Member Info for FatherTedCrilly

I’ve also taken a few more today…

Hey JimBeann
The value will likely take account all parts of the trial (planning, volunteer screening, number of volunteers, cost of the challenge agent, monitoring, staff... etc. etc. ). The number of volunteers who complete the trail will be determined by the clinical endpoints - or an AE halting the trial. This may have a small impact on the final amount received depending on whether less or more are required - but this is part of the trial process. It is not a variable that can be actively influenced.
IvySpivey - this is more your area than mine - please correct/amend this reply if you read this... (thanks :-)
Cheers Ted

Agile trials details here: https://clinicaltrials.gov/ct2/show/NCT04746183?term=agile&cond=Covid19&draw=2&rank=1

I'm not sure this will have any direct effect on Imutex's AGS-v...
It is great news though - and thanks for posting the link. I remember reading about this a few years ago so really pleased to see the success. However I see it as one tool in the fight against mosquito borne disease - I don't think other programs will stop.
And on the plus side - anything which puts this field into the press is a good thing IMHO

And this isn't news that anyone was waiting on... An £8 million contract from an area (Asthma challenge trials) that hasn't received much publicity. A very timely reminder about how strong a company ORPH is becoming.

The U.K. Government (no matter how shambolic) will not allow a foreign acquisition of HCT capability during a pandemic. I’ve no doubt SGS are interested - the synergies are obvious. Either the U.K. government ring fences some of ORPH’s capabilities or this gets put on ice till other companies (universities) have the ability to run HCTs.
Also, the value of ORPH will not be fully realised till after the Covid Characterisation study is complete and the first vaccine trial begins. I can’t CF agreeing to a take over before this point (and a hostile takeover is a non starter at the moment ).
Once the characterisation study is finished this share (and hopefully this board) will be in a very different place. There is about 25 million pounds of government contract sat in limbo at the moment - with additional 8 figure contracts to follow.
Frustrating as all hell - but I’ll be looking to buy more shares before the end of the characterisation study.

Hi Mafuta
I know what you mean - I've almost given up posting on the ORPH board. Hopefully the disruption here will be short lived (and as you say, their presence is usually a good sign - though annoying :-)

Hi Thince
With Disease in Motion I'm inclined to agree - I think it is complimentary and doesn't 'necessarily' need to be spun off.
However, the other 3 are drug/vaccine-development businesses. Higher risk and higher reward but very expensive to take to trials. I can completely understand why these need to be separated (as a late stage failure in phase 2/3 would be very costly).
Also, as another poster said (apologies for not remembering who) there may also be conflict of interest issues. Would a business engage ORPH to run a challenge trial knowing that they have a competing product?
IMHO

There won't be human challenge trials on these particular nasties... However, this is more evidence for CF's 'decade of vaccines' comments. The more press and attention this gets the better for ORPH (and everyone to be honest).
https://www.telegraph.co.uk/global-health/science-and-disease/oxford-vaccine-team-make-big-step-forward-fight-against-deadly/

Just about feeling human again after over-doing the British Lions celebrations last night. Here's a to a good week

1. The vaccine task force names hvivo in their strategy paper.
2. If the ethics committee go soft**** then CF just moves the trials overseas (SGS facility possibly). Politicians are risk averse - but also suffer from massive fomo ( I’ve worked with politicians in various capacities for 20 years - this is not an observers comment, this is repeated learned experience). Covid challenge trials are going ahead
3. ORPH are the only credible Covid Challenge trails inn the market

We won't know the exact conditions required by the regulator. A services company will always have contracts at various stages of prospect - so it may be more complicated than waiting on a single piece of news.
However, given the potential value of the Government work (both what we know about - and what 'might' be coming) I'd say the ethics approval decision was the key here. Especially as CF's purchase was the morning after approval was made public.
As for entering a quiet news period now - I very much doubt it. There is likely a lot going on behind the scenes that doesn't fall into the regulators definitions of open/closed period. Also, the sale (rather than spin out) of an asset could drop at any time.

