studies.
‘PC786 is a new medicine being developed for treatment of respiratory syncytial virus. The main purpose of this study is to evaluate the antiviral activity of PC786 in healthy adults infected with RSV virus in a viral challenge study.’
Nice to see positive results coming from the PC786 RSV hVIVO study being released for Pulmocide Ltd :
https://academic.oup.com/jid/advance-article/doi/10.1093/infdis/jiaa716/5995608
Whilst this study pre dates Open Orphan, it further demonstrates the benefits and effectiveness of conducting challenge services through hVIVO.
Should be another good evening out!
https://www.sharesmagazine.co.uk/events/event/shares-investor-evening--webinar-091220
Great to see so many positive posts after tonights presentation. I think all LTH’s understand and appreciate the vast potential in ORPH and the Herculean effort Cathal is making to progress everything.
The highlight for me (apart from a possible large lucrative China deal!) was SGS more or less being confirmed as the third facility and ‘sharing revenues’ with ORPH (I’m quite relieved that no imminent buy out appears to be on the cards, but I think SGS may make this move at a future date).
SGS’s new 45 bed facilty in mid 2021 can potentially double ORPH’s revenues yet again (in addition to the Royal Free Hospital beds) and secure further recurring revenues in future years (hopefully we’ll get a more accurate broker update soon, taking these factors into account).
Cathal moving to London with his family, reinforces his commitment to the business and no doubt will drive further expansion, which is set to grow significantly in the short to medium term.
IMHO GLA
"Open Orphan subsidiary hVIVO has been selected to lead a highly-respected group to create international standards for drugs used in human challenge trials....
.....Wellcome Trust is an historic London research charity with a £25.9bn endowment, making it the fourth-wealthiest charitable foundation in the world. It provides grants of up to £5m to research teams developing faster vaccine trials using human challenge studies in low to middle income countries."
https://www.valuethemarkets.com/2020/11/19/open-orphan-leads-weighty-wellcome-trust-bid-to-define-human-challenge-drug-standards/
When ************* caught up with CEO Cathal he told us:
“hVIVO has been selected to lead a consortium, on behalf of HIC-Vac and the Wellcome Trust, to generate regulatory style guidelines on the manufacture of human challenge agents for subsequent use in controlled human infection studies. We are delighted that hVIVO has been chosen to lead this consortium as it positions hVIVO front and centre in setting international standard guidance for development of human challenge agents for human challenge studies going forward. Such a role opens many doors amongst the international pharma companies for hVIVO as well as with many of the worldwide researchers who we would not usually have the opportunity to engage with in the normal course of business. Quite a number of other CRO’s and organisations around the world would have pitched to win this prestigious and very important collaboration and with great pride our hVIVO team will be leading this work. As such, we are now very much at the centre of the expansion of challenge studies for the development of vaccines and antivirals around the world.”
https://www.***************************/open-orphan-beats-off-global-competition-in-new-collaboration-with-hic-vac-and-wellcome-trust/412938781
‘Among the expert reaction to the announcement, Prof Julian Savulescu, Co-Director of the Wellcome Centre for Ethics and Humanities, University of Oxford, said: “It is surprising challenge studies were not done sooner. Given the stakes, it is unethical not to do challenge studies.”
The benefits were also outlined by Deputy Chief Medical Officer Jonathan Van-Tam: ‘First, for the many vaccines still in the mid-stages of development, human challenge studies may help pick out the most promising ones to take forward….for vaccines which are in the late stages of development and already proven to be safe and effective through Phase III studies, human challenge studies could help us further understand if the vaccines prevent transmission as well as preventing illness.’
Very interesting and comprehensive article, with experts discussing the Covid CHIM process and timescales ( including some reassuring comments regarding the likley ethical approval in the UK).
Well worth a read.