RE: MM Tweet3 Dec 2021 08:06
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.
clinicaltrials.gov/ct2/show/NCT04…
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