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CW

FDA clearance of an IND clearance is entirely different from a sumbission to the FDA for marketing approval. The former grants permission to run a clinical trial and the latter is full regulatory approval to market, sell and administer a new drug to the general public. They have completely burdens of proof, different processes and completely different evidence is required. The FDA have cleared INDs for phase 3 trials for BOTH companies and has also granted breakthrough therapy designation for IO Biotech's vaccine. The knock back for IO Biotech from the FDA came at the end of their phase 3 trial when the FDA advised them not to submit for marketing approval based on the phase 3 trial results. Scancell have yet to even start their phase 3 trial.

So you can't draw any conclusions from the fact that Scancell's IND was cleared by the FDA but IO Biotech were advised not to submit for marketing approval and it's simply wrong to claim regulatory superiority. You won't be able to do that until Scancell's phase 3 results are in and a BLA has been accepted by the FDA.

Chelsea11,

Thanks for posting link to SCLP's AACR poster yesterday and very well spotted. Good to see that Scancell will be at AACR and I'm surprised there have been no other comments or discussion about it. Title of the poster:-

'CT237 / 2 - SCOPE, A phase 2 clinical trial with off-the-shelf DNA plasmid vaccine in first line advanced melanoma combined with check point blockade, shows good T cell responses which correlate with long progression free survival

So another SCOPE study poster and it'll be interesting to see whether it includes updated survival data. Couldn't find any other presentations, let's hope that they'll be presenting something on Moditope at ASCO in June then.

TF,

Yes they clearly will have data to support that approach.

Re. phase 3 PFS results, it will all come down to the comparison with the placebo arm of the trial. Whilst we're hoping the iSCIB1+ arm of the phase 3 will at least equal the SCOPE study for PFS, end results may be much better or they may not be quite so good. Either way, the results will be judged on the size of any improvement over the control arm of the trial so even a drop in PFS over the SCOPE study could actually mean better results and vice versa.

Vascular,

As far as we know, the patient population for phase 3 will be the same as the SCOPE study target population which produced 74% PFS at 16 months. Results from non-matched HLA types were excluded from the iSCIB1+ results and therefore we should be hoping for/expecting the phase 3 results to replicate rather than improve upon the SCOPE study results and it will be fantastic if they do . It's unrealistic to ever expect a 100% response rate in advanced disease in a large study and as Sath pointed out in his presentation, a very small increase in PFS/response rates is enough to secure regulatory marketing approval and lead to a highly successful outcome for patients and the Company alike.

I guess it's possible that accelerated dosing may lead to some improvement. I think Scancell have confirmed that they're going to be using the accelerated dosing regime which was adopted for cohort 4. As you know, cohort 4 was halted and results weren't published so we don't know whether the new dosing regime resulted in any improvements in PFS/responses.

Vascular,

The PFS results shown of the graphs in Sath's presentation relate only to the target HLA population and exclude non-matched HLA types. The initial fall relates to patients who progressed too quickly for either the CPIs or SCIB1/iSCIB1+ to have any impact.

Wild,

Indeed!

In one of her previous roles with an Indian CRO, Nermeen Varawalla advocated for clinical trials to be used by the tobacco industry to compare the impact of different products on health outcomes and for the tobacco industry to adopt a pharmaceutical type of approach to gathering of data and regulation. For example comparing the rate of respiratory infections in smokers using e-cigarettes as opposed to traditional tobacco cigarettes. Her comments were published in tobacco industry trade publications etc. and this is probably why she was invited to present at previous tobacco/nicotine conferences.

It's highly likely that as a previous presenter she was simply asked to participate again this year and agreed to do so. Hopefully nothing to do with Scancell and nothing to do with SC134.

I'm struggling to understand why Scancell's Chief Medical Officer is attending a conference sponsored by and devoted to promotion of the nicotine and tobacco industry. I know she has attended in previous years, presumably in line with previous roles and her own consultancy business but it seems an odd conference to choose for the CMO of an oncology company.

I like the way Redx quietly get on with the job in hand and excellent news this morning with the FDA granting Fast Track designation to RXC008, Redx's pan-ROCK inhibitor. Worth noting this sentence:-

'Redx have been working closely with the FDA and the STAR consortium to define the regulatory pathway for this disease '

Well worth reading up on the STAR consortium, (Stenosis Therapy and Anti-Fibrotic Research consortium) a crohn's research group involving two top ranked crohn's institutions , the Cleveland and Mayo Clinics. In fact I think the Mayo Clinic is the top ranked hospital in the US for Crohn's. The consortium is headed up by Dr. Florian Rieder who is also one of Redx's expert advisers. Will be interesting to see whether the RXC008 clinical trial incorporates and of the biomarkers/imaging developments from the STAR consortium.

