Member Info for Saxondale

New trial for Traumakine now up on site as of yesterday -

Start date December. 24 patients .Phase 1/2

Fred Hutch Cancer Center running the trial.

Patient receive doses for 3 or 5 days of treatment . Then will be assessed after 28 days / 90 days and onwards .

So shouldn't be a long drawn out affair to get some indications .

Interferon-Beta-1a (FP-1201) to Prevent Toxicities After CD19-Directed CAR T-Cell Therapy

This phase I/II trial tests the safety and how well intravenous interferon-beta-1a (FP-1201) works in preventing toxicities after CD19-directed chimeric antigen receptor (CAR) T-cell therapy in patients with B-cell cancers that has come back after a period of improvement (recurrent) or that has not responded to previous treatment (refractory). Interferon beta-1a is in a class of medications called immunomodulators. It works by protecting the lining of blood vessels, and preventing brain inflammation. Giving FP-1201 may prevent cytokine release syndrome (CRS) and immune effector cell associated-neurotoxicity syndrome (ICANS) toxicities in patients receiving CD19 CAR T-cell therapy with recurrent or refractory B-cell malignancies.

https://classic.clinicaltrials.gov/ct2/show/NCT05936229?term=faron&draw=2&rank=10

I got frustrated and sold about a month ago . At this discount I had to get back in ( although you can't buy much) , even as a punt there is a big reward to be had if they manage to oil the right wheels and get the permit . Not over yet by any means .

Huge amount of work done - and they are sitting on a massive resource - there is big money to be made for lots of people when this gets rolling .

The market fro MDS treatments is expected to grow from $3billion in 2022 to $6 billion in 2030

according to this study

https://www.coherentmarketinsights.com/market-insight/myelodysplastic-syndrome-treatment-market-775

Biggest growth driver to achieve that increase is expected to come from increased regulatory approval for new therapies .

US accounts for nearly 30% of the world market .

But Asia Pacific region also very large , also Europe .

AML treatment market is expected to be worth $2-3 billion by 2030 . Growing 10% each year.

Big players - Bristol Myers Squibb . Novartis .Pfizer .Otsuka . Sanofi . Takeda .

My money is on BMS being the favourite preferred partner , just on the basis that they have a great relationship with the LLS . But who knows ? The next few combi trials with Bex could open up even more options for treatment combis .

It will be interesting to see what comes of this . The AML/MDS market is literally just be the tip of the iceberg in terms of valuing Bex .

Looks like the Matins trial for Bex has all the participants it needs .

Update on the site now shows it as Active - but not recruiting .

https://classic.clinicaltrials.gov/ct2/show/NCT03733990?term=faron&draw=2&rank=4

216 patients involved in total .

The goal of measuring safety and preliminary efficacy looks to be complete , as may well be the dosing and frequency levels for optimum effect ( marked as 'ongoing' on the pipeline page - but that has been up there for a while now )

All that's left for them to do now is write a price tag on the package . No doubt they won't be making any decisions until the FDA meeting around Bexmab - which may change the playing field dramatically ( in our favour )

Could be nothing , but the Sp is doing a little bubbling this morning . Often this is like a little tremor before big action ( often with no RNS to explain ) .

Also had one of my tweets retweeted by Farons head of communications today ( yes there is someone in that post - and amazingly its not me ) - first time ever - so I also take that a good omen that they may have dusted her off in preparation for communicating some good news lol .

METHOD FOR USING INFLAMMATORY MARKERS TO GUIDE ANTI- CLEVER-1 BASED CANCER TREATMENT

https://patents.google.com/patent/WO2023105118A1/en?assignee=faron+pharmaceuticals&oq=faron+pharmaceuticals+&sort=new

This one was published 15th June 2023

Looks to be relating to the use of a simple blood sample taken from patient prior to any treatment to measure levels of certain biomarkers - to see suitability to anti Clever 1 treatment ( Bex)

Another fine tuning selection tool to massively increase the odds of success for patients who fall into the suitable category - also hugely helpful for those pivotal trials where patient selection will be key . Very nice .

