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All my own words 😂Suspect very serious partnering talks are taking place , scientifically as read over the weekend , Scancell have some the competition does not have

,"OFF THE SHELF"unlike Moderna/Merck’s personalised vaccine.FDA Fast Track and FDA-agreed Phase 3 design. RE CAR T as stated by Phil working in the body not the lab

Smeone pointed out Moderna/Merck have been banging on that old drum of personalised approach for ages and its too expensive and logistically complicated .

however the bottom line is Scancell is scientifically well positioned versus peers, but commercially held back until funding or partnering is resolved. with the patent cliff looming and the large pharmaceutical know only too well what Scancell has , its who can not afford to ignore a deal to protect their standard of care revenue in the melanoma space ? thats before the other stuff Glymab , Modi and beyond . Lindy has been busy in the lab ? with what ? whats next ?

Find the link thanks Roses

https://www.trinitydelta.org/research-notes/iscib1-pivotal-trial-plans-advancing/

C11 will find something negative in my posts 😂😂😂which I always find hilarious

Would value posters opinions Purely a thought experiment…

If Scancell were listed on Nasdaq rather than AIM, with:
FDA Fast Track
A Phase 3-ready melanoma programme
Off-the-shelf cancer vaccine technology
translational data supporting the mechanism
Multiple pipeline assets and GlyMab

Would it still be valued at only around £120m-£230m?

Personally, I suspect not. I know £8 gets mentioned a lot on the other board maybe £7.99 😂

seriously this is so hard and nothing as I believe as been revalued since the FDA fast-track , one thing we can all be certain of news is due and when it lands hopefully with a loud band of a starting gun . good luck to one and all

Thanks wildforce , This is excellent

I have combed through and shared specific mention of Scancell and what I think maybe most relevant . time is indeed racing towards an RNS goodness knows what will it will reveal , Fair to say for a tiny Aim company they get A LOT attention

wildfire said :

“Other analysts reports’ on the scancell web site .. I’m not sure I’d seen this before but if anyone hasn’t or looking at scancell just out of interest then it’s an interesting read (from Feb) ..

https://scancell.co.uk/wp-content/uploads/2026/03/Edison-Report-Redesigning-Immunity.pdf

In the world of healthcare,

investors have to be on their

guard. With so much research

progressing so quickly, it can

be difficult to distinguish hard

facts from the pseudoscience.

Which is where a trusted

research house like Edison

comes in.

Give us a call

Page 10

Genetic delivery platforms – mRNA and DNA as scalable backbones: New-generation cancer

vaccines are increasingly using genetic material, such as mRNA or DNA, to instruct the body’s own

cells to produce tumour antigens, rather than introducing the antigens directly as proteins or

peptides. This approach helps the immune system recognise the targets more effectively and

generates both killer (CD8+) and helper (CD4+) T cell responses. It also naturally activates the

early immune signals needed for a strong and durable reaction, reducing the need for additional

adjuvants. Moderna’s personalised mRNA vaccines and BioNTech’s personalised and shared

antigen programmes (including BNT111) highlight the speed and flexibility of this technology, while

Scancell’s DNA ImmunoBody platform (iSCIB1+) shows how a potent off-the-shelf option can be

combined with checkpoint inhibitors.

◼ Scancell – iSCIB1+: iSCIB1+ is an off-the-shelf DNA cancer vaccine from its ImmunoBody

platform designed to induce tumour-specific T-cell responses and enhance checkpoint inhibitor

efficacy in advanced melanoma. The programme has successfully completed the 140-patient

Phase II SCOPE study in combination with nivolumab (Opdivo) + ipilimumab (Yervoy),

demonstrating a strong progression-free survival signal in a defined (human leukocyte antigen

(HLA)-selected population. Following this data, the FDA has cleared the investigational new

drug application for a global registrational Phase III trial, expected to initiate in 2026, positioning

the asset as a late-stage, potential SoC-expanding combination therapy.

