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Morning Maxparker
As far as I can recall there have not been any promises to update us on any trial data in the first quarter 2024.
However our CEO is presenting at a conference in late April. Please see link attached.
https://www.immuno-oncologyeurope.com/cancer-vaccines
Chester.
There is a very high probability that the Scope trial will continue in a positive way.
Just presuming for a moment that iSCIB+ plus the Doublet of CPI moves forward and successfully completes a Registration Trial.
Our ‘off the shelf’ DNA vaccine plus CPI’s will benefit the vast majority of the estimated 60,000 patients per annum.
Not only a cost effective alternative to personalised therapy’s but also very attractive to health providers like the NHS.
Immunobody will also be proven to be a highly valuable platform.
Chester.
While it feels that news is slow to arrive we must remember that SCIB1 and MODI1 are both at work in their respective patients every day.
Waiting for our next trial update is a challenge but it must be so much harder for the patients currently on our trials to await news of their treatment results.
We do know that there will be updates in April due to our conference heading at the end of that month. The next two months will fly by, Christmas is already 8 weeks in the past.
Chester.
When I considered what could be achieved this year I was thinking more along the lines of chocolate digestives and jaffa cakes piled up at this years AGM. That's what I'd call Shareholder value....... 😄
Chester.
I have followed the journey of SCIB1 from small successful trial in Resected Melanoma to the stalled FDA's clearance of Ichors ‘TriGrid’ device resulting in the change to PharmaJet needle free delivery.
You could argue that around five years were completely wasted and we could be years ahead in the current Scope trial, except for the word ‘But’ !
Three major factors have meant that SCIB1 is exactly bang on time. The FDA holding up the trial with the TriGrid device was actually a blessing as it directly lead to Scancell actively looking for an alternative.
The Pandemic allowed both the PharmaJet delivery and the in human testing of AvidiMab.
The successful rise of Checkpoint Inhibitors and especially their move to first line Standard of Care has opened up SCIB1’s chance to show off an 85% ORR.
Would Redmile have put £40m into a trial that was using Electroploration, I very much doubt it.
The SCIB1 journey has had its twists and turns but it has by this convoluted route ended up at the right time with the right delivery device backed back the right investors.
Chester.
Hi WTP
I think most of us on this board see through any such attempts to create doubt.
To be honest as we begin to receive more data from SCIB1 and Modi1 it would be interesting to see if the doomers pop up even more. A kind of ‘doom mongers’ inverse graph.
Chester.
Hi Desouzaa
The ORR of 85% achieved by Scancell when combined with the two Checkpoint Inhibitors, is amazing. There is no doubt that any other Biotech or Pharma companies in the same space will be very aware of SCIB1.
Currently the number of patients in the reported data is only small but that is being dealt with as each week passes.
If by July 2024 we have treated 35 or 40 patients and the ORR is still well above 70% ( to maintain 85% would be nice ) large Pharma will be extremely interested and the likes of Iovance will be very aware that an ‘off the shelf’ therapy has the potential to push their product to the margins.
We will see data reports by the end of Q3/24 that will have the potential to propel Scancells share price above the most recent high of 29p. The amount and quality of that data could be what I have waited for these past 10 years.
Chester.
Hiya Ray
We have probably discussed the price tag for a commercial SCIB1 + CPI treatment in the past but if it was I cannot remember the details. What would be Scancell's revenue be for a three dose treatment ?
Any rough idea would help me understand the early potential of gaining approval.
If iSCIB+ plus CPI's is successful then I could multiply by 2.5
Chester.
Another unique and groundbreaking cancer treatment now FDA approved and we should wish it every success possible.
This treatment cannot be used on unresectable tumors, here’s a quote from the article :
“ For starters, because Amtagvi is made with TIL cells from a patient’s own tumor, patients with unresectable tumors won’t be eligible for the therapy”.
So Scancell’s SCIB1 + CPI’s is needed just as soon as is humanly possible.
Chester.
Good spot, I'm obviously just checking that everyone is awake ..... 😉
With your permission I will change that to Relative Survival Achievement.
I'm really thinking about the results seen in the original SCIB1 Mono trial. Of the original 16 patients would I be correct in saying that the majority are still alive after 10+ years.
Chester.
At the latest Analyst Presentation Q&A, Lindy said this :
"I think our data is better than Ultimovacs, but I would say that"
Our CEO attests that SCIB1 plus the Doublet of Checkpoints is producing better data. The crux of the results will be around survival expectancy. Will Immunobody plus checkpoints in the SCOPE trial induce memory 'T' Cells and give years of survival rather than months of ?
Chester.
On the question of what news and when, my thoughts are.
Possible in the next 8 weeks :
Modi1 + CPI Trial Update Early April.
GenMab decision to move to a Phase1 trial with our 'Target'.
