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We all know that Scancell are planning a registration trial and of course the CMO is going to highlight that when talking about the pipeline, but I don't read anything that suggests a deal has been struck. Points of interest IMO are that they're no longer calling it a phase 2/3 registration trial but just phase 3 so perhaps they're planning to drop the 2 part study and go straight into phase 3 and also whether CVLP will be involved in that - assume it's highly likely that they will.

Interview with Scancell's CMO has been uploaded today to Scancell's website - not sure whether it's a transcript of a previous interview or something new.

https://scancell.co.uk/news/

Back in 2020 and 2023 peer reviewed papers were published looking at a possible role for Scancell's glycan mAbs in imaging for surgery. The research was carried out (and funded) by the Department of Surgery, Leiden University Medical Center in collaboration with Scancell. Interesting to note that this project obviously continues as new preclinical research has been pubished which further investigates the potential of SC88 and SC129 mAbs in this setting.

Less invasive surgical techniques such as keyhole surgery, robotics etc. are great for patients but mean that surgeons no longer get to actually feel the tumour to distinguish between healthy tissue and tumour and so NIRF imaging has been developed as a tool to guide surgeons. A fluorescent dye is administered, activated by infrared light and then shows up as fluorescence on imaging. Clearly it's important that the dye targets and concentrates in tumour tissue and not healthy tissue and so targeted dyes that include antibodies or peptides which will bind to the tumour cells have been developed but they have their limitations.

The team at Leiden have been looking at the potential of Scancell's SC88 and SC129 glycan mAbs as the targeting agent in these NIRF dyes, evaluating their performance using both tissue samples taken from 88 cancer patients and mouse models. The conclusion :-

'Our findings showed that bimodal NIRF/PA imaging using CH88.2-800CW and CH129-800CW allows real-time, high-contrast visualization of tumors at 96 h post-injection. Considering the strong and tumor-specific expression of Lea/c/x and sdi-Lea on gastric, colorectal, and pancreatic cancer, both tracers may be broadly applied for gastrointestinal cancers. This preclinical evaluation warrants further evaluation of both agents in a clinical setting.'

Worth checking out the affiliations of the authors - Leiden University, Scancell and University Medical Center Utrecht amongst others. SC129 is of course the mAb licensed to Genmab and perhaps it's no coincidence that Genmab's CEO is professor of Immunotherapy at Utrecht University and that they have very close ties to Leiden. A good example of the collaborative academia/biotech ecosystem in action.

https://pubmed.ncbi.nlm.nih.gov/40478321/

I don't think Scancell has ever issued any warrants.

Kashdog - good for you. Think I'll stick with hold :)

Kashdog,

There was a collaboration years ago to evaluate ImmuneRegen's Homspera as an adjuvant to SCIB2. Although there were some signs of activity Scancell decided not to go down the adjuvant route and instead licensed Ichor's Trigrid device for SCIB1. So the collaboration went no further. I don't think Homspera has ever made it to market but would need to check on that. So in short, as is so often the case with very early stage biotech, there was a collaboration which benefited both parties but a better route was found.

As for your question re. SCIB1 - I agree that it has taken far too long to get SCIB1 to this stage. There are all sorts of mitigating factors but at the end of the day the years spent between the original SCIB1 trial and the commencemet of the next trial due to the issues with clearance of the IND from the FDA were very costly. All compounded by Covid of course. Very frustrating for shareholders and I'm sure even more frustrating for Scancell themselves.

Interesting Ivan thanks. Seems that the UK are really promoting the CVLP

East-ender - lovely comments and am sure everyone here would echo those sentiments (apart from the West Ham part of course!)

Chelsea11 - I may have missed it but can't find any abstracts from Scancell so it looks like they may not be presenting at ASCO this year. Having said that I'd be very surprised if they weren't attending, not least because it's an ideal opportunity for a meeting with the iSCI1+ clinical advisory team.

There is some interest for Scancell though, Southampton are presenting a poster on the Cancer Vaccine Launch Pad and although it will probably focus on the BioNTech trial, it may include a reference to the iSCIB1+ trial and give some insight into how the CVLP collaboration will benefit Scancell.