Designed for checkpoint inhibitor synergy: Newer cancer vaccines are also being positioned as

immune primers for checkpoint blockade rather than as standalone therapies. The vaccine trains

the immune system to recognise the tumour and brings T cells into the tumour, while drugs such as

PD-1, PD-L1 or CTLA-4 inhibitors stop those T cells from being switched off. Together, this helps

overcome two key problems: many tumours do not already have tumour-fighting T cells, and the

tumour environment suppresses immune activity. The positive data for V940 with pembrolizumab

show this approach can work in practice. Similar combination strategies, including Scancell’s

Redesigning immunity | 18 February 2026 10iSCIB1+ with dual checkpoint blockade, also make it easier for vaccines to fit into current treatment

pathways.

P11 and 12 there is a table Also pointing out Deal activity in cancer vaccines

Cancer vaccines are transitioning from a historically high-risk modality to a combination-driven,

platform opportunity, supported by randomised clinical validation in the adjuvant and MRD settings.

The shift to neoantigen targeting, genetic delivery and PD-1 synergy materially improves probability

of success and commercial scalability. Earlier-line positioning expands patient populations and

treatment duration, while recent large-scale transactions signal renewed big pharma appetite.

Companies with biomarker-led development, checkpoint-combination data and scalable

manufacturing are therefore best placed to secure premium partnering and valuation re-rating.

P16 Patent cliff explained

The notable event in this cycle is the expected biosimilar exposure of Merck’s Keytruda from 2028,

currently the world’s largest oncology drug with c $31.7bn in sales in 2025. BMS’s Opdivo, with

over $10bn in revenue in 2025, faces a similar timeline. Together, these two PD-1 inhibitors account

for over $40bn of at-risk revenue, making IO one of the largest contributors to the late-decade

patent cliff

Page 19

Mitigating factors

Several factors help mitigate traditional IO investment risks.

Strong external demand for innovation

◼ Patent-cliff driven deal flow: Loss of exclusivity for PD-1 franchises is creating a structural

need for revenue replacement, increasing partnering probability for differentiated assets.

◼ Combination relevance lowers commercial risk: Therapies that enhance checkpoint activity

can integrate into existing treatment paradigms rather than displace them.

Page 26 the interview page 26

Scancell

Developing potent and safe active immunotherapies for a cancer-free future

Scancell (LSE: SCLP) is a clinical-stage immuno-oncology company developing targeted active

immunotherapies designed to generate durable, tumour-specific T-cell responses and address the

Redesigning immunity | 18 February 2026 26large proportion of patients who fail to benefit from checkpoint inhibitors (ICIs). With approximately

half of patients not responding to ICIs and five-year survival in stage IV melanoma below 23%,

Scancell’s off-the-shelf platforms aim to enhance efficacy without adding toxicity while improving

accessibility versus personalised approaches.

The lead asset, iSCIB1+ (DNA Immunobody), is a needle-free DNA vaccine that induces high-

avidity T cells against gp100 and TRP-2 melanoma antigens, selected from patients with

spontaneous tumour regression. In the Phase II SCOPE study (n=140), iSCIB1+ in combination

with ICIs has demonstrated clinically meaningful improvements over historical CPI outcomes.

Progression-free survival in the target HLA population reached 78% at 11 months versus ~46% for

nivolumab/ipilimumab, with 69% PFS at 22 months across cohorts. Updated data remained

encouraging with PFS of 74% at 16 months in the target population. These data support the

potential to establish a new standard of care in advanced melanoma. With FDA IND clearance in

place, development is being accelerated towards a randomised registrational study in 2026, likely

incorporating a precision biomarker. A commercial-scale GMP manufacturing process with strong

stability has already been established, supporting future scalability.

The second clinical programme, Modi-1 (Moditope), is a peptide-based active immunotherapy

targeting post-translationally modified tumour antigens and is currently in Phase II evaluation in

hard-to-treat solid tumours, including head and neck cancer, with further data expected in early

2026.

Beyond vaccines, Scancell’s GlyMab platform, developed within its Glymab Therapeutics

subsidiary, generates high-affinity antibodies against tumour-specific glycans, with two assets

already licensed to Genmab, providing external validation and potential non-dilutive value.

See below for our recent Edison TV executive interview with Scancell

At Outsourcing in Clinical Trials in London last week, Scancell presented a three stage framework to deploy AI in clinical trials: start low risk, build maturity, advance deliberately.

It sounds obvious. But in practice, many organisations either delay AI adoption entirely because the stakes feel too high or they move too fast into complex, high-risk applications before they have built the governance and oversight structures to support them.

The smarter approach is a staged one.