Wild,

Correct, it is Glymab SC134. CW's post refers to the US patent which has recently been granted. The European Patent was discussed here back in August when the intention to grant was issued and the patent was actually granted in October 2025. I see theat the Chinese patent has also been granted for this mAb but not sure about other patent officces. Previous post:-

Bermudashorts

Posted in: SCLP

Posts: 13,033

Anti Fucosyl-GM1 antibodies European patent8 Aug 2025 17:10

Was just checking something else and noticed that the European Patent Office issued an intention to grant letter on 14th July for Scancell's anti Fucosyl-GM1 mAbs. This patent covers SC134, the mAb Scancell intend to take into clinical trials. Good stuff.

https://register.epo.org/application?number=EP20767753&lng=en&tab=main

I haven't checked whether this has already been posted so please ignore if you've already read this. The link below is to quite a comprehensive article from Edison looking at the current state and future direction of immuno-oncology. Scancell is one of the companies featured and quite a few soundbites will resonate with SCLP holders. Have picked a couple below:-

'Next-generation cancer vaccines are transitioning from monotherapy setbacks to high-value immune-priming partners capable of generating high-avidity, tumour-specific responses and converting immunologically cold tumours into ‘hot’ tumours................ Platform scalability, precision biomarker strategies and consistent combination benefit across tumour types will be critical to partnering activity and peak-sales realisation.'

'The growing challenge is no longer whether immunotherapy works, but how to make it work for the majority of patients, across a broader range of tumours, with acceptable safety, cost and scalability. The next phase of value creation is therefore less about a single breakthrough drug and more about expanding the responder pool and durability of benefit through new checkpoint targets beyond the current PD-(L)1 and CTLA-4 combination strategies that address tumour-resistance mechanisms and new immunotherapy modalities such as therapeutic cancer vaccines and next-generation cell/CAR-T therapies.'

https://www.edisongroup.com/thematic/redesigning-immunity-the-next-frontier-in-immuno-oncology/BM-2910/

ResearchGate showing that Lindy Durrant's work has been cited 8000 times.

https://www.researchgate.net/profile/Lindy-Durrant-2

Looks like Redx's collaboration with the Garvan Institute is now producing some tangible benefit for Redx with the Australian Government funding clinical trials to test two drugs in pancreatic cancer, one of which is Redx's ROCK2 inhibitor, Zelasudil (RXC007):-

'Two new clinical trials led by the Garvan Institute of Medical Research will test whether targeting the dense, fibrous tissue surrounding pancreatic tumours could make one of Australia's deadliest cancers more vulnerable to treatment'

https://www.garvan.org.au/news-resources/news/new-clinical-trials-to-target-pancreatic-cancers-protective-shield

Balerno,

AFAIK the FDA don't publish details of cleared INDs. Whilst major biotechs and large pharma companies would probably announce the grant of one of the FDA's expedited programmes such as breakthrough therapy, I don't think they would routinely announce the clearance of an IND. As you say, these INDs were submitted back in November and the 30 days clearance timescale has long gone, Genmab haven't announced any issues and have registered the studies on clinicaltrials.gov so I think it's safe to assume that the INDs have been cleared.

Balerno - Why do you think that Genmab's INDs haven't been cleared by the FDA?

Either I'm missing something or perhaps it's best to wait for confirmation from Genmab or Scancell because we don't know yet whether either of these mAbs are Scancell's.

Genmab acquired ProfoundBio in 2024 and their pipeline included two ADCs called PRO1107 and PRO1106. Genmab changed the name of PRO1107 to GEN1107 and terminated the clinical trial last year due to poor risk/benefit profile. It seems likely therefore that GEN1106 is ProfoundBio's PRO1106. Indeed if you listen to the Q&A session from today's webcast from Genmab (link below) they were asked about the new INDs at about 49 minutes in and do say that one was a ProfoundBio product. I think they described the other as a Hexabody so it may be one of Genmab's own.

Genmab's preclinical pipeline will be stuffed full of mAbs either developed in house, in collaboration with other bio/pharma companies or bought in via licensing deals or aquisitions and we have no idea which category GEN1079 falls into. Let's hope that it is SC129 but even if it isn't, they have confirmed that there are more INDs to come this year.

https://ir.genmab.com/events-presentations

Ponsonb,

We don't yet know the exact number of patients or how many study centres will be involved but even so I think 6 to 9 months for the last patient to be dosed and full recruitment is way too optimistic. If they managed to complete recruitment within 18 months it would be impressive IMO. The trial officially ends after the last patient reaches the end of the follow up period. This was 2 years from their first dose for the SCOPE study and assume the phase 3 will be the same. Before they publish results the data must be unblinded, verified and analysed. So you'd be looking at 3 to 4 years if they recruit quickly. At that stage they'd hopefully publish results but it would still take several more months for marketing applications to be submitted and for the regulators to review and make decsisions. So you can probably add on the best part of a year before commercialisation.

