Member Info for Saxondale

hypercholesterolemia - High Cholestorol ?
Interesting for them to add that into the description of the patent , along with cardiovascular disease .
Possibly some lab work / tests have pointed towards this ?
Not sure how stimulating the immune system reduces cholesterol .
But Bex seems to work in many ways - and how's this for a tenuous link ...
High cholesterol levels have also been associated with increased coagulopathies (blood clots) in those with COVID-19.

One ring to rule them all !

Just looking at this patent - it really hits home how involved and complicated a process it is - bringing a drug to market .
The detail , just in this one little patent , is immense . The legal detail to maintain intellectual property rights of Bex have to be spot on if this is go all the way .
Faron look to be doing everything in their power to make sure this route is done properly .
Most of us wouldn't even think of some of the details that are being worked on .

It looks like they have the commercial formula for Bex then , maybe this was worked on with AGC Biologics , who will be making it for us .
http://www.agcbio.com/news/agc-biologics-partners-with-faron-pharmaceuticals-to-manufacture-cancer-treatment

Spotted a new FARON patent just published - relating to the stabilising formulation for Bex - so it can be stored and keep a good shelf life for use in clinical settings .
https://patents.google.com/patent/WO2021255336A1/en?assignee=faron+pharmaceuticals&oq=faron+pharmaceuticals&sort=new
An object of the present invention is to provide a stable formulation of an anti- CLEVER-1 antibody or antigen binding fragments thereof for pharmaceutical use, in which formulation of an anti-CLEVER-1 antibody or antigen binding fragments thereof will be stable during storage and hence has a sufficient long shelf-life for clinical use.

It has been observed that chemical denaturation seems to be the most critical degradation pathway of anti-CLEVER-1 antibodies. Hence, according to the present invention especially chemical degradation of anti-CLEVER-1 antibody is avoided by providing storage stable composition. Maintaining the stability of the antibody is also crucial for preserving the antibody's functionality and efficacy, which is now achieved by the formulation according to the present invention. Further, a pharmaceutical formulation according to the present invention provides colloidal and thermodynamic stability.

Worth re-reading the last 2 sentences of this final paragraph - relating to intented and potential uses of Bex...

According to the present invention, anti-CLEVER-1 antibodies or antigen binding fragment(s) thereof include those which specifically bind to human CLEVER-1 or are capable of inhibiting CLEVER-1 expression. Anti-CLEVER- 1 antibodies or antigen binding fragment(s) thereof can be used to increase, enhance, stimulate or up-regulate an immune response. The present invention also concerns a formulation comprising anti-CLEVER-1 antibodies or antigen binding fragment(s) thereof for use as a medicament. A pharmaceutical formulation according to the present invention can be used in removing immunosuppression. A pharmaceutical formulation according to the present invention is suitable for use in treating and/or preventing cancer. Further, a pharmaceutical formulation according to the present invention is suitable for use in a treatment of chronic infections and/or acute inflammatory infections leading to immune exhaustion. A pharmaceutical formulation according to the present invention can also be used as an adjuvant of vaccine. Further, a pharmaceutical formulation according to the present invention is suitable for use in a treatment of hypercholesterolemia, dyslipi- demia and/or atherosclerotic cardiovascular disease.

I posted this before - but there are plenty of IFNG studies - this one pointing to low IFNG levels being risk factor for long covis ( lung fibrosis in particular)
https://www.frontiersin.org/articles/10.3389/fimmu.2020.585647/full

The fact that Bex raises IFNG levels may well have just been the start of the discovery .

Another one here regarding Covid in areas of the world where people suffer from parasitic infections .
https://gutpathogens.biomedcentral.com/articles/10.1186/s13099-021-00427-3

Quite complicated - but seems to point to there being a connection to those having a parasitic infection not being affected so badly by Covid due to their immune system producing IFNG ( in order to fight the parasite ) but also shielding them from the worst of Covid . The most severe cases of Covid were found to have mostly low IFNG levels .
The?+ve role of parasitic infections in modulating the human immune response to COVID-19 infection was evident in the high level of IFN ? in mild cases .

So both of these articles show how raising IFNG levels is a good thing .

I wonder if anyone has ever recorded the % of patients coming in for Immunotherapy treatment that have low IFNG levels ?
And how that relates to the 87% of non responders on the pie chart

Article here relating to Interferon gamma - and how it is an effective biomarker , and also noting that patients with higher levels of it fare better .
From 2018

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5784541/

That article highights potential of the latest trial posted up by Faron a few weeks ago
https://clinicaltrials.gov/ct2/show/NCT05171062?term=faron&draw=2&rank=8

A total of 17 NSCLC patients received nivolumab . Progression-free survival with nivolumab was significantly longer in NSCLC patients with high versus low IFNG expression (5.1 months versus 2 months, p = 0.0124)

Nivolumab is otherwise known as Opdivo , so this trial showed that patients with a high IFNG expression fared better .

