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*Q4 2021 or Q1 2022
got your Q's mixed up there I think PK could have been Q4 2021 but more likely Q1 2022
For VelosBio their lead candidate was in phase 1 dose-escalation and expansion. VelosBio was bought for $2.75 billion. Any positive top-line PK data and this would imply a wide range of other pre|Cision pro-drugs become part of the pipeline and significantly increases the market value of Avacta. Although the trial finishes later on, we were told during the presentations by Alastair Smith that top line PK data would be available from Q3 2021 or Q4 2022. It's not long to go!
Remember, they license it from Bach/Tufts.
What they can/can’t do will be heavily restricted by the terms of that license, which we’ll never be privy to.
I doubt if they can farm anything out without Bachs explicit agreement.
I think the next precision is son of velcade but I also think they won't progress this to clinical testing until they have a better feel for Ava006.
Ava004 had been timetabled to move forward pre-covid but ava006 leap frogged it and it was put on hold - I think because less favourable timelines and resources.
The conjugate space and possibly PD 1 in particular is becoming more conjested - Avacta cannot wait for ever. Without wishing to open a can of worms their choices seem to be - get some revenue, find a partner (and lose margin) or raise some money. We can paint as many pretty pictures as we like but that is where that program is. AS is a bit stumm on money coming in - covid LFD or milestones seem only significant options - no news is probably not great news.
Decision is probably waiting for Ava006 readout.
Given the marketing and multinational nature of pharma I doubt Avacta will try and go it alone with Ava006 but a positive readout will enable higher price to get paid.
I can imagine an RNS next summer (;-) ) that Avacta have signed a deal for AVA006, son of velcade and another precision drug. Milestone payments of £2Bs + 40% transfer price. Either that or someone stumps up £8B.
Oh look some tea leaves.
I'm kind of thinking Avacta are in a really really good place. They have a number projects that have moved forward substantially in 2021.
A) Leading the pack is Ava006 which has gone from animal testing to use in human clinical trials. Big individual step.
2) The project with LG hit a milestone. These are predetermined and by nature get paid when something significant occurs.
3) Deal with precision - extends use in to radioisotopes.
This is all great.
As projects move through the various stages what we know about them increases. If the projects continue then the chances of success rise. Comparatively Avacta's projects are making good progress - seriously good given we are in a pandemic, they have done well.
Some of the comments about what any small bit of news means in terms of proof it works is frankly reading the tea leaves (or is it a pump and dump?). I rate the science and hope i have someunderstanding of the risks biotech entails and thus haven't ordered another Porsche just yet.
AVA006 is in phase I. That on its own is huge. It has regulatory approval for trial use in phase I - by nature a slow and high failure rate stage. Quoting values if everything goes well is a bit "if it goes in, its a goal". We can all predict that - what is harder is valuation in light of current knowledge.
Next up will be Ava004 (pd-1) and Velcade precision. The later will be slightly derisked IF Ava004 passes through phase I. High POTENTIAL reward - shall I mention unproven, high risk.
Current share price is what the market judges the balance between the potentially high rewards and high risks. We may all take a different view but my guess is we are also either more tolerant or more unaware of risk. Interesting to see SP fairly stable in light of no news - suggests market is waiting for real news. The SP will move on that but it may be good, it may....
We continue to wait whilst radio silence from the mother ship is maintained.
Anyone fancy a cuppa?
Ramp? More like a novel
Is this a deramp then?
Is that a ramp then?
As the pre CISION linker is a platform tech, #AVCT believes that - provided it works for doxorubicin, which as I have tried to point out, already looks probable - it could be used on more than a dozen other chemotherapies currently on the market, to drastically improve their safety profiles.
Provided that cost of manufacture of pre CISION pro-chemotherapies isn't significantly more than standard chemotherapies - why wouldn't pre CISION prodrugs rapidly displace standard chemos from the global market?
The STANDARD chemo market is forecast to reach $74bn per annum within five years. But, as #AVCT itself has stated, a working pre CISION platform could multiply that market - MORE patients would be eligible for chemo, and ALL patients could endure more doses.
Back to ADCs, and their relevance in this thread to #AVCT and its current AVA6K trial.
Last year, @AstraZeneca #AZN signed a $6bn ($1bn of which was upfront) collaboration agreement with Daiichi Sankyo, to develop and commercialize DS's new ADC.
