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I'm not sure how that is good news.
The companies that were hived off from CIC Capital for the purpose of financing listings has been shutdown, replaced with 2 private companies that Bromley is the sole share holder of.
In terms of "what next" - one thing I haven't seen discussed here is the timelines for Genmab defining their Antibody Drug Conjugate using the MAB they bought from us. Lindy described that they would be fast-tracking the development of the product. Definition of this product would presumably trigger another milestone payment. I wonder if anyone has any knowledge or experience of the length of time it might take to get to this milestone? Given that we know Genmab were granted the permission to analyse and validate the MAB before purchasing, then I would hope this could be quicker than normal.
@JohnnyB1 I totally agree something has changed. To go from "Late Dec/Early Jan" to "Q1 2023" for release of results, and already be into Feburary.. it does suggest something has changed. I really do want to believe that it is because a pharma is looking to buy it.. and the longer it goes without reporting makes me believe it more. But I just don't know.
I raised a bit of an eyebrow at the "as previously disclosed", because I don't believe they have previously stated this in this way.
This from the previous set of financials -
"Given the large size of later stage trials, the Company intends to partner this programme once it has generated proof of concept data from the Phase 1 trial."
Now there is now no mention of partnering, just that they won't be taking it forward. Had the previous statement said "Scancell will not take this programme forward unless a partner can be found" - then i would agree that it would be "as previously disclosed".
Of course, the line from this financials could be interpreted as "a partner has been found that want to take it forward themselves without Scancell" and that is the optimistic interpretation, and not entirely impossible. Its why I am so keen to see the trial results, because this may suggest one way or the other. Can we read anything into the fact that they haven't yet released the results? Maybe they are holding onto the disappointing news? Maybe they are in discussions with a company to buy the programme?
All just "imho" as always.
LL - as per my post the other day, and quoted directly from the RNS
"As previously disclosed, given the large size of later stage trials and the competitive landscape the Company does not intend to do further trials and will focus its resources on the oncology platforms."
100% confirmed by the company that they themselves will not be doing anything further with Covidity. The pessimists will believe this is because the results themselves weren't great. The optimists believe this is because someone else will take it forward without Scancell. I'll let you decide which camp you are in.
berm - good points, I hadn't considered the fact that a lot of the patients may already be on combination treatments that exclude them from the trial. Perhaps if the monotherapy arms start to throw out some good results, consultants (he or she) will be more inclined to recommend the combination over the standard of care.
Berm - I wonder of recruitment rates may become a factor in the neoadjuvant, and the whole Ci+Modi trial as a whole. We have only managed to recruit and dose 1 patient in the combination cohort so far. I was expecting to have moved into the second combination cohort by now, if we were following the same time lines as the monotherapy cohorts. That leads me to wonder are we (a) being ultra-cautious and taking one patient fully through the dosing before recruiting any more, or (b) struggling to recruit. What do you think?
@RR - I guess it depends on your definition of active. All patients are recruited, treated and all follow appointments and tests have been done. I'd consider that no longer active.
The post trial results have yet to be published.
@LL Scancell will not be carrying out any further trials with Covidity.
@DeAar That method will prove "how" it is working, we should know before 2024 "if" it is working. Of course they also took biopsies of the responding patient, so that may start to deliver some of this information sooner.
Last patient follow up was, I think, early December. I can't get the actual date at the moment, as the South Africa trial website isn't responding. We were told by Lindy at the AGM to expect trial readout late December/early January.
yes it is a basket trial, so could be argued is many trials in one. Safe to say that Scancell have many irons in the fire, even with technically just "two trials running".
As someone who has been here throughout the wilderness years of no clinical action, I am more than content with the amount of clinical trials on the go at the moment. I would just like a full update on the status of all the trials, in particular the Coviditiy read-out and the up-to date findings in the SCIB1 trial so far. Both of which are overdue.
Moditope I have a lot more patience on, as they will really be waiting to see the first imagining of the full monotherapy cohorts, before they start to conclude what's working and what isn't. Contrary to some posts here, inducing an immune response alone isn't conclusive proof that it is "working". Plenty of trials have failed to meet end points despite inducing an immune response. It's certainly a good indicator that "something" is happening, but how powerful and effective that is, is yet to be fully determined. Nor are pre-clinical results in mice a guarantee of the same response in humans. Moditope only works when it shrinks (or alternatively stabilises) tumours in sufficient quantity, and it may be a few more months before we can start to form an evidenced based view of that. Fortunately, given the lack of treatment options for these patients, it doesn't have to be successful in large numbers to be deemed commercial, we just hope that it is.
This is probably more a Burble question - but i will do my best to answer it. Moditope is dependent on Autophagy, this occurs as the tumour cells become stressed when the tumour grows so large that it is no longer receiving sufficient blood and nutrients to sustain itself. In other words, the more stressed the tumour, then potentially the stronger the response to moditope. I imagine there will be a "sweet spot" where the tumour is large enough to be stressed, but the immune system is still functioning sufficiently. I expect that is one of the things they are trying to determine from this current trial - what indications respond best at each stage of disease.
I expect the Checkpoint Inhibitor combination will best come into play when the tumour is particularly immunosuppressive, or the generated immune response isn't as strong.
"we know trial patients have seen significant reductions in tumor size (confirmed by LD at the AGM)"
Trial Patients... plural? I don't think that is true. We know of only one patient that has responded with a reduction in tumour size, confirmed by the RNS afaik.
@hyms - 100% spot on.
The extrapolation from that one patient was off the scale ridiculous. Comments along the lines of "Well it works for one so will work for all" (and I paraphrase there so don't ask me for a direct quote) were just unrealistic. The problem is, when you set that expectation, then anything less than that is seen as a failure.
That said.. I don't think the drop in SP is all about the ramping on this board. The company shoulders most of the responsibility by their failure (once again) to hit their self declared targets, and for me this pattern is really starting to be a millstone around the SP.
@boom I typed a fairly long response to this thread earlier about the clash of expectation versus reality, and then deleted it because I thought it came across all a bit "I told you so", but I am glad you have highlighted it.
IMO, Moditope doesn't have to be, and probably won't be, a miracle cure. If it shrinks tumours in 1 in 3 previously untreatable people then it will be massively beneficial to humanity and commercially viable.
Covidity always seemed to be struggling and appeared less promising the longer it went on. I get that some people still have hope and it may yet get taken on by someone else, but Scancell have made it clear they won't take it any further, and to me that says it all.
One other thing that I noted from yesterday was the fact that only 1 patient has been dosed in nearly 4 months of CI+Modi arm. Any explanation why recruitment would be so slow?
Highlight are:
-continuing to explore further deals.
- Making progress on recruiting in Modi trial in monotherapy
Worries are:
- covidity seemingly abandoned
- Only 1 patient dosed in nearly 4 months of Modi1+CI
- Only 1 patient showing tumour shrinkage so far - not exactly the "melting of tumours" we expected
- Upfront payments not enough to turn the period profitable
- Scib1 IND abandoned in the USA
- Scib1 still ambiguous on recruited numbers and conflicting statements on the progress of recruitment.