Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
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Morning,
Yep depending who announced partner may or may not be will be a major determinant factor of how successful Covidity will be in terms of promotion and communication and of course pricing across the globe.
All SCLP can do is produce stellar results and the scientific logic fully supports this possibility and of course will gain tremendously for any pharma deal.
Thanks Burble, seems with good results we would need a Big Pharma to achieve those inroads into the powers that be and utilise the marketing and manufacture their resources allow. Given the EU is just 13% of the worlds population I wonder if Covidity could be priced accordingly for South America, Africa, Third World countries and emerging nations?
Thanks Burble , what an informative post and it encapsulates the booster picture realistically. I agree wholeheartedly that
"This government will of course shout and dance if Covidity shows stellar results. They’ll praise British innovation, Innovate UK funding and use this as a poster child of the UK being a science superpower etc. so I suspect we would see especially within the UK some traction for Covidity going into further trials/widespread adoption of results are good."
just hope Boris doesn't take all the credit
C7 in response to your question ‘ what are your thoughts regarding the Approval of Modernas Covid vaccine in relation to what we are trying to achieve with Covidity??’
I have mixed feelings. I think the public are really becoming far less worried about covid than they should be. As such, I suspect vaccine take up for Moderna or any other omicron specific vaccine will be low.
I also believe yearly injections as covid mutates wont really be financially viable for big companies if the rates of uptake drops. Though globally the market will still be large.
This government will of course shout and dance if Covidity shows stellar results. They’ll praise British innovation, Innovate UK funding and use this as a poster child of the UK being a science superpower etc. so I suspect we would see especially within the UK some traction for Covidity going into further trials/widespread adoption of results are good.
Watching the tug-of-war between those is going to be interesting. Especially as Covidity isn’t an mRNA vaccine. Some questions that come to mind are:
- Will the public want a pan coronavirus vaccine after already having three/four shots already?
- Will the public want a DNA vaccine, given what we have seen with the scaremongers around mRNA vaccines?
- Would people be happier to have Covidity if it meant they didn’t have to have yearly jabs?
- Is there government appetite to buy it? (Even though it should be cheaper to make and store than mRNA vaccines).
- Will people want something from a UK biotech over and above a Moderna/Pfizer/big name pharma jab?
I have a hunch that if results are good and show good immunity against omicron and other variants, then success may hinge more on published media, promotion, branding and education to government and the wider public.
just wondering if anyone saw this :
https://www.fiercebiotech.com/biotech/gsk-turns-down-one-solid-tumor-collaboration-ideaya-thinks-its-best
maybe GSK , know there is something better out there
Yeah it did, some really good posts again yesterday.
(Don"t mention Harry Kane, lol)
I would suggest Burble’s 05:38 re TGN1412, most fully underlines the magnitude of yesterday’s positive RNS.
Burble, I wish I could, but finances will not allow. I am just grateful that when I had to retire 11 years back(20 years too early!!) I very slowly built up a holding of 250k. Scancell remains my last chance to make a life altering sum. I"m down to 180k now, but just for me if we get to 50p that will make a huge difference to my budget and I have always just had that feeling it could happen here.
That is why I found yesterdays RNS exciting as after so long we really are leaving the station and I look forward to the months/years ahead eagerly.
Burble, what are your thoughts regarding the Aproval of Modernas Covid vaccine i relaton to what we are trying to achieve with Covidity??
Likewise. Though selfish me thinks the longer this goes under the radar, the more I can have at these levels.
Morning All/Burble,
I was surprised to see that late RNS yesterday evening and both excited and reassured at the contents therein. I was actually surprised that the SP fell from 13.50/14 to the close but again the volume is so small it pales into significance. Will be interesting to see the trading today and hoping for a decent rise. Have a good day all.
Great post Chester.
Stakis, if you want to read more about why trials of this type are slow to recruit at the beginning, take a read of the horror that was the TGN1412 trial at Northwick Park. (https://en.m.wikipedia.org/wiki/Theralizumab)
This gives you a real life example of why a trial such as moditope which is testing a first in man and a first in class therapy has to proceed slowly for the sake of patient safety.
Like Chester said, it’ll soon ramp up and dare I say, probably will be the easiest to recruit to of all of our trials if these next three patients don’t show any safety concerns.
Also to note, the TGN1412 trial was in healthy participants. The playing field ethically changes slightly in patients with late stage cancer because their motivation for joining a trial especially one at an early stage is very different than for a healthy volunteers.
Thanks Konar and Chester. Makes sense
Chester and Konar, good points and the more I read the Rns the more I like it.
We had a good conversation about what might or not be happening at the moment and where the emphasis lies. Ivy raised some pertinent points which I countered by we just do not know what is happening till we get news and I do think many of Ivys concerns have been dealt with today.
