Blencowe Resources: Aspiring to become one of the largest graphite producers in the world. Watch the video here.
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 .
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.
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 .