Start with lower-risk, lower-regulatory-impact activities, recruitment support, document classification, data quality review, medical writing assistance. Build experience. Establish human oversight. Learn what the technology can and cannot do in your specific environment.

Build maturity by strengthening governance, validation processes and data quality frameworks. Gain regulatory confidence before advancing.

Then move into higher-impact applications endpoint assessment support, safety signal identification, predictive analytics, regulatory submissions where the stakes are higher and the scrutiny is greater.

View image

This was an interesting post and very positive about Scancells approach

https://www.linkedin.com/posts/fatimafarzana_at-outsourcing-in-clinical-trials-in-london-share-7473285055658926080-r3DU?utm_medium=ios_app&rcm=ACoAAAEMEUEBR5Mb_OU2hPfmsCUuIdHTi7HAtoc&utm_source=social_share_send&utm_campaign=whatsapp

Thanks, Bil, for posting the full link.

I particularly liked this quote from Lawrence Tallon, MHRA Chief Executive:

“By creating dedicated liaison roles, we are taking our collaboration to a new level, improving how we share expertise, align on regulatory science and technology, and respond to the pace of innovation.

This will help product developers cross the Atlantic, in both directions, because our regulatory decisions will become more closely aligned, reducing friction to market from the UK to the US and vice versa.”

As Phil has previously highlighted, Scancell’s FDA application progressed remarkably quickly, even taking the Christmas period into account.

It does make me wonder when we might hear from the MHRA. Could approval already be in place behind the scenes? Or might the MHRA be waiting to review a broader protocol amendment, perhaps incorporating adjuvant and neoadjuvant settings and the addition of another trial cohort?

Pure speculation of course, but the increasing alignment between the FDA and MHRA is certainly encouraging for UK biotech companies

Potentially significant development for UK biotech and life sciences companies.

The UK’s MHRA and the US FDA have announced a new liaison programme that will place dedicated liaison officers within each agency, strengthening day-to-day collaboration on medicines, medical devices and emerging technologies such as AI. More importantly, this builds on earlier announcements that the two regulators are exploring greater regulatory alignment and potential mutual recognition mechanisms. (GOV.UK)

For innovative companies developing new medicines, this could help reduce regulatory duplication, improve predictability and ultimately accelerate patient access on both sides of the Atlantic. While this is not yet mutual recognition of drug approvals, it is another step towards closer UK-US regulatory cooperation. (GOV.UK)

For companies such as Scancell and other UK biotechs, closer MHRA-FDA alignment could increase the strategic value of UK-led development programmes and make the UK an even more attractive location for innovation and investment.

Official announcement:

MHRA and FDA liaison programme

Post from Cerlin Roberts

Founder & CEO, Oxford Global | Accelerating R&D in Life Sciences

https://oxfordglobal.com

Regulatory Considerations to Immunotherapies - Approaches to innovations

https://oxfordglobal.com/nextgen-biomed/online

Date: 1 July 2026
Time: 4:00pm – 4:40pm Uk Time

Agenda

Format: 40-minute panel discussion

Panel Discussion: Regulatory Development and Approval Pathways for Immunotherapy Products

Regulatory strategy and agency engagement for immunotherapy products

* Preclinical stage

* Early stage interactions

* CMC considerations

Lessons learned from early stage development

Moderator: Livija Deban, Chief Scientific Officer, Prokarium

Panellists:

Callum Scott, Senior VP, Development, Scancell

Margareth Jorvid, Senior Partner, LSM Group / Life Science Management

Agree Chester , it’s an exceptional time for Scancell

Yes great post EE and a reminder The interesting thing about this group is that patients had tumour samples taken before treatment and again at surgery afterwards. That means researchers have a rare opportunity to see whether the treatment actually changed what was happening inside the tumour.

Did more cancer-fighting immune cells move into the tumour? Were there signs that the immune system had been activated against the cancer? Did the treatment appear to alter the tumour environment in a meaningful way?

So far, we've heard that the head and neck cohort passed its non-futility assessment, which is encouraging. But we haven't yet seen any data from these post-treatment tissue samples.

Those findings could be important. Positive results wouldn't just support Modi-1 in head and neck cancer – they could provide real-world evidence that the underlying Moditope approach is working as intended.

