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The SCOPE study record on clinicaltrials.gov has been updated to show that Christies, Manchester is now recruiting. So all study centres are now up, running and actively recruiting.

https://clinicaltrials.gov/study/NCT04079166?term=scancell&rank=2#contacts-and-locations

It's highly likely that Redmile's agreement to extend the CLNs again was conditional upon a seat on the Board - it's probably as simple as that.

From ADVFN courtesy of Marcus -

https://www.oncologypipeline.com/apexonco/scancell-faces-its-big-decision

No, I believe this is new research - the paper was submitted for review in January this year, accepted on 25th June and published on 2nd July.

It appears to follow on from a previous project and a collaboration between Scancell, Nottingham Trent and the University of Portsmouth which was also funded by the Headcase Cancer Trust and there have been other collaborations with Nottingham Trent in prostate cancer so that's why it may seem familiar.

Excellent find WTP - thanks for posting.

Worth noting:-

'We have been able to demonstrate that immune cells activated using the SCIB1 ImmunoBody® vaccination can exert therapeutic efficacy in an intracranial tumor model prolonging the time-to-death of mice when combined with anti-PD-1 immune checkpoint blockade'

'This work was funded by the Headcase Cancer Trust (UK), the John and Lucille van Geest Foundation, Nottingham Trent University QR allocation and the John van Geest Cancer Research Centre (Nottingham Trent University). Scancell Ltd also generously provided materials used in this study.'

https://link.springer.com/article/10.1007/s00262-024-03770-x

The links below are to part 1 and part 2 of an article in which 5 experts give their views on cancer vaccines. May be of interest to longs here - especially part 2. This quote is from Ultimovac's CMO:-

' I believe that therapeutic cancer vaccines are poised to become an established standard of care in several different tumor types, most likely when combined with checkpoint inhibitors. There is opportunity for several different modalities, such as RND, DNA, and peptide vaccines, as well as strategies ranging from personalized vaccines to more generalized vaccination approaches. Moving forward, the issues of cost and access in terms of affordability and patient accessibility will be increasingly important. '

https://themedicinemaker.com/manufacture/cancer-vaccines-activate-the-immunosoldiers-part-i

https://themedicinemaker.com/manufacture/cancer-vaccines-activate-the-immunosoldiers-part-2

Scancell are making a couple of very interesting presentations at Pegs Europe in Barcelona in November. We know they've been working on preclinical development of anti glycan mAb SC134 as a T cell redirecting antibody and it seems they've now taken that a step further and are looking at merging a TCB with one of their cancer vaccines. This really is cutting edge stuff. Presentations are as follows:-

Harnessing the Power of Combined Vaccine and T Cell Redirecting Bispecific Antibody to Maximise Anti-Tumour Immunity

Foram Dave, PhD, Research Scientist, R&D, Scancell Ltd.

The success of T cell redirecting antibody in solid tumours is limited due to inherent immune suppressive nature of the tumours, resulting in minimal T cell infiltration. Our proposal merges our in-house vaccine with a T cell redirecting bispecific antibody to overcome this challenge. The vaccine induces initial activation and influx of peripheral T cells, providing an initial boost for CD3 bispecific antibody engagement. Our presentation will highlight the advantageous impact of combining two novel modalities, offering a new approach for cancer treatment.

Fucosyl-GM1: A Versatile Target for SCLC Therapy

Mireille Vankemmelbeke, PhD, Principal Scientist, Biodiscovery, Scancell, Ltd.

