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Wow! Those results have even surpassed my expectations. Especially as Avidimab and the expanded epitopes in iSCIB1+ could broaden this out to more patients.
Then imagine adding Avidimab to the two checkpoint inhibitors - if that extended the patentable life of those….Scancell technology could become very valuable indeed!
Berm,
Would I be correct in thinking that Cohort 1 would be the Keytruda only cohort and Cohort 2 would be the Opvido +
Yervoy after the amendment. I wonder if they are swapping terminology between cohort 1 and cohort 2 and stage 1 and stage 2.
This was detailed in the 15th June RNS (https://www.scancell.co.uk/Data/Sites/1/media/publications/rns/phase-2-scope-trial-of-scib1-vaccine-in-metastatic-melanoma-patients-expanded-final-15.06.22.pdf)
So I would assume that the read out may be just from the Keytruda only patients as I would assume that this cohort has been considered fully recruited to given the treatment standards changed. Therefore there would be no longer patietns recruited onto keytruda only if guidelines had changed to the doublet therapy.
As such is the Trinity Delta note mixing these up
Cohort 1 (Keytruda only) = 15 patients
Cohort 2 (Doublet therapy) = 28 patients
Total = 43 out of a total of 87
Having said that, that only accounts for approx. 50% of the patients. So unsure where the other 50% are coming from. Could it also be that they are now testing electroporation vs needle free? Or the final paragraph within the Trinity Delta note suggests that they may recruit a second cohort using the iSCIB1 'A repeat of Cohort 1 using iSCIB1+ in combination with doublet therapy could start by YE23 for top-line data H1 [20]24'
Some clarity from SCLP I think is needed because I sure can't wrap my head around things having looked over previous RNS and AGM data, there doesn't seem to be a clear rational for numbers.
A tumour is usually considered unresectable meaning surgery is not a treatment option available. There are a number of different factors that may contribute to this clinics up decision, such as the size or location of a tumour (for instance if it is located in a difficult to reach place, or one that would seriously risk harming or killing the patient during surgery attempt) or if it is too big (for instance a tumour which has invaded the majority of the liver). Often, though, the reason surgery is not possible is because the cancer has spread from its original site for example through the lymph nodes.
In some cases, radiation, chemotherapy and other treatment alternatives such as immunotherapy or in this case Modi-1 may cause shrinkage of tumours.
For some patients, if a tumour size is smaller after treatment, then surgery may then become a possibility. It also may be possible if the cancer has only spread to a few sites that resection can now be performed on these sites whereas before this wasn’t the case.
However, for many patients unresectable sadly remains unresectable. If the tumour stops responding to a treatment and other lines of treatment are exhausted then it sadly is the end game.
I had another thought too.
Being a first in class therapy, Modi-1 would probably never have been able to be run in early stage patients. These patients have exhausted their other options, so are prepared to sign up to the trial, take a punt. Earlier stage patients with options available to them would probably not consider signing upto an experimental treatment.
If we think about our patients, being in the first cohort of people to be dosed in the world with Modi-1 is pretty incredible and they have made a mark in the scientific tapestry of knowledge.
Modi-1 has given somebody an extra year of life. With minimal side effects and with a period of improvement across that year in their quality of life. Without it, disease progression may have been swift - we’ll never know what would have happened had they not consented to be on this trial.
So on a patient level, for this one patient (and possibly more that we don’t know about) moditope has been beneficial.
I think we get very emotionally attached to money (and as investors this is natural). But we can’t lose sight of the benefit that moditope has brought to patients in the trial, their friends and families.
So have been away with work today and playing catch-up on things. I note the negative reaction to this but wanted to provide some balance. Cards on the table, my holdings have not changed and I'm happy to sit tight.
A few things that sprung to mind. Patients on this trial are at the end of their journey, many will have exhausted all other options. As such, their tumours are heterogeneous mixes, with many different lineages. What we may have seen is a response in some cell lineages but not in others. Hence the quoted reduction in tumour bulk. This means that what hasn't responded to Modi-1 remains within the patient and then has an opportunity to grow again.
I think many people fail to realise this and think that a tumour is a single cell type (in many cases this is true with easy to treat tumours or for other diseases at an earlier stage). The more difficult to treat or the later stage tumours are, the more likely they are mixes of different subpopulations which react differently to treatment.
This is where the biopsy/resection group should help answer some of these questions. Is there a subpopulation of cells which respond well to Modi-1. If so, what is it? What biomarkers can be identified on that population? Phase 1 of the modi trial is predominantly about safety and understanding the drug. Phase 2 onwards would be honing the patient population who will most benefit from the drug.
Furthermore, as mentioned earlier, these patients have exhausted many treatments. They have gone through round upon round of chemo/immuno. All of which will have put selective pressures on the cells and basically selected for the most difficult to kill lineages. These are genetically unstable populations where the cancer is basically using every tool possible to survive. If Modi-1 trial shows that the treatment is safe and tolerated well with patients. Then there is nothing to say moving forward Scancell opt to go into earlier stage patient populations. Still in these difficult to treat cancers, but where the patient hasn't been through so much beforehand.
I would say on balance, whilst this is a setback. We're not down and out and we're really only at the beginning. As data flows in, we understand more about the drug in humans and how it is working and can tailor trials/patient populations accordingly.
Yes it's sad, but it is part and parcel of pharma research unfortunately.
