Member Info for Burble

That was posted five months ago. He started working at GHP in November 2024. Stuart has since deleted his post on X

Interesting that the Business Dev staff member isn’t going but CMO/CEO are.

A new LinkedIn post appeared this morning.

As melanoma and skin cancer awareness month draws to a close, today we are shining a spotlight on our ongoing Phase 2 SCOPE study in advanced hashtag#melanoma.

Buoyed by a landmark hashtag#partnership with the NHS Cancer Vaccine Launch Pad, this hashtag#ClinicalTrial is investigating the potential of iSCIB1+, Scancell’s next generation, ‘off-the-shelf’ targeted hashtag#CancerVaccine, in combination with checkpoint inhibitors (CPIs), the current standard of care in immunotherapy. While the standard treatment in advanced melanoma, only around 50% respond to CPIs alone, and there is a critical need for convenient, safe and effective treatments that would allow patients to receive immediate care.

We have previously reported compelling results from cohort 1 of the SCOPE study, with initial data from 25 patients receiving the first-generation vaccine SCIB1 showing 80% progression free survival (PFS) at 6 months and 20% of patients showing a complete response. Data from further cohorts is expected later this year, and we look forward to providing updates as we continue to progress iSCIB1+ towards a global registrational study in H2 2026.

For more information on the Phase 2 SCOPE study: https://lnkd.in/eZyhFYRn

So again, we see the narrative highlighting iSCIB1+ being the product they will be moving forward next year 'and we look forward to providing updates as we continue to progress iSCIB1+ towards a global registrational study in H2 2026.'

Genmab - absolutely not a scooby. I'm surprised we've not heard a dicky bird from them in ages, especially given our CEO says that they receive regular updates from them.

So Greenland has struck one deal - https://www.thelondoneconomic.com/news/greenland-humiliates-trump-by-agreeing-lucrative-minerals-deal-with-europe-393493/

Now hopefully they do the same for Graphite

Dracula, it was me being facetious! Everyone’s focus is on SCOPE results, yet we also were told at the last analysts call that Modi-1 results would be around mid year. So I was joking that the results they drop weren’t the ones people have eyes on but the lesser talked about Modify trial.

You mean like Modi results?

Two things that have stood out

Lead product - iSCIB1+ - this has been highlighted before but there seems less talk about SCIB and more talk about iSCIB1+. So we sit and wait to see what the data is like on this.

Secondly, Phil's talk about FDA timelines and looking elsewhere. I wonder whether these have been kicked up a gear and actually any Ph3 trial will have less of a focus on the US and more on places like Europe, Australia etc.

On top of that remember according to Lindy at the AGM we were due an update from Genmab regarding the GlyMab progress in December/January. So if that was correct, that's nearly 6 months overdue.

Very sad to hear of Chelsea7’s passing and I appreciate you letting us know.

Thoughts are with his family and friends at this difficult time.

A really interesting podcast which features Meygen

https://youtu.be/EJfYhOlCYeE?si=wYOmQUPElfJQVBXy

Great UK Cancer Vaccine Summit Awards - UK Oncology Form 2025

'Building on the success of the Great National Cancer Vaccine Summit, the UK Oncology Forum is proud to host its inaugural Cancer Vaccines clinical session in June 2025. The landmark session will bring together the nation’s leading trialists from world-class centres to share their insights and the latest breakthroughs in cancer vaccine research.

New for 2025, Great UK Cancer Vaccine Summit Awards will be presented to those driving the UK’s ambition to be a global leader in cancer vaccine development. Five awards will honour individuals who have demonstrated exceptional contributions to this national effort.'

Lindy, Christian and Heather are all up for nominations. It's a public vote which can be found here https://forms.office.com/pages/responsepage.aspx?id=G96VzPWXk0-0uv5ouFLPkYpPfKEgwhJFsxnChwrvUPhUNThPRkRLTDYyQ0lFT0E0NTZFVEFCQUMxWC4u&route=shorturl

Link to the event https://neoantigen-summit.com/

Then the event guide https://web.hansonwadegroup.com/rs/355-DOS-429/images/8th%20International%20Neoantigen%20Summit%202025%20Event%20Guide.pdf?version=0

Nermeen Varawalla (CMO) is running a pre-conference workshop at the International Neoantigen Summit titled 'Identifying rational, synergistic neoantigen combination strategies maximise clinical efficiency and overcome tumour resistance to improve patient response rate'.

