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Vascular,

In order to get regulatory approval they'll need to provide really comprehensive CMC (Chemistry, Manufacturing, and Controls) data to the FDA/EMA/MHRA. If you're interested it's worth reading up on this, if nothing else it helps to appreciate the sheer volume of work required for these regulatory submissions. The CMC section of any IND or CTA application will include every aspect of the drug manufacture, from the substance itself to all other inputs, the manufacturing process, reproducibility, stability and quality control testing all the way through to storage and shipping.

Applications for clinical trial approval for Phase 3 trials require more data and information than earlier stages and also evidence that the manufacturing process is fully developed and 'the same or highly representative of the one intended for the final marketed product'. There's clearly been a great deal of work going on in the background at Scancell to prepare for the phase 3 trial and as Johnny has posted below, the manufacture and release of a commercial scale batch of iSCIB1+ is part and parcel of this.

Others here or elsewhere will know better, but I assume that 'released' means released to Scancell and the batch is currently being stored. As far as I know, Scancell haven't yet selected or signed contracts with a CRO or any clinical trial sites for the phase 3, indeed the design won't even be finalised until they have their pre IND meetings with the FDA. They can't ship supplies to the US anyway until the IND is cleared but I can't imagine they'd be able to send any supplies until contracts are signed and clear instructions re. storage etc. are agreed.

Billy,

Thanks for posting the link - a long but excellent article and very much worth spending the time to read the whole thing. Although I had appreciated the need (and risk) around selecting the right neoantigens for these personalised vaccines, it hadn't crossed my mind that the more a cancer type mutates the harder it is to do this and that actually it may be the 'cold' tumours with few mutations that are the most responsive to personalised vaccines. Of course it's not just selecting the right antigens at the time of the tissue biopsy, it's selecting those that are likely to continue to be expressed. No point in creating a vaccine targeting certain antigens if the tumour has stopped expressing those antigens.

Also interesting to read about the process from the time the tissue biopsy is taken - so many steps and processes to go through before the vaccine can even be created. Although I'm sure over the coming years the process will be streamlined, it still means that access to personalied vaccines is likely to be limited to healthcare systems and countries that can afford them and have the infrastructure and skills to support them.

Finally a little glimpse of the impact of RFK on cancer research and the FDA and all the while the US is becoming ever more dependent on China for vital supplies and the chinese biotech/pharma sector is going from strength to strength.

127tolmers,

Thanks for the link to the latest Trinity Delta report.

A few points really stood out when reading the report. This is 'research' that has been paid for by Scancell and is aimed at retail investors which means that we are reading the message Scancell wants to get across. Someone posted a link to a podcast with Phil L'Huillier the other day and it struck me how he avoided using the term ' vaccine' when describing Scancell's products. The TD report IMO confirmed that they are actively distancing themselves from having their platforms pigeonholed as just cancer vaccines and are now just using the term immunotherapies. A very sensible move IMO.

The other point was that it's great to finally have the SCOPE study results clarified in a way that allows you to understand where we are and what we need to see from forthcoming results. The only patients excluded from cohort 1 appear to be screening errors (brain mets & acral melanoma) with 43 patients treated and 41 reported on. I believe Checkmate 067 also excluded 1 patient due to a screening error and this seems perfectly reasonable as inclusion of patients who don't meet the recruitment criteria would completely skew results. So we see that that ipi/nivo alone in the checkmate 067 trial produced a median progression free survival figure of 11.5 months but at 23 months the SCIB1 cohort still had not reached median PFS. Cohort 3 excluded certain HLA types and we now need to see that cohort 4 results confirm and support the HLA typing in terms of responders/non-responders.

Finally, Trinity Delta are including potential Genmab revenue in their Glymab Therapeutics valuation so assume the decision has been taken to move those licensing deals across to the new company.

Burble,

I can only imagine how frustating it must be.

Johnny,

Another good spot!

