Member Info for Saxondale

Yes thanks Gggg . So much proof stacking up now .

Don't worry over the SP , we we never gonna sell at £5 anyway .

So much info coming out its hard to keep up , on both fronts .

Another publication yesterday - showing that although Covid knocks out the IFN beta expression , it doesn't affect added Interferon - so its possible to treat Covid by adding IFN Beta .

This is really good news for us

Our findings demonstrate that this coronavirus has devoted a significant proportion of its genome to block IFN-I production, presumably in order to help it establish early stage infection. Nevertheless, this virus remains sensitive to the effects of added interferon, providing an opportunity to treat COVID19 patients with IFN-Is therapeutically.

https://journals.plos.org/plospathogens/article?id=10.1371/journal.ppat.1009800

One interesting fact regarding safety of upping the frequency of dosing ( imagine upping frequency of chemo by three ).
The highest dosing they are using on the trial is still 300 fold lower than the amount tested on primates - who even at that level showed no toxicity .
Hence the continued reminder of how safe this drug is .
Another massive plus when going into commercialisation.

Itsall , I think they are now at the point where they have proved enough where they can relax .

The number of new trials kicking off sets up multiple shots at goal , but they already have 4 P2 sets of data , that show 30-40% ORR .
Checkpoint Inhibitors with a ORR of 10-20% have been approved after P3 . And like Markku says , at the moment the patients we are trialing are often pretty worn out after many therapies . The response rate should be even better if given to patients who haven't had their immune system battered by chemo etc .
A lot more detail in this latest presentation , lots going on .
Upshot - its going well , its all coming together , don't rush us , as we've got a lot of data coming together , the more we have , the better the package is going to be .

We've got the ESMO Congress 16-21st Sept .
They seemed pretty keen to get that latest data in to showcase there .
Big Pharma will for sure be circling now .

Well I threw two questions in , couldn't really think of how to ask the important ones .
Could Hibiscus be expanded to look at long Covid - yes , although the interim data is key first , but they are doing many studies already around Covid/ARDS symptoms to learn about how IFN will help .
When will we see Soluble data findings - Hopefully Q3 - some of it , they have so much data that they are compiling that they need to get it right before announcing . So it will come out in dribs as they see fit to release .

Both mentioned the funding possibilities - but without any expanding on the RNS .

Also Toni explained that in addition to the cash holding , there are still tranches of grants and loan funding coming into the pot through the next few quarters - so not quite so clear cut .

They didn't seem concerned about rushing into anything , rather more choosing what path is best .

From Bayers head of their Immunotherapy division ( Leaps )
There are already approved immuno-oncological therapies. What kind of patients is immunotherapy suitable for?
We currently believe there are several hundred different types of cancer. The therapies that are already available on the market so far only work for a small number of tumors. They achieve good results primarily when used to treat blood cancers, i.e. liquid tumors, but aren’t so good at treating solid tumors, such as breast cancer, prostate cancer, bowel cancer, liver cancer and so on.
Ermm.... hello

The 250 million euro investment will further strengthen Bayer's footprint in Finland and Turku's position as the contraceptive capital of the world.

Contraceptive capital of the world lol ???

Well they have a big Cancer Immunotherapy division - what a tie up that would be !

https://www.bayer.com/en/news-stories/immunotherapy-to-treat-cancer-using-the-body-s-own-defenses

And with over 47 million people vaccinated - just in the UK , how many would want to know whether they have antibodies before rolling their sleeve up for another booster , and another booster...

over 160 patients now recruited ( up from 140)

New study about to start with RENACOL - one dose of Bex 2 weeks before operation. Localized renal cell and colon carcinoma .

Very important study ( he says )
prior surgical tumor removal

Looks like they save the best for last
Hepatocellular cancer - ( 4/10 patients respond positively ) 40%

wow - looking to discuss with FDA regarding what they need for conditional approvals .
He is very upbeat

New presentation too
https://www.faron.com/sites/default/files/August%202021%20Half%20Year%20Presentation%20-%20FINAL%20-%208-25-21_0.pdf

Interesting video to show that people with impaired interferon response is totally linked to how Covid 19 affects you .

Shows why kids generally don't get it bad , as they have high expression . More receptors for interferon response in their upper respiratory tracts , but more importantly they are almost actively primed ready to go - so they can get to work on Covid before it plays its ace and shuts down the ability to express IFN .

There is a small window of opportunity for these cells to express IFN before the Covid infection shuts them down .

Bottom line , Covid proteins obstruct bodys ability to produce IFN .

https://www.youtube.com/watch?v=9OZZ6_M4OB0

spread is actually 460-463 at the moment .

Dan - yes that sounds like they have plenty of financing options.
Markku said before that loans could be extended .
EIC /Business Finland ?
I trust the BOD to do whats best for shareholders

They had me at UBS and Piper .
Been holding for jam so long , another day won't hurt

Hibiscus looking to be run at 10-15 sites across US
That should help enrollment

Not read the whole thing yet , but interesting that they now have this guy . He appeared on the RNS's only in July .
A role SNG also created recently - due to expected increase in communications .

Media Contact
Faron Pharmaceuticals
Eric Van Zanten
Head of Communications

Confirmation that all is on track then .
P3 trials looking to initiate in Q4
4 cohorts as it was thought . 30-40% disease control rate observed . I'm liking the 40 !

Then -

Additional MATINS data was accepted as a late-breaking abstract and will be presented at the European Society for Medical Oncology (ESMO) Congress 2021 in mid-September.

They had 7 million euros cash at end of June .

Four P3 trials on track for Q4 - so question is - who's paying for them ?

See if we get any answers later on

Clinicaltrials.gov site updated today
https://clinicaltrials.gov/ct2/show/NCT04860518?term=faron&draw=2&rank=2

Now has the active comparator : Intravenous Dexamethasone

So the trial will effectively run the 2 drugs on the same trial , both with saline placebos .

Patients will get randomly chosen for either therapy ( or placebo) on a 1:1 basis

140 patients for the whole trial - thats a small number to start with .
If I'm reading it right , thats 70 per group ( 35 drug / 35 placebo for each arm)

This is marked as a Phase 2 at the moment .
Interim analysis will be done after 70 patients have reached primary efficacy point ( 14 days )- to determine final study size .

This perhaps gives them the chance to apply for an EUA if Interim data is great , or carry on with larger study if still required .

RNS blurb from Januray says :
The study will recruit 140 hospitalised COVID-19 patients with 1:1 randomisation assessing Traumakine against placebo with a primary endpoint of clinical status (WHO 9-point ordinal scale) at day 14. Secondary endpoints are clinical status at day 28, and in-hospital mortality at day 28 and day 90. The study protocol will have an interim analysis once 70 trial subjects have been assessed for the primary efficacy endpoint (clinical status at day 14). A further assessment of the conditional power will also be conducted in the interim analysis based on the observed result and the sample size will be adjusted accordingly, allowing completion of the study with confidence for regulatory compliance.
Also it states :
Faron has also applied for new patent protection relating to the induction of CD73 for organ protection, followed by the use of steroids for the treatment of systemic inflammation. Hence, the best effects of both drugs are optimised in a sequence for patient benefit.

Start date August 5th
Expected primary completion date : December 2021

Two study sites so far :
University of Colorado Anschutz Medical Campus - recruiting
Beth Israel Deaconess Medical Center Boston - Not yet recruiting

Jan RNS says they would look to set up to 5 study sites.

Upshot is it looks like we should get some data sooner than the study completion date .