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Bob

That's not quite right. iSCIB1+ doesn't extend the patent life of the CPIs.

Chester,

IMO the most important near term news is that recruitment to the SCIB1 clinical trial is complete and top line results for stage 2 of the SCIB1 study are as good as stage 1.

Bojo,

I agree.

Anyone with even the most basic level of research here will know that the whole liquid biopsy field is an emerging market at the cutting edge of science. The eventual size and value of that market depends entirely on the information CTCs are able to provide and whether or not it is clinically useful. The only way to establish that is through development of assays and processes to enable that information to be extracted.

As you know, following a huge amount of intensive r&d work, Angle have created and recently launched an immunofluorescence staining kit and HER2 assay. Remembering that every single breast cancer patient should have HER2 testing it makes absolute commercial sense as part of the launch to present at such a high profile conference. You only have to look at the international press coverage over the last couple of days to appreciate the attention this conference is attracting not least due to some big phase 3 read outs including Merck's Keynote 756 and Roche's IMpassion030 trials.

So we have new products being launched to top experts and big pharma at a conference being closely watched by industry media. Let's give credit where credit it due and welcome this for the positive step that it is.

Hadley,

I think it may have been Keytruda rather than Yervoy. Updated results from Merck's Keynote 756 trial were presented yesterday at the European Breast Cancer Conference in Milan. The trial is investigating Pembrolizumab (Keytruda) in combination with chemo in the neoadjuvant (before surgery) and adjuvant (after surgery) setting in early breast cancer. The study is showing that Keytruda may benefit a much wider group of patients - good news for Merck and other anti PD-1 developers and excellent news for patients.

https://event.eortc.org/ebcc14/2024/03/20/ebcc-14-news-new-data-show-pembrolizumab-improves-breast-cancer-outcomes-regardless-of-age-or-menopausal-status/

Konar,

Agreed, Sally Adams is the most likely candidate although you'd have thought she'd have exercised her 8.5p options rather than 10p. I'm assuming it's been rounded to 10p on the form but refers to the 10.5p options because as far as I know Scancell have never issued any options with an exercise price of 10p to any directors although I guess they could have issued them to other key staff or suppliers/collaborators/partners.

Haven't been able to keep up with the bb recently and I suspect this has already been posted, but I was researching another stock today and came across the Immuno-Oncology Summit taking place in London on 24th and 25th April. This is from the agenda:-

'Clinical Update on the DC Targeting Melanoma Vaccine, SCIB1 and The Modi-1 Vaccine Targeting Citrullination

Lindy Durrant, BSc, PhD, Professor, CEO, Scancell Ltd.

SCIB1 a DC targeting DNA vaccine gives at impressive 85% response rate in combination with ipilimumab and nivolumab in advanced melanoma. Citrullination occurs in stressed tumor cells and makes an excellent target for a universal cancer vaccine. Modi-1 targeting citrullination is currently in phase II clinical trial'

It's interesting that this follows hot on the heels of AACR where Lindy will be presenting SCIB1 results but neither conference featured on the recent RNS. I assume we'll be getting another RNS in due course outlining any conferences Lindy is attending and look forward to seeing whether that also includes ASCO.

https://www.immuno-oncologyeurope.com/cancer-vaccines#

Konar,

I believe Keith Flaherty has moved onwards and upwards and he's no longer actively involved as investigator in clinical trials but think it's highly likely that Scancell would like Mass General too be one of the study centres for the phase II/III. It will be interesting to see whether they're able to get any big US names involved.

Konar,

I hadn't picked up that Lindy was making an oral presentation at AACR so thanks for that.

The Keith Flaherty link is interesting and highlights how impressive it was that Scancell were able to attract an expert of such calibre in the first place. We'll never know whether he had any input into the selection of the SCIB1 results for presentation. It may simply be the case that cancer vaccines are now attracting a huge amount of interest and there actually aren't that many around so any reporting clinical results are likely to be selected.