AFAIK it's not unusual for study investigators to present results of trials they're involved in, nevertheless it's good to see, especially when that investigator is from the top cancer centre is the UK and one of the top globally. A reminder of the title of the abstract:-

'A DNA plasmid melanoma cancer vaccine, SCIB1 and iSCIB1+ combined with nivolumab and ipilimumab in advanced unresectable melanoma induces potent clinically meaningful CD8 T cell responses in 80% of the patient population'

https://www.royalmarsden.nhs.uk/our-consultants-units-and-wards/consultant-directory/dr-kate-young

Violindog,

Honestly I'm sure the whole Scancell team are working flat out to move iSCIB1+ on as quickly as possible and I don't think lack of focus will be an issue. Sadly uncertainty around funding goes with the territory and is almost ever present in biotech. It's an issue that is there and will be discussed regardless of Glymab Therapeutics. We are emerging from one of the, if not the worse biotech bear markets in history which affected US, European and UK companies alike. Then you have the problem that the UK seems incapable of supporting home grown innovation to scale up but that's another soapbox for another time.

Dracula,

Well just prior to joining Scancell, Phil L'Huillier closed a $150m round of funding for his previous company so he certainly has the experience and the contacts but I don't think Scancell would contemplate trying to raise that level of cash at this stage. I think they'd more likely raise enough to reach certain goals and look again when sentiment and market conditions have improved.

We don't yet know the intentions re. funding of Glymab Therapeutics. If they raise funds via GT then you'd assume that would cover the costs of taking SC134 into the clinic and they'd also transfer across other costs (staff, share of lab/office space etc). That of course would reduce the funding burden on Scancell, so much depends on the strategy with GT and any other subsidiaries they may set up.

Johnny,

Well spotted. Link to conference website is below - looks like Scancell are presenting a poster:-

265P - A DNA plasmid melanoma cancer vaccine, SCIB1 and iSCIB1+ combined with nivolumab and ipilimumab in advanced unresectable melanoma induces potent clinically meaningful CD8 T cell responses in 80% of the patient population

Lecture Time

17:15 - 17:15

Speakers

Kate Young (London, United Kingdom)

https://www.esmo.org/meeting-calendar/esmo-immuno-oncology-congress-2025/programme

Dracula,

What do you classify as 'handily'? Not sure whether you mean via funding or a deal?

Botski - Sorry I should have been clearer. I don't think for one second that Scancell will be attempting to fund two phase 3 studies. You asked me whether I thought the mention of the neoadjuvant study in the abstract signified that a deal had already been agreed and I don't think it necessarily does. More likely IMO is that they'll want to get iSCIB1+ (wish Scancell would change the name btw) truly phase 3 ready including confidence from discussions with the FDA that the trial designs will be adequate for marketing approval (subject to results of course). That's the time to open serious discussions with potential partners, collaborators and investors. Others will clearly believe that a massive deal is already done and dusted.

Bibio - sorry have only just noticed your earlier post. Agreed that is a possibilty as is taking it a stage further and going for an outright sale. It would certainly give Redmile their exit and make more sense of the movement of IP to new companies.

Johnny thanks for that - always good to be able to visualise something. I remember the first time I saw a photo of a poster hall . I think it was from ASCO and I'm not sure what I had imagined it to be like but it was certainly nothing like the reality. As posted previously, Scancell have done really well to get this slot.

Van Van - you'd hope at the very least Scancell will take a photo and not only post it to linkedin but also make some use of their twitter account. Worth checking out #SITC25 on twitter to get a feel for the event.

Botski,

I'd like to listen to your AGM recording again and wish Scancell would upload the slides to their website. In September Scancell said that a randomised phase 3 in the advanced unresectable setting was 'planned development subject to financing' and that the neoadjuvant phase 3 was an 'additional opportunity'. It's hard to tell whether the short conclusion in the word limited abstract means that they have now taken the strategic decision to go ahead and have found a partner/funding or whether it simply means that is the next developmental step.

It makes absolute sense to target the neoadjuvant market, not just because it's bigger, but it's also growing rapidly and being hotly contested as we speak. It's a market that is still very much up for grabs. Last month at ESMO, Bristol-Myers presented 2 year follow up data from their ongoing Nadina trial in which they're comparing neoadjuvant combination of ipi plus nivo (same as SCOPE study) with adjuvant nivo as a monotherapy. The trial is producing some cracking results showing neoadjuvant combination therapy is superior to adjuvant anti PD-1 monotherapy. I don't know if/when BMS plan to file for FDA approval but there are nearly 100 ongoing clinical trials in this setting and we are witnessing the emergence of the market and changing clinical practices.

