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Evening Knowlesi,

You have to be a bit careful about drawing any conclusions based on the ImmunityBio trials.

For a start, the results announced this week were only interim results based on a pre-planned safety analysis by the DMC (data monitoring committee). It would have been written into the trial protocol that a safety review should be carried out after dosing a set number of patients. In this case the review took place after dosing only 6 patients in each trial and so the amount of data is going to be limited. Having said that, there'll be a whole load of unpublished data that will currently be undergoing analysis.

More importantly though, I can see why you think it's taken 5 months for ImmunityBio to get to this stage but it's a bit more complicated than that. They're actually running two phase I trials for the same drug but with different delivery methods. Although the first trial started back in October/November, the second didn't start until the end of Feb - less than 3 weeks ago. They appear to have taken the decision to align the 2 trials and report on both at the same time which makes sense as the whole idea is to use them to select the best delivery system. So whilst one trial has taken over 5 months to report interim results, the other has only taken 3 weeks.

Sorry, I know I'm going on a bit here but one final point. You're dead right, phase I trials are primarily about safety but they'll give ImmunityBio and Scancell a huge amount of data that will give a very clear indication regarding potential efficacy. There will be a complete analysis of each patient's immune response covering levels and timings of antibody and T cell responses. That data can be compared back to responses seen in successful vaccines as well as patients who have been naturally infected with Covid and have recovered.

Obviously it wouldn't be sufficient for approval but if the results are good enough then it will be enough to attract a partner and that's the investment case here.

Jayne,

Yes orphan drug status can only help and in view of the trial results you'd hope that there's a good chance of approval for RDEB patients - time will tell but looking at the price movement today it seems others may think so too.

Jimbob,

Have only just noticed your post to me a couple of weeks ago - sorry for not replying. I'm good thanks and hope you and yours are keeping well too. I'm not in ORPH but know a couple who are and who are very positive about it. Did you buy in the end?

Re. Your 21.22 and 21.25 -

Are those copies of posts from Inanaco on ADVFN, I can't see them over there. Were they from today?

Richard Barfield is presenting at a Shares/AJ Bell investor event on 24th March

https://www.sharesmagazine.co.uk/events/event/shares-investor-evening--webinar-240321

ImmunityBio published interim results from their Covid vaccine trial today - looks promising and has shown robust T cell responses according to their PI. It can only help Scancell's cause if ImmunityBio's vax is successful and demonstrates that the N protein is a useful target - it will raise the profile of all NP vaccines and we know there's only a handful of them at the moment. The very last thing we want or need is failure from the competition. This comment is from the hAd5 clinical trial principal investigator and very much reinforces Scancell's approach:-

'“Unlike most of the COVID-19 vaccines currently available, ImmunityBio’s hAd5 generates T-cell immunity, which is important for long duration immunity. Based on the results of subcutaneous/oral regimen in the nonhuman primate study where the vaccine provided complete protection against the virus challenge, we are excited to explore with ImmunityBio the potential for the vaccine to provide a T-cell boost to currently available vaccines. I am particularly encouraged by the immune response to the nucleocapsid protein, which may mean this vaccine will remain effective against the many emerging spike protein variants.”

https://www.businesswire.com/news/home/20210315005272/en/ImmunityBio-Announces-Positive-Interim-Phase-I-Safety-Data-of-hAd5-T-Cell-COVID-19-Vaccine-Candidate-in-Oral-and-Sublingual-Formulations#.YE-B0u-kPms.twitter

Angle seem to be on a bit of a recruitment drive good to see them putting infrastructure in place to take the Company through next phase of development.

https://angleplc.com/careers/

Jayne,

Given the lack of any approved treatments for EB, the bar must be set fairly low for approval. We can only hope that Filsuvez will become the first approval for EB and will make a real difference to patients' lives.

Very sorry to hear that you had a very close family member with D/EB - you will know better than any here the suffering involved and what a truly dreadful disease it is. Fingers crossed for a swift approval followed quickly by reimbursement approvals from healthcare providers/insurers so that patients actually have access to the treatment.

Two new patent applications were published yesterday :-

WO/2021/044039 - I believe this one relates to FG2811, Scancell's ultraspecific mAb recognising SSEA-4 on stem memory T cells

WO/2021/043810 - think this one is FL134 the anti fucosyl-GM1 mAb which has potential in targeting lung cancer

Both were filed in September last year - good stuff.

https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2021044039&tab=PCTBIBLIO&_cid=P12-KM6EJ5-68819-1
https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2021043810&tab=PCTBIBLIO&_cid=P12-KM6EYA-73755-1

The

tick tock, rat-a-tat-tat, keys to the kingdom are we minted yet and whatever happened to Puritas?

Copy of my post from ADVFN

Yes I make it about the same but more interesting perhaps is the fact that according to Scancell's website, as at 17th February Calculus only held 49,844,165 shares (6.11%) but according to today's RNS their holding was 56250099 - 6.9% as of yesterday. So it seems that between 17th Feb and yesterday they had actually bought 6.4 million shares taking them to 6.9% - just below the notifiable threshold.

