Member Info for Burble

Here are two really interesting articles regarding the manufacturing hurdles for mRNA both in terms of manufacturing and also quality control.

https://www.ttp.com/insights/personalised-mrna-therapies-pose-a-qc-challenge/?utm_campaign=LS-CGT-BIO-brand-awareness&utm_content=175985657&utm_medium=social&utm_source=linkedin&hss_channel=lcp-122597

https://www.ttp.com/insights/with-personalised-cancer-vaccines-on-the-rise-is-manufacturing-scalable-yet/

Also noticed that Poonam Vaghela is speaking at the OxfordGlobal biologics conference next month.

Good spot! Also interesting conference topic! The OG conferences are generally very well attended..

Interesting to see the progression in the right direction! Seems CPI+Modi-1 may indeed be the way to go (caveat N=1). Hopefully not long until we get further news on the Modify trial in more detail. I’m so interested to hear about the pre/post surgery arm results to see what is actually happening inside these tumours.

Do you think we’ll get a first patient dosed RNS for the new iSCIB1+ arm.

Bojo - yes happy. They replied pretty promptly to me last time, so I'm hoping similar.

Have just emailed the investor relations email address on the SCLP website to ask when it was notified. We shall see if they are monitoring this inbox.

Sally Adam’s leaving was not on my 2024 RNS bingo card.

Add to what Bermuda has said.

You can also profile the status of T-cells within these patient samples, so those expressing low levels of certain surface markers such as CD44, LY6C and killer cell lectin-like receptor subfamily G member 1 (KLRG1), could be a sign of T-cell exhaustion in the CD8 population.

The presence of regulatory T-cells could also be a sign that the immune system is preventing the full T-cell function within the tumour in specific patients, suppressing the anti-tumour response.

Website does say the following: 'These five mAbs are undergoing preclinical characterisation, with target validation underway for a number of other mAbs to add to the growing portfolio.' So I'm curious as to how much work is ongoing in this area.

Something which I don't think we hear much about though is SCLPs ability to generate more glycan mAbs. I know we hear a lot about the ones we have already generated, but I'm curious as to whether we have any background work going on trying to identify more glycan mabs.

I can't remember I'm afraid and the actual recording has not been posted online.

To add to that, in the notes I took, I have written 'Genmab for ADC to treat pancreatic cancer.' Unsure whether anybody else can flesh this out further.

Something that stood out to me was how much Lindy stressed using the mAbs for ADCs. We know from things hitting up across the sector that ADCs are coming into vogue, especially if you can get ‘exquisite specificity’ to target your drug to your cancer cells.

I wonder whether LD was dropping hints about what indications people are exploring these for. Lots happening in this space,

https://www.biospace.com/article/biopharma-industry-continues-to-bet-big-on-antibody-drug-conjugates/

Interesting also Sath said something during his financial presentation saying something along the lines of 'depending on finances, we may look to take TC134 into the clinic ourselves'. This refers to the highly selective antibody which SCLP has reformatted into a T cell redirecting antibody.

Written questions submitted

Are you still looking to raise further cash next year on the back of trial results?

Sath: Cash raise highlights that the cash runway runs through to 2025 and we anticipate that this may be boosted with further deals/milestone payments which would be non-dilutive. Worth noting that we have a strong cash position but we have value creation in mind.

How likely are Scancell to receive income from avidimab and glymab in the near term?

With the pre-clinical deals, the up front payment from GenMab of £6m is what we would anticipate for deals done. There is a good chance we will get one or two of these deals over the next 12 months, some of those evaluating the glymabs are ongoing, some are new.

Do you plan to run the iSCIB1+ Phase 2/3 trial in US and UK.

Yes this will an IND under the FDA and we would look to run it in the UK and US. We would like to do Europe but unlike in the US/UK, in europe you need to pay for checkpoint inhibitors in Europe. So that would be about £100k per person on the trial. In the UK/US means because CPI is standard of care, you do not need to pay for this. Though this may chance and if we can run trials in europe we would look to do so.

Franc Gregori - Trinity Delta

With SCIB1 - would it be sensible to accept partnering with the data you have now or would you get better value at first phase 2 data on study?