A method for choosing a patient to anti-CLEVER-1 therapy prior to beginning anti-CLEVER-1 therapy using one or several of the inflammatory markers selected from interferon gamma (IFNγ), tumour necrosis factor alpha (TNF-α), interleukin 6 (IL-6), interleukin 8 (IL-8)and C-reactive protein. When the measured level of the inflammatory marker is substantially within the reference values of the inflammatory marker or lower than the average reference value of the inflammatory marker, it is an indication to choose the patient and begin the anti-CLEVER-1 therapy.

The present invention relates to use of one or more inflammatory markers to guide anti-CLEVER-1 based cancer treatment and a method for choosing a patient to anti-CLEVER-1 therapy prior to of anti-CLEVER-1 therapy.

Mcap of approx £150m .

So for a breakthrough therapy ( status of which may also have been applied for by now )

CB and Markku are right on the future valuation .

You can add a 0 to the SP should it come good .

They must be doing something right in the Markets eyes .

Placing at 2.55 euro , and the Nas is currently 2.90 euro.

No investor in his right mind is going to throw in the towel now , after all the build up , and with market approval tantalisingly close . We've followed this story for years now . And we've never been closer to that major rerate than in these next few months .

Its a little confusing what they will actually be asking for Stu , as up until recently , the FDA discussions had been about the MATINS trial with Bex being treated for solid tumours . They had that meeting , and FDA was supportive of further pivotal trials . The dosing amounts were still being decided , and then we were hopeful of some kind of partnership .

But this last year the Bexmab trial has kind of overtaken those discussions , as the immediate amazing results they got there , gave them the opportunity to use the Leukemia treatment opportunity to get Bex to market .

So a few months ago during one of the presentations , MLF said that they would be talking to the FDA in Q3 in respect of gaining expedited market access . They had applied for various status forms for Bex too , orphan drug status I believe , being that there is a clear unmet medical need .

This aim is also on the pipeline page on their website .

So the hope is that so long as Bexmab patients keep reacting in the same way - Faron will have a strong case for gaining approval . The answers and decisions form FDA should come not much longer than a 60 days after the meeting.

So Q4 is a realistic timeframe for getting that decision ( if that's what they have asked for) - which personally I think they have .

You are correct Stu . I guess I was generalising .

What I should have said was they were funded through to the important FDA meetings ( happening in Q3 ) and their decisions.

These type of companies will always only be a few quarters from running out of funds , and £5 million isn't a big raise for Faron . If push comes to shove they could have probably raised twice as much I reckon .

In my opinion ,they really believe that this Bexmab data will open the door to some kind of commercial conditional approval - possibly by Q4 ( hence the emphasis on manufacturing too ).

That will tie in with some kind of partnership deal one would hope - and from then on , funding will be a lot less painful .

The finishing line always seems to be just one quarter away , but the fact that Timo is still onboard and adding large amounts is reassuring , given that he has a huge stake and a vested interest in not letting them stall at the last hurdle due to lack of funding .

Another 1000 for me too .

There has been so much good news coming through - just look at the BOD , the US connections being built , the LLS support , the new trial sites . Fast track applications . The team they have . The Bexmab study results so far - FDA meetings next month . Fully funded now through this year .

For any new investor - what a great entry point given how much risk has been removed .

Also no accelerated book build - all done beforehand .

They didn't have to go chasing it - and I'd rather have a small dilution than any more debt deals ( like IPF - which possibly was partially responsible for them to have to make a placing to keep to their rules of funding in place )

Markku has 5% - he doesn't want his share going south either in the long term .

Well if it gets us hopefully to the point where Bexmab will have enough data to present to FDA for potential conditional approval - then it will be worth it .

Timo adds again - he wouldn't be chucking more in unless he could see the reason .

