London South East prides itself on its community spirit, and in order to keep the chat section problem free, we ask all members to follow these simple rules. In these rules, we refer to ourselves as "we", "us", "our". The user of the website is referred to as "you" and "your".
By posting on our share chat boards you are agreeing to the following:
The IP address of all posts is recorded to aid in enforcing these conditions. As a user you agree to any information you have entered being stored in a database. You agree that we have the right to remove, edit, move or close any topic or board at any time should we see fit. You agree that we have the right to remove any post without notice. You agree that we have the right to suspend your account without notice.
Please note some users may not behave properly and may post content that is misleading, untrue or offensive.
It is not possible for us to fully monitor all content all of the time but where we have actually received notice of any content that is potentially misleading, untrue, offensive, unlawful, infringes third party rights or is potentially in breach of these terms and conditions, then we will review such content, decide whether to remove it from this website and act accordingly.
Premium Members are members that have a premium subscription with London South East. You can subscribe here.
London South East does not endorse such members, and posts should not be construed as advice and represent the opinions of the authors, not those of London South East Ltd, or its affiliates.
The Avacta AVA6000 pro-drug is based on their pre|Cision technology. The FAP-alpha protein is present at high concentrations in the tumour and on interaction with inert AVA6000, it cleaves it to doxorubicin (i.e., the chemotherapy warhead targeted to the tumour). The pro-drug continues to circulate in the system until most of it is targeted to the tumour site and pre-clinical mouse studies show a high level of targeting: 18x more in the tumour than the heart. There is a ~93% similarity between the human and mouse FAP-alpha.
In human phase-1a trials AVACTA administer an effective dose of 54mg/m2 (0.68 of 80mg/m2) of the prodrug. This is similar in concentration to the current dosage for doxorubicin who will generally undergo 6 rounds of chemo before off target toxicity kicks in. However, AVA6000 has two benefits:
1. higher concentration of doxorubicin will be targeted to the tumour
2. lower concentration of doxorubicin will be circulating off-target
3. because of the above fewer rounds of chemo would be necessary
The clinical trial started ~mid-July 2021 and FDA submission would include pre-clinical data for at least 3 clinical trial patients’: One patient with maximum 6 cycles of pro-drug chemotherapy, one patient with 2 cycles and third patient with 1 cycle. The FDA approved investigational new drug status after 30 days review. Furthermore, the last company presentation by AVACTA indicated that the trial was going well. Finally, this week’s news that AVA3996 also strengthens evidence that AVA6000 has progressed well with top-line PK-PD data to be announced soon.
Once this news is announced, AVA6000 positive date will open up multiple drugs under the preCISION header. Further pipeline to include the pre|Cision forms of Paclitaxel, Oxaliplatin and Gemcitabine. With the reduced timeframe, expense, exceptional pre-clinical data, so far positive news (i.e. no negative news from NCT04969835).
GLA
Great post Marik... Worth reminding everyone why we are here and reasons to top up sub 80
Did you just make this up?
"The clinical trial started ~mid-July 2021 and FDA submission would include pre-clinical data for at least 3 clinical trial patients’: One patient with maximum 6 cycles of pro-drug chemotherapy, one patient with 2 cycles and third patient with 1 cycle."
"Great post Marik... Worth reminding everyone why we are here and reasons to top up sub 80"
@Hullaballoola you are welcome. It's always worth refreshing the information. I realised that in some cases people glance and forget information and/or just don't understand timeframes etc.
Hullaballola, good to see that you enjoy Mariks made up information as much as the rest of us. I'm more for Nordic Noir detective stuff, but a quick read of Mariks posts always helps me feel rainbows and unicorns are really are out there.
FDA probably has no data re phase 1, the trial started after Marik "out of his arse" date. FDA moving forward didn't need a prerequisite that indication were ph1 was successful- That said if patient (who is likely very sick, my fingers are so crossed for them, best luck mate), and a huge adverse reaction, there may have been a pause. All we know is currently one patient being dosed. Result unknown.
Risk hasn't changed from before trial data, but it's one hell of a payout if it works. I think it's a buy, but not cause the FDA has seen anything about ph1.
Sorry to be Marvin, I think Marik enjoys the attention, so keeps posting any old *******s just so some one speaks to him.
Hopes are high.
ps Marik say high to his Lordship, ask him if FDA would have need ph1 data set, thinking for yourself is so important.
@Hullaballoola if you need further info you can DM me on https://twitter.com/marik_investor
Travel Light - FDA require any available in-human data to be submitted for trial approval. Given the FDA's 30 day response time and known date of first dosing, this would have been available for inclusion.
Ergo it is not unreasonable to take FDA approval as a positive signal regarding the trial. In a recent Vox market podcast, Gervais Williams of Premier Miton took the same view and he seems to be good as his job...
First patient announced 11th August not mid July.
4XBen, nice to see you back. What do your journo friends think about Javid still insisting on jabbing NHS workers under coercion whilst otherwise indicating that the threat is over?
Difficult to see how six cycles of data from patient one would be available when there are 21 days between cycles and it was submitted in October.
Duck me this thread is pointless.
" FDA require any available in-human data to be submitted for trial approval. Given the FDA's 30 day response time and known date of first dosing, this would have been available for inclusion."
@benbenbenben absolutely agree, this has to be included. The first site started recruiting as per the clinical trials website.
talk about making a mountain out of a molehill.
The way you put it Marik is that without the "data" supplied FDA would not have moved forward. You then imply it has reduced the risk of investment.
Does FDA know about p1, yep. Was the enough data to make any conclusion other than the limited dose (90%) and a couple of cycles max, didn't have a significant or unexpected side effect so bad that they were unhappy.....nah.
Marik how much data do you think they need before making a conclusion, how much is significant. Why do you think more than one patient is included in the trial. How many data points do you think are needed to make any conclusion ? sk his Lordship why he ignores those basics (see below)
Marik et al, ava6k is full of promise, it could change peoples outcomes in a major way. This is gonna take sometime.
my only conclusion is you are trying to pump and dump.
Marik, no need to pump and dump, this thing is up and down like a *****s drawers. Of course if you got your timing wrong that would explain your desperation to make every little titbit of information mean way more than it does.
People on this thread talking crap either positive or negative.
Instead of blagging either way let's wait for an update instead of yet another tranche of mere assumptions
Any data from non-US trials has to be submitted for review to the FDA.
Mark as a ramper and others as derampers.
Please stop with all the assumptions.
It's a lot of hype both ways.
The best bit is you actually think what you say has a direct effect on the SP.
GET A LIFE AND GET REAL.
S83 please feel free to put me in your green room. That will keep you happy
Every time Marik talks horse **** and makes up “information” IMHO, I’ll try to point it out. It stops the bull**** spreading to every other thread. You may of course feel my opinion is wrong and why Marika is right, after all it’s a BB.. Happy to discuss why that is, welcome an opportunity to learn. That keeps me happy
Win win.
Lots of love TL