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Botski,

Thanks for the link to the short video from the CEO and CMO during which Dr Varawalla mentions an accelerated vaccination schedule. I emailed Lindy Durrant to ask about this and she has confirmed that they are changing the dosing schedule for cohort 4 and accelerating the early doses to ensure they stimulate memory T cells before toxicity from the ipi/nivo risks any delays/interruptions to treatment.

They're clearly learning a great deal from data produced so far and adapting accordingly.

Keir Starmer, the Prime Minister, said he was taking steps to fast-track clinical trials and “cut red tape for researchers”.

He said: “This kind of innovation is nothing short of life-saving and I want to see more of these world-leading treatments being developed in the UK.”

https://www.telegraph.co.uk/news/2025/04/14/nhs-trials-skin-cancer-vaccine-melanoma-personal-treatment/

........and Proactive interview with Phil D'Huilier

https://www.youtube.com/watch?v=-72t4Njcuas

.......and here too

https://www.mirror.co.uk/news/politics/skin-cancer-stopped-tracks-new-35048415

CW

Re. your 8.31. It's quite common for press releases to be issued with an embargo date and time for when the news can be released. I strongly suspect that's what has happened here. ie. Scancell have issued a press release and the BIA have simply missed the fact that it wasn't for immediate release but was embargoed and have published it too early. As soon as the mistake was spotted it was pulled. Highly likely that the correct publication date/time will be 7am on Monday to coincide with an RNS with the same announcment.

CW -

Good find and thanks for posting.

I can't get the link to work either. It may well be that the BIA have jumped the gun a bit and the announcement was due to be released together with an RNS on Monday? Whether that's the case or not, it's good news for the following reasons:-

1) Anything that speeds up recruitment particularly to that 4th and last cohort has to be positive.

2) Cohort 3 (iSCIB1+) is now fully recruited

3) Focus of CVLP until now has very much been all about personalised mRNA vaccines and BioNTech in particular. It's high time that home grown life sciences companies were given the same level of support and commitment.

Dracula,

Where they're heading depends entirely upon the trial results and the appetite amogst potential partners to acquire an off the shelf cancer vaccine when those results become available - both unknowns at the moment. In the meantime all Scancell can do is expedite the trials and communicate with potential partners (both pharma and institutional investors) hence their participation in these conferences.

As for the current SP - hardly surprising given they're mid-trial so you have the traditional bio drift exacerbated by the fact that we're in the middle of one of the worst biotech bear markets for decades. It's frustrating that the SCOPE study has take so long and predicted timescales have been missed but we are where we are and early iSCIB1+ results will be give us a much better idea of the direction of travel here.

Obviously just IMO

Dracula,

Depends which conference you're referring to and whether it's a scientific or investor conference. Either way, none of them are aimed at existing LTSH.

The clinical trial record for the Scope study has been updated on clinicaltrials.gov to reflect the addition of cohort 4 who will receive iSCIB1+ via the intradermal PharmaJet device. Main changes are:-

1) Administration is simply via PharmaJet needle-free injection device and references to intramuscular and Stratis device have been removed.

2) Total estimated recruitment increased from 130 to 173 patients

3) Last dose of any prior adjuvant treatment must have been at lest 24 weeks prior to first SCIB1/iSCIB1+ dose (previously was 4 weeks) and also neoadjuvant treatment now included.

4) Patients will only be recruited to the new cohort 4 if their HLA type doesn't match cohort 3 or they can't wait for screening results to start treatment or cohort 3 has closed to recruitment. ie. Cohort 3 takes priority over cohort 4.

https://clinicaltrials.gov/study/NCT04079166?term=scancell&rank=3

Could well be Johnny. Will be interesting to find out in due course as well as what the target actually is.

Thanks, definitely not SC129 then. Given their changing priorities, it's good to see Genmab progressing phase 1 studies, let's hope SC129 is next.

Thanks, I understand that according to the terms of the agreement they can do either but I have a vague recollection of Lindy mentioning in an interview or presentation that they were developing it as an ADC and wondered whether anyone else remembers this?