This is a significant moment for Scancell. Reporting of phase 2 clinical trial results is an important milestone for any biotech/pharma and Scancell has had to battle to develop SCIB1 against a backdrop of lack of interest and scepticism towards cancer vaccines from industry and investors alike. It's good to see Lindy Durrant being given the opportunity to present those results at one of the biggest scientific confences in the World and at a time when there is renewed hope and interest surrounding the whole field. She deserves this moment and I hope she enjoys every second.

Miavoce,

Scancell have said that recruitment to the SCIB1 arm of the Scope trial should be complete in Q1 and the title of the AACR presentation does seem to suggest that they'll be presenting results from the study although I guess they won't include scans from some of the later patients.

'A DNA plasmid melanoma cancer vaccine, SCIB1, combined with nivolumab + ipilimumab in patients with advanced unresectable melanoma: Efficacy and safety results from the open-label Phase 2 SCOPE Trial'

In terms of an RNS, I'm sure Scancell will be keen to close the SCIB1 arm to recruitment and move swiftly to iSCIB1+ as it may be problematical to recruit to SCIB1 when what is believed to be an improved version of the vaccine is also recruiting. Much cleaner and neater if there is no choice to make for the investigators. So I hope/expect that in the near term we'll at least get an RNS to announce SCIB1 is fully recruited and possibly an update on results at the same time.

Ray - good point and of course also worth remembering that Scancell took the strategic decision to bring formulation work /manufacturing process development in-house.

Scancell have told us that they intend to follow the current trial with a phase 2/3 for iSCIB1+ and that they'll run it in the US and UK which means they need to apply for clinical trial approval to both the MHRA and FDA. Those applications will require comprehensive CMC data packages and it may be that Scancell are planning ahead and getting the right resources in place in advance. Howver, even with the current trials there is an ongoing requirement for oversight and controls of CMC processes and the need to make submissions to the regulators if there are any manufacturing changes.

It looks like this new recruit is going to be busy.

Worth doing a bit of research into Lisa Anson's background if you're going to make judgement calls about her remuneration package. She has a wealth of commercial experience in the sector including as President of AstraZeneca UK. She is also ex-president of the Association of the British Pharmaceutical Industry and a current board member of the Bio-Industry Association. She's about as well connected as you can get and it was a coup for Redx when they managed to persuade her to leave AstraZeneca to rebuild the company.

Finding and retaining top quality CEOs is a real issue for the UK biotech sector and I believe Lisa is arguably the best or one of the very best on AIM. She would have been instrumental in attracting the blue chip life sciences specialist funds to Redx and her remuneration package would be average in the US. I hope it's sufficient to retain her services.

Nomadme,

Bios attend and present at both scientific and investor conferences all the time, but when it comes to scientific conferences there are 3 major conferences that are the holy grail when it comes to presenting cancer research and they are the AACR (American Association for Cancer Research), ASCO (American Society of Clinical Oncology) and ESMO (European Society for Medical Oncology) annual meetings.

These conferences have tens of thousands of attendees from all over the world and attract the best experts presenting the best and most exciting research. If you want your research or trial results to reach the biggest possible audience of industry insiders and fellow scientists then there is no better place to do it.

It seems that progress has been made with the Angle/BioView collaboration on the HER2 assay. They are presenting a joint poster at AACR in April which details prgress. Title as follows:-

'3705 / 17 - Development and analytical validation of a novel assay for HER2 assessment on circulating tumor cells using Parsortix® isolation and BioView imaging technologies'

From the conclusion:-

' An assay integrating HER2 identification by IF and FISH to characterize CTCs in metastatic BC patients was successfully developed. The assay enables the identification of both HER2 protein and gene copy information from each target cell with minimal cell loss, with the potential for minimally invasive patient monitoring during treatment and better classification of patients who may qualify and benefit from HER2-targeted therapies. An added value of the assay is the practicality of utilizing preserved blood samples, allowing streamline batch shipping of clinical samples'

https://www.abstractsonline.com/pp8/#!/20272/presentation/1909

I don't know why Scancell haven't issued an RNS this morning as others have done, but looks like they're presenting a poster at AACR in San Diego in April. Lindy Durrant is down to present in the 'Cancer Vaccines: Ready for Prime Time?' session and seems that we'll be getting the SCIB1 results.

