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Nice find - thanks for posting

cleanerworld-

Suggest you take a few minutes to look back at my posting history - it's all there on advfn, here and twitter. I am simply a long term private investor, no more and no less. I have no connection whatsoever to Scancell, Vulpes, Redmile, any other institution and most definitely not to CEPI, although I'll take that one as a great compliment as I hugely admire their work.

Cleanerworld - I'm still here watching from the sidelines.

In the past I have been one of those calling for better communication from Scancell. It's clear that Violindog's post represents the views of most here and I understand why. However, even though I'm probably in a minority of 1, I just don't agree. Preclinical development for any new Covid vaccine must be incredibly challenging now with almost every aspect rapidly changing and evolving. Plans will have to constantly be refined and changed to reflect this. Apart from the obvious changes which may be triggered by emerging variants and mutations, just designing and securing approval for clinical trials must be one of the biggest difficulties.

Whilst it's great that the UK has one of the most advanced vaccine programmes in the World, it makes life much harder for the clinical development of new vaccines. The Government has said that within a few short weeks every adult in the UK will have been vaccinated. This means the recruitment pool for new vaccines and those already in trials is rapidly shrinking but at the same time not enough is yet known about the virus and the immune response to use biomarkers as surrogate endpoints in trials. Also, placebo controlled trials will also become a thing of the past (ethics). It's so important to get the design of this trial right, not just for now but also to ensure the easiest and quickest potential route to market. For all we know they may well be in discussions with the MHRA right now.

Under the circumstances I think we should at least wait until published timescales have expired before applying pressure to the Board for updates etc. I don't think communication has been a strong point for Scancell but I would absolutely hate to see it become one of those bios issuing regular hype filled announcements simply to please retail investors. IMO that would simply undermine the credibility of the Company and its science.

enteleon

I agree with your comment regarding patient numbers and the MRx0518 /pembro trial, however the setting of the trial somewhat mitigates this risk. These patients have already developed resistance to PD-1 therapy and their cancer has progressed and the percentage who would be able to overcome this resistance when given a second round of treatment of anti PD-1 as a monotherapy is very low regardless of cancer type. It would be quite something if part B of the trial produces similar results to part 1. It would be different if this was a phase III but this is a phase I/II study and the objective is primarily safety and proof of concept to establish whether or not the drug warrants taking into a phase III, it has been designed in conjunction with Merck and will be powered to provide the data they require.

Just noticed that Joe Wiley has also been shortlisted for Chief Executive of the Year Award

Redx make the shortlist in a couple of catagories:-

Capital Market Transaction of the Year Award

Chief Executive of the Year Award

http://www.mediscience-event.co.uk/nominations-overview/

Amryt have been selected for the shortlist in the Breakthrough of the Year Award - stiff competition as BioNTech are also nominated and will no doubt sweep the board in a few catagories

http://www.mediscience-event.co.uk/nominations-overview/

welcome!!

Chester - I'm sure Scancell will issue an RNS when they receive clinical trial approval from the MHRA for both Covidity and Moditope.

Ray - yes exactly so - post rec.

I very much hope you're wrong and that Scancell aren't the company mentioned by N4P. Apart from the obvious risk of laying themselves open to accusations of cronyism, it would mean that the delivery system is a long way from being finalised.

We've also been told that 'Gene therapy scientists at the new University of Nottingham’s Biodiscovery Institute (BDI) are formulating the vaccine as peptide nanoparticles to be delivered efficiently with a simple injection.' If Scancell were to enter into a collaboration with N4P it would suggest that Nottingham's efforts have been unsuccessful. So whichever way you look at it, I wouldn't see it as a positive - unless you're an N4P shareholder of course:)

WTP/Violindog -

Not sure I agree, what news have we been given by the media that is new and worthy of an RNS? As far as I can see the situation remains the same - Covid trials will start asap this year.

New research here from John Van Geest Cancer Centre/Nottingham Trent into using Scancell's ImmunoBody DNA vax to target HAGE and WT1 antigens. Early research in mice only and worth noting that they're evaluating the vaccine in a prophylactic setting. Results look encouraging:-

'the combined HAGE/WT1 ImmunoBody® vaccine significantly delayed tumour growth in the B16/HHDII+/DR1+/HAGE+/WT1+ tumour model and prolonged mouse survival in the prophylactic setting in comparison to non-immunised control mice'

' This combination vaccine could be given to patients whose cancer expresses HAGE and WT1 in parallel with existing therapies in order to decrease the chance of disease progression and relapse.'

