Member Info for Ivyspivey

Hi Flakey,
Hope all is good and nice to see you here though the drop below the recent trading range is more to do with the change in Covid sentiment rather than any change in fundamentals here.
Enjoy the w/ end

I found this quite interesting and presume the SCLP Approach will generate both S and N AB response as well as T cells.

https://reut.rs/3cFwkUu

Hi Ruck,
If this is true and I really like RG and respect his knowledge in this area but I do feel that they should be looking externally for a major commercial appointment.The danger of constantly going internally is the bias towards “ cosiness” and the absence of new ways of working and experience which an external appointment would essentially bring.
Sometimes it is easier to judge how best to progress from the outside.

Sorry TF did not realise my link is exactly the same as the one you posted earlier just from a d different platform.
Many thanks fir that plus your BBC one you are turning into a good source on info these days.

Very nice explanation of how Covid immune response works and some pointers for future.

https://www.nature.com/articles/d41586-022-00214-3

Very good news this morning and confirms all is well with manu of SCOV2 and no real impediments to completion of SA arm.
Also confirmation of pre clinical activity vs Omicron a very big positive and if replicated should confirm choice of SCOV2 for U.K. arm

Thanks Ray been a nice discussion and certainly I have learned more about protocol

Or are they going to boost half of initial ones with SCOV1 and the other half with SCOV2 then I can see how the difference could be measured but as they are only planning Covid Vaccine as a booster rather than prime and boost which I was initially told by CH they were testing .

Hi Ray,
Have looked at CT site protocols and your interpretation seems correct about each patient getting 4 doses.
It still seems an odd way of doing it to me but as long as regulators are happy then fine.
Apologies for any confusion but as I say it seems an odd protocol to me.

OK Ray and Bermuda I need to read the trial protocol as I did not read it as each of 40 get 4 doses so two of SCOV1 and then another two of SCOV2 but 20 get SCOV 1 and then another 20 get SCOV 2 with both lots of 20 split by half get ID and half get IM so creating 4 study arms of 10 patients each.
It defies logic to me to get 4 doses when it is a prime and boost so 2 doses you are testing.How can you accurately compare the difference between SCOV 1 and 2 if they are getting 4 doses so 2 of SCOV1 and then another 2 of SCOV2 how can you tell the difference when you will still have an immune response from the first two doses.
Also that only creates two study arms when I am sure they are looking to compare 4.

Hi Bermuda,
I actually used your quotes in an earlier post.My point was that hopefully the main reason for halting the trial was the fact it was hard to recruit people who had not been in recent contact with Omicron and that has passed.
Being Covid free by PCR and allowing a 25% excess for being Covid naive opens up a much bigger pool than 100% naive.
Ray do appreciate your thoughts and nothing to say which will receive SCOV 1 and 2 in what order. Howeber the SCOV 2 could only be done on day 113 at the earliest ( think to allow completion of manu) so makes sense to me given the original choice of SA as a relatively accessible population that they do the 20 SCOV 1 patients first during the first 113 days and certainly we know the 16 patients will be SCIV 1 as All were treated before day 113 of the trial starting.

From CT website re SA Trial

This study is expected to enrol 40 participants (20 per study arm) at one study centre in South Africa. At least 15 participants in each arm should be negative for antibodies against SARS-CoV-2 upon entry into the study.

So you don’t need all 20 in each study arm to be Covid AB free just a minimum of 15.

AB as for trying to predict timelines it really is not difficult to work it out what you do need is any clear starting points such as FPI which we have.Now we have had a delay then we need to know when it resumes and then of course we have the 2nd part of the p1 in U.K. and SA

Hi Ray I may be wrong and the SCOV1 protocol means the initial 16 would be given both ID and IM doses.
However if memory serves me right the SCOV2 was not likely to begin until the first 20 had been recruited as that was at a later manu stage.

Saw that Miavoce and is important to recommence ASAP as don’t forget the additional patients are to test delivery system and SCOV2 rather than just further validate initial data amongst 16.

Morning sometimes in times like this it may be worthwhile stepping back and note comments of very respected posters like Bermuda.

For all we know they have still been actively trying to recruit but have been unable to get any patients through screening - worth noting the inclusion criteria for the trial. It's not just that patients can not have been infected themselves, but also they must have had no known exposure to SARS-CoV-2 virus in the last 14 days. So if they have had any contact with anyone who tested positive for Covid in the last 2 weeks, they have to be excluded.

So it may be that with the Omicron wave past it’s peak if it is the contact rather than past infection point that is issue to recruitment then this position can be quickly reversed.Ifvthe results had been accompanied by an interview to clarify things then maybe some of this speculation can be avoided.

Some of us have been criticised for wanting a more open and transparent communication on trial progress over the years and in fairness I don’t think it is any kind of wish to conceal matters just a common trait amongst many small bios whose scientific imbalance and inward looking nature tend to reinforce these actions.

Am sure in time as SCLP grows it will realise than the non scientific part is as valuable as the science although we all recognise it is the science that provides the ultimate value here.
ATB

Hasiba,
Won’t make any further comment on here but well done on ARB.

Extrader agree with Elrics view re Covid data but do appreciate the progress of Covid CHIMs has been much slower than anticipated so has been largely excluded as guided by CF.
Think that is split into 2 bits the U.K. Govt slots and the wider commercial application.The wider one I am very happy with and do feel those contracts will come in due course.
Think the 3 Govt ones are harder to predict coming to fruition as yes an important need but not sure about Govt commitment moving forward in terms of current Covid challenges and preparedness for future Pandemics but that is due to issues outside of ORPH control

Thanks Burble,
We know the environment for recruiting trial patients is very difficult and we look forward to these interim results statements for guidance on all platforms but I really don’t see anything new and no imminent indication of any trial results.

Morning
Dies not the 16 patients represent the current total.

Highlights (including post period):

Vaccines:

· First subject dosed in the Company's COVID-19 vaccine Phase 1 clinical trial (COVIDITY) in South Africa, with 16 patients having been recruited to date.

I am actually disappointed with this progress as yes the 16 patients have experienced no safety issues which is good but did expect much quicker progress than this.Plus slow progress in getting Modi 1 underway.
Just my thoughts but happy to be proved wrong.

Evening extrader,
The fact the ORPH CHIMs are not based on the most up to date variant is not a concern as until Covid becomes an endemic disease threat then the CHIMs will always be behind the latest variant.
It is what you can learn on the HC trials that is important plus they are there to compare against each other not necessarily vs Omicron as it is yes more transmissible but less severe than say Delta.
The Pfizer-Bion Tech based on the mRNA is simply designed to change the antigenic focus like a plug and play when a new variant becomes dominant.
This does not mean other Covid 2.0 approaches or in particular the 3rd generation Covid Vax which seek a more universal approach will likely follow a similar pathway or more likely consider HC trials esiecuslky in a phase 2 taking into account the current difficulties of doing larger p3 trials except as straight boosters.
Omicron is much more closely related to Beta than say Delta so testing of Vax vs Delta is harder to evaluate than you may think.
So plenty of future for Covid HC work and CHIMs imo