Member Info for Bermudashorts

Deepestblue

What hype? Thought traders here had an issue with the lack of hype from AN.

chippy,

Not sure there would be any takers for a non-exlusive deal on SCIB1, perhaps Avidimab? Think we'd all be very happy with any commercial deal, whatever the form and perhaps the first might come from one of the glycan mAbs.

Ruck,

A licensing deal does bring the potential of long term revenue but it also carries risk, especially with early stage drugs like SCIB1. There is no guarantee that the licensee will continue to develop the drug and so it may never reach the market or even the next milestone trigger point and may never generate any revenue at all.

Excellent news, adding another $5m to the $26m earned in milestones last year.

The significance of today's RNS isn't so much the cash, but the fact that Jazz have assessed the preclinical data for JZP815 and decided that it's good enough to take into the clinic which involves serious financial and resource commitment. So far, Redx have signed 3 deals and so far all 3 have been taken further triggering milestone payments. Total potential milestones for these 3 deals is $1b with royalties on top. Current situation is:-

AstraZeneca has already taken Porcupine inhibitor RXC006 (now known as AZD5055) into clinical trials triggering milestone payment - that trial is currently recruiting with primary completion date of Feb 2023.

Jazz have FDA clearance to take Pan-RAF inhibitor JZP815 to commence trials

Jazz has continued collaboration for 2 Ras/Raf/MAP kinase (MAPK) pathway candidates into 2nd year triggering a $10m milestone payment to Redx

All on top of Redx's own pipeline of course.

Jazz have FDA clearance to take Pan-RAF inhibitor JZP815 to commence trials

jollyspectator,

This is what AGL themselves have said about funding:-

'As previously communicated, we are funded out until Q2 2023 and the raise last June was designed to get us past some major value inflexion points, the FDA clearance being only one of these. Future financing could be from multiple sources including issue of equity but also from corporate partnership and co-development agreements. At this stage we have no short term requirement for funds and are focused on delivering on our strategic goals.'

Ruck,

It has to be a female patient as the two monotherapy arms of the trial are in ovarian and breast cancer and they need to run through a dose escalation for vimentin and enolase before running a safety cohort in combination with checkpoint inhibitors. So I believe at this stage, it can only be female.

Thanks for that miavoce and thanks to Andrew Smith for a comprehensive answer. In short there are codes they can use temporarily but until they are actually offering a test, they can't apply for a code.

ShearClass,

Some thought provoking posts - thanks. You're quite right to highlight the importance of reimbursement codes in the US and also reimbursement agreements with health providers in Europe, but I wonder whether we have enough information to make any judgement calls on Angle's approach versus RENX.

I'm not very familiar with RENX, although your posts have piqued my interest and will have a closer look at them, but it seems they are selling testing kits for their KidneyIntelX test - a very specific blood test aimed at predicting the risk of kidney failure. As miavoce has pointed out, Angle have confirmed that there are already some existing codes they can use and I suspect (but don't know) that these were created for CellSearch - as a liquid biopsy to simply capture CTCs, but of course Parsortix goes beyond that as their marketing approval is for CTC capture AND SUBSEQUENT ANALYSIS. In Renalytix's case, you know what the subsequent analysis is - it's the KidneyIntelX test and so reimbursement is quite straightforward. However, there are a whole host of downstream assays that can be carried out using Parsortix and I assume the price will vary according to the test being carried out.

It may also be that potential partners will be the ones to apply for reimbursement codes. For example, Abbott may wish to license Parsortix for HER2 testing and secure their own reimbursement code and Angle may well have taken the commercial decision that applying in advance would hinder potential deals.

I guess the point I'm making is that we just don't know and don't have the information to judge one way or another. What we do know is that Angle have some hugely experienced and clued up advisors and reimbursement is something that will have been built into their overall commercial strategy.

What slowly slowly approach? AN has confirmed that no other CTC liquid biopsy developer has even started the FDA approval process. If a new technical/medical advance happened tomorrow, they'd still need to go through the whole clinical testing and FDA submission process. The fact that Angle have already signed up 5 pharma clients and some are even paying Angle to create bespoke assays clearly shows that no matter what is discovered tomorrow, there is a clear unmet need today and as of today only Angle has FDA approval to meet that need.

Konar,

I remember the press coverage of that case being discussed here but I don't think the patient died. I'm pretty sure that this may be the patient you're thinking of. She had advanced melanoma and was given just one dose of anti PD-1 (Opdivo) in combination with anti CTLA4 (Yervoy) and her tumour disappeared:-

'Her case shows that immunotherapy can work quickly: Her tumor vanished within three weeks of receiving her first treatment, the researchers found. "I was astonished; I'd never seen anything like that," Chapman said. "She said the tumor had just kind of dissolved." However, the combination may pose a risk if it dissolves a tumor somewhere else the body, and leaves a hole behind.'

By the way 'Chapman' in the above quote is Memorial Sloan Kettering's Dr Paul Chapman who was one of the investigators for that study and also for Scancell's US SCIB1 trial that never was.

https://www.livescience.com/50618-melanoma-immunotherapy.html
https://www.nejm.org/doi/full/10.1056/NEJMc1501894

Chester,

In response to your 16.38, this is from the inclusion criteria for the Modi-1 trial:-

'Patient has completed their last dose of prior cancer therapy at least 4 weeks before the first dose of study treatment'

New briefing note from Trinity Delta issued this morning to be followed by a revised valuation.