'A platform to identify patients for cancer vaccine trials: The NHS England Cancer Vaccine Launch Pad (CVLP).'

2025 ASCO Annual Meeting

Authors

person

Victoria Goss

Cancer Research UK Southampton Clinical Trials Unit, University of Southampton, Southampton, United Kingdom

Victoria Goss, Nicole Keyworth, Dan Muller, Sam Wilding, Simon Crabb, Emily Shaw, Nicola Chapman-Hart, Max Shen, Patrick Ezeani, Gillian Rosenberg, Gareth Griffiths, Peter Johnson

Rats,

What very sad news and thanks for letting us know. Rest in peace Chelsea and God bless.

Matt,

Sorry have only just seen your post.

I don't think that you need to fully understand the biochemistry involved to appreciate the aims of the research, why it's needed and whether or not they had any success. So I think any ticks weren't from readers claiming to understand every aspect of the whole paper but from folk who appreciated what they were trying to achieve and also the fact that Scancell continue to explore and push the boundaries of the science of cancer vaccines.

At the moment, Moditope is the only peptide vaccine platform in Scancell's pipeline and I'm sure all longs here will remember the effort and resource put into selecting the best adjuvant and then the frustrating and very costly delays caused by the manufacturing difficulties. So in anwer to your question, the selection, manufacture and administration of the right adjuvant is vital to the success of peptide vaccines and the conclusion IMO is simply that it's interesting to see potential future developments and whilst there's no immediate impact for Scancell it may be a glance into the future depending on how it progresses from here. Next step:-

'Due to the promising results obtained from the Pam2Cys‐SK4‐NY‐ESO‐1157‐165 3 scaffold, future work will involve the integration of additional components into this vaccine (such as T‐helper epitopes) to further enhance the potency of this self‐adjuvanting vaccine construct.'

New research involving Scancell has been published looking into the creation of self-adjuvanting peptide cancer vaccines. So instead of administering the adjuvant alongside the vaccine, it's covalently grafted onto antigen structure thereby creating a self-adjuvanting vaccine. It's very early stage research and looks like a collaboration between University of Nottingham and Scancell researchers. . Interesting to note the value of animal testing. They created 3 different constructs using 2 different antigens (NY‐ESO‐1 & BAGE4) and experienced unexpected and unexplained severe toxicity with one of them despite the fact that the component parts are non-toxic. Have a read of the last paragraph of section 3.4 in the link below which highlights perfectly why regulators insist on animal testing prior to allowing human clinical trials.

Anyway, they seem to think that the NY-ESO-1 version shows promise and whilst this obviously has no immediate impact for Scancell, it's worth keeping an eye on with a view to future developments.

https://pmc.ncbi.nlm.nih.gov/articles/PMC12053792/#psc70022-sec-0018

They can self nominate but haven't seen any requirement for a fee - do you have a link? Regardless, the shortlist is selected by a juding panel of industry experts as are the winners and so good to see that panel has selected Scancell. It's recognition for the R&D teams at these bios and raising awareness amongst their peers/fund managers/analysts alike has to be a positive thing surely?

Good to see that Scancell have been shortlisted in the Best Technology Award category for the European Mediscience Awards

https://www.mediscience-event.co.uk/nominations-overview/

EE/Dracula

Please see my 18.24 post from last night. This does perhaps have significance for Scancell, but not in the way you think.

Try this one ...............

https://www.england.nhs.uk/2025/04/nhs-rolls-out-5-minute-super-jab-for-15-cancers/

Yes thanks for that Breakingeven.

Good to see that Nivolumab administered via simple injection rather than IV will now be available on the NHS. Perhaps not a major development but will make a real difference to patients as well as the obvious cost benefits to the NHS.

Nivolumab of course is the anti PD-1 element of the doublet therapy in Scancell's SCOPE study. Assume that it's highly likely the registration trial will be using the injectable version meaning only the Ipilimumab part will need to be administered via IV

Odd that the new role reports to the Head of Development (Callum Scott) and not Head of Manufacturing. Perhpas AP is leaving or they're having a reshuffle.

