Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
C7, good to hear from you! Life throws us all a curve ball at times, but I'm glad you're still with us! Fingers crossed that this is the year SCLP can turn a corner and you get to see the end game and how that plays out! Wishing you well. Burble
Following on from CWs post.
Also important to highlight of those 15 blockbusters coming off patent, seven are antibodies:
- humira - adalimumab
- keytruda - pembrolizumab
- stelara - ustekinumab
- opdivo - nivolumab
- xgeva - denosumab
- cosentyx - secukinumab
- entyvio - vendolizunab
So theoretically, if Avidimab were able to be incorporated into any of these and demonstrated to work better than the parent, these companies could potentially look to extend their patent life by producing a second generation therapy.
TF
I agree with what you’re saying, but how do you get people to read an RNS. Youve got to entice them in.
Scope trial, to me sounds like something a company that makes medical equipment would release. Endoscope, microscope etc.
A single word or a handful could have changed that RNS and made it more interesting to people who maybe have no idea what Scancell is about (especially given we are listed as Scancell Holdings, not Scancell Pharma).
For me instead of ‘Update on scope trial’ any of the following would be an improvement.
- update on SCOPE melanoma trial
- update on SCOPE DNA vaccine trial
- MHRA approval granted for SCOPE trial
Or permutations of the above.
I don’t have time to read every RNS put out by every company. I read the ones which have a title that draws me in. If my interest is peaked, I start researching the company before making a decision to invest or not. Without good RNS title, I just gloss over them
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We have said this before, so often the RNS title does not fully reflect the information held inside. It doesn't need to be rampy but 'Update on SCOPE trial' does nothing to fuel interest in the company. As others say, detailed RNS titles could help support a higher share price..
for those people new to the board, can i just draw people's attention back to slide 20 and 21 of the 2022 agm presentation (https://www.scancell.co.uk/data/sites/1/media/docspres/agm-presentationnovember-2022_final.pdf).
we known scib1 is performing well in the scope trial with a current objective response rate of 85%, but patients eligible for this trial are limited to patients with hla-a2 (meaning only 40% of patients are able to join this trial and benefit from this treatment).
iscib1+ includes multiple epitopes which means that it can be used to treat all patients. it also includes sclp patented avidimab modifications which enhance the efficacy and also extend the patent life (making it more attractive to potential partners).
on slide 21, we see in mouse models after 21 days, scib1+ (without avidimab) has a demonstrable effect, with reductions in tumour volume. this is improved significantly further, by the addition of the avidimab modifications with iscib1+. i assume that the control is just the c56bl mice and not comparing this to standard scib1.
if you look at the right hand ******-meier survival curves, (again comparing scib1+ without avidimab to iscib1+ with avidimab) we see further improvements in survival of these mice. for reference, 50 days post tumour implant is equivalent to 5.5 years human time. also note that after a patient has been in remission for 5 years this is the time clinicians usually consider a patient to be ‘cured’.
so in summary: this news (and if this translates through to clinical benefit) regarding iscib1+ means
- increased potency
- increased efficacy
- greater patients able to benefit from this
- larger market size
- extended patent life
and like the original scib1 in trial this is:
- not a personalised medicine (which is a positive)
- an off the shelf product
- cheap to produce
- easy to store (doesn't need low temperature storage like mrna drugs)
- easy to deliver (needle-free).
Fantastic news! Ray, I was thinking the same. Clinicians know the results are good, they knew this was coming. Wouldn't surprise me if we get a recruitment completed for the iSCIB1+ cohort RNS sooner than their timelines. Hopefully their timelines are conservative and this proceeds quicker than previously. I know LD has previously said that the expanded patient eligibility criteria should speed up recruitment.
Sorry pressed post message too soon.
Meant to add this 'The company also noted at that time that it had received MHRA correspondence which paves the way to a test of iSCIB1 in the first quarter of their next year (May-July).'
Great find.
An interesting post 'Lindy noted that they will need a new contract manufacturer for iSCIB1'. Given that we are still waiting for MHRA approval, even if we got that tomorrow, this means that iSCIB1 probably won't start any time soon.