The reason I ask is that Genmab have quietly listed a new clinical trial for a candidate called GEN1078 in solid tumours. They haven't released any details regarding exactly what GEN1078 is and the documentation is heavily redacted including which tumours are included in the study, but they do state that it's a bispecific so I think it's unlikely to be SC129.

https://clinicaltrials.gov/study/NCT06771921?term=genmab&rank=2

Does anyone here know whether Scancell have ever commented on whether Genmab are developing SC129 as an ADC or a bispecific?

Miavoce - will be a long while yet. At some stage (think within 30 months of priority date) the application has to enter the national phase where individial patent offices for the territories applied for will examine and process in line with their own systems, rules and proceedures. They'll then each reaach their own decision as to which claims are allowable or not as the case may be!

Burble - not sure, although claim no. 1 just mentions PD-1 and CTLA-4, claims 14 and 15 do specify Nivolumab and Ipilimumab. Best check with Scancell perhaps?

Scancell's patent application for SCIB1/iSCIB1+ in combination with PD-1 and CTLA-4 checkpoint inhibitors has been published today. It was filed in Sep 2024 and IF granted it looks like it would extend the patent life of both SCIB1 and iSCIB1+ to September 2043 (when given in combinationn with those CPIs)

https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2025061794&_cid=P12-M8RFIB-72202-1

Green453,

As I understand it the content of the abstract can be edited/amended up until the deadline for withdrawal which is 14th March. Have to remember though that the abstract is just a basic summary and the poster presentation itself will be far more detailed.

Will be interesting now to watch whether or not Scancell intend to present/attend ASCO which is in early June. ASCO is even bigger than AACR with over 40,000 attendees. In fact I think it's the largest cancer conference in the world so would be a great place to present early iSCIB1+ results.

Green453,

'Abstracts are considered "late-breaking" if the works meet the following criteria: The research must be new and of sufficient scientific importance to merit special consideration after the standard abstract deadline.'

Essentially it's a matter of timing - the deadline for submission is later meaning the latest results can be included. Text will be embargoed until 25th April and I suspect we'll get an RNS much nearer the time. I

The AACR Annual Meeting is being held in Chicago in April and abstracts have been published tonight.

Scancell will be presenting a late breaking abstract and looks like it will be the SCIB1 phase 2 results:-

'LB214 / 11 - 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'

At the moment all we have is the title of the abstract but the full text will be published on 25th April.

https://www.abstractsonline.com/pp8/#!/20273/presentation/10098

Burble,

If there were any risk of a trial being pulled then that's a completely different matter and I don't think any responsible bio/pharma would embark on a trial under those circumstances but I had (perhaps mistakenly) thought that risk only applies to NIH funded studies. If a trial isn't government funded I assume that once an IND has been cleared they can't halt it for anything other than safety. Interesting and rather depressing times!

Burble,

There have been several excellent articles on the impact of events in the US on the FDA and it seems that the jury is out at the moment. There's a huge amount of uncertainty which is not good at a time when the US pharma industry is facing a real threat from the Chinese and I hope they come to their senses sooner rather than later.

Having said all of that, FDA approval is still the gold standard and Scancell have yet to run any trials outside of the UK. They have clearly gone some way down the path to a US based study, built relationships with potential study investigators and centres in the US etc. Also a shift to other territories may well impact on the cost of the trial as Scancell would likely to have to cover the cost of the Ipi and Nivo. It would be a significant amount too at around $100k per patient in up to 500 patients.

So my guess is that Scancell will press on with a US trial with perhaps one or two others such as Australia thrown in. In the short term they may find they have less access to advice/guidance from the FDA and I guess it's possible that the IND may take longer to clear but by the time iSCIB1+ gets to trial the situation will be much clearer and things will surely have settled down.

The risk of the impact of RFK's stance is on sentiment and uptake of vaccines and that comes further down the road if/when iSCIB1+ secures marketing approval. However, that risk is the same whether they run the trial in the US or not. Hopefully by the time iSCIB1+ gets to that stage this will all be a bad memory!