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JPM is a massive event and the whole industry seems to descend on San Franciso whether it's to attend the (invite only) conference itself, one of the many other conferences set up to coincide with JPM or simply to network. In the past Richard and Lindy have attended and whilst they didn't present at JPM itself, I'm pretty sure they did present at Biotech Showcase at least once. I seem to remember Richard talking about wearing out his shoe leather traipsing up and down the streets of SFO going from one meeting to the next. As I understand it, the idea is to fill your diary with back to back meetings with potential investors and partners and hopefully get invites to the best evening receptions. The blog below is old but gives some flavour of the event - sounds exhausting.

Not sure whether Scancell will attend for networking purposes, but I'd imagine they'd want to have more data and more results from the Modi1 trial before actually presenting at such a major event, this year could be just a little too early - perhaps next year?

https://cglife.com/blog/your-free-guide-surviving-jpm-san-francisco-2018/

rats/rigga

' no need for any dilemma between getting rich versus positive feelings for cancer patients - the two go hand in hand'

- exactly so rats, I don't think anyone here is kidding themselves as the two positions aren't mutually exclusive.

Just a quick message to wish everyone here a very Happy Christmas. I think it's also a good time to take a moment and spare a thought for the patients currently taking part in Scancell's clinical trials and indeed all those affected by cancer. Occasionally it's good to remind ourselves that some things really are much more important than ££££.

ee

Whilst you may be right about the actual date of their release, I strongly disagree with the argument that 'results being available' means only available to Scancell. The statements from Scancell lead to a clear expectation of an update to shareholders within the timescales given - as I say whether or not they hit that timescale is another matter. This is an open label study and as such data will constantly be being made available to Scancell on an ongoing basis. It would be utterly bizarre to make a statement to investors that they expect data to be available but mean only to them without actually saying so.

As for generating interest, firstly we need to remember that at this statement refers only to safety and immunogenicity data - if we get further updates on patient progress it will be a bonus, but we shouldn't expect it. Secondly, afaik, the only analysts covering Scancell are Trinity Delta - there are no independent analysts and so to a certain extent Scancell can be sure of coverage regardless of the timing of the release.

IMO

Konar,

The Company have been saying for several months that safety & immunogenicity data will be available in H2 2022 and early efficacy data in 2023. IMO that sends a clear and unequivocal message to shareholders that there will be an update with immunogenicity data in H2 2022 and another on efficacy in 2023 - whether they hit those timescales is another matter. The words used in Scancell's announcements are always very carefully chosen and I think it would be playing with semantics if we are told that 'being available' to Scancell doesn't entail sharing with shareholders.

Will be interesting to see whether they comment on progress with any of the out-licensed products. Looks like there has been some progress with RXC006, the porcupine inhibitor licesnsed to AstraZeneca - now known as AZD5055. Back in January, Redx received a $9m milestone payment when AstraZeneca commenced a phase 1 trial.

Looks like AZN have now set up 2 new trials. The first is comparing bioavailability of AZD5055 when administered as a tablet versus infusion and the second looks at the impact of AZD5055 on the pharmacokinetics of IPF drug Nintedanib when given in combination. I assume that if and when AZD5055 moves into a phase II trial, it's likely that patients will already be receiving Nintedanib as standard of care treatment. Both of the new trials are small quick studies and it appears that as AZN approach the end of the main phase I trial, they are trying to establish the optimum dosing method and understand the interaction with current SOC treatment. Hopefully this is with a view to informing the design of a phase II trial and bodes well for the continued development of AZD5055.

It was confirmed only 3 to 4 weeks ago at the AGM that a Modi1 trial update would be issued in H2 2022 and we know recruitment is going well so I'm expecting the new fully funded and fully resourced Scancell to hit their own published timescales.

'the Company has entered into a clinical trial collaboration and supply agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA), for the supply of KEYTRUDA® (pembrolizumab), MSD's anti-PD-1 therapy, to be used in the combination arm of Redx's ongoing PORCUPINE2 Phase 2 clinical study evaluating RXC004 as a potential treatment for patients with biliary cancer.'

Excellent news for Redx.

More on the excellent results from Pirtobrutinib here:-

'This comprised an expansion cohort of 247 patients who had received a prior BTK inhibitor, and the group put up a stunning waterfall plot, showing tumour shrinkage in all but six patients, and an 82% overall remission rate. Not only that, but 100 of these patients had failed Abbvie’s highly efficacious Bcl-2 inhibitor Venclexta as well as BTK blockade, and the ORR held up in these too, at 79%.'

https://www.evaluate.com/vantage/articles/events/conferences-trial-results/ash-2022-pirtobrutinib-leads-post-imbruvica

A new patent application from Scancell has appeared in this week's UK Patent Journal. It's obviously part of the GlyMab platform and is likely related to further development of Scancell's SSEA4 mAb, iSC2811. This is the lead candidate for Avidimab enhanced mAbs and as discussed at the AGM has potential in the CAR-T field. We'll have to wait now until the full application is published to find out exactly what this patent covers. It does show however, that R&D continues apace in Scancell's labs.

14 December 2022
(Journal 6969) GB2216025.3 Applicant: Scancell Limited
Title: SSEA-4 binding molecules and uses thereof
Date Lodged: 28 October 2022

Lilly have just announced new updated data from their Bruin phase I/II trial which shows that pirtobrutinib continues to show excellent results across a range of blood cancers in patients who have failed on treatment with SOC BTK inhibitors. They have at least 4 ongoing phase III trials and have applied for FDA approval in mantle cell lymphoma (rolling review).