So whilst they may have sold 7.4m their overall position has only dropped by 0.12% from 17th Feb - just over a million shares.

......and let's all hope that CEPI believe Scancell are capable of carrying out a phase I clinical trial and don't mind cardboard labs.

LL

It's the grey Filters tab above

If CEPI are about to announce a funding call for a universal coronavirus vaccine then there'll be a strict application process which no doubt will include a full application with preclinical/clinical data, a budgeted plan and some form of review by independent experts. If Scancell apply they will obviously have to follow the application process.

The significance here is that:-

1) CEPI (and their donors) clearly feel development of a universal vaccine is important enough to fund with a nine figure amount - it reinforces Scancell's approach and validates the decision to take a different path from most of the crowd.

2) It's fantastic (and a big deal) that Scancell's vax has been singled out for mention - great PR

Next news will be the announcement from CEPI and then it'll be interesting to see whether Scancell apply.

Excellent and thanks for the heads up Wild

With reference to the comments on the Covidity delivery system, This job advert from October may give an indication of the system being developed - click on link to Job Description/Role Profile

'Support research staff and consortium towards development of nanoparticle formulation of Covid19 vaccines
? Support to test iterations of GET peptide system '

The position reports to Nottingham's James Dixon and is funded by UKRI as part of the Covidity project. James Dixon and his team have developed the GET peptide system. which targets Heparan sulphate - a sugar expressed on cell membranes with a cell penetrating peptide and delivers its cargo (in this case plasmid DNA) across the cell membrane and into the cell. Link to patent application is also below.

https://jobs.nottingham.ac.uk/Vacancy.aspx?id=31323&forced=2

https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2015092417&tab=PCTBIBLIO

There clearly is a growing awareness of the need for 2nd generation vaccines to combat possible future mutations. Interesting to see Austria and Denmark collaborating with Israel:-

'“We must therefore prepare for further mutations and should no longer be dependent only on the EU for the production of second-generation vaccines,” the conservative chancellor said in a statement on Tuesday.'

https://www.reuters.com/article/us-health-coronaviurs-vaccine-europe/austria-and-denmark-break-ranks-with-eu-to-produce-vaccines-with-israel-idUSKBN2AU11D

Max/Chester

I think they're just going by what's already been published by Scancell - the only official notification that they're going with SN15 was buried in the interims I think. Could be wrong, who knows but that would be my guess.

Crumbs - at the moment I'm not taking this as anything other than recognition of Scancell's vaccine by CEPI and as you've identified, it's a big deal. If anyone isn't sure worth checking out the names and institutions involved with CEPI. The following is nearly a year old but gives an idea of the the level CEPI are operating at. It's really quite something that they've singled out Scancell/UoN:-

'So today leaders came together at a virtual event, co-hosted by the World Health Organization, the President of France, the President of the European Commission, and the Bill & Melinda Gates Foundation. The event was joined by the UN Secretary General, the AU Commission Chairperson, the G20 President, heads of state of France, South Africa, Germany, Vietnam, Costa Rica, Italy, Rwanda, Norway, Spain, Malaysia and the UK (represented by the First Secretary of State).

Health leaders from the Coalition for Epidemic Preparedness Innovations (CEPI), GAVI-the Vaccine Alliance, the Global Fund, UNITAID, the Wellcome Trust, the International Red Cross and Red Crescent Movement (IFRC), the International Federation of Pharmaceutical Manufacturers (IFPMA), the Developing Countries Vaccine Manufacturers’ Network (DCVMN), and the International Generic and Biosimilar Medicines Association (IGBA) committed to come together, guided by a common vision of a planet protected from human suffering and the devastating social and economic consequences of COVID-19, to launch this groundbreaking collaboration. They are joined by two Special Envoys: Ngozi Okonjo-Iweala, Gavi Board Chair and Sir Andrew Witty, former CEO of GlaxoSmithKline.'

https://www.who.int/news/item/24-04-2020-global-leaders-unite-to-ensure-everyone-everywhere-can-access-new-vaccines-tests-and-treatments-for-covid-19

Great coverage here from CEPI for Scancell

'Instead of using the spike protein of the COVID-19 virus, which is prone to mutations, as the key target for coronavirus vaccines, researchers are assessing other parts of the virus that are known to be more stable.

For example, scientists at the University of Nottingham in the UK are working alongside pharmaceutical company Scancell and Nottingham Trent University to test its COVID-19 vaccine candidate, SN14, which targets both the spike protein as well as the nucleocapsid, or N-protein. By targeting this additional viral structure, which is far less likely to mutate, the vaccine if found safe and effective could work to protect people against COVID-19 irrespective of any mutations to the spike protein and, in theory, could work across other coronaviruses.'

https://cepi.net/news_cepi/going-universal-the-search-for-an-all-in-one-coronavirus-vaccine/