Several pieces of brilliant news this morning.
1. CHIM agents secured - so no take-over by the back door (buying the CHIM team instead of the company). This was always a slight worry so this is massively reassuring!
2. Delay explained - it was the Ethics committee slowing things down. They have now twice approved the use of ORPH's Covid challenge agent.
3. Imperial are recruiting for a research assistant to work with "samples from a SARS-CoV-2 human challenge study" - (thank you Eskers :-) https://twitter.com/Eskers1/status/1414952268760297474
The post is "full time, fixed term 1 year the possibility for extension."
This sounds as though Imperial are expecting the Covid HCT work to continue long after the characterisation study (IMHO).
ORPH is out of the holding pattern and moving forward again - with considerably less risk than before.

Initial results - not interim. Can't seem to type today - off for coffee

Interim results have already been verbally presented to SAGE / NERVTAG. I believe the characterisation study is complete - awaiting written results (but timing prob dependent on SAGE and UK gov who are funding this
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1001160/S1300_SAGE_93_minutes_Coronavirus__COVID-19__response__7_July_2021.pdf
(Hat tip to Jigger for first posting this)

https://www.theguardian.com/global-development/2021/jul/08/climate-crisis-may-put-8bn-at-risk-of-malaria-and-dengue
Notice the Bill and Melinda Gates foundation tagged in this.
ORPH is developing a Malaria Challenge agent - and Imutex/conserv bio have ASG-v (phase 2 ready mosquito bourne disease vaccine)
Not new information - but a timely reminder of what is in the background

Credit goes to Mr. Clayton on the Telegraph group for posting this...
(has this all been about having to reprint the brochures to get Handc0ck off them? Will the news now flow? I need a coffee)

https://www.gov.uk/government/news/bold-new-life-sciences-vision-sets-path-for-uk-to-build-on-pandemic-response-and-deliver-life-changing-innovations-to-patients
In particular
"Building on the progress made by the G7 on Clinical Trial Protocols to actively champion
and utilise novel clinical trial designs and regimens in the UK and internationally, to
reach clinical endpoints more quickly. This will build on the UK’s established leadership
in areas such as Human Challenge Studies and other novel trial methodologies."
And
"Continue to improve core immunology, vaccinology and clinical trial design and
infrastructure – so that the UK maintains its academic excellence in these areas and
can continue to operate as a global hub for the development of new vaccines and their
trialling in first-in-human and larger, late-stage efficacy trials. This would also include a
strong focus on clinical immunology, and the widespread alignment and integration of
studies on natural immunity with vaccine clinical trials, by using standardised assays;
and increasing the use of Human Challenge Trials, which can allow for much faster time
to result and would help cement the UK’s reputation for excellence in this research
method. "
Is this what we've been waiting on???

(I should note, there are existing challenge trials using malaria - but they involve being bitten by an infected mosquito)

This isn't new information - but worth restating as I think might have been lost amongst the current discussion topics. The following is taken directly from the annual report:

-hVIVO, which is now home to our main London offices, offers a much broader suite of human challenge study models which can now test vaccines and antivirals for influenza, RSV, RV, COVID-19, asthma, malaria, hRV, COPD, and a number of other diseases.

-Expanding our challenge business in London beyond Influenza and Respiratory Syncytial Virus (RSV) through the
development of new models in the areas of Malaria and Pneumococcus, which are already in advanced stages of validation
and are targeted to commercialize in 2022.

Do not underestimate the significance of this. Almost all Hvivo's contracts to date (excluding Covid) have been for RSV and Influenza. Adding multiple new Challenge models creates multiple new revenue streams. And there is currently no competition in this space. Like Covid, no-one else has these challenge agents!

Not today... (unless something has been sold - that might be announced after hours)
Next week however, very much so. If I had to speculate, then government contract would be my shout. There has been a lot of positioning this week - papers on rapid vaccine development, ethics etc.
https://www.gov.uk/government/news/64-million-funding-to-back-uk-wide-plan-to-strengthen-clinical-research-delivery (Gov strategy)
https://philpapers.org/archive/ROHTEO-3.pdf (HCT Ethics)
https://www.washingtonpost.com/outlook/2021/06/24/covid-challenge-trial-participant/ (HTC Volunteers)

GLA - have a great weekend (Lions v Japan and Wales v Denmark for me :-)