Looking at the Genmab deal announced on the 25th October 2022 (https://www.lse.co.uk/rns/SCLP/signs-commercial-license-agreement-with-genmab-wsksutknedqtof9.html) we saw the first glymab deal made. With single digit upfront payment, followed by potential milestone payments of up to $208 million for each product developed and commercialised, up to a maximum of $624 million if Genmab develops and commercialises products across all defined modalities.
If you look at the announcement today from C4X discovery (https://www.lse.co.uk/rns/C4XD/astrazeneca-11m-milestone-payment-to-c4xd-irwuew9nnd3ak14.html) where they have just received an £11m milestone payment from AZ for preclinical milestone payment under it's exclusive agreement worth upto £402m. It starts to paint a bit more of a clearer picture for how things may play out here.
C4X announced the original partnership in November 2022 with an up front £2m payment, followed by development milestone payments. So similar timelines to us (obviously v.different drug types and we don't have sight of what Genmab or AZ have deployed to move these products forwards respectively).
It'll be interesting to see when SCLP receiev their first milestone payment.
In addition if you scroll down a few tweets, you see this - https://x.com/DJPinato/status/1730520519936475185?s=20
That's the same disease that Lindy mentioned Modi-1 could go into to test checkpoint inhibitors with...
Agree, especially as Lindy said that many patients cannot go on a full course of CTLA-4 inhibitors because the side effects are too much for patients.
Imagine if iSCIB1+ can mean patients can be given a slightly reduced dose of the CTLA4/anti-PD1 but still get the same effects or better. That would open up more avenues for treatment for patients.
We can live in hope.
Wouldn’t surprise me though if Moderna would be a company to make an early move.
Violin,
So in response to your 'i simply can't understand why mouse safety studies were not submitted with the original application'.
Something to note, there is a principle within the industry for a thing called the 3Rs with relation to mouse and other animal work. These are replacement, reduction and refinement. It promotes the use of alternative methods where possible, reducing the number of animals used, refining experimental techniques to minimise harm and replacing animals with non-animal models if at all possible.
As such, it wouldn't surprise me if SCLP had done all the pre-clinical work that they believed was necessary to satisfy MHRA requirements to provide approval for iSCIB1+, whilst also adhering to these principals. Therefore they didn't feel it necessary to do further mouse work on iSCIB1+ when they had data to suggest that it was safe/efficacious from other non-animal experiments. Therefore, the submission would have been done without the need for more animal work. After looking at the data submitted by SCLP, the MHRA have requested this animal data.
IMHO, whilst delay is annoying, I have faith it won't delay things too much longer.
Random musing. It wouldn’t surprise me if we get data on this cohort sooner rather than later once the MHRA amendment is granted. I suspect site Principal Investigators may be chomping at the bit to get more of their patients on the study given the earlier results.
I think the limiting factor will be site clinical trials teams being able to process and deploy the amendment. So fingers crossed that they can work efficiently and recruitment can begin as soon as the MHRA green light turns on.
Cleanerworld the glymabs themselves are a full monoclonal antibody which targets particular sugar motifs. The glycosylation that is described in this video describes sugar molecules which are present on the Fc region of antibodies in abundance. These sugar molecules play crucial roles in the structure and function of monoclonal antibodies and influence various aspects of antibody function including action and half life for example.
Where they talk about duobody technology being compatible with glycosylation in the Fc region, this is because the sugar molecules on the Fc region of antibodies can be engineered as part of a monoclonal antibody development process with the aim of modulating the overall antibody properties. Examples of this are things like enhancing binding affinity of the Fc region to receptors on immune cells, increasing the serum half life (meaning antibodies stay in the blood stream longer), reducing effector functions to improve cytotoxicity, ensuring consistency between batches to improve efficacy and safety, manipulation of properties or addition of non-natural glycan structures.
As such, whilst the glycan antibody licenced from SCLP could be used in a duobody technology platform, it in itself is not the glycosylation that they talk about here.