https://www.frontiersin.org/articles/10.3389/fonc.2021.636977/abstract

The other day someone (cc I think) posted a link to the CIMT Annual Meeting as LD was listed as a speaker. Not sure whether this has already been posted but in case it hasn't, abstracts have now been published and there are 3 from Scancell:-

1) Superior T cell responses from DNA vaccines encoding Fc-engineered antibody and Fc-fusion proteins through enhanced
intermolecular cooperativity -

The first research we have seen published (I think) re. the enhancement of ImmunoBody with Avidimab and covers both cancer and covid DNA vaccines. Conclusion is that 'vaccines containing the modified human IgG1 Fc region stimulate higher frequency and avidity T cell responses and superior anti-tumour responses compared to vaccines containing the unmodified Fc region'

2) Post translationally modified peptides containing homocitrulline can be an effective anti-tumour target for multiple HLA-types. -

Looks like further Modi2 research into immune responses to homocitrullinated epitopes by HLA typing with the conclusion that if epitopes are carefully selected then the right combination of epitopes can induce an immune response in most regardless of HLA type which of course means that Modi2 has the potential to cover the majority of the population.

3) Citrullinated epitopes identified on tumour MHC class II by peptide elution stimulate both regulatory and Th1 responses and require careful selection for optimal anti-tumour responses -

Moditope - demonstrating the importance of characterisation of the immune response of individual peptides, showing that some may have stronger responses when used individually than when combined with others hence the need for prior characterisation.

Click on 'abstracts' in the link below to download pdf

https://www.meeting.cimt.eu/program

Crumbs, sorry posts crossed. As you can see by the time difference, took me ages to post mine (interrupted by phone!)

Chelsea - no real changes to recruitment criteria and in total the trial will recruit 25 patients. The first 6 will form a safety run in cohort and I guess it's likely that we'll get an RNS for 1st patient dosed and then another update when that cohort has been dosed and they are allowed to expand the trial to recruit the remaining patients.

Ivy - yes a couple of months slippage isn't bad at all given that recruitment has been on hold for so long - all made possible of course by the reduction in the SCIB1 treatment period.

Konar - assume that Dr Miller will now be the contact point for all of Scancell's clinical trials.

Konar,

Well spotted and thanks for posting.

Also note that Scancell's new Medical Director, Dr Robert Miller has replaced Sally Adams as the central contact person for the trial. Good to finally see some signs of life with this study and hopefully first patient dosed RNS will follow in the not too distant future.

Chelsea,

The agreement between Sanofi and Modrena is simply to assist with manufacture to boost supplies, not to develop a new vaccine. Sanofi will be using their manufacturing plant in New Jersey to fill and finish 200 million doses of Moderna’s COVID-19 vaccine. They're also manufacturing 125 million doses of the BioNTech/Pfizer vax and 12 million doses per month of the J & J vax. They may not have managed to develop their own vaccine but great to see them offering their production capacity to others to help where they can.

Just also wanted to point out that the SCIB1 combination study has specific reasons why recruitment is likely to be slow - only patients who are receiving their first ever treatment for advanced melanoma, who are being prescribed Keytruda as SOC (which probably excluded all the BRAF positive patients) , who are the correct HLA type - and that's before you even get to the rest of the inclusion/exclusion criteria. The situation with Covidity phase I is entirely different - they just need to sign up healthy patients and provided Scancell crack on, it's hard to see how/why there should be any problems with recruitment. So it's really not fair to predict recruitment issues for Covidity based on the SCIB1 combo trial.

ERGO has been a cracking stock to hold and seemingly completely under the radar which is an added bonus!

Prof. Jonathan Van-Tam gave a special lecture to University of Nottingham tonight - link below if anyone is interested.

https://mediaspace.nottingham.ac.uk/media/Professor+Jonathan+Van-Tam+guest+lecture+-+April+2021/1_dpac1vv8

Correct, this study has been designed to verify the performance of the optimised version of Angle's ovarian cancer detection assay and if successful, the assay will be offered directly by Angles labs. Worth noting one of the improvements made was the ability to allow for patient blood sample processing for up to 96 hours after collection without significantly compromising the assay sensitivity. This makes it ideally suited for a centralised lab test - allowing plenty of time for transport without comprimising on sensitivity.

It was interesting this morning to see that Angle are already looking beyond using the assay for initial diagnosis and suggesting the possibility of regularly repeating assays to monitor patients:-

'With validation, there is also the potential for use of the ovarian cancer test to extend beyond the initial intended use of pelvic mass surgery triage to include conservative management (watchful waiting) to avoid a surgery for pelvic mass where malignancy is not suspected, monitoring of ovarian cancer patients after treatment, and molecular evaluation of the tumour to aid in drug selection'