SCLC patients are faced with limited treatment options. T cell redirecting antibodies have shown great promise in liquid tumours and are now at the stage where encouraging results are becoming evident in solid tumour settings. ADC modalities have already delivered therapeutic benefit, but careful target selection is warranted for both. The tumour selectivity of the SCLC-associated glycolipid fucosyl-GM1, its expression being virtually absent in normal tissues, combined with evidence of functionality across two modalities open the door additional targeted treatment options for SCLC patients.

https://www.pegsummiteurope.com/next-generation-immunotherapies#ForamDave

Worth remembering that all clinical trials must be registered and the update on clinicaltrials.gov is essentially just record keeping. The main change with the latest update is the addition of the iSCIB1+ cohort and as Johnny has mentioned Scancell have already issued an RNS to confirm first patient dosed and another previously to announce MHRA approval to add this cohort. Other than that the changes of interest are the addition of new trial centres. These are obviously welcome additions as they should speed up recruitment but Lindy had already confirmed plans to open new centres in April. It seems these are all now up and running and Scancell have updated clinicaltrials.gov accordingly.

C7 - Scancell are well funded to late 2025 which allows them time to reach important inflection points - SCIB1 and iSCIB1+ trial results, early Modi1 results and the outcome of the recently announced glycan mAb evaluation. Can't see why they would even begin to think of another funding round in advance of these events. They certainly don't need the cash anytime soon.

The 130 figure is just the estimated total no. of patients required across all arms of the study. We know that the SCIB1 and iSCIB1+ arms in combination with doublet therapy will recruit up to 43 patients each giving a total of 86 patients. I assume that the SCIB1 in combination with single checkpoint inhibitor makes up the difference.

The SCOPE study record on clinicaltrials.gov has been updated today to include iSCIB1+. Estimated total no. of patients now 130. Also good to see the following changes (as far as I can tell) in study centres:-

1) Guys and St Thomas' are now open for recruitment

2) Christies Manchester has been added but not yet recruiting

3) New centres have opened in Cambridge, Royal Marsden London and Leeds and all are recruiting.

https://clinicaltrials.gov/study/NCT04079166?term=scancell&rank=2#study-plan

What a very sad announcement from Scancell this afternoon. MND is a dreadful disease and I'm sure all Scancell holders would wish to send sincere condolences to John's family and friends.

https://www.scancell.co.uk/it-is-with-great-sadness-that-scancell-announces-the-death-of-former-chairman--john-chiplin

Yes well spotted DeAar - thanks for posting.

Moving on and much more important, a big round of applause for Merck who have today announced FDA approval of Keytruda in combination with chemo for advanced endometrial cancer. This is the 40th indication for which Keytruda has secured FDA approval - an incredible achievement and who knows how many lives have been saved/extended thanks to these PD-1 inhibitors.

https://www.businesswire.com/news/home/20240617180729/en/FDA-Approves-Merck%E2%80%99s-KEYTRUDA%C2%AE-pembrolizumab-Plus-Carboplatin-and-Paclitaxel-as-Treatment-for-Adult-Patients-With-Primary-Advanced-or-Recurrent-Endometrial-Carcinoma?utm_campaign=shareaholic&utm_medium=twitter&utm_source=socialnetwork

This will be my last comment in relation to Scinv_Temp and the only reason I'm commenting is that his claims re. ORR are simply not true and it's important that holders realise that the objective responses achieved so far are banked as far as the overall trial is concerned.

The posts are all there to see from 9th June when he claimed that if any of the 11 patients with an objective response showed progression at a subsequent scan then the ORR would be reduced. Moreover he claimed that the only objective responses that would contribute to ORR would be the last measure taken (in this case at 2 years from outset). This is simply not true and if anyone is unsure then please do check with Scancell - the objective responses achieved to date are banked and will count as part of the ORR for the whole trial, just as they did for the Evaxion trial in my last post.

So then you have to ask yourself why someone who claims to have 'led the biology' to take drugs into clinical trials and who now is a full time investor advising biotech. companies on a part time basis would make such a basic mistake. Moreover when challenged would scrabble around trying (but failing) to find evidence to support his claim whilst responding in an aggressive and accusatory way to posters on this bb.

Much more revealing though are his accusations of dishonesty towards Lindy Durrant. Quite apart from the fact that Lindy is a well known and highly respected Professor of Cancer Immunotherapy with an academic career spanning decades, it seems very odd and frankly unprofessional for someone who claims to act on an advisory basis to biotech companies to accuse a biotech CEO of dishonesty on a public forum.

