Member Info for Saxondale

The science pages have also been rewrittten on the Faron website now (at last ).

All 3 drugs have new summaries.

https://www.faron.com/bexmarilimab

https://www.faron.com/traumakine

https://www.faron.com/haematokine

EHA 2023 tomorrow , with Faron presenting a Bexmab abstract

https://library.ehaweb.org/eha/2023/eha2023-congress/386371/mika.kontro.a.phase.i.ii.study.to.assess.safety.tolerability.and.preliminary.html?f=listing%3D0%2Abrowseby%3D8%2Asortby%3D1%2Ac_id%3D386371

This I believe is from data up to Feb , so they don't have the latest April additions .

Would be nice if they dropped another update asap - been 7 weeks since last one nearly .

Summary/Conclusion:

The initial data show that BEX treatment is well-tolerated without additional toxicity to standard treatment.

Preliminary efficacy shows 3 responses out of 5 patients in the first dose cohort. The study is ongoing

All focus is on gaining ' expedited market access for Bex ' via Bexmab with LLS assistance .

In my opinion , that is what they are busy doing . Once that happens ( via FDA meeting to evaluate the Bexmab data )

, then the ball will firmly be rolling .

AS noted - no RNS's in April . Matins data is being finalised . Bexmab data being studied . New sites being prepared . Finance guy laying the foundations for future moves .

The quiet before the storm ?

Very touching post . Best wishes .

It's building up to something soon I'm pretty sure .

The pipeline page on their website may be a clue .

As well as the new wording around the Bexmab trial goals , the new labeling of the other 2 drugs into a ' Cancer Supportive care ' category is a new shift . We haven't heard much there at all - yet there is a trial planned to start at the Fred Hutch cancer center .

Https://www.youtube.com/watch?v=NUxeK8kqZAo

Two very positive bits of news . cracking on - well done

Talking of AI , looks like Faron are using it themselves .

https://www.aiforia.com/blog/spatial-biology-cancer-research?utm_content=249976186&utm_medium=social&utm_source=twitter&hss_channel=tw-4349146708

The automated scoring of Clever-1 positive cells sped up the pathological scoring of our tissue samples, which we are routinely staining as part of our ongoing clinical trials. Pathologists at a contract research organization currently do this work, and the availability of pathologists is often a limiting factor in obtaining timely results. This research project will help us identify patients who can benefit from our experimental cancer treatment, so we foresee promise in Aiforia as our companion in diagnostic development.

Compared to many on Aim we are holding pretty well .

But yes , we need , and should get something soon .

It's almost ironic that every time we get to an important moment for the company , the US finances seem to be in turmoil .

Lets hope that our new CFO and board members are helping get things moving.

It may be a month or so , or we may get news tomorrow .

I'll go for either a Bexmab patient data update , or some kind of Fast Track/ Orphan approval

Probably be something totally different like Traumakine/Haematokine ( both of which should still bring us significant value at some point )

And as if by magic - they immediately drop the price . Good job Sax lol

I was going to buy some more this week anyway - so happy to get them at 8.53p

Roll on the next news update ;-)

Farons CSO Maija is hosting a conference today in Turku - regarding novel therapies .

For those unaware , the In Flames organisation has Sirpa ( Markkus wife) as a lead member too - pushing and promoting Immune research programs .

Hopefully Bex will be mentioned as a success story that is unfolding .

https://twitter.com/InFLAMES_Health/status/1656592939852677126?s=20

They should hopefully give us the next installment of Bexmab results soon .

Big news may come after talks with FDA about - accelerated approval pathway for Bex in the AML arena .

I'm sure the LLS team are guiding them down this route .

They are applying also for various orphan drug and fast track designations .

Something financial could drop anytime - regarding partnering/funding /Traumakine sale .

For 'Breakthrough Therapy Designation ' they needed a few more patients - so possibly Q3 , but in Bexs favour is the fact that well over 200 people have already been treated - so they have plenty of safety data etc .

The team and KOL all seemed very excited and positive back at the last presentation , so just a few more Bexmab positive indications and we may well get the green light .

Finally lol .

And just look at that management team .

Heading for the big time.

FDA should give Faron an answer within 60 days of requesting FT or OS .
They seem pretty confident given that they have what appears to be convincing data .
Looking at the Bexmab data so far on one of the slides today - they seem to be achieving double the efficacy of the original drugs alone . Clearly a justification for expedited approval - given that they already have years and over 250 patients worth of safety data.

Orphan drug status (designated by the FDA) gives a company exclusive marketing rights for a seven-year period, along with other benefits to recoup the costs of researching and developing drugs to treat rare diseases.

Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.

Understanding the FDA expedited approval process may explain to payers, providers, and consumers that drugs undergoing accelerated approval are still safe and beneficial to patients. According to Regulatory Focus, in 2021, 74% of drugs approved by the FDA were approved through an expedited pathway.

Yes they all seemed very keen on that possibility .
I asked the question of how they were planning on funding the next stages - but it was not put forward .
Most of my others were - and it was good to see them all so upbeat .
Next few months will be exciting .

2 patients rercuited in US already.
MD Anderson should hopefully start in May . Dr Daver is very keen to get going with Bex .
They only need 8-10 good responses in this area to start positive talks with FDA regarding accelerated approval options.
Looking good .
They are all very enthusiastic . LLS has been a great help too .

MLF just said that Faron will be applying for both Fast Track Status and Orphan Drug Designation for Bex in the next few weeks in the relapsed/refractory AML .
They would also like to be doing Breakthrough designation - but don't have enough patients yet (20-30)

Really looking forward to tomorrows update and discussion . This Dr Daver has a good following , and high standing - so if he makes positive noises about Bex , there will be plenty of people taking notice .

Possible coincidence , but today on Clinical .Gov website - the Bexlung trial date was reset to June 2023 .
This has been nudged a few times already , but may be a sign this time that it's about to be started .
https://clinicaltrials.gov/ct2/show/NCT05171062?term=faron&draw=2&rank=10

These data suggest that bexmarilimab therapy is well-tolerated and show that macrophage targeting can promote tumor control in late stage cancer.

Add that together with the Bexmab data - how much proof do the potential partners need ?

Price tag goes up after every successful trial update / research note ?