Member Info for Saxondale

Maybe we will see some more activity as money now moves towards the logical alternative .

Gilead acquired magrolimab as part of its $4.9 billion acquisition of Forty Seven back in 2020. However, the antibody has had a bumpy ride through the clinic, with a number of trials placed on hold by the FDA last year due to adverse reactions.

The ENHANCE study had randomized over 500 patients with higher-risk MDS to either receive either its anti-CD47 antibody magrolimab in combination with Bristol Myers Squibb’s Vidaza or Vidaza alone. But Gilead announced in a post-market release Friday that it had discontinued the study due to futility after taking a look at the results of a planned analysis. The primary endpoints were complete response and overall survival.

The Phase 1 combi trial for Bex and Pembrolizumab that was being sponsored by San Antonio Texas has been withdrawn .

Reason given - The sponsor notified the PI that a Phase II trial had been allowed to proceed by the FDA.)

So does this mean that P1 trials are not necessary anymore - as we have been given green light to proceed straight to a Phase 2 trial ?

Faron have so much safety and dosing data now .

I don't know if this is that significant , but the Bexcombo trial is stated on the pipeline page as being 'P2 ready' . This trial wasn't called Bexcombo - but perhaps theres no point doubling up on trials is a bigger P2 Bexcombo is going to unveiled soon ? or maybe this trial will re emerge as a P2 ?

Faron haven't spoken much about this planned trial . Hopefully we may get some combo news to put us in the picture soon .

https://classic.clinicaltrials.gov/ct2/show/NCT05171062?term=faron&draw=3&rank=11

Just caught the last bit of the update -

Asked about how many patients they are expecting to need before pivotal studies .

Her answer was about 50 patients with accelerated approval .

They are hoping for at least 25% OR , and to add at least 3 months to average life expectancy (5 months in these cases) .

Very low bar - as so far they are far exceeding that ( patient 1 is over 13 months , and others are over 8 months already)

So lets see what FDA say . We are still awaiting news on application for breakthrough status / fast track / orphan drug status , and comment on 'accelerated approval ' .

No questions of funding /partnerships today .

The questions were phone in only , and I think they just wanted to get the info out there , via their new IR company .

They are super excited - reading between the lines , this is exactly what they were hoping for - going into Q3/4 - new sites opening in US , so that will be 8 in total - should get 50 patients without too much trouble .

15 so far - probably others been added - so only need about another 4 patients from each site to complete this stage .

One of the unmentioned bit of news that came today was this new LifeSci group - who seem to be the big dog in in the IPO fundraising circle . At some point - US funds are going to want a slice of this pie , if it keeps heading in this direction .

So we have LLS putting us under their wing , and opening doors , 4 US sites now confirmed , and results coming in that are better than anyone could have hoped for at this stage .

Large percentage of shares in stick hands already - so lets see where we go from here .

Good luck everyone .

I normal get a fair price with mine , recently 250 ish before this rise .

The last few weeks have been sticky as I haven't had an instant quote - they seem to turn off when not much going on .

And even today I can't get a quote - despite thousands of shares going over to the Naz ( 100k volume of shares today)

I think maybe the MMs had loaded up or have ben buying from someone needing to sell and are clearing their stock first , hence the low offer for your shares .

When the dust settles should be orderly again .

LifeSci were hosting the event .

I was watching live but got cut off - hopefully it'll be online later .

2 new US sites coming - YALE and UCL in Q3

MLF went through patient details - all pointing to Bex being the main reason these patients responded - as most of the patients that responded had previously relapsed or failed on the Az treatment.

Pipeline showed the trial splitting into two areas I think into P2 - leading up to approval request .

Q&A was just starting when I got cut off -

No . It may get posted up by Faron later for free ( done before) .

I'm sure it's just a update saying that better data is great- further derisks project etc etc .

Just good that this update seems to be quite newsworthy .

Https://www.redeye.se/research/923704/faron-pharmaceuticals-positive-bexmab-study-update

Anyone else notice that there is a new contact at the bottom of the RNS .

Instead of Investor contact being Yrjö Wichmann at Faron , we now have a new US based company - LifeSci Advisors.

They specialise in cross over financing - and have case studies of doing just that for companies like Faron .

Eg - ABIVAX - This process ultimately led to two oversubscribed cross-over financings resulting in an uptick in the stock. Abivax was originally trading at EUR 7.63 on September 1st before their first cross-over financing of EUR 49.2 million and is now trading at EUR 16.2 after their recent deal in February of EUR 130 million, more than 2x the original trading price.

So it appears we may now be being guided and promoted to a much wider and influential investor base .

https://www.lifesciadvisors.com/about-us/

In the newspaper today in Finland -

Faron from Turku is applying for a marketing license for its cancer drug on the US market - could bring help to malignant blood cancers

https://www.ts.fi/uutiset/6053689?utm_medium=Social&utm_source=Twitter#Echobox=1689749120

You'd assume a partnership well before BLA , as it gives Faron the funding , and gives the Partner an early entry price , and more say on future combo direction .

My money has always been on BMS since Bexmab announcement , but who knows .

Either way - Naz is up 13% with good volume - so the market sees this a very positive

Webcast at 1.30pm today -

https://viavid.webcasts.com/starthere.jsp?ei=1625480&tp_key=01bb7cc4d7

Also we have a conference call and webcast - today - so they are getting this out quick .

Looks like things are moving at a faster pace since opening up the US sites - results good enough to get FDA approval for market access ?

I believe Faron think so .

Soon as I saw all that Pipeline update - I knew they must be busting to tell us something .

Great news update - so they are getting even better results now .

Shows that they are well up the dosing ladder now too ( 6mg/kg) and getting even better results .

Lets see what the conference call tells us - very happy with this !!

Three of five patients in the 6 mg/kg bexmarilimab + azacitidine doublet cohort achieved objective responses (CR and mCR)

· Eight of 15 objective responses observed in all three doublet dosing cohorts

· One patient has stayed on treatment for 13 months

Fresh update to the pipeline page - looking very promising .

Of note - Faron now expect a BLA filing in H1 2025 ( sounds a long way off - but A BLA is submitted AFTER an investigational new drug has been approved and is required for interstate commerce in the US )

So why would they highlight the fact that they are expecting to file for BLA ?

ESMO 2023 abstracthas been submitted too - later in Oct 2023

Also flagged up was that Bexmab new data is expected in Q3 2023 - along with the initiation of P2 trial - from which I read loud and clear that the data coming out is good enough for them to be confident that they will be progressing to P2 .

Bexcombo trila is IND approved and Phase 2 ready .

So we have some new, interesting mid and near term goals being announced here , with some fairly confident next steps .

Perhaps an RNS is coming shortly to put some meat on the bone for us .

Maija Hollmén and Sirpa Jalkanen own stock in Faron Pharmaceuticals. The study was financially supported by grants from Business Finland, the Jane and Aatos Erkko Foundation, the Academy of Finland (#350117), and the Finnish Cultural Foundation. Olli Moisio is a PhD student partially supported by the Drug Research Doctoral Program of the University of Turku Graduate School and the doctoral module of the InFLAMES Flagship. No other potential conflict of interest relevant to this article was reported.

Might as well finish the day with a somewhat oddball Bex story I just found ...

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10071790/

According to this , in addition being associated with cancer, CLEVER-1 is also associated with fibrosis.

Maijia and Sirpa have been working on rabbits with renal fibrosis in a study to help PET studies.

Positron emission tomography (PET) scans produce detailed 3-dimensional images of the inside of the body.

Conclusion: The characteristics of 89Zr-DFO-bexmarilimab support future human PET studies to, for example, stratify patients for bexmarilimab treatment, evaluate the efficacy of treatment, or monitor disease progression.

Just goes to show that the team are constantly working in the background .

I green binned Cov so can't read his no doubt blinding insights into the stock market .

Digging into who are the team at LLS - they have some pretty eminent people-many with years at Big Pharma with high up positions at BMS , Roche , Pfizer etc .

They've done due dilligence on hundreds of potential investment opportunities .

Only a few get selected .

And LLS invested in equity purchases in Faron back in June 22 and in Jan 23 .

So they have a financial interest in our success too .

Since then - we have had exceptional data - and now also the 2 new US trial sites .

https://lls.org/research-team

Yes , most don't make it , but getting on the LLS TAP program I think was the point where the odds fell in our favour , and having such success with BEXMAB - it's the perfect situation now .

They've never been as close as now .

Looking at other TAP partners - news comes regularly of fresh approvals , Fast Track designation etc . It's like being in a VIP lane .

This one popped up last week - Caribou - another TAP partner -

Pfizer chucked in $24m investment in equity to boost their program - they are P1 trial company . Ok Small amount , but the attention boosted their Share Price back up ( now Mcap $440m)

https://www.lls.org/research/caribou-biosciences-announces-25-million-equity-investment-pfizer

Faron have just what these big companies want - a safe and effective combi drug that can boost the revenue and profits on existing and older drugs .

We should be due another Bexmab update soon of some kind .

Latest FDA approval of a drug sponsored by LLS -

Perhaps this could be a very similar path that is being planned for Bexmarilimab . you could almost copy and paste the blurb and it would make sense .

https://www.lls.org/news/fda-approves-bite-therapy-adults-and-children-leukemia-subtype?utm_source=Twitter&utm_medium=Social&utm_campaign=07-10-2023-LLS-FDA-Approval-BiTE-Therapy-ZGM

The U.S. Food and Drug Administration (FDA) this month awarded full approval to blinatumomab (Blincyto®) for use in adults and children with CD19-positive B-cell precursor acute lymphoblastic leukemia.

Blinatumomab was approved by FDA in 2018 under an “accelerated pathway,” which provides earlier access to treatments for rare diseases. The latest decision by FDA is based on larger and longer-term studies confirming the drug’s safety and efficacy. Blinatumomab was the first of now five bispecific antibodies approved to treat blood cancers.

Some of the latest research has focused heavily on harnessing the power of a patient’s own immune system, and LLS has been from the outset, and continues to be, committed to being a part of this innovation.