The relevance to Redx holders is that Pirtobrutinib was originally developed by Redx. When Redx were put into administration, the administrators were forced into a fire sale of their most advanced product and this BTK inhibitor was sold to Loxo Oncology for a one off payment of $40m. It was enough to pay off all debts and bring Redx out of administration, but the sale included no milestones and no royalties. Loxo were subsequently bought by Lilly for $8 billion and the rest is history.

Pirtobrutinib is now one of the jewels in Lilly's crown, but sadly Redx holders won't share in its success in terms of any hard financial reward. However, it does demonstrate Redx's ability to discover and develop effective drugs.

https://investor.lilly.com/news-releases/news-release-details/loxolilly-presents-updated-pirtobrutinib-data-phase-12-bruin

Picathartes, some interesting posts and links thanks.

This may already have been posted and I might have missed it, but a new research paper from Scancell was published last week in the Discovery Immunology peer reviewed journal. The link to the abstract is below and from there you can download the full PDF.

https://academic.oup.com/discovimmunology/advance-article/doi/10.1093/discim/kyac011/6874811?login=false

Konar,

Well spotted.

I see they've also confirmed the make up and targets for Modi2. Not sure whether they've been published before - if so I'd missed them. Modi2 will consist of 4 ****citrullinated peptides, Aldolase A, Immunoglobulin binding protein (BiP), Cytokeratin 8 and Vimentin and will target breast, colorectal, NSCLC and prostate cancer.

So they'll be targeting the 4 most common cancers in the UK - good stuff.

This may already have been posted, but the SCIB1 clinical trial record has been updated today to show another study centre (Preston) has opened for recruitment.

https://clinicaltrials.gov/ct2/show/NCT04079166?term=scancell&draw=2&rank=3

hyms,

Re. your earlier question about randomised trials. This is probably one for Burble to answer, but worth noting that this really only applies to the monotherapy arms of the Moditope trial. Where Modi1 is given in combination with a checkpoint inhibitor, I assume that a randomised study would compare Modi1 plus CI versus CI alone.

For Modi1 in the monotherapy setting, afaik placebos are only ever used in cancer trials where there are literally no other treatment options. Not only would the use of a placebo be unethical, but also it would make recruitment very difficult. If you have advanced cancer and are prepared to join a clinical trial, then why would you agree to one where you had a 50/50 chance of just getting a placebo? I'm not sure how this would be handled by Scancell - I've seen trials where the control group are simply given the investigators treatment of choice. Will be interesting to hear Burble's view.

rats,

This from your earlier post simply isn't the case:-

'but nobody seemed to pick up on this at the time, even our resident 'I work in the pharma industry and know more than you plebs' experts.'

This is my post on the morning of the 31st Oct after reading the RNS:-

'Bermudashorts

Posted in: SCLP

Posts: 12,183

Price: 15.80

No Opinion

RE: Update31 Oct 2022 07:36
This really is excellent news. The first patient to receive Modi1 at the full dose has already shown a partial response - their tumour has shrunk after only 2 doses. Hopefully that response will continue over the treatment period. Worth remembering that these are patients with inoperable advanced tumours who have already received all other available standard therapy.'

There then followed a discussion on the bb specifically about the partial response and I explained that I believed a partial response usually meant a 30% reduction in tumour size. This was all before the markets opened on the morning of the RNS. I have no clue who you mean by resident pharma expert - Burble? Whoever it is, perhaps they simply hadn't read the RNS and so hadn't commented, but there was certainly a great deal of discussion on the bb about the partial response that morning.

'

Wild,

Regarding BioNTech, you have to look at their existing pipeline and strategy which on the oncology side is all about personal therapies/vaccines and neoantigens. At the moment, the main way of identifying neoantigens is through analysis of tissue biopsies from individual patients to find genetic mutations that may make good neoantigens to target. They use algos to select up to 20 neoantigens with the best potential and only then can they encode the mRNA to create and manufacture a vaccine. This is obvioiusly expensive and time consuming and the vaccine produced can only treat one patient - they have to start all over again for the next patient.

As you know, Moditope also targets neoantigens, but they're created by post translational modifications - citrullination for Modi1 and ****citrullination for Modi2. So one vaccine has been created and manufactured that has the potential of targeting neoantigens in many patients across multiple cancer types. I suspect that's where BioNTech's interest lies - but wdik?

IMO of course

havealot,

In preclinical testing, mice with bulky aggressive tumours that had been cleared through previous vaccination with Modi1, were implanted with new tumours without any further treatment. They still generated a CD4 T cell response and rejected the tumour rechallenge. So in animal models at least, Modi1 generated immunological memory and the hope must be that this will be replicated in humans.

You are right to be cautious, because it's only with time and long term survival data that Scancell will know whether or not Moditope protects against any lurking metastases, but how wonderful is it to even be contemplating long term survival for these patients?

Konar

Thanks very much, I appreciate your reply. Have to admit that I thought it was just an attempt to discuss clinical results from another cancer trial rather than an attempt to drive interest in FARN. A perfect example perhaps of the perils of internet communication - different people taking a slightly different message from the same words!

Apparently someone reported BOJO's post this morning and my reply re. the FARN clinical trial and they have been removed by admin. The reason they were reported was that they were discussing another share. Slighly bemusing given the number of times we discuss other bios., their products, clinical trials and results on this board. Anyone any clue why someone had a problem with these particular posts?