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 .
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 ?
This Forum was this week ( 20-21st April in Carlsbad , California ) Not a bad spot for a conference , I stayed there a few years ago . Hopefully Farons recent trial news would have been a topic of conversation amongst the experts there . I wonder if anyone from Faron made it to the event too ?
Dr Daver is a busy man - tweet here shows him in action at the Acute Leukemia Forum 2023 .
https://twitter.com/LeukDocJZ/status/1649480983534768128?s=20
Subject on screen behind him reads - The Big Picture -Immune based Approaches in AML/MDS
Tuesday should be interesting - I won't be able to watch it live but it should be very enlightening.
Not sure if posted yet -
https://www.youtube.com/watch?v=dtwNnKTg-8c
4 non binding offers at present.
3 site visits completed .
Have talked with 4 gold producing companies , 2 TSX listed 2 Chinese
Timeline - Investment bank need to convert a couple into binding - and when that happens - if half acceptable , it will be announced .
4-8 weeks for that he thinks - maybe quicker .
All due diligence and legal stuff going on .
SP doubled in month - Gold price has helped - not just the Condor effect . Political situation improving.
Speculation that this is actually a real deal .
Heavy discount for Nic location ( 5 x discount compared to if it was in canada)
Another trip for Mark to Nic on cards soon as another company looking for site visit .
New Condor presentation coming - things progressing nicely .
Faron have the right people , and also now the connections .
LLS support will be invaluable over the next few months.
Q3 is not far away . Lets see what the KOLs have to say . Things can happen very fast .
Meanwhile , another drug associated and supported by LLS gets FDA approval
https://www.lls.org/news/fda-approves-treatment-patients-newly-diagnosed-most-common-lymphoma?utm_source=Twitter&utm_medium=Social&utm_campaign=04-20-2023-LLS-FDA-Approval-DLBCL-ZGM
Elephant country .
The presence of steep dipping veining within the mineralised zone increases the potential that the mineralisation extends to the top of the basement at approximately ~550m below surface. For context, the Havieron deposit occurs at ~420m below surface.
Worth absorbing what the below blurb means - it has been life changing for those who enrolled in the first cohort .
Every bit of data they put out is just super positive - safe and effective.
· In the second doublet cohort (3mg/kg + azacytidine), two patients have objective responses thus far, including one complete response with incomplete blood count recovery (CRi) and one patient with hematological improvement in platelets (HI-P). There are two patients with SD, of which one has > 50% reduction in bone marrow blasts, and one patient with progressive disease.
· The first doublet cohort (1mg/kg + azacytidine) has seen a complete response with incomplete hematological recovery (CRi) in a patient with relapsed/refractory AML. The patient is still responding after 10 months. Another patient with MDS that experienced CR is still in remission after 9 months. An additional patient that achieved a partial response has undergone a possibly curative allogenic stem cell transplantation.
· No bexmarilimab-related Grade 3 or higher adverse events (AEs) or serious adverse events (SAEs) observed in the second dosing cohort and enrolment into the third cohort (6mg/kg) ongoing.
· The first triplet cohort (1mg/kg + azacytidine + venetoclax) was well-tolerated and the second cohort (3mg/kg + azacytidine + venetoclax) has opened for enrollment.
· Additional efficacy read-outs for all cohorts expected in the upcoming months.
· On a potential path to a Biologics License Application (BLA) submission, the Company plans to seek FDA advice during Q3 2023.
25th April - new event marked as a KOL Call ( Key Opinion Leader ?)
Is this something to do with one of the SAB team ?
Either way - possible update in the pipeline ?
https://www.faron.com/investors/calendar