Against that backdrop Scancell may have found a partner/collaborator or they may simply have made a very sensible strategic decision to maximise the opportunities for iSCIB1+ by opening as many doors as possible. A phase 3 ready candidate in both advanced, unresectable and neoadjuvant melanoma is a very different prospect to one that has simply completed single arm phase 2a trial. So it makes absolute sense to seek regulatory approval for a phase 3 in both settings and with manufacturing sorted they can really then market iSCIB1+ as phase 3 ready.

I know this won't be popular, but I really hope this is what we are witnessing because in terms of valuations of any deals it makes sense to wait and seek interest when you already have phase 3 ready asset rather than cut a deal at an earlier stage when you don't and I wonder whether this explains the urgency around regulatory submissions and whether those submissions will also include an application for one of the FDA expedited pathways.

https://dailyreporter.esmo.org/esmo-congress-2025/immunotherapy/sustained-benefits-of-neoadjuvant-immunotherapy-demonstrated-in-resectable-melanoma

As for the trials, I had assumed they would be 2 completely separate trials.

For those that weren't around in the early days, the original intended setting for SCIB1 was as an adjuvant therapy - I don't think neoadjuvant was even a thing back then. I'm pretty sure there was a comment in the 2008 Admission to Plus document regarding Lindy's belief that the ideal setting for cancer vaccines was at an earlier stage but haven't been able find the document online. What I did come across was the link below discussing Scancell's 2008 IPO onto the Plus Exchange (now Aquis) :-

https://www.buyoutsinsider.com/scancell-is-uks-first-venture-ipo-of-2008/

At that time Scancell had just 5 employees working out of the labs at Nottingham University. The link really brought home to me the journey Lindy Durrant has undertaken. I'm sure way back when the Company was first fouonded or IPO'd onto PLUS or even when they transferred to AIM she would not have expected to be starting a neoadjuvant study some 20+ years later. It's funny how things have sort of come full circle. Despite many setbacks together with the poor environment and lack of support in the UK to scale up home grown innovation she has just ploughed on and has built Scancell into a £100m market cap company employing 60 people and which is about to present results at the high profile 40th anniversary annual meeting of the Society for Immunotherapy of Cancer.

Whatever your views on Scancell you have to admire and acknowledge what an achievement that is.

Well spotted CW, thanks

Yes and Ira Melman was of course one of the members of Lindy Durrant's CRUK Grand Challenge Project Blueprint team.

Completely agree re. lack of edit function here.

Bibio - now there's a blast from the past

Cleanerworld/marcus

Thanks for the links to the SITC presentation.

Have to admit that having waited for several years for the results of the SCOPE study, it was more than a little disappointing to find that Scancell were only presenting an e-poster at ESMO last month. So it's really good to see that they have been selected for oral presentation of this LBA at SITC and will be interesting to see whether it contains any updated results from the SCOPE study. Scancell will be presenting alongside some highly respected and pretty impressive institutions and worth noting that it is the only presentation on that shortlist from industry. All of the others are from institutions - either major cancer centres or universities. Just for some added context, Scancell have presented several times in the past at the European SITC annual meeting. I may be wrong but I don't recall them ever presenting at the US meeting.

Many thanks to those who made the effort to attend the AGM and have shared feedback here - much appreciated. Botski, as ever thanks for taking the time and effort to record the presentation and also I'm pretty sure I heard at least a couple of useful questions from you. Balerno, hope your flight isn't delayed for too much longer and safe onward journey to you.

Moonparty,

Press release below is from March 2023 and outlines the Comapny's new strategy and confirms the reduction in the size of the EVX-01 trial:-

'Phase 2b clinical trial reduced in size and expected to reach interim data on time (Q4 2023)'

'Cash runway is extended significantly through the new focus, clinical trial optimization, and staff reductions'

They did indeed produce the interim data at which point recruitment ceased and further updates have been on the same patients with more mature data.

https://www.globenewswire.com/news-release/2023/03/28/2635570/0/en/Evaxion-Announces-Increased-Focus-and-Fast-Tracking-of-its-New-AI-Discovery-to-Patients.html

Good to see you posting Bibio and thanks for that - comments are interesting too.