Member Info for Burble

Fingers crossed it passes swiftly, it’s crazy how different people have it. A colleague had it in December and is still off work with Long covid. Someone else I know had it without even knowing. Nuts how the same protein and lipid covered strand of RNA can cause such variation in symptoms and outcomes.

So after two years dodging it, I’ve finally tested positive for C19. Made worse by having it coupled to having it alongside a six week chest infection and an underlying lung condition. To say I feel rough is an understatement.

Here’s hoping that we hear positive top line results soon for Covidity. Wouldn’t wish this on anyone and a pan-coronavirus variant proof vaccine could help stop many from getting this dratted disease.

Would be good to hear what’s happening with all our clinical trials. I wonder whether to coincide with the new website update the team could produce a one sheet RNE updating us on each of our trials in recruitment/start up.

What sites were in trial start up, what sites are open for recruitment, how many patients have been recruited (and ideally what this is a a % of total patients). Would just give us a sense of where we are at with everything.

It wouldn’t be massively difficult to pull together, but I think it would really demonstrate whether timelines were on course or whether it is factors outside of our hands that are causing delays in start up and recruitment.

Just a thought I had been having as to how I would want to manage an organisation like this and ensure open and honest dialogue with investors or stakeholders.

Gold

For some yes it is less severe than a cold. For a significant proportion that isn’t the case - whilst deaths yes have gone down, the lasting effects of even mild cases of covid mean that this pandemic is far from over.

Fantastic news and again, puts how strong our IP and technologies are.

I did say earlier in the year I suspected that this was a new platform. At the time it was thought that the term platform was being used to describe each of the existing identified mAbs (which is true too).

Exciting times. Hopefully we shall see findings from this move forward quickly.

Corrected link: https://www.constructionenquirer.com/2022/03/16/saudis-to-invest-1bn-in-teesside-on-green-aviation-fuel-plant/

https://www.constructionenquirer.com/2022/03/16/saudis-to-invest-1bn-in-teesside-on-green-aviation-fuel-plant/This mentions that the plant will use gasification. I wonder whether this will be the Eqtec Billingham plant or whether we will have competition right on our doorstep!

Agree with Berm, the radio silence doesn't mean there is nothing going on. I suspect there is a lot of work going on behind the scenes as we speak. But yes, almost 3 months down the line with no sign of a Modi-1 start. It would be nice to have some form of update on why this is, especially when LD just before Christmas spoke about Modi-1 start-up being soon.

For me, the frustrating really lies in the fact that this could be 3 months of patients with difficult to treat diseases missing out on a potential game changer for them. Here's hoping that we get an update in Q1 and it doesn't slip any further.

I hope you feel better soon Moonparty. I'm currently dying of week 4 of a nasty chest infection (non-covid thankfully) but am paranoid about getting both at the same time.

Dracula,

I can hazard a guess as to why no pharma wanted to take a punt back then - mainly there were historic interest in DNA vaccines but whilst they demonstrated a good safety profile they faced problems with low efficacy and immunogenicity compared to other immunotherapies, as well as more complex delivery through electroporation etc. As such, the focus of the pharma world moved away from nucleotide based therapeutics towards things like CAR-T and biologics such as antibody therapeutics.

DNA vaccines are quite niche in that aspect, in comparison to antibodies where we see the M&A and licensing activities of pharma routinely picking up antibody therapeutics and ADC platforms.

However, I do feel covid has shown that mRNA (and therefore nucleotide based therapies in general) to be of value. Look at Pfizer, collaborated with BioNTech…yet now have dropped that partnership and set up their own mRNA research division and going at it alone. Hence, I think we are on the cusp of more people embracing nucleotide based technology and it moving from niche into mainstream.

Just the other day I was in a call where the discussion was on how do we make antibody therapeutics cheaper - someone raised the question of could we deliver it using a DNA based vaccine and get the patients body to produce the drug instead. Reducing costs of production, formulation and storage. Many in the room agreed that the pandemic has shown us new technologies and people now are really focussing on building on that. As an aside; this above comment is basically what Immunobody does - it delivers the genetic material for the patient to produce a antibody like protein which the immune system then responds to. So again, Scancell are one step ahead.

It’s these reasons why I don’t give up hope. We may be before our time, but that just means we have a wider IP portfolio. Our time will come I’m sure and Covidity may be the thing which acts like a springboard.

So out of curiosity I've been trying my hand at some data mining of SCLP RNS's dating back to 2010. It's been quite fascinating reading through old RNSs and seeing the direction of the company change over the years. Definitely learned a lot going back and re-reading these announcements over the last decade.

Some things it threw up for me and would be keen to hear what other LTHs think/know about these things

2013 - update on patient recruitment in clinical trials - markets were updated to say that the final patient was recruited for one cohort and then again in 2015 to say that patient recruitment complete. I wonder (hope) will this be happening again with SCIB1 and Covidity?
2015 - ImmunID collaboration to determine what patients may respond to SCIB1 - what happened to this data? Did anything come of this? Is this what has now fed into the updated Immunobody backbone increasing the target population that a second generation iSCIB1 would be able to target?
2016 - San Diego office opened. What came of this? Is this still a thing or was this mothballed?
2019-2020 - Three avidimab collaborations. Are these ongoing? If so, when will we receive an update on these? If not, will we find out why? Will data from this be published in peer-reviewed journals?

More broadly
Across 2010 - 2022 we have averaged 2.32 RNS a month (excluding price monitoring extensions) with 2020 being our best year averaging 4.58 a month (but this is heavily skewed by 11 and 10 RNS releases in October and November respectively. Currently this year we are slightly down on this average, with 1 per month average YTD but then again we are only coming to the end of Q1, however quarterly averages across 2012-2022 are as follows - suggesting that unless we receive a flurry over the next three weeks Q1 this year will have been subdued.

