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TF

In response to your 12.33 and in particular this line:-

'Sorry Bermuda 10.31 - what was this ? . . . . 'the success of the world leading Covid Recovery trial and genomics consortium during covid'.

I'm surprised that you have an issue with this. There were many mistakes made during Covid, some obvious at the time and some only obvious with the benefit of hindsight but the Recovery trial and genomic sequencing were 2 areas in which the UK excelled. Both were much admired and praised by other nations and are examples of what the UK's scientists and NHS can achieve.

During the pandemic, the UK was responsible for over half of the global sequencing data uploaded to GISAID which was open-access meaning it was freely shared with scientists across the world alterting them to new strains and facilitating research to further the internatioinal fight against the disease. See the link below. Something to be proud of - no?

The Recovery trial was the result of a mammoth effort across the NHS. It was an incredible success and ultimately may be practice changing when it comes to national and international responses to future pandemics. If you are in any doubt whatsoever, please read the write-up from Gavi below.

Ivy's post nicely sums up the response to the rest of your post.

I sense some indignation in your reply and would ask you to have another read of my post. I made my opinion of the BioNTech deal clear when it was announced back in Jan (from memory) and you shouldn't assume that I agree with the UK supporting overseas companies, but I certainly can understand the rationale behind it.

https://www.wsj.com/articles/how-the-u-k-became-world-leader-in-sequencing-the-coronavirusgenome-11612011601

https://www.gavi.org/vaccineswork/inside-story-recovery-how-worlds-largest-covid-19-trial-transformed-treatment-and

Corr. establishment

Violindog,

An alternative view might be that it was the UK Government and establishement who were courting big pharma with incentives to build upon the success of the world leading Covid Recovery trial and genomics consortium during covid. The deal was brokered during Boris Johnson's tenure, indeed Boris hosted a breakfast meeting for the BioNTech team at Number 10 and you may remember the photos which suggest that BioNTech were very much the ones being courted.

I'm sure that the Government's scientific advisors believe in the potential of these vaccines and if they work, we will all benefit and their decision to back such early stage tech. will be vindicated. However, perhaps their decision was as much about waving a very clear 'open for business' flag to the rest of the world in a post brexit era - an attempt to 'showcase' the UK and NHS as a centre for drug development and clinical trials by attracting arguably one of the most successful life sciences companies in Europe and indeed the world. Would backing of a UK company have had the same impact? Sadly I doubt it.

Burble,

Thanks for the response and it will be interesting to see whether Scancell do ever decide to revisit those other PTMs.

Burble,

Interesting. So now I'm confused as to how the scope of a patent - ie. the IP protected can go beyond the claims that have been granted?

Just to clarify, in discussions yesterday there was a suggestion that post translational modifications other than citrullination were protected by the Moditope patent. This is because when Scancell first applied for the patent back in 2012/3 the first claim included additional PTMs, although the supporting evidence was limited to citrullination. I believe Lindy Durrant said at the time that as is common practice, they included other PTMs but expected them to be knocked back by the examiner.

If we take the European patent as an example, following initial examination back in 2015, as expected claims 1 and 2 were rejected by the examiner as there was insufficient supporting evidence in the description to allow the examiner to form any opinion at all. In response Scancell withdrew the claims for all PTMs other than citrullination. Kilburn and Strode confirmed that modifications of 'nitration of tyrosine, oxidation of tryptophan and deamination of glutamine or asparagine' had been deleted and claims 1 and 2 were restricted to citrullination and resubmitted. These were the claims that were finally granted.

I understood that the PTMs of nitration of tyrosine, oxidation of tryptophan and deamination of glutamine or asparagine which were deleted don't form part of Scancell's IP. Is this not the case?

Wild,

My previous post seems to have lost all capital letters - sorry about that!

Yes Moditope has a broad coverage for citrullination. I think there are still some additional/continuation/divisional applications undergoing examination in some regions. The granted patents are all available to view online and it's the claims granted at the end of the whole examination process that define the scope of the patent, not what's in the description or the claims at outset - at least that's my understanding.

It's a highly complex area and worth checking directly with Scancell to be sure.

wild/crumbs,

thanks for the links.

should probably clarify that other than citrullination, the other post translational modifications listed in your 10.01 wild aren't covered by the granted patent. scancell submitted the application with a substantial body of research supporting the citrullination claim and knowing that the other ptms were likely to be dropped during examination and that's exactly what happened. of course since then they have submitted additional patent applications to cover ****citrullination (modi2) and citrullinated cytokeratin and nucleophosmin peptides.

the section on post translational modifications in the link from crumbs starts with and covers the ptm of glycosylation in some detail. whilst this isn't a target for moditope, it's worth remembering that scancell's pipeline has a whole platform with glymab and its anti-glycan mabs based on exploiting this ptm.

Crumbs,

Correct, there will be 2 cohorts of head & neck cancer patients who have resectable disease and haven't yet received any other treatments. They'll be given Modi-1 as a neoadjuvant therapy with one cohort receiving Modi-1 as a monotherapy and the second in combination with a checkpoint inhibitor for 6 weeks prior to surgery to have their tumours removed. They won't open these cohorts to recruitment until the high dose combination safety cohort (cohort 4) is complete and approval is given to expand the combination arms of the trial.

