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CW...yes you'd think the likes of NICE/NHS would definitely prefer something off the shelf and far cheaper than the very costly personalised approach.
Thinking allowed the bespoke vaccine will take longer and be more expensive to produce. So could cause a significant delay
The off the shelf offering from Scancell could reach the required patient numbers quicker
Pros and cons of both vaccines.
Ray,
SCIBI has produced some fablulous results in the adjuvant setting albeit in small numbers in a single arm trial but as a monotherapy. The issue I have with comparing the 49% from the Moderna vax's with SCIB1 lies with that 49% fiigure. If it represented the RFS rate of the Moderna arm of the trial then I can see how you might start to make a comparison, but it doesn't. It's the improvement in the likelihood of a recurrence compared to the results produced by Keytruda alone. So in that trial the Moderna patients were 49% less likely to have recurrence compared to the patients on the same trial receiving Keytruda alone. We have absolutely no clinical results from SCIB1 to compare that with.
Moderna still have to a long way to go with this vaccine. There's the Phase 3 clinical trial itself, a double blind randomised study in just under 1100 patients and then there's the whole process of seeking approval with the various regulators. It will be fantastic for Scancell if they're successful and should Scancell ever want to revisit the adjuvant setting with SCIB1 it might even provide an easier path through to approval. Just matching the results of a personalised vaccine with an off the shelf solution should be enough.
From Inan on the other board...
"lets assume that moderna and merck get approval ...
and they become the standard of care
Opdivo and Yervoy left in the cold
Bristol Myers being a poor relative losing business thinks ....
we want that market .... SCIB1 tested with our product is stunning ...
Ok .. make a move"
On sky news as well
Just noticed the headline has changed in The Times from :
Skin cancer jab trial targets high-risk melanomas
New headline
Bespoke cancer vaccine targets tumours in landmark trial
https://www.thetimes.co.uk/article/e23343c5-91c4-49b0-9fa4-c1eec5c2bb2c?shareToken=
They are discussing the MRNA skin cancer vax btw
Good listen. I have whattsapped them about SCIB1. Expect to be ignored!
Bear in mind that there has already been a clinical trial for SCIB1 on it own (i.e. without checkpoint inhibitors) in the adjuvant setting.
The numbers were small in the trial and the delivery method was different to that of the current SCOPE trial.
However, the famous swimchart is testament to the high level of success in this trial, albeit with the limitations stated in the previous sentence.
This will not escape the notice of pharma keeping their eyes on SCIB1 and iSCIB1+ results.
For years cancer vaccines were considered a no go area. so this exposure is a great thing as we obviously think ours is better and universal, cheaper and currently with better results subject to expansion of trial.
Perhaps this may be the nudge needed for a bid approach 🤔 🙏
Ee
I apologise if I should have understood that from your post but it wasn't obvious to me because SCIB1 has never been trialled in this setting - ie. in combination with PD-1 CPI in the adjuvant setting. So how can you compare at this stage?
Keytruda is approved as an adjuvant therapy in melanoma and the Moderna trial was a randomised study with Ketruda alone as the control arm versus Keytruda plus the Moderna Vax. So the 49% figure is the reduction in the risk of recurrence/death when taking the combination versus treatment with Keytruda alone.
That is the whole point of my last sentence - if the phase III study is successful it validates the combination setting for cancer vaccines.
Bermuda,
It should have been totally obvious to you that I was drawing a comparison with SCIB1 and its potential effectiveness. 🙄
Plainly if “the only game in town” offers some smallimprovement, you would take it.
Bermuda,
I thought the same when I read the post - I'd jump at the chance of a 44% better chance of survival. (The figure in the daily mail article)
I'm not sure this halves the chances.we'd need to know the figure it's an improvement on.
Ee
Seriously? Think if I was about to face surgery to have melanoma removed but was told I was in the very high risk category of it returning and someone offered me a vax which halved the chances of recurrence I'd jump at it. Credit where credit is due.
Success of any cancer vaccine is great news for Scancell but as 2cvguy mentioned earlier, this is particularly important as it establishes the utility of cancer vaccines in combination with checkpoint inhibitors.