Q1 average 6.5
Q2 average 5.9
Q3 average 7.5
Q4 average 8.0

Tuesdays seem to be preferred for RNSs with 25% of all RNS announcements released on this date, with Thursdays less so (16%). Monday, Wednesday and Friday are pretty much even, though trending downwards towards the back end of the week (21, 20, 18% respectively).

Most years there is quite a cyclical reporting cycle across the year - with peaks of RNS released every few months - usually on a three monthly basis - though this does not always coincide with end of quarters. This is logical in some sense because of standard reporting requirements for the business, but it's still interesting to see how data comes in ebbs and flows. Other companies I have looked at seen to have a more regular flow of information to share holders.

Across 2014-2018 there was 13 announcements for presentations at conferences etc. Then nothing reported in 2019, 3 conferences reported in 2020 and then nothing since (obv. pandemic hits, but conferences did still continue virtually) despite us knowing that there are presentations going on. Has reporting of this activity been dropped?

We laugh, I had a full head of hair when I first invested here. Now I’m going grey, crows feet have deepened and definitely have started receding at a rapid pace. Yet I hold tight and add more where I can!

Thanks Bermuda,

That's my Friday breakfast reading sorted.

I wonder whether we may hear something to coincide with the 7-8th March CEPI summit held here in the UK.

Even just a ‘everything going fine; report on Covidity soon’.

Wouldn't we all like £1000. Sadly when it says 'participants would be reimbursed for time and travel', we are probably looking at bus fare and a few £ extra'. It really won't be massive amounts.

One of the most recent covid vaccine trials going on in the NHS Trust here is paying £100 for having a vaccine, £50 for any trip to the hospital (be that for blood tests, covid PCR test for suspected covid). This is pretty unique in terms of payments, part of the uplift in costs was because they wanted to recruit people who had yet to have any vaccine and the rest I think is there to try and keep people on the trial - especially as being on an unlicensed vaccine trial means you possibly cannot travel to some countries because the vaccine status isn't recognised. Most of the time these things are more like £20 for your time kind of thing.

KashDog

Remember that the aim of a phase 1 trial is to find out how much of Covidity is safe to give, what the side effects of this are, what happens to the drug in the body and finally if the treatment helps. Furthermore, patients are generally recruited slowly onto P1 trials - we know that Lindy has alluded to this late last year.

I would suspect recruitment would be quicker on Covidity than say the Modi-1 trial (when it gets going) because Immunobody has been trialled previously in a different indication with SCIB1, but there are components of Covidity which haven't been trialled before - delivery method, Avidimab and any additional components. So they may be taking a slightly more cautious approach to phase 1 recruitment rather than rushing ahead. This also is determined by the SA clinicians, so is most likely out of the hands of Scancell.

I would hope though that 16 patients would be enough to get an idea as to whether the delivery system was generating a strong immune cell response - B and T, as well as understanding more about the delivery method to choose to go forward. So long as all patients who entered the trial, get through all doses, measurements and blood samples then I would think Lindy et al. will have a pretty good idea as to whether Covidity is working in the way they thought it would and can move into the next stage of clinical trials - be that a larger P2 trial or a booster trial.

https://www.prnewswire.com/news-releases/alvea-launches-scalable-shelf--stable-dna-vaccine-development-against-new-sars-cov-2-variants-301483557.html

Also to note, this is pre-clinical atm. But the way this press release has been constructed, demonstrates to me how our PR game could be improved.

So this was released yesterday saying that 22 research projects have been selected by the government's UK Vaccine Network (UKVN) to hep tackle viruses.

https://www.ukri.org/news/10-million-to-combat-potential-epidemics-in-developing-countries/

£462,462 to the University of Nottingham for a single-dose DNA vaccine platform to safely induce protective immunity against Zika virus.

https://www.miragenews.com/uk-aid-funding-for-nottingham-research-to-727730/
The research, being led by Dr James Dixon in the university’s School of Pharmacy and Biodiscovery Institute (BDI) with Professor Janet Daly, Professor of Viral Zoonoses and Deputy Director of the Wolfson Centre for Global Virus Research, will focus on a new DNA vaccine platform to induce safe protective immunity from Zika.

The virus is mainly spread by mosquitoes in regions of the world including Central and South America, the Caribbean and Africa, and is a serious risk to pregnant women and their unborn children, as there is evidence that it can cause birth defects, particularly abnormally small heads (microcephaly).

The work will also involve scientists at Nottingham Trent University’s John van Geest Cancer Research Centre. Our vision is to produce an effective, safe, single-dose prophylactic vaccine platform for Zika using our peptide-based delivery system which is applicable to any emergent virus.

He added: “This project builds on our previous experience in developing a DNA vaccine for COVID-19 with Innovate UK funding.”

Am I right in thinking the last sentence suggests the use of ImmunoBody?

Pretty spectacular isn’t it! It’s equally amazing and horrifying in equal measures. Amazing that an antibody is able to cause such destruction, but equally as horrifying that a single cell like that could be the beginning of a disease which will kill if left untreated.

If you want to see something amazing, check out this Twitter post and the image from UoN. It’s beautiful. Showing one of our antibodies destroying a cancerous cell.

https://twitter.com/uon_bdi/status/1494446857774596096?s=21

RP

That links into what I was talking about earlier when I say 'long term, I think there is a general realisation in government that the NHS as a place to do clinical studies is pretty unique in the world and in this post-covid post-brexit world, this is something that should be supported and strengthened. The relatively joined up nature of the system has demonstrated that for clinical trials it has a real unique selling point. Hence I suspect we may see this aspect of the NHS strengthened going forward.'