And also last year, Merck acquired VelosBio for $2.8bn. VB had completed a Phase 1 for its first ADC, but hadn't even started P2.
Looking at more advanced ADCs:
@GileadSciences $GILD acquired Immunomedics for $21bn last year. Immuno had just had its first ADC authorized by the FDA. It had so far racked up sales of only $20m, before $GILD swooped in. It valued Immunomedics at over 5x peak sales of $4bn (estimated to be reached in 2029!).
Precedent is there for #AVCT to be taken out for $ billions in the near term.
The bull case thesis is that pre CISION prodrugs COULD be more targeted (so could be made more potent), cheaper, and are based on already widely used, successful drugs.
More valuable than ADCs?
Of course, we have no idea how much 'safer' / how much more 'targeted' AVA6000 is than standard dox, at this stage. And unforeseen side-effects may yet flare up.
But fundamentally, dose escalation entails that an improvement in the safety profile of standard doxorubicin has been made.
There are those who have digested the info in the public domain, and positioned already. And there will be those who will wait on DE confirmation before taking a position.
Hopefully, @avacta #AVCT gives an explanation (and perhaps a sliver of data) on HOW/WHY DE has been granted by the regulatory body - as the market clearly doesn't seem to grasp the implications yet.
There are numerous types of targeted cancer therapy.
The closest to what #AVCT is attempting with pre CISION (and even more so, the TMAC platform) are antibody-drug conjugates ('ADC').
An ADC is a molecule consisting of a monoclonal antibody ('mAb') linked to several warheads (e.g. a chemo). Very broadly, the mAb takes the inert warheads to a tumor cell, enters via endocytosis, where the warheads are released, to destroy the tumor cell.
There have been many issues with ADCs to date, not least severe side-effects.
Having gone through much preclinical and clinical data, I haven't found anything that remotely resembles #AVCT's pre CISION (at least, the data generated in preclinical mouse studies).
Assuming the best case: preclinical data are replicated in man.
At a tumor/heart ratio of 18:1, THEORETICALLY a patient could receive pro-doxorubicin that was 6 TIMES as powerful as the dox that is currently used, but with a reduction in cardiotoxicity by two thirds.
Surely EU HUA can’t be too far away but in the meantime Myles’ post on AVA6000. I appreciate those not holding may want to ignore or deride.
I came to appreciate long ago that AIM is an inefficient and irrational market.
But the share price of @avacta this week takes the biscuit. Following Monday's RNS, I was convinced we'd be at ATHs by now.
My explanation for what I think the market is missing on #AVCT
On Monday, #AVCT announced that it had received FDA approval for its Investigational New Drug ('IND') application, to expand its Phase I clinical trial for AVA6000, into trial sites in the US.
The timing of the submission and the length of review are critical.
The FDA has a 30-day review and turnaround time. Given #AVCT announced the approval this Monday, owing to LSE disclosure laws we must assume it received the approval sometime between Friday and Sunday.
Give a few days for post / admin / comms delays, and we can assume that #AVCT submitted the IND application around 22nd-26th October.
The 1st patient in cohort 1 ('C1') at the Royal Marsden was dosed on 11 August. Subsequent dosings are done every three weeks.
Thus the first patient would have received their 4th dose on 13th October. Now, a key point to consider in the IND Filing (thanks to @BigBiteNow for highlighting on Monday):
"The IND application must contain... any previous experience with the drug in humans (often foreign use)."
For #AVCT's AVA6K, that includes the already-dosed UK patients.
So the FDA gave its approval to expand the P1 trial into the US, after having seen the data of - at the very minimum - one patient being dosed at least four times.
Two more points to consider.
1) C1 patients are being dosed at 90% of normal doxorubicin dosing level.
2) At the time of IND submission, three hospitals in the UK were already recruiting.
So what can we take from this?
Firstly, that recruitment in the US would be for subsequent cohorts - with the required three patients for C1 already recruited by the UK hospitals (this was confirmed in Monday's RNS).
Secondly, that the FDA considered the data from the patients dosed in C1, and evidently liked what it saw.
C2 can only start once the third patient in C1 has had their third dose, and then had a 21 day observation period.
We do not know when the third patient in C1 had their first dose, and so cannot precisely say when dose escalation / commencement of C2 may be.