The blurb says:

Helping the industry to overcome challenges in efficacy and tumour resistance, combination strategies have been hailed the future of immunotherapy, with neoantigen-targeted cell therapies and vaccines increasingly being administered alongside other immunotherapies. However, navigating the complexity of administering multiple drugs

requires smart protocol design, identification of distinct biomarkers, careful monitoring of toxicity, and precise assays to elucidate the effect of each therapy.

This workshop will cover:

- Understanding the limitations of neoantigen monotherapies and identifying the most rational, synergistic combination strategies

- How to optimise patient selection based on individual patient and tumour characteristics and immunopeptidomic data

- How to schedule administration, determine dosing, and monitor toxicity in patients to maximise efficacy and tolerability of neoantigen-targeted therapy combinations

- Effectively monitoring immune response and identifying unique biomarkers to elucidate the effect of each individual therapy to determine synergy versus independent action

In addition in the session titled 'rethinking clinical trial design to optimise patient selection, administer neoantigen therapies in the correct setting & appropriately determine clinical success Nermeen has a half hour presentation titled 'smart design of neoantigen clinical development'

- selecting the cancer type, disease setting and patient subpopulation

- determining dosing schedules, mode of administration and alignment with standard of care

- deciding on end points of immune and clinical response to demonstrate improvements over standard of care.

Interestingly the presentation after her is by Sebastian Klobuch and with a title of 'BNT221 - a first in human trial with a personalised, autologous, neoantigen-specific T cell therapy in metastatic melanome'. I.e. a presentation on the BioNTech personalised medicine for melanoma.

Step by step Ilika keep achieving their milestones. This RNS is another step closer to commercialisation of Goliath

You say cohort 4 doesn't delay timelines. If the decision to go with iSCIB1+ has been made, then yes it wouldn't delay the manufacturing of API for the registration trial. However, if the final decision as to whether to go with the intramuscular or the intradermal requires that cohort data, then this could delay formulation, final manufacture and fill-finish of the API into the final dosage form. Furthermore, CDMOs get booked up months/years in advance for GMP manufacturing slots, so any delay in knowing which delivery route could have knock on effects.

In addition, I would assume that any filings with the regulators would want to see a full dataset. So again, any regulatory filing as part of the registration trial would most likely need to wait for a full cohort 4 readout. Hence, I wouldn't say 'good thing cohort 4 doesn't delay timelines' because there is a likelihood it may impact them. Though I would hope with the CVLP collaboration recruitment is swift and we get data soo enough to make that decision and proceed with manufacture/regulatory submission.

Miovoce,

There are a number of reasons behind this but the main one that comes to mind is that in unresectable patients, the treatment may possibly last longer. Whilst in the neoadjuvant/adjuvant treatments, these would typically be given for a defined period - i.e. in conjunction with other therapies like surgery or radiation. Shorter treatment durations would lead to lower cost per patient, but the neoadjuvant/adjuvant cohort is larger.

Others may have other ideas as to the differing costs.

I think the standout slide for me was the inflection points, mid year for read outs from arms of SCOPE and Modify. There was a confidence to this which suggested they know when these should read out and therefore will be sticking to timelines. Here's hoping. Overall, like Moonparty said, positive and confident.

Scinv, my turn of phrase has obviously rattled your cage. Having presented my data at numerous international conferences during poster sessions I fully understand how these sessions work.

For the avoidance of doubt in case you didn't undestand the meaning I was using, I will point you to the wikipedia page on this (https://en.wikipedia.org/wiki/Poster_session) which states 'A poster presentation, at a congress or conference with an academic or professional focus, is the presentation of research information in the form of a paper poster that conference participants may view. A poster session is an event at which many such posters are presented. Poster sessions are particularly prominent at scientific conferences such as medical and engineering congresses.'

'I'll be surprised if there is no RNS tomorrow, given the conference this weekend too....'

I suspect any RNS will come on Monday or possibly Tuesday. Chicago is 6 hours behind us currently, meaning Nermeen's presentation on Monday will be between 2000-0100 UK time. Given that we have a poster at the late-breaking session, the abstract is under embargo until tomorrow April 25, 2025. IIRC I believe that for the late-breaking sessions the data cannot have been published elsewhere before the presentation, but unsure how far in advance this caveat stands.