While it's quiet, longs here will remember Keith Flaherty who had agreed to act as principle investigator for the planned US 2017 SCIB1 clinical trial. For reasons well documented that trial never took place but have just read that Keith Flaherty has been elected as AACR president. He becomes president-elect today and will take over the presidency at the AACR Annual Meeting next year. This is about as A list as you can get in the field of oncology and cancer research and evidence of great esteem in which he is held by his peers.

Bittersweet for Scancell holders as you can't help but wonder where we'd be if that trial had gone ahead but bearing in mind that he is one of the world's very top melanoma experts, it's worth looking back at just what a big deal it was to secure his services and how it came about. In the video below Richard Goodfellow answers a question (from a familiar voice!) at about 27 minutes in and explains all.

https://www.youtube.com/watch?v=sC4LI0dtXRI

https://www.massgeneralbrigham.org/en/about/newsroom/press-releases/keith-t-flaherty-appointed-to-lead-aacr#:~:text=The%20American%20Association%20for%20Cancer,%2DElect%20for%202025%2D2026.

Scancell's late breaking abstract for AACR next week has now been published. The text is below:-

Session LBPO.CL01 - Late-Breaking Research: Clinical Research 1

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

Abstract

Background: Targeting melanoma with T cells drives anti-tumor responses. We previously showed that a DNA vaccine, SCIB1, incorporating T cell epitopes from TRP-2/gp100 into an antibody framework to allow Fc targeting of activated dendritic cells, was successfully as a monotherapy in Stage 3/4 melanoma patients in a Phase 1/2 clinical study. Unresectable melanoma patients showed a 60% ORR and 88% of patients treated with SCIB1, post tumor resection, remained disease free for 5 years [1]. The current SCOPE trial tests the hypothesis that unresectable patients may have an improved response when SCIB1 is combined with checkpoint inhibitors (CPI) compared to CPI alone.

Methods: Patients are treated with nivolumab with ipilimumab and SCIB1 (8mg) i.m. using needle-free injection at a fixed dosing schedule for up to 10 doses over 24 months. The CPI therapy is administered i.v. in accordance with their respective SmPC. ORR as measured by RECIST 1.1 in the overall intention-to-treat population is the primary endpoint. The study is designed using Simon's two stage methodology with 80% power when the true response rate is 70% versus 50% RR of no interest with an overall type I error of 5%. In the first stage, 15 patients needed to be enrolled and if there are eight or fewer clinical responses (RECIST 1.1 objective response [CR or PR] within 25 weeks of the first dose of SCIB1), further recruitment would have been stopped. The null hypothesis will be rejected if 27 or more responses are observed in 43 patients. T cell responses are assessed using a cultured ELISpot assay following TRP-2 or gp100 peptides stimulation

Results: To date, 43 patients received the combination of SCIB1 with nivolumab and ipilimumab. 25 patients had reached 25 weeks, and had 80% PFS, 84% DCR and 72% ORR with 20% of patients showing a complete response. 94% (16/17) of the clinical responders had a T cell response, 80% (4/5) of the patients with stable disease had a T cell response, 33% (1/3) of patients with progressive disease had a T cell response. T cell receptors isolated from patients showed strong, peptide, ImmunoBody® and tumor recognition. Of interest was that in a patient who showed a pre-vaccinated response to the encoded epitope a different TCR was stimulated by the vaccine. Most of the SCIB1-related adverse events were Grade 1/2. The only Grade 3 related events were a rash, pulmonary embolism, neutropenia and raised GGT. No exacerbation of immune-mediated adverse events was observed when SCIB1 was added to nivolumab with ipilimumab .

Conclusions: SCIB1 in combination with nivolumab and ipilimumab as first line treatment for unresectable Stage 3/4 melanoma resulted in 80% 6-month PFS with strong vaccine specific T cell responses without an increase in clinically meaningful adverse events. These results, if confirmed, in a larger patient cohort provide confidence in initiating a randomized registration program in unresectable melanoma patients with our novel DNA plasmid technology.