'Successfully raising money against a challenging environment for the sector, coupled with the current macroeconomic backdrop, is a testament to strength of the Redx Pharma investment case. Doing so without a share price discount and raising more than expected suggests the quality of the equity story is beginning to be truly appreciated. '

https://www.trinitydelta.org/research-notes/34-3m-raise-extends-runway-through-key-data-points/

Sorry, forgot to add that it looks like they've moved to SCOV2 completely and dropped SCOV1 - even newly recruited unvaccinated patients will be given just 2 doses of SCOV2 whereas previously they'd have been given 2 of SCOV1 followed by 2 of SCOV2. It was always the intention to move to SCOV2 anyway and this significantly reduces the length of the trial.

bajookajr - meant to say, thanks very much for posting the link to the new trial record and well spotted!

miavoce/ray - The planned UK trial was in effect an additional arm to the phase 1 trial to test SCOV2 as a booster in people previously vaccinated with already approved vaccines. So it was still a phase 1 and primary objective would be safety. Given that the SA trial is now also testing for safety in that same patient group, it's hard to see any merit in proceeding with the UK arm as it stands, unless of course they're unable to complet the SA trial for any reason. So perhaps they'll look at amending the UK trial to a phase II or they'll be satisfied that they already have sufficient data for their needs. Will be interesting to see how it plays out.

Burble,

Thanks very much for picking out the important bits! Just to add another couple.

1) For the first time we see Omicron mentioned:-

'Antibodies induced by SCOV1 and SCOV2 also show strong binding to the B.1.617.2 (Delta) and B.1.1.529 (Omicron) variants in nonclinical models.'

2) We knew that the protocol had been amended to inculde previously vaccinated people and all participants whether originally vaccinated with Covidity. Pfizer, AZN, Moderna or whatever will still require 2 shots of SCOV2 as a booster. However, previously infected participants will only require 1 shot of SCOV2

3) Although the estimated number of patients has increased to 80, they can stop when they have 10 evaluable patients in each arm of the trial and if this is a problem, may even be allowed to stop earlier:-

'This study is expected to enrol up to 80 participants at a single centre in South Africa. Enrolment will attempt to continue until at least 10 evaluable participants receive all protocol-required SCOV2 vaccinations for each immunogenicity analysis population. However, should the epidemiology be such that certain populations cannot be enrolled, the Safety Review Committee may determine that enrolment for that population be considered complete.

Konar,

Re. your 9.03, the patent covers a new Moditope target protein - Cytokeratin 8.

This application only covers citrullinated Cytokeratin 8 (also known as Keratin 8) but I see it's listed on Scancell's website as one of the peptides being considered for Modi2 - see the 'keratins' bullet point in the link below which briefly explains what this protein does. Of course if it's being used for Modi2 then the it will be homocitrullinated rather than citrullinated, so it may well be that Scancell have also filed a patent application for homocitrullinated Cytokeratin 8 which has yet to be published.

https://www.scancell.co.uk/modi-2

A new patent application from Scancell was published last week - 'WO2022106696 - ANTI-TUMOUR RESPONSES TO CYTOKERATINS.'

It was originally filed back in November and covers citrullinated Cytokeratin 8 peptides.

https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2022106696&_cid=P12-L3U8V6-10352-1

Johnny,

I think only Scancell can answer that question. As far as I know, we've not been told how many patients they planned to recruit to the UK arm of the trial, which as you know was intended to test Covidity purely as a booster to previously vaccinated patients and we have no idea of the split between vaccinated/unvaccinated in the SA trial, so it's impossible to even guess. It will obviously depend entirely on the quality of the data coming from SA and whether they've recruited enough previously vaccinated patients to negate the need for the UK arm.

Scancell will also have to decide on their strategy regarding Covidity going forwards. Are market conditions are right to take Covidity to the next stage themselves or do they already have sufficient data in the bag to secure a partner? Konar mentioned a phase II expansion in an earlier post and I guess it's also possible that SA will provide the necessary safety data to allow Scancell to change the UK arm into a phase II.

Of course the other angle to consider is that this trial is also testing Avidimab for the first time and again we really don't know how that may influence decsion making.

Johnny

Excellent research - thanks very much.

So it would appear that the changes reflect the protocol amendments announced back in March - ie. that in effect this has now become a trial for Covidity as both a primary vaccine and also a booster for those already vaccinated with an approved vaccine.

Konar,

Responsibility for updating clinicaltrials.gov can lie with either Scancell or the study investigator - possibly also the CRO although don't quote me on that. Updating requirements depend on the type of information, for example changes in things like recruitment status must be updated within 30 days, however, other changes, including protocol amendments only need to be updated every 12 months, although they recommend that it's done every 6 months. Nevertheless, like you I 'm a bit surprised that the Covidity record hasn't yet been updated.

Re. your second paragraph, given the above, I'm not sure we can make any judgements based on whether or not clinicaltrials.gov has been updated. It may well be that they now have a good idea of which device to take forward - I thought they'd already made the decision to go with SCOV2, but either way they may now know which device and which vax they want to go ahead with. They may even have already applied to the MHRA for clinical trial approval for the UK arm of the trial. I just think that in view of the fact they issued an RNS for the protocol amendment to include vaccinated patients, they would certainly issue one for something as fundamental as a change to a one dose vax or an expansion of the trial. Moreover, the RNS issued in March wasn't RNS REACH, it was a regulatory RNS so they clearly believe such changes must be announced.

So unless we hear otherwise, rather than getting my hopes up, I'm sticking with the more boring explanation that it's down to the PharmaJet devices or some other innocent explanation.