'CT024 - A DNA plasmid melanoma cancer vaccine, SCIB1, combined with nivolumab + ipilimumab in patients with advanced unresectable melanoma: Efficacy and safety results from the open-label Phase 2 SCOPE Trial'

https://www.abstractsonline.com/pp8/#!/20272/session/663

Just for clarity, the decision as to whether the loan notes are repaid in cash or with stock is completely down to Redmile - Scancell have no say in the matter and we should expect the CLNs to be converted. It's likely that Redmile would seek either a partial or full exit at the same time. The last sentence is obviously just IMO.

...............but their pipeline is

Dracula,

With respect I think you need to be a bit careul about reading these headline grabbing links without any explanation of the context and relevance (or otherwise!) to Scancell. Amtagvi is not the new kid on the block turbo charged therapy leaving others behind as you seem to think - far from it. TIL therapy has literally been in development for decades yet Amtagvi has only just become the first FDA approved therapy. The decision from the FDA was based on a trial which commenced in 2015 and iis also in a completely different setting to SCIB1. So I'm not sure what judgement calls you can make about Scancell based on that link, but if anything the it simply confirms that Scancell is by no means unique - drug development takes a long time!

TF

Why nonsense?

Redx has now clearly demonstrated it's ability to create small molecules that are successful and commercially attractive with a string of licensing deals and the creation of FDA approved Pirtobrutinib which is being marketed by Lilly. Arguably their ROCK inhibitors are the most exciting products to come out of their labs with real potential to become best in class and first in class assets. If you're long here then it's very much worth reading up on the preclinical research. RXC008 has been tested in multiple animal models with cracking results. If those results are replicated in humans then for the first time a drug could not only halt but also reverse the formation of fibrotic tissues and prevent the need for surgery. Should stress that it's very early days and as with any drug, the earlier the stage of development the higher the risk. Nevertheless RXC007/8 are the reasons I remain long here.

Worth noting that Panmure have increased their target price from 125p to 130p and Trinity Delta from 94p to 99p.

https://www.thebusinessdesk.com/northwest/news/2129388-brokers-back-pharma-companys-game-changing-new-treatment-trials

Desouzaa -

I'm not sure whether that was actually a rhetorical question , but in case it wasn't, no the patients aren't the same. The lovance trial was run in a different setting to the SCIB1 trial and so it's not possible to compare the results. The SCIB1 study is in patients being treated with the Opdivo/Yervoy combination as a first line therapy and the patients haven't received any previous treatments for advanced melanoma. The lovance trial is in patients who have previously been treated with anti PD-1/targeted therapy but have still progressed. I think I read somewhere that on average the lovance patients had already undergone and failed on 3 prior lines of treatment and so really were out of all options.

It's makes a big difference when looking at results. With Scancell's trial we know that around 40% to 50% of patients will respond to the checkpoint inhibitors alone and the aim is to improve that response rate to at least 70% by adding SCIB1. So far the results have been fabulous and they are comfortably exceeding that target. However, given that the lovance trial is in a tougher setting and that patients have already failed on PD-1 therapy, a 31% response rate is also impressive.

Worth noting that lovance have received accelerated approval from the FDA and need to back up the results with a confirmatory trial which I think is ongoing. It will be interesting to see if that trial produces good enough results to maintain the marketing approval. Also and in the meantime how well lovance are able to commercialise Amtagvi and how it performs in the real world setting, especially in terms of safety.