Out come of the 6 month Evaluation of GlyMabs by a USA Biotech.
iScib+ 1st Patient Dosed.
Mid Year ( June / July ) :
GenMab to agree another GlyMab or Target of.
A GlyMab deal with other than GenMab.
Neo-Adjuvant Cohort Early Results.
Scib1 + CPI Trial data Update.
Aug / Sept :
Strong Interest in AvidiMab leading to Agreed Evaluation.
iScib+ CPI Trial Initial Update.
Always the chance of some left of field news but all of the above is within the boundaries of what we know or what we have been told.
Chester.
I realise that it's frustrating, to be once again waiting for SP moving news.
Medical breakthroughs, the type that Scancell are attempting, can take many years to cross the threshold of 'science hope' to 'accepted and valuable science fact'.
There are two facts that we need to acknowledge:
1) Without Vulpes £4.5m and subsequently Redmiles £40m Scancell would be many many years behind where we are. Those two investments were crucial in paving the way to afford both trials and bringing many functions in-house.
Also to attract the quality of staff we now take for granted.
2) Both Scib1 and Modi1 have had to start in populations of very poorly cancer patients. We long term holders all hoped that Moditope would be the new miracle treatment for human cancers after the outstanding lab tests on mice.
In time we may find that Moditope is what we wished for when treating very early cancers but that has to come after it has proven itself to a population of patients that are willing to take the risk. The terminally ill.
Looking backwards from where we currently are, you can see that it was inevitable that we needed the influx of large funds and poorly patients willing to be our guinea-pigs.
As far as I'm concerned the results so far are outstanding considering the challenges facing a new drug. The fact that Standard of Care 'Checkpoints' have also allowed Scib1 to do its best work is also a matter of very fortunate timing.
Chester.
From the AGM we know that the 1st Neoadjuvant patient was given their first MODI1 injection just a few days after the AGM. That very first patient should have their tumour removed at the very end of January or the first week of February.
This Cohort requires 15 patients in both, with and without the addition of the single checkpoint. I have no idea of how many patients can be treated each month but I'll guess at 6 per month, that will take us to April / May with a read out sometime in June or July.
The next 3 to 6 months are packed with potential news and results to finally unshackle the SP.
Chester.
Posted back in Feb 2023 :
We have four GlyMab collaborations. I presume the GenMab one was the first back in September 2019.
The second announced on the 16th December 2019 was with a Chinese BioTech.
The third 20th January 2020 with a US Based Clinical Stage Antibody company.
Then the pandemic shut everything down for a year at least.
The fourth and most recent 17th March 2022 with a Major European Pharma.
Bringing that list up-to-date we need to add in the announcement back in June that a new Biotech / Pharma Co was doing a six month evaluation.
Chester.
Morning Burble
Thank you for your thoughts on my questions.
The fact that we can make any significant dents in these hard to treat late stage cancers is a credit to Scancell's science.
I'm reminded that the journey of Checkpoints was a hard sell in the mid-90's.
mRMA is the current in-vogue path to treatments and cures but maybe Immunobody and Moditope with continued success will supplant any in oncology.
I hope that there is sufficient interest in our GlyMabs to win at least one new customer in 2024. I think AvidiMab will be a great success but it will take many months of laboratory work to prove up and achieve the first deal. After the first one is over the line there could be many more.
Again thank you for your insights.
Chester.
Hi Burble
There is a kind of blinkered view that mRNA is the way forward. That's where the money is and that's why the scientific talent is being drawn towards it.
In late stage cancer tumours Modi1 in monotherapy has found it difficult to mount enough of an attack to overcome the vastly mutated micro-biome. It would be very interesting to see how it performed at a much earlier phase of a tumours development.
Do you agree that it's because Scancell are having to start with the most difficult stage cancers that we are flying so under the radar.
Chester.
Thanks Ray,
So the idea of 30 patients is a threshold where the the sample size is not thought of as being to Small to be representative of larger group study outcomes. That makes sense.
Large Pharma probably just use it as 'Risk Guide' when considering early clinical data. They do seem to suffer from the 'Fear of Missing Out'. To understand where Scancell are we need to see at least 30 to 40 patient outcomes and if we are still hitting that 80% to 85% range then job done in a very positive way.
Chester.
Hi Ray
Yes, my thoughts are that at the AGM LD said it was 11 out of 13 that had responded.
One of the 2 was Progressive and had left the trial and the other had reached a 24% response which is classed as Stable. The hope is that that patient would respond further as time goes by and does reach 30% at some point. That would be amazing at 12 out of 13.
The key clinical response would be 27 out of 34 ( 79.4% ) as that would be statistically significant.
13 at the AGM had reach their 12 week 1st Scan, so now, some 7 weeks later it could be, fingers crossed, anywhere from 15 to 18 ish. Obviously it depends on the recruitment timeline.
Chester.