Perhaps the analyses are still ongoing, or maybe Scancell is saving the data for a future scientific meeting. Either way, it's a piece of the puzzle investors may have overlooked.as everyone is focused as CEO intention was to get scope funding/ investment partnerships over the line

It will be interesting to see what those tissue samples eventually reveal ? 👏🥂👍

The speaker for the Melanoma session was

Dr Pippa Corrie

Name:

Dr Pippa Corrie

Post-nominal Letters:

PhD FRCP

Job Title:

Consultant Medical Oncologist and Affiliated Associate Professor

Organisation / Company:

University of Cambridge

Biography:

Pippa Corrie qualified in medicine at Oxford University, having previously undertaken a PhD in anti-cancer drug development. She has been a Consultant Medical Oncologist at Cambridge University Hospitals NHS Foundation Trust (Addenbrooke’s Hospital) since 1997 and is an Associate Lecturer in the University of Cambridge. She has over 25 years of experience leading a regional melanoma clinical service highly integrated with research and been directly involved in development of modern melanoma therapeutics, She previously chaired the NCRI skin cancer group and is a co-founder and Trustee of the UK national charity, Melanoma Focus. Pippa works regionally, nationally and internationally to conduct melanoma clinical and translational trials: she is currently Chief Investigator of the NIHR portfolio MITRE microbiome study and PREMIUM, evaluating neoadjuvant BRAF targeted therapy. She is the NIHR Clinical Research Network National Specialty Lead for Late Phase and International Cancer Trials.

There was a session on head and neck cancer one of the speakers was

Dr Will Ince ( who is listed on Scancell website as the contact lead at Addenbrooks for the Modify trial )

Name:

Dr Will Ince

Job Title:

GU/Head and Neck oncologist

Affiliated Assistant Professor

Organisation / Company:

Addenbrookes, University of Cambridge

Biography:

I am a GU/Head and Neck oncologist at Addenbrookes and an Affiliated Assistant Professor at the University of Cambridge. I am research lead for urological malignancies and have an interest in all phase clinical trials. I have a particular interest in vaccine combination and monotherapy trials and have been chief and principal investigator in multiple trials both in the perioperative and metastatic settings. I have a link with a large internationally renowned translational biology laboratory with a specific focus on tumour epithelioids. Together with colleagues nationally I have been part of policy advisory committees trying to shape the future of vaccine delivery strategy nationally

We have only waited another week for news , however patients have had another week with their loved ones , this was the presentation from the Scope trial . we are exception another one from the Modify trial soon ,

the opening page on the Scancell website states "Potent and Safe Active Immunotherapies

for a Cancer-Free Future" have a read and a reminder of the pipeline https://scancell.co.uk/pipeline/

however this presentation is important and it will not have gone unnoticed

https://scancell.co.uk/wp-content/uploads/2025/12/SCOPE-data-update-presentation-11-December-2025.pdf

The prolonged progression free survival demonstrates iSCIB1+ in combination with checkpoint

inhibitors has potential to redefine standard of care. This therapy combination increases the

number of advanced melanoma patients who would benefit and improves the duration of their

clinical response versus equivalent timepoints with checkpoint inhibition alone, thus representing

an important step forward for patient outcomes

Dr Heather Shaw

Lead for the Medical Oncology Skin Cancer Service at University College London Hospital

Principal investigator of the SCOPE trial at Mount Vernon Cancer Centre

Https://www.oncology-forum.co.uk/

We are delighted to be holding the UK Oncology FORUM conference at the Harrogate Convention Centre on Thursday 11th & Friday 12th June 2026.

This meeting is for UK Oncology NHS Healthcare Professionals ONLY

The UK Oncology Forum programme has been wholly designed by the UK Oncology Forum Faculty and session chairs. No sponsors have had any input in to the UKOF programme or the choice of speakers and have provided sponsorship monies used towards venue, catering, audiovisual and materials. Sponsoring companies will have the opportunity to have an exhibition stand during the meeting.

The faculty, chairs, and speakers of the UKOF have had no input or influence over Industry symposia. The UK Oncology Forum is ABPI & RCP compliant. CME will NOT be awarded to all industry symposiums. All HCPs must attend the required sessions to qualify for CME certificates of attendance. PATIENTS AND MEMBERS OF THE PUBLIC CANNOT ATTEND, due to ABPI code, compliance, and guidelines.