But from the info in the public domain, it now seems pretty nailed on. C2 will be receiving doses of AVA6000 that may be in the region of 50% more potent than standard-dox.
So what does that mean? It means that #AVCT pre CISION platform is - at least to some extent with doxorubicin - working.
It means that the initial dose level has a better safety profile than standard dox, a drug that is already generated annual revenues of ~$1bn.
Of course, we have no idea how much 'safer' / how much more 'targeted' AVA6000 is than stan
Good Morning Wyn "Better to remain quiet and be thought a fool than to post and remove all doubt."
Have a good day
I see he has purchased a mirror.
The thing is this.
An investors outlook is governed by whatever research is out there to understand the company but their short term expectations are based on RNSs.
The reason Wyn and NDN are so vilified is because no matter what the RNS is, it’ll be spun into a negative. So all this ****e they come out with about being proven correct is complete crap. If you spout 1000 negative ideas a week then one is bound to be correct. The current favourite lot of carp is AVA6000 is a long haul event. It is, in terms of when the product can go to market. The LFT was also a long haul event in the end and the SP climbed to 280 in anticipation. So my point is and has always been that people will always try to buy in on anticipation of great news. That’s how I see it happening here with AVA6000. The dumbnamic duo on the other hand want you to believe it’s a flatline SP until the morning of good news. If that were the case then we’d be trading at 18p (based on their also ignoring all other positive developments over the last 18 months) and that is why they are hated. Because they promote famine vs feast.
Morning Wyn. I repeat what I said last night.
Relentless trollsThu 19:05
Wyn and Ndn if MM's tweets are so misinformed and untrue then why do you two both have to jump in straight after him trying to discredit his line? Is it because you're trying to protect all us LTH's from his evil spin? What a joke. You two look after no one other than yourselves. You are actually threatened and afraid of MM. He is making a very valid point that he expected a better reaction to FDA clearance for trials while you two are trying to protect your own trading position. No one here believes a word you say. I only hope that my post might stop a weaker holder from being poisoned by your agenda.
You guys really should not either invest on the basis that you do, or not read these types of BB's.
Don't , don't get involved in personalities, (easy though it is),
What was the SP 12 months ago, what were the expectations (and yours) then?
Has it it turned out as you expected? If not look at what formed your expectation. (don't shy away from being influenced by BB's.)
This is a small(ish), high risk bio pharma, that was hyped to be NOT high risk.
Don't look to blame me or ND or a MM or anyone else. Consider why you bought in the first place.
Those that bought on the AVA6000 trial can legitimately say it was always going to be a long haul.
Those who bought primarially for the LFT, well, their hopes have been dashed up to now. Maybe it will still come good , we will see.
But don't blame me or anyone else. This is the nature of the game.
The irony is, the only 2 who post about the short comings that have thus far proved to be correct in their analysis are villified.
Think about that too.
Me and ND are terrible people who have all sorts of agenda's and are only posting to lose you money... are the only 2 who have identified potential shortcomings,
You think I am weird. What do you think I think of you?
I appreciate the nod Bein.
Not to make him blush, but this about sums it up; https://twitter.com/MrRipley21/status/1466523462802026499?s=20
ndn trying to claim he was right again with his predictions? Go back over his posts, and you'll see over the past few months he and wyndrum were both trying to steer the narrative towards the sp dropping to 50p without LFT news . Well, it has continued to range from 100-120p, as some of us were saying back then, even in the face of zero lft news. Avacta is a strong proposition regardless of lft sales. The FDA news this week will not have gone unnoticed, and will only serve to boost sentiment when the initial read outs come our way. It is definitely *not* unimportant as ndn said yesterday.
ndn and wyndrum like to castigate the rampers, but they're no different, happily playing the dump side of every pump and dump.
NDN, you are “Caster” , one stage from a Blue Bottle!!
No worries Myles. I was just getting sick of the trolling and decided to have some fun at their expense. I think I was too convincing like my namesake haha. I used to think it was shorters. Now I think it’s more disturbing (since I don’t believe any PIs can short any covid stocks) than that and it’s a case of serious misery wanting company and wanting to harass. But blocking (and recording any harassment you do receive) is the safest and best bet.
They’re relentless. The LFT will catalyse the SP in short order.