LD: We would get better value if we wait. We anticipate to get the best value would be after the phase 2 adaptive design - would probably be when we get a good deal. Though obviously it all depends on the deal.

Edward ??? (didn't catch surname) - Singer Capital Markets.

E? - A broad question on doublet therapy combination in modi-1. BMS released positive data this week in colorectal cancer. Is this a potential patient cohort to expand into?

LD: This is a subset of patients which has a high mutation frequency. The data is stunning. They almost don’t need a vaccine in there. In theory - anything where there is a double checkpoint approved we could put [modi-1] vaccine alongside. As we prove double checkpoints are the way forward with this vaccine. It's also important to note that many of these CPIs are coming off patent and biosimilars are coming on the market. As such, good data with double checkpoints will mean a good market out there for modi-1.

E? - Have you seen interest from 3rd parties with SCIB1

LD: Yes there has been interest, most pharma - want to see 43 patients at least.

We anticipate going into randomised phase 2 before partnering. You have to take it further than ADCs which can do deals pre-clinically or after Phase 1. We will see interest further if data is stunning. but we need to complete one of these studies first.

James Osbourne - Stifel

JO: in relation to ISCIB1 MHRA approval, will you use the same sites for recruitmetn of patients. How do you expect recruitment to progress with both arms going forward?

LD: Initial idea is patients who are screening failures due to HLA type will go into the iSCIB1+ cohort. We will continue to recruit patients to SCIB1 until full.

Same centres will be used, two new centres have being brought online and a further two new centres to start in April. The quickness to recruit to the iSCIB1+ cohort will be down to screen failures for the SCIB1 arm. 2 out of 3 of patients fail and will go to iSCIB1+ arm of the trial.

JO: WRT the glymab platform, you talk about 5 potential partners which has increased from 3. Have you seen a step change in frequence of these conversations?

LD: Genmab gave people a vote of confidence. However, the ones who are currently evaluating the platform are fighting for exclusivity. This does pose a bit of an issue for us. Each partner needs to evaluate with their own drug checking whether their antibody and drug work together.

JO: SCOPE data is highly encouraging are you beginning to see a shift in sentiment towards cancer vaccines?

Do you see it being a patient numbers game.

LD: Yes there is definitely interest in cancer vaccines, it would be very nice if this starts looking positive in some of the randomised studies. The Moderna data will be important in spurring interest in cancer vaccines - though that will be another 3-4 years before we get that data. The sooner the better.

I've also then written '5 ADCs being developed towards a single antibody target - but unsure what that specifically relates to, whether that's a following question or not. Am on the train atm so have lousy signal.

Q&A - Mike Mitchell - Panmore Gordon

MM: Regarding teh Phase 2/3 adapted trial, the assumption is this would be an iSCIB1+ trial. What is the relative risk with the iSCIB1+ cohort and could this fall back and be SCIB1 only.

LD: Yes you’re right, we anticipate it will be iSCIB1+ but clearly it’s down to what happens in the clinic. In bigger cohort of patients, it’s a much more marketable drug. If for some reason it was too potent, or doesn’t work in as many patients as we want, we can go with SCIB1

LD also mentioned that a new patent has recently been filed with SCIB1 in combo with double checkpoint.

MM: In trial design, are these decisions which need to be made now? Is a partner required before you begin?

LD: The benefit of the adaptive approach is that we can plan now and start the phase 2. end points will be decided at a later date but most likely progression free survival and other standard statistics. This shouldn’t change if/when we partner. If the trial results are as good as they are currently, we may be able to get away with fewer patients and do it quicker. However it should be noted that Phase 2 patients do not count towards phase 3 trial. LD then mentioned that they need to ‘Talk to the FDA about the trial design’.

MM: Safety study for protocol amendment for MHRA to include iSCIB1+

LD: Main issue was whether we needed to do a new toxicity study, even though it was 90% similar backbone to SCIB1. They [the MHRA] were very comfortable with the safety profile of SCIB1 in patients currently, and were happy to proceed with this without the need for any further data. They were amenable but it took a bit longer than we had hoped.

Presentation link for those able to join. I sadly am travelling today, so most likely wont be able to listen till later.

https://www.lsegissuerservices.com/spark/ScancellHoldings/events/f581274b-146c-4a89-af15-05bcae874775