Patients who showed response to Bex best are those with low IFNG levels , and after first treatment - showed significant increase in IFNG levels .

So my take is that if Opdivo , and hence Pembrolizumab (Keytruda) work best on patients with high IFNG , then if Bex is given first to fix that , then the Odivo/Keytruda + Bex combi should show even better efficacy - and a successful data set .

That what Faron obviously think anyway - but it's nice to start finding how the IFNG element may be more than just a handy biomarker .

Good spot Oil - interesting new vacancy - they obviously see a need for their own legal counsel in preparation for a busy 2022
One main role - Reviewing, negotiating and drafting various kinds of commercial agreements.
Building a strong team - positioning themselves for the long term - multiple agreements in the pipeline .

Given what we know on Bex progress - the current SP could be the best opportunity you may see ever again ( if you are looking to buy ).

Another significant trophy there . US broadcasting networks must surely be becoming Blackbirds cash cow .
Had another top up during the recent dip .
Looking forward to seeing more of their plans , and tie ups .

Great focused presentation on Bex today from Markku .
Change from usual in as much as -
1.) Spent time running through the team , and in particlular Marie-Louise Fjallskog - who is really going to be running the whole program stateside. Highlighted how much experience is in the team from BOD to SAB.
2.) Bex talk was focused on the biomarker discovery , and how Bex may be so well suited to work as a combi with other drugs .
3.) Clear timeline now to talking to FDA - dosing seems to have just about been decided it appears .
4.) R&D day in Feb will allow all their plans to be discussed in more detail .
5.) Pushing on the fact that this is now becoming a serious , close to market , and very effective therapy .

Overall - seems very happy and excited about the IFN G discovery - as it now gives them clear targets to really make a dent into the 87% unresponsive part of the Immunology pie chart .

Yes I see this as a positive for Avacta . This shows that they can future proof the usefulness of our LFTs .
And as for SP - the therapeutics Div is why I'm here long term .

Its a more Bex focused presentation - just concentrate on the game in hand so to speak .
Slide 8 - they've inserted a comment from New England Journal of Medicine - about how companies should focus on international partnerships in order to develop novel agents ( such as Bex) to be used with Anti PD1 and PDL1 antibodies .

Worth a re-watch of this interview back in October - as RM highlights how much the US Govt has invested into trials for SNG , and how important it is . No wonder the focus initially will be pushing forward commercialisation in the States .
All his points are as relevant if not more so today .
https://www.youtube.com/watch?v=yxlrmA8vdvc&t=30s

Good reminder today of who else they may be talking to .
SNG001 would tick a lot of boxes in the BARDA dept .
Biomedical Advanced Research and Development Authority
https://www.medicalcountermeasures.gov/newsroom/2021/mile/

All part of the US Gov front line defence against possible health threats , now and in the future .
https://aspr.hhs.gov/AboutASPR/Pages/default.aspx
#Stockpiling

So in the last 24hrs they inform us that they have partnered up with IQVIA and now Ashfield Engage .
They have seen the data.
You don't need to be Columbo to see where this is going .

Looks like they are spread across the globe -
Many offices in USA too .
https://ashfieldengage.com/en-gb/company-information/

The board approved this policy on Dec31st , the day after the RNS came out regarding EUAv2 .
Its all getting wrapped up .
At least 80%.....

https://www.rns-pdf.londonstockexchange.com/rns/5730X_1-2022-1-5.pdf

Income at the moment is poxy - but income on sale of assets will be huge .

80% of their net income - thank you very much indeed !

RM is a role model for other CEO's in this field .
Honest , diplomatic , and very aware that he is part of a wide team . The same could be said for SSH .
Both can also explain the science in a very understandable way .
It's been a long journey from Manic Monday , so to get to this point , I think todays tweet was a celebration of what was achieved in 2021 , and also a message that they are prepared for the next stage in the journey #2022ready .
Tweets aren't RNS's , or Journals etc , they are communications to those who follow them on twitter . So this tweet was a thank you to those who have helped them get to where they are , and recognition to those who have supported them .
The timing comes as we are awaiting big news , and they know that . Yes it was a New Year message , but at this stage , putting out an almost celebratory message would not really fit with Synairgens modus operandi if things were not going the way they hoped .
The SP has had some rough waters over the last few months , so I think as well as a thank you to partners , this was a quick reassurance to investors too . Some of whom will have very large amounts of money riding on this , and no doubt RM will feel that the investors who have supported , taken time to share the companies work on social media , and stood up against mis or disinformation around SNG are also in some ways 'part of the team '.

It sure feels like that sometimes lol

Tweet gives a nice summary of progress made so far , and how they have geared up with the right people to push this forward at speed .
Very positive - all very bullish to come out with this slick little presentation