I'm sure this post will generate more accusations and outrage and attempts will be made at yet more negative blanket posting but he has already admitted to previously being banned from lse and I suspect he'll eventually be banned again.

Violindog,

It means that having previously responded and demonstrated shrinkage their tumour(s) had started growing again.

Danish biotech Evaxion published phase 1 clinical trial results for their personalised cancer vaccine EVX-01 today - see link below. The results are for patients with advanced inoperable melanoma receiving CPI in the first line setting. This is the same setting as the SCIB1 study although the Evaxion trial is in combination with a single PD-1/L1 checkpoint inhibitor as opposed to the doublet therapy for Scancell's trial. Nevertheless there are some interesting comparisons to be made

1) Evaxion reported an objective response in 8 out of 12 patients which equated to an ORR of 67%. This included 2 complete responses and 6 partial responses. As we know Scancell to date has reported an ORR of 85% (11 of 13 patients).

2) All but 1 of the Evaxion patients with an objective response subsequently progressed at a later scan with duration of responses of 2, 4, 5, 8, 9 and 10 months. We don't yet have this data for Scancell, as far as I know the latest update showed all 11 responses ongoing at 19+ weeks.

3) The Evaxion vaccine took between 6 and 8 weeks to manufacture but as it had to be administered on the same day as the PD-1 it took between 7 and 10 weeks for patients to receive their first dose.

Scancell does have the advantage of testing in combination with both PD-1 and CTLA4 CPIs and it's too early to compare duration of response, however given the cost and time to manufacture Evaxioin's personalied vaccine SCIB1 seems to more than hold its own in this setting. Have to stress that we need to see results for both vaccines in larger patient numbers but Evaxion's results do give some perspective I think.

Finally, in light of recent discussions please note that ORR is given as 67% (8/12 patients) and the timescale on clinicaltrials.gov is 3 years. Despite the fact that all but 1 patient had progressed, the ORR remained at 67% - if responders progressed at a subsequent scan the response was banked and it did not reduce the ORR of the trial. The same is true of the Scancell trial despite comments on this board.

https://jitc.bmj.com/content/jitc/12/5/e008817.full.pdf

https://clinicaltrials.gov/study/NCT03715985?term=NCT03715985&rank=1#study-plan

Wonder whether this could be Genmab again - we know they were interested in a second mAb. Whoever it is, it's good to see that they're serious enough to part with hard cash to secure exclusive access. Well done Lindy.

......and where in that document does it state that PD in a previous responder affects the ORR of the trial? One of us is busted and it isn't me. You have shown your hand and I won't be responding to any further posts from you.

.......and nowhere on the clinical trial record does it state that ORR has to be maintained until the last measurement given in the timeframe section. The timeframe is simply the period of time over which the measurement is taken.

To be absolutely clear to those who you may have been concerned to read Scinv's comments - once an objective response has been recorded it is in effect banked as far as the clinical trial results go. Even if that patient subsequently progresses at a later scan it will not affect the ORR of the overall trial as he/she has already demonstrated a response that meets the criteria laid down in the trial protocol. He/she does not have to maintain that response for 2 years in order to be counted and the objective responses shown so far by the 11 patients can not be taken away.

The whole point of ORR as a measure is to understand the percentage of patients responding to treatment. The length of the response and the impact on survival is measured by duration of response, progression free survival and overall survival.

I have no idea why someone who claims to be an expert with industry experience would post such misleading information or appear to misunderstand such a basic element of clinical trials. Scinv - you owe me an apology, I won't hold my breath and I expect you'll respond in your normal aggressive manner.

Moonparty,

The 2 year timeframe quoted by Scinv_temp is simply the period over which the measurement is taken. My 18.42 is absolutely correct - once a patient has demonstrated an objective response, it is effectively banked in terms of the overall study. If they subsequently progress it has no impact on ORR.