Chester,

Making the transition from academia to a commercial enterprise must be a huge culture shock. Not so bad perhaps for a small privately held company with a handful of committed investors, but running a publicly traded company is a different ball game entirely and I'm sure there's a very steep learning curve, particularly on the regulatory, financial and IR fronts.

Of course Lindy Durrant made that transition years ago and the reason I posted the link was really because I think her comments are important and go beyond Scancell. Apologies for getting on my soapbox, but the UK in one of the most innovative countries in the world and yet is poor when it comes to commercialisation. We really have to do better. Part of it is down to funding, but it's also making sure the right support is given to help academics adjust to the corporate world to give them the very best chance of success.

Not sure whether this has already been posted, but link below gives details on a new investment fund being set up to help fund spin outs from universities in the Midlands. Lindy Durrant's comments are interesting and spot on IMO:-

'“[Mindforge] also needs to provide intellectual support for the businesses to enable them to understand the nuances of running a business in comparison to working in academia,” says Lindy Durrant, the CEO of Scancell'

https://www.fdiintelligence.com/content/feature/uk-midlands-universities-to-boost-spinouts-with-investment-vehicle-82560

Douve

Whilst there is no doubt that NASDAQ provides access to a much deeper pool of capital, it won't necessarily result in greater publicity - there are hundreds of NASDAQ bios competing for attention. Scancell have dangled the NASDAQ carrot before, but I'm not sure it's the panacea for all the evils of AIM that many seem to think. A NASDAQ listing will be expensive and take up a great deal of management time and focus on an ongoing basis. They'll need resources with the appropriate skills set in place before they can even begin to contemplate it and even then the market conditions will have to be right.

Who knows? Perhaps the appointment of a CFO is the first step and the quality and location of whoever they appoint may give some clues. However,I think there's quite a way to go yet in terms of resourcing, growth of the company and development of the pipeline before the time is right. Obviously just IMO.

Cc24601 thanks for the link to the Observer article and crumbs thanks for the LGB & Co link - well spotted both!

Thank goodness they are finally strengthening the support around Lindy Durrant by bringing in a business development officer and CFO - both much needed IMO. I'm intrigued by the comment from Jean-Michel Cossery that recruitment of the BDO 'has not been a straightforward hire'. Anyone have any suggestions as to why that could be and do we think they will both be UK based?

Konar,

I think perhaps more of an issue for recruitment to the combination arm is that patients receiving checkpoint inhibitors as standard of care therapy may well already be receiving it in combination with other treatments which would rule them out for the Modi-1 trial. So for example with triple negative breast cancer Keytruda is approved as a SOC treatment in combiation with chemo, with renal cell carcinoma it's approved in combination with lenvatinib (tyrosine kinase inhibitor). So presumably the recruitment pool is limited to those patients who for whatever reason aren't suitable for or have already failed on those combinations.

Botski,

Well spotted.

I don't think we have officially been told that the trial is fully recruited for the ovarian cancer. As you know, Modi-1 is only being tested in the monotherapy setting for Ovarian cancer and the intention is to recruit 16 patients to the expansion phase. As at February (last update) they had already recruited and dosed 11, so it's possible, even likely perhaps that recruitment to this arm of the trial is complete.

Lofas -

Re. your comment 'We also know that trial is sold out, 168 patients across the four cohort'

I don't think that's quite right. As far as we know they are recruiting to the expansion monotherapy cohorts and are still recruiting/dosing the second safety cohort in the combination study. They will then seek approval from the SRB to open up the combination expansion cohorts and the neoadjuvant study.

Good to see George Freeman, Minister for Science, Technology & Innovation is also at Bio 2023 in Boston where he's banging the drum for UK biotech. One of the few ministers with real world relevant and direct experience outside of politics having spent 15 years working in biotech and I think his enthusiasm for the sector comes across.

https://twitter.com/IAmBiotech/status/1666880270455144463

Crumbs,

Yes, completely agree and we're back to the old UK versus US funding issue.

Crumbs,

Re. your earlier post, I think the UK has probably done more for Scancell than we realise. Scancell has operated during both labour and conservative periods of government so this isn't a party political point, but listed below are some of the ways Scancell has benefited.

1) Many of Scancell's products were created at the University of Nottingham and therefore through research funded by the UK taxpayer.

2) UoN facilitated and supported LD in the spin out of Scancell and also provided investment. They are still shareholders today - support and investment funded by taxpayer

3) Scancell's products have been developed with the help of several million £s in grant funding - again funded by the taxpayer

4) Tax credits received to date are now approaching £10m. Last year alone they were £1.7m

5) Government funded bodies such as NIHR are working hard to promote and improve the UK clinical trials landscape - worth a read of the 'Improving efficiency of research set up' section in the link below to see what improvements have already been introduced leading to direct benefit for companies such as Scancell.

I could go on, but you get the drift. Of course as a Scancell shareholder I'd like more, but as a taxpayer, I'm not so sure.

https://www.nihr.ac.uk/news/nihr-welcomes-oshaughnessy-review-into-commercial-clinical-trials/33554

Violindog

Correct - he's recruited his first patient to the kidney cancer combination arm of the Modi1 trial. This means that patient has signed consent form and now undergoes screening. If they clear screening they'll either be dosed as part of cohort 4 or potentially even the combination expansion study.

Not sure whether this has already been posted, but looks like Scancell are attending Bio 2023 in Boston next week - apparently the World's largest biotech/pharma partnering event.

https://www.bio.org/events/bio-international-convention