This was possibly my thought process.
I then started wondering whether said person would make a bid just for iSCIB1+ or whether they would go for the entire platform, especially as the patent life had now been extended AND it has shown clinical application in a number of different fields and results in the clinic.
I was just reading through the July update and something I had missed previously, jumped out at me with regard to the SCIB1+ trial.
'An adapted registration trial could yield Phase 2 data within 2 years and would provide the Company with a pathway to a potential deal. '
The use of the word 'could' [yield Phase 2 data within 2 years] followed by 'would' [provide the company with a pathway to a potential deal]. Does that mean that there is a draft deal on the cards already, subject to results from the iSCIB1+ trial? I wonder who that would be with? Roche? BMS? Someone else?
Surely if this wasn't the case this line would read 'An adapted registration trial could yield Phase 2 data within 2 years and could provide the Company with a pathway to a potential deal.'
Or am I over thinking things?
Https://www.pmlive.com/pharma_news/bristol_myers_squibbs_opdivo_approved_by_ec_for_expanded_melanoma_use_1496698
Wonder what the impact of this will be if we get positive SCOPE trial results.
May not be beyond the realms of possibility. We know there is a shift in gears in the UK when it comes to preparing for the next pandemic - whatever that may be.
https://news.sky.com/story/amp/uk-scientists-begin-work-on-defending-against-new-pandemic-caused-by-disease-x-12934956
Obviously putting the governments involvement/interest with moderna and mRNA vaccines more broadly aside, there is an understanding that storage, supply chains, mass production and ease of delivery are high up the list of wants for any new vaccine.
What’s also of interest is the interest in developing something better than mRNA lipid nanoparticle delivery - because the UK supply chain for this isn’t fantastic and there are complexities around patents and IP.
SCLPs Immunobody vaccine has a lot of these ticked off, long patent life and vaccines which have been demonstrated multiple times in the clinic as being safe to use and effective.
IMHO it may not be as crazy an idea as we may imagine.
'Why don't Scancell at the very least just give the RNS descriptive titles?'
This I believe is something that they fail miserably to do. If you look through a load of the historic RNS titles:
Modi-1 trial open for expansion in CPI combination
Scancell to present Modi-1 data at ASCO
ModiFY phase 1/2 poster presentation at AACR2023
Encouraging early efficiency data from ModiFY trial
Positive response in COVIDITY trial
Licenses vaccitech technology to advance Modi-2
First patient dosed in expansion phase of ModiFY
Phase 2 SCOPE trial of SCIB1 vaccine expanded
First patient dosed in SCIB1 phase 2 trial
First subject dosed in COVIDITY clinical trial
Scancell selects PharmaJet’s Needle-free systems
COVIDITY trial planned in South Africa and UK
Now just slightly reword them and see what would happen if investors were glancing down then daily 0700 RNS list.
Modi-1 cancer vaccine trial open for expansion in checkpoint inhibitor combination
Scancell to present Modi-1 cancer vaccine data at ASCO
ModiFY cancer vaccine phase 1/2 poster presentation at AACR2023
Encouraging early efficiency data from ModiFY cancer vaccine trial
Positive response in COVIDITY covid-19 T-cell vaccine trial
Licenses vaccitech technology to advance Modi-2 cancer vaccine
First patient dosed in expansion phase of ModiFY cancer vaccine trial
Phase 2 SCOPE trial of SCIB1 melanoma cancer vaccine expanded
First patient dosed in SCIB1 phase 2 melanoma cancer vaccine trial
First subject dosed in COVIDITY Covid-19 T-cell vaccine clinical trial
Scancell selects PharmaJet’s Needle-free systems for delivery of cancer vaccines
COVIDITY covid-19 T-cell vaccine trial planned in South Africa and UK
These additions are not changing the message at all, but would go some way to drumming up additional interest and support, both from PIs and others.
An exciting title too - 'Clinical update on the DC targeting melanoma vaccine, SCIB1 and the Modi-1 vaccine targeting citrullination'
I wonder when the cut off date for the titles for her talk was.
An interesting point from Andrew Forrest regarding the UK position on climate action.
https://twitter.com/bloomberguk/status/1685972812299714560?s=46&t=A6vOxblM5AgE5_ReawinRA
What impact would that have if he pulled investment in GGP? Would the ASX cross-listing insulate us from some of this?
I will be really interested to see what the AGM data this year looks like. By then we should have nice lengths of time from the early cohorts, further data from the monotherapy cohorts and some nice data coming in from the CPI cohorts. In turn I hope to see some histology images of H&E stained slides from pre- and post-resected tumour. It hopefully will be very exciting!
‘Modi-1 treatment were well tolerated in Cohort 4 with no safety concerns. Encouragingly, the first patient to be assessed has shown a tumour regression at their first radiological assessment at 8 weeks. The remaining patients have not yet been assessed radiologically.’
Will be interesting to see if this is replicated across the CPI cohorts.
Please note that this article posted in the thread below is from 2022.
At the time Merck were wanting to purchase Seagen, but that fell through.
Pfizer has subsequently offered to buy Seagen in March of this year, but I'm unsure whether that has been approved by the Federal and Trade Commission as they have asked for further information on this. https://www.fiercepharma.com/pharma/ftc-asks-pfizer-seagen-more-information-proposed-43b-merger