However, the trial is being designed with an interim review which means that after a certain number of events the results are unblinded. I seem to remember someone (Scancell?) suggesting that the trigger point fot the interim review will be 180 events, which means that after 180 patients from either arm of the trial have had disease progression or died, the data will be unblinded and analysed. At that point, the trial can go in different directsions:-

1) Worst case scenario would be that results show that the trial has no chance of meeting endpoints and it's halted for futility.

2) It could simply continue as planned

3) They could decide that they need a greater sample size and increase the number of patients

4) The results could already be showing clear and significant benefit and Scancell are able to apply to the FDA for accelerated approval and I assume they would publish some results at this point

So the interim review will be crucial here and will tell us a great deal about how the trial is going. Although we want to see results as soon as possible, the longer it takes to get to the interim review the better as hopefully it will be because the iSCIB1+ arm is being effective at reducing deaths and extending PFS.

I'm sure someone will correct me if I'm wrong but I believe the 2029 timescale for commercialisation from Scancell refers to point no. 4 above rather than the trial going to full recruitment and the normal study completion date.

Chester - more cash can certainly help to speed up recruitment through the addition of extra study centres but I'd have thought there's a limit to what it can achieve to speed up the opening of each centre once they've been selected. Each location can only open to recruitment as and when they have capacity and it's then completely dependent on what patients walk through the door, whether they're referred for the trial and whether they meet the recruitment criteria.

Wild - good to see you posting and hope things are a little easier for you. Another very well researched SCLP holder mentioned elsewhere that Keith Flaherty is no longer involved in clinical trials so it would have been great but sadly unlikely. You're right, Scancell have done it before, but only in the UK and only single arm, open label. It will be quite a milestone for the Company when they issue that first patient dosed RNS for their first randomised study, their first phase 3 and their first in the US.

Chelsea, thanks for the link, will have a read.

Chester,

There is still much work to do before the trial can begin. They will have to select, agree terms with and appoint a CRO, Principal Investigator, study centres and study investigators. They'll have to fine tune and fully document the trial protocol, draft training manuals, consent forms and documentation etc. They'll need ethics committee approval and will need to appoint an independent data monitoring committee. Then they'll need to train all investigators and staff from each study centre. On top of that you have all the logistics of scaling up production, shipping supplies etc. etc.

Sounds daunting for a small team like Scancell and obviously the more study centres/countries/regulators there are, the greater the task in terms of setting up the study and ongoing management. However, worth remembering that much of the heavy lifting will be done by the CRO rather than Scancell. Scancell may well already have appointed a CRO and they may/may not be involved in choosing and contracting study centres and investigators. They may well also already have selected and signed up a Principal Investigator and it'll be interesting to find out more. It would be great to have some high profile investigators from the more prestigious institutions in the US involved.

Most of the discussions seem to assume that Scancell will either have to have a massive raise or massive deal to fund the trial, but they don't need to have all the funding up front and nor will all the study centres open at the same time. They could simply raise enough to start the trial and the deal or further funding could come further down the line. There are so many possibilities and permutations in terms of funding, collaborations, deals etc. that it's hard to call.

Burble,

This is a general comment and not specific to Scancell but your post highlights just one of several examples of the UK Government spending UK taxpayers' cash on high risk, early, as yet unproven tech from overseas companies when there are plenty of UK companies with equally promising innovation .

Another is the deal with BioNTech who of course were the first (and prior to Scancell ONLY) beneficiaries of the CVLP scheme. The UK agreed to provide 10,000 patients with personalised BioNTech vaccines in return for a commitment from BioNTech to build R&D hubs in the UK. Only last year they were given a £129m grant from the UK in return for a promise to invest up to £1 billion on what seems to be those same R&D hubs. Then you have the deal with US company Grail for what is essentially a 165,000 patient clinical trial for their ctDNA liquid biopsy with Grail agreeing to build a new UK sequencing lab in the UK in return. I'm sure there are plenty of others.

It would be interesting to see how much of the pledged investment from these companies actually materialised and time will tell whether they have chosen the right tech to gamble on. The UK excels when it comes to life sciences innovation, particularly in genomics and oncology. We have had successive Governments with various plans, reports, initiatives telling us how they support the UK life sciences sector and yet we have big pharma (AZN, Lilly, Merck) cancelling or reducing investment in the UK and we seem incapable of providing an enviroment that allows home grown innovation to flourish or scale up with the seemingly inevitable loss of IP to other countries.