As mentioned earlier in the week by Bermuda
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.
article
Abstract
Authors
Heather Shaw
Heather Shaw
Mount Vernon Cancer Center
Heather Shaw, Poulam Patel, Miranda Payne, Satish Kumar, Sarah Danson, Martin Highley, Kellati Prasad, Ruth Board, Clare Barlow, James Larkin, Kate Young, Amanda Fitzpatrick, Ioannis Karydis, Maria Marples, Rebecca Lee, Philippa Corrie, Robert Miller, Georgia Goodhew, Fayaz Master, Lindy Durrant
Organizations
Mount Vernon Cancer Center, Nottingham University Hospitals NHS Trust, Churchill Hospital, Velindre Cancer Centre, Weston Park Cancer Centre, Sheffield Teaching Hospitals NHS Trust & University of Sheffield, Derriford Hospital, Lancashire University Hospital, Lancashire Teaching Hospitals NHS Trust, Musgrove Park Hospital, Somerset Foundation Trust, The Royal Marsden Hospital NHS Foundation Trust, Royal Marsden Hospital NHS Foundation Trust, Guy’s & St Thomas’ NHS Foundation Trust, University Hospital Southampton NHS Trust, St. James's University Hospital, The Christie NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, Scancell Ltd
Thanks C11,
Just to add that both may prove to have further utility and each will plough it's own furrow so to speak. It is important to remember the development opportunities that may arise from these types of platform. There-in lays the real value me thinks. But first lets get iSCIB1+ validated!
Bermuda, thanks for your reply to my concern!
This is the lead story in The Daily Telegraph today. A 49% improvement doesn’t sound enough for a personalised vaccine to me. Lets hope that one of the reasons for Scancell’s recent quiet period in RNSs is that they are preparing a blockbuster update - together with attendant front page publicity!
Violindog,
Sorry, missed your post. Don't worry, the Moderna clinical trial won't have any impact on recruitment to the SCIB1 trial because it's in a different setting and recruiting from a different patient population. Moderna's trial is in the adjuvant setting - patients who have had their tumours surgically removed and are vaccinated to prevent recurrence whereas Scancell's trial is recruiting patients with advanced inoperable melanoma with tumour in situ.
C11 agree with your point room for more than one type of cancer vaccine Heather Shaw referred to “ these will be game changers in immunology “
See Bermuda post on ASCO earlier in the week . Also heather shaw in on the advisory board for the Scope Trial
Skin cancer jab trial targets high-risk melanomas
https://www.thetimes.co.uk/article/e23343c5-91c4-49b0-9fa4-c1eec5c2bb2c?shareToken=6d03ef8920e19e9d3d4fd5f793fc9d06
Dr Heather Shaw, consultant medical oncologist and the national co-ordinating investigator for the trial, said: “I think there is a real hope that these will be the gamechangers in immunotherapy.”
Each patient has their own personalised jab manufactured within weeks, using mRNA genetic code found in their tumours. When injected, the jab instructs the body to create proteins identical to those found on the surface of tumours, triggering an immune response.
From Bermuda shorts
Really good to see that Heather Shaw, one of the SCIB1 study investigators will be presenting a poster at ASCO in Chicago in June.
SCIB1 & iSCIB1+ - Scancell
The abstract title:-
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.
Presenter: Heather May Shaw, MD, FRCP, MRCP | Mount Vernon Cancer Center
Abstract: 9535
| Poster Bd #: 319
ASCO isn't just another scientific conference, it's the largest oncology conference in the world and it would have been disappointing if Scancell were not represented.
Chelsea
Absolutely spot on.
IMO, it won’t be a case of either MRNA, or DNA as an available treatment option and there will be room for both as ammo against melanoma. In the same way that there are often multiple treatment options for other diseases. Assuming of course that trial data proves they both work well.
The publicity is positive on a number of fronts. Scancell now need to get their own data published. We already know that should be this year and we’re already in April, so it’s just a handful of months away.
Explains why recruitment has been a little slow....Moderna will be first in the queue!
I like the way the BBC website article has the quote 'you couldn't give this to the next patient in the line because you wouldn't expect it to work.
"It's truly personalised."'
Makes it.sound like an advantage rather than a drawback. If Scancell vaccines come along as hoped, imagine the quotes available for them - ' off the shelf', 'universal' etc.
Just have to wait and see.