For all the quality posts here nobody had a clue of the funding that Redmile and Vulpes were about to announce and I guess that applies to much of what we heard today in the RNS. IF anything we are well ahead of the game I envisaged by todays RNS.
Goes without saying I wish us all the best in the road ahead
@stakis this is exactly as the trial is designed and approved. This is a novel treatment, its never been in humans before and these are seriously unwell people. You don't just go slamming it into dozens of people and hope for the best. The initial cohort have all had two doses and trial can now move on according to plan. As Chester says, acceleration will come down the line once the first two cohorts have cleared dosing.
Hi Stakis, I will try to answer your question as best I can.
The trial can only start with 1, 2 or 3 patients who sign up knowing that this drug has never been tested in a human being. They are both poorly and very very brave. The trial is designed to go slowly at first so any adverse effects only affect the minimum of patients. Once these safety protocols are passed and proven to be, indeed safe, more patients are allowed to join the trial.
That is what happened today, the Trial moved cautiously forward bring in a further 3 patients in to become Cohort 2.
The ModiFY trial has just three clinical centres open to do the Safety / Toxicology part of the trial, in two months time if we have another RNS saying that Cohort 2 has passed the Safety protocol all the other recruitment sites ( 20 in total ) will then be able to join the trial and not before.
Lastly, from the quality and number of cancer centres wanting to be part of our Trial you can surmise that there are many patients willing and ready to be enrolled if they meet the correct criteria.
I hope that answers your question and helps pacify your concerns.
Chester.
I'm feeling a bit underwhelmed by this RNS. Of course its great that Cohort1 has seen no adverse side effects but am I right in thinking that after several months Scancell have only recruited 3 patients? Someone please tell me I have got this wrong!
If I haven't we may be waiting a long time until Cohort 2 is fully recruited and even further for efficacy data.
corr - vimentin
Konar,
I'm so glad you (and some others) have mentioned the patients behind this news . You're right, we do owe them a huge debt of gratitude.
I'm not aware of any automatic switch from the low vimetin only dose to the higher dose of the full Modi1 vax (all 3 peptides) for this cohort, but obviously Scancell would need to confirm one way or another. The dosing period is up to 2 years and clearly it wouldn't be right to leave these 3 patients on a less than optimum dose for 2 years. A similar situation arose with the original SCIB1 trial and Scancell applied to the MHRA for permission to switch the lower dose safety cohort (also 3 patients) to the higher dose they had selected for the expansion phase of the trial. I assume they'll do the same here if required, but again it's a question for Scancell.
@Bermuda thanks for posting that link. I know we discussed the peptides/cohorts thing before but couldn't remember where the info had come from.
On your second point.. I'm ngl, I was looking for a bit of a cherry on top of the already good news. I do think the initial safety cohort is a huge step forward. I dont imagine adding another peptide is going to make too much difference to the safety profile, but you never know. Looking at the updated trial design it does look like we cam accelerate quickly as a monotherapy following the second cohort.
One thing you might have insight into (again I couldn't tell from the trial details).. do the low dose cohort have the option to take the higher therapeutic dose now? If not we (as investors) and the subsequent patients owe a huge debt of gratitude to those 3 that agreed to take the low dose.
Interesting part for me.........
"""Modi-1 is the first candidate of Scancell's Moditope® platform. This open label study will recruit up to 125 patients in up to 20 clinical trial sites across the UK."""
Wonder who is being lined up for our next investment?
Another great, informative discussion.
It is a pity the health journos don't read this site;)
Konar,
You're correct, that slide is out of date, the best place to go for the final Modi1 trial design is Trinity Delta's note of the 12th April - see figure 7 in the link below.
Regarding your 15.11 - we can't read anything at all into this regarding efficacy. Regulators won't take into account efficacy when making decisions regarding dose escalation in a phase 1 study. It will be done on safety alone and an initial cohort of just 3 patients is fairly standard. However, given the strength of the immune response generated in preclinical research and the fact that Moditope really is breaking into new territory, safety and toxicity was by no means a given. If the MHRA had any concerns , they would have asked for data from more patients at this dose, so today's RNS is really very good news indeed.
https://www.trinitydelta.org/research-notes/a-fresh-impetus-in-delivering-immune-oncology-vaccines/
OK that'll teach me to read the posts first :-)
Thanks Ray - but this is the slide i was referring to earlier. It shows cohort 2 as being just vimentin peptides, but we know from today's RNS that cohort 2 will receive both Vimentin and Enolase peptides - hence my comment that this is out of date.
This shows 3-6 patients have been dosed with the low dose and presumably all OK :-)