Charles Jillings, CEO of Utilico, energized by strong economic momentum across Latin America. Watch the video here.
Crumbs - all I know is that some people blame coral reefs for the hundreds of shipwrecks surrounding the shores of Bermuda but it's very easy to convince others that mysterious forces are at play. I'd go along with the straightforward simple explanation - coral is very sharp. Either way it makes for great diving.
Crumbs,
From memory CI's are approved in TNBC but in combination with chemo which of course would exclude a patient from the Modi-1 trial - so that may be it.
Crumbs,
See slide 12 from AGM presentaion, just a few months ago. The intention was certainly there and now we're not sure and we don't know why. To be honest I'm more interested in the neoadjuvant study and what's happening there as well as Modi2. As you say, it could be that they are streamlining to conserve cash and if that's the case then Lindy and her team will have chosen to develop the parts of the pipeline with the best/quickest chance of success and we obviously have to accept that.
Nevertheless, we have just received initial results from the first fully recruited arm of the Modi-1 trial. This could/should (?) have been a major inflection point, but actually the message is 'still encouraging but we now need further studies'. They can't even apply to run those studies until they have data from the combination arms of the current trial and they don't yet have approval to open those arms to recruitment.
As you can tell, I'm a little disappointed and have reduced my holding. Timelines have potentially extended yet again and it seems that Scancell's strategy going forwards is to carry out phase III registration studies and apply for marketing approval themselves. A massive commitment and I hope they are able to partner beforehand.
I will keep a much smaller core holding and can honestly say that I would be more than delighted to have called this wrong and to find myself having to buy back the stock at a higher price if good news lands.
https://scancell.co.uk/Data/Sites/1/media/docspres/agm-presentationnovember-2022_final.pdf
https://scancell.co.uk/Data/Sites/1/media/docspres/agm-presentationnovember-2022_final.pdf
Crumbs/Violindog,
The original intention (according to the published trial design) was to expand the combination arm of the study to recruit 21 patients for each tumour type - head and neck, renal and breast cancer. The intention to run a combination cohort for TNBC was confirmed in the AGM presentation so this has come directly from Scancell and CI's have been approved in TNBC (albeit in combo as with renal cancer I think) However according to the RNS yesterday they are only expanding in head and neck and renal cancer patients. There is no mention of a combination arm in breast cancer and no explanation as to why. Nor is there any mention of the neoadjuvant study in head and neck. It may be the RNS was incorrect and they simply forgot to mention TNBC (highly unlikely), it could be that due to SOC issues with the CI that it would be difficult to recruit or they may intend to run these arms at a later date - who knows? ...........and I think that's the point, we don't know hence my comment last night about raising more questions than answers.
Matt,
Agreed - as often is the case, the RNS seems to raise as many questions as it answers. Very pleased to see that Lindy possibly will be doing an Investor Meet presentation and hopefully we'll be given the chance to ask some of those questions.
Green453,
In answer to your 8.06 - yes Nivolumab is Bristol Myer's PD-1 inhibitor Opdivo. Both Keytruda and Nivolumab are approved as standard of care therapies for advanced melanoma and so both are included as combination CI's for the SCIB1 trial. Otherwise recruitment would be restricted to those patients being prescribed Keytruda. I think it's as simple as that.
Interesting that according to the RNS, the combination study is being expanded in head and neck and renal cancers but no mention of TNBC. Perhaps due to labelling for checkpoint inhibitors in this type of cancer or maybe it will be added later?
Below is a link to a peer reviewed research paper from scientists at the FDA which was published yesterday. The paper reviews the most promising glycan targeting immunotherapies and Scancell's research featuring the SC129 glycan mAb is cited in the paper. This is the mAb that has been licensed by Genmab and I have also added a link to the cited paper.
The review is long and probably beyond most of us here with the exception of Burble but well worth at least a read of the intro and conclusion. This in particular:-
'As the glycoimmunology continues to evolve, our better understanding of the process, presentation of the carbohydrate antigens on immune cells, and their responses to the TACAs (especially the engagement of T cells) will lead to better designs of TACA immunogens which will not only elicit more specific mAbs with higher affinity for applications of mAb therapy and CART therapy, but also develop more effective anti-cancer glyco-vaccines. Thus, the TACA-targeted immunotherapy is expected to evolve as one of the effective anti-cancer regimens in the treatment of solid tumors in a new era.'
Finally, in light of discussions yesterday, worth noting that the SC129 research from Scancell was actually government funded via a grant from the Medical Research Council.
https://www.mdpi.com/2072-6694/15/14/3536#B179-cancers-15-03536
https://aacrjournals.org/mct/article/19/3/790/92797/Monoclonal-Antibody-Targeting-Sialyl-di-Lewisa
'
TF
Well as a Scancell shareholder I'd agree with you although of course Scancell has had support over the years. The discovery of much of its IP funded by the state and it has received millions of £s in grant funding and R&D tax credits. So, whilst we'd be happy with extra support for Scancell, as taxpayers would we be happy with the same level of support for other bios? I'm not so sure - the cash has to come from somewhere.
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?