But yes it does make you wonder when they will ever make some kind of proper deal .

Its a positive move in as much as they remain funded - and certainly building up to something .

I suppose I will add a bit today too if we drop to placing price .

Also over 20 new contact names for the Finnish sites have been added to the site study ( sub investigators ) .

They have a large number of people involved now by the looks of it .

Update to clinical site yesterday - 2 US sites added -

United States, California

City of Hope National Medical Center

[Recruiting]

Duarte, California, United States, 91010

Contact:Contact: Rochelle Hernandez 626-218-0247 rochernandez@coh.org

Contact:Contact: Diana Oganesyan '626-218-0247 dioganesyan@coh.org

Contact:Principal Investigator: Anthony Stein, MD

United States, Texas

University of Texas, MD Anderson Cancer Center

[Recruiting]

Houston, Texas, United States, 77030

Contact:Contact: Shenell Alexander 713-745-8290 SAAlexander@mdanderson.org

Contact:Contact: Joie Alvarez 713-792-7321 jalvarez1@mdanderson.org

Contact:Principal Investigator: Naval Daver, MD

WE know about Nval Daver MD , but now we have Anthony Stein MD at City of Hope Cancer Center in California .

He looks to be a top man in his field ( Leukemia research)

Anthony S. Stein, M.D., a member of the City of Hope team since 1985. Dr. Stein is a professor and physician in the Department of Hematology & Hematopoietic Cell Transplantation and associate director of the Gehr Family Center for Leukemia Research within the Hematologic Malignancies Research Institute.

Educated in South Africa, Dr. Stein received his medical degree from the University of Cape Town. He completed his residency at Montefiore Medical Center in Pittsburgh before joining City of Hope as a fellow in hematology/oncology.

Dr. Stein is principal investigator in multiple clinical trials examining the newest drugs for battling acute myeloid leukemia and acute lymphoid leukemia and hematopoietic stem cell transplantation.

City of Hope - also a top notch set up -

City of Hope is one of only 53 National Cancer Institute-designated comprehensive cancer centers in the U.S. The NCI designation recognizes excellence in treatment, research and expertise to address the many facets of the disease. We’re also a founding member of the National Comprehensive Cancer Network (NCCN), reflecting our national leadership in advancing research and treatment. NCCN member institutions are recognized for their world-renowned experts and for treating complex, rare and aggressive forms of cancer.

Exciting times - we are now firmly set up and recruiting in 2 of the most prestigious sites in the US for Leukemia and cancer studies - with two high ranking principal investigators , along with full backing and investment from the LLS.

Well they can take the brakes off now - got my top up finished .

Super news again today - just take the shares when they are cheap .

They won't be for ever .

Panel discussing Bexs latest data from the Bexmab trial - 20th June

https://www.vjhemonc.com/feature/post-asco-eha-2023-aml-highlights/

Panel is chaired by Naval Daver ( our man in the US with high hopes for Bex )- with Farons Mika Kontro on the panel .

Should be seen by all the right people in this sector .

New patent just posted up

https://patents.justia.com/patent/20230167173

Lots of detail on how Bex in combi with Interleukin inhibitor - can have beneficial effects against a host of illness ( including sepsis , virus and cancer )

Must admit I'm not sure how this affects current strategy with Bex - but it looks like another big step in locking in the IP of Bex and laying out in detail what further value it has .

Read as much as I could - and it seems to contain some pretty bold statements !

Breaththough status details ( possibly out of date now - but gives you the basics)

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3745545/

One requirement is that the Company must be able to manufacture the drug at commercial scale - which Faron has in place .

It would lead to -

Conditional or full approval

Expedited development

Rolling submission

Review shortened

Faron are in my opinion fairly confident it will get approval - just how soon depends on the FDA .

Fantastic update . Won't be long until Faron apply for Breathrough Status for Bex in AML treatment .

Only reason they hadn't already was small number of patients . I think MLF said they needed 12 .

So not far off that .