Member Info for Bermudashorts

Perhaps the UK Governement should look a little closer to home for a variant proof vaccine..............

'Saint-Herblain (France), September 13, 2021 – Valneva SE, a specialty vaccine company, today announced that it has received a termination notice from the UK Government (“HMG”) in relation to the Supply Agreement for its COVID-19 vaccine candidate, VLA2001.'

https://www.globenewswire.com/news-release/2021/09/13/2295435/0/en/Valneva-Receives-Notice-of-Termination-of-COVID-19-Vaccine-Supply-Agreement-by-UK-Government.html

Should have added that I can't see that there's any connection to LD's sell.

Yep also worth going back and looking at some of AB124's posts - he has been commenting for months now that the SP is being kept in a tight range.

Chester,

Ah right I'm with you now, thanks for the explanation.

I know I'm being slow here, everyone else clearly understands but can you explain your 8.42, especially this part:-

'The PDMR route was the only way causing the instant sale'

By the way - not a trick question, I genuinely don't understand.

The phase I study is complete and we've already been told via RNS that the 2mg dose has been selected for phase II based on the safety profile observed during that dose escalation study. This is taken from the RNS:-

'Preliminary data from the study in patients with unselected advanced solid tumours, showed that RXC004 2mg once daily was safe, tolerated and provided target coverage at levels required to assess monotherapy efficacy in Phase 2 clinical trials in selected patients with Wnt-ligand driven cancers.'

Why on earth would you suggest that Redx would present phase I results at ESMO that will reveal safety issues and cause the SP to tank when we've already been told that the drug was safe and tolerated at the selected level?

New note out today from Trinity Delta regarding Sanofi's $1.9 billion purchase of Kadmon for their ROCK2 inhibitor. Here's a couple of lines:-

' Redx Pharma is a recognised expert in ROCK pathways, with its RXC007 novel small molecule being the only other ROCK2 inhibitor in clinical development. '

'The importance of the ROCK pathways has been known for some time, but the chemistry is complex and historically identifying safe and effective selective inhibitors has proved challenging. Redx Phama has a proven medicinal chemistry expertise and has generated what, in our view, is a possible “best-in-class” small molecule.

https://www.trinitydelta.org/research-notes/kadmon-acquisition-has-read-across-for-rxc007/

Who knows, but I hope that's not the case.

Possibly Crumbs, but if it's a question of looking at the tumours of long term survivors of cancer and trying to identify common antigens as potential targets then not sure Moditope is a natural fit. At this stage, it also appears to be very much an academic collaboration and not strictly related to Scancell.

Crumbs,

Interesting, thanks for that.

UoN are recruiting a research fellow to join Lindy Durrant's team - see below.

This line from the job description makes me wonder whether part of their time will be spent working on the Continuum project:-

'The research will focus on the identification of immune responses to tumour antigens in in vivo models and also in long term cancer survivors.'

https://www.jobs.ac.uk/job/CIX644/research-associate-fellow

The Sunday Times article mentions Redx's BTK inhibitor that was sold to Loxo Oncology - the first of Redx's molecules to be monetised. Loxo was subsequently bought by Eli Lilly and Redx's BTK inhibitor now goes under the name of Pirtobrutinib. Lilly have been pressing ahead with clinical trials and Pirtobrutinib is now regarded as one of the most promising candidates in their pipeline.

Only a few days ago, really impressive phase I/II results in lymphoma were presented at the 2021 Pan Pacific Lymphoma Conference with an overall MCL response rate of 52% and a complete response rate of 25%. These rates were achieved in patients who had been heavily pretreated and failed on other therapies, including other BTK inhibitors, CAR-T and stem cell transplants. Even higher responses were seen in other types of lymphoma. Pirtobrutinib is now undergoing phase III studies.

The point is that industry will be aware of the quality of the molecules coming out of Redx's labs and the success to date of Pirtobrutinib will not be lost on any who may be watching the progress of RXC004 - phase I clinical trial results are due to be presented at ESMO in a couple of weeks.

https://www.onclive.com/view/pirtobrutinib-exhibits-promising-efficacy-in-heavily-pretreated-mcl-and-other-non-hodgkin-lymphomas

Yes, excellent coverage - link below together with a couple of excerpts.

'For a company that sold off its star asset in 2017, Redx has made a remarkable recovery.'

'One issue with Redx is getting hold of the shares — big blocks are hard to come by. Some 79 per cent are held by US investor Redmile, which snapped up Moulton’s holding — although that is down from almost 90 per cent a year ago. Number two and three on the register are Sofinnova and Polar Capital.'

'The shares closed on Friday at 59p, valuing the company at £162.3 million; Panmure Gordon, the company’s broker, has put an ambitious 135p target on the stock. While it may be some way from these lofty heights, Redx is reaping the rewards of its turnaround. Buy.'

https://www.thetimes.co.uk/article/tipster-drugs-maker-redx-has-a-dose-of-good-news-wstvpc3z8

Yes, at the moment Redx seems to be under the radar but 3 products coming out of their labs have now been monetised, they have one of the strongest management teams of any AIM bio, an exciting pipeline and are backed by highly quality specialist funds. IMO one of the most promising bios on AIM.

Yes, excellent news and next milestone due on FDA clearance of an IND. Redx going from strength to strength now.

Basscadet,

Unpublished as in not in the public domain, the Company, the CRO and the study investigators will have full access to the data.

An ever increasing percentage of the population in most countries has now either been vaccinated or caught and recovered from Covid. This makes the standard randomised clinical trial design used to test the 1st generation vaccines largely redundant. An interesting development this morning has come from GSK and CEPI funded SK Bioscience with the announcement of their phase III study for GBP510 - a spike protein targeting vax being administered with GSK's adjuvant.
They are planning a 4000 patient trial going head to head against AstraZeneca's ChAdOx1-S - so patients will be randomised to receive either GBP510 or ChAdOx1-S.

This has implications for all vaccine developers and the reason becomes clear when you look at the trial design in a bit more detail, particularly the primary and secondary outcome measures. The primary endpoints are simply levels of and increases in neutralising antibodies and the secondary endpoints are a mixture of the results various antibody and T cell assays and safety. Not a single endpoint for efficacy measured by actual covid infections - it's all biomarkers.

You can see the impact of this when you look at the speed of the trial which has a primary completion date of March 2022 - that's astonishingly quick for a phase III study and looks like they're hoping for approval in H1 (possibly EUA). It'll be really interesting to see how the regulators handle this but shorter (and less costly) covid vaccine trials can only be a good thing for people and developers alike.

https://www.londonstockexchange.com/news-article/GSK/sk-bio-gsk-start-ph3-covid-19-vaccine-trial/15115838

https://clinicaltrials.gov/ct2/show/NCT05007951?term=GBP510&draw=2&rank=1

On the Road to Developing a Variant-Proof COVID-19 Vaccine

A nice article on Charles River's website about Scancell's Covid vaccine - Charles River own Cobra Biologics.

https://www.criver.com/insights/road-developing-variant-proof-covid-19-vaccine

Rats,

Truly so sorry to read such sad news and sending very best wishes and sincere condolences to you and your family.

The happiness and welfare of loved ones is the most precious thing to us all and I'm sure that absolutely nobody will be relishing in your grief.

Take care.

There's probably an embargo over the presentation at the moment - data must be previously unpublished afaik to present at ESMO but hopefully an RNS will be issued to coincide with the presentation - possibly the next morning.