The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
Previous results for bexmarilimab have been incredibly positive, and the new posting suggests this was no fluke. Of the 22 patients in the cohort, 50% entered remission in doublet dose, and the drug remains well-tolerated at all tested dose levels.
Explaining the development process of bexmarilimab, Faron COO Dr Juho Jalkanen told Clinical Trials Arena: “Bringing the drug into the clinic, we started out with a rather traditional first-in-human approach in advanced solid tumours and did see encouraging activity in a number of indications there too, but then we got this AML and MDS trial going and started seeing extremely exciting results.
“For now, we are pursuing blood cancers because of the huge unmet need in r/r AML and MDS, and one of our biggest supporters being the Leukemia & Lymphoma Society.”
There are also plans to continue research into the drug’s efficacy on solid tumours, with Dr Jalkanen suggesting it could be a “game changer” in this field too. For now, however, the company is continuing to focus on blood cancers: “As a small biotech we cannot be pursuing everything at once.”
https://www.clinicaltrialsarena.com/news/signal-farons-blood-cancer-drug-bexmarilimab-continues-to-impress/?cf-view
Without immediate follow up news , the vacuum was always gonna suck us back again . But it hasn't been too erratic .
Plenty coming in Q4 . It may be a fund raise , but like western says , that wouldn't necessarily be a bad thing .
Small P2 trial with quick enrollment , and predictable results . If we achieve that alone - and gain further FDA designations along the way , then we would likely cross the line into having a marketable product whilst still owing 100% of the platform . Quite an achievement .
Faron has become a much larger company over the last 2 years . Ambitions may have changed .
Whether it takes a month , a quarter , or another year - the plan looks to be coming together , and when it does , we won't be complaining too much I think .
To be fair it didn't actually budge up much anyway . Its been lovely news for us LTHs , but the market won't budge until we get funding/partnering details .
To have that cracking P1 data in your back pocket can't be a bad thing ?
Rather like having your belt tightened up another notch as you go into a trouser pulling competition .
Should protect you even more form having them pulled down whilst meeting BP.
Interesting convessation with Markku here .
https://www.wyantsimboli.com/bioboss/markku-jalkanen-founder-ceo-faron-pharmaceuticals/
More of a chat about his background and how he came to become CEO , and what drives him .
Talks a little about the US , how Boston is the centre of activity now , for both funding , and the biotechs .
Passionate about how these new modes of action sometimes get overlooked - has been a battle to get progress.
Nice little chat - really shows he is a genuine guy , with a very complete plan of where he wants things to go .
Well , it was a good one again - but no rabbits pulled out of hat .
Most questions were just on the science - but the FDA signals look to be all green - and more news expected soon .
Markku - amazed that this data is so good - it really nails on the chance of approval - as the bar is so low already .
Looks like they still haven't settled on a deal yet - as the next months will be meetings a plenty .
Main objective other than getting Bex approved - is shareholder value . and he says that for the best result - they will not be rushed .
Last words - expect more soon .
Yes I should be tuned in . Anyone got a specific question - stick up up here and I'll try and ask .
They have the Senior Medical Director/Program Lead Oncology Inka Pawlitzky co hosting .
So assume this will be quite technical - so I doubt a 'when lambo ?' question will be worth asking lol.
Phase 2 will start with dose optimization and is expected to enroll 28-32 patients randomized between two selected doses. Faron plans to increase the number of US clinical sites from two to five sites to accelerate study recruitment.
5 sites in the US , (plus the ones in Europe )( all probably AML focused hospital sites) - should see a rapid P2 trial , considering the data comes out almost immediately .
Today they should really clarify for us who is going to be assisting us in this -The usual reply we get is 'Don't worry about that we have it in hand ' .
But if they are telling us how they plan to run the next 6-9 months - they will have to tell us how it is being funded surely .
Should be interesting
To put it into context -this data is really good .
A quick search on the efficacy of AZA on its own -
Complete remission (CR) was achieved in 14% of MDS, 7% of AML and 10% of CMML patients. Overall response rate was following: 27% for MDS, 20% for AML and 20% for CMML.
Faron are achieving superb responses .
I'm not making any wild guesses that Weds could be ' THE DAY ' . I doubt it will be .
But , and it's a big but , I'm assuming that if they are making a bit of a event around this latest data , then it will be 'as good' if not ' better' than what they've been getting .
If we hadn't had the shuffle of MLF , and the appointment of CR recently , you might expect the usual ' we need more data ' before ..... spiel . But somethings being worked out behind the scenes in strategy I'm sure . You don't need to be Sherlock Holmes to work that out .
Faron need funding to continue . Bayer have a huge chequebook and their head of their Oncology Strategic Unit has just taken a seat on our board . Talk about putting you towel on the sunlounger ( they are Germans after all lol !)
The insertion of Bayers top Oncology business honcho Christine Roth into little old Faron just doesn't make sense unless she will be part of some kind of transition , in my opinion.
Likewise the sudden change in CMO - just as the best data is just emerging .
I just can't understand why CR would join Farons BOD unless they had ambitions in that direction .
Despite the fact I'm always uber optimistic here - it's pretty clear something is finally going to happen here at last .
Just a thought regards these moves within the board. A similar situation is in place over at Avacta , where they have taken on a highly regarded consultant to oversee the program whilst they seek a full time CMO .
They too are on the verge of detailing their P1 data , also known to be groundbreaking .
Any potential buyer/partner - will be needing to justify any large buyout/spend to their own shareholders . And that will require Faron and Avacata to demonstrate that the incoming investment is justified.
So perhaps these management position changes and the very quick move to update us all with this data presentation is being led by the potential suitor in order for them to satisfy their own board that a deal is both value for money and a great move .
Laying out the latest data from Bexmab should tick all the boxes .
The only other major piece of the jigsaw would be the FDA recommendations surrounding Bex and AML .
But If they are presenting us the plans for the next 6-9 months next week , you'd assume they know what they are.
66m shares - £221 million Mcap.
£1billion Mcap would give us a £15 share price
I think Faron see their platform as being in that kind of valuation as a minimum - the more they prove up the bigger the price .
All depends on how they cut the cake up ( licensing deals etc ) , or sell the whole shebang ( my preferred option lol )
A pile of new dates added to their calendar today .
Busy Autumn for the team.
https://www.faron.com/investors/event-calendar
These Big companies are all circling around the small successful biotech companies that have clinical trials in oncology that have platforms that can be multiplied in value in the future .
Now at Faron , Bayer have pulled up a chair and have a thumb on the corner of the paperwork should anyone try and muscle in .
I'm intrigued as to what is really going on here . They rarely announce data coming in advance .