Member Info for jive_turkey

Agreed. As they were working on the scaled up tests batches months ago, there is little doubt that TT has been completed in all but name. I'm guessing they are holding back some final paperwork to complete the TT, waiting for something, likely the CTDA review. Announcing TT is complete and not starting directly on manufacturing would be a SP killer. Waiting for a couple weeks to get the final approvals and then announcing TT is complete in order to start processing Avacta's order is a no brainer.

For those here who have experience in investing in young, low-cap bio companies on AIM, I have some questions for you. I understand the general principle of an RNS, that the company must disclose information that would have an important influence on the stock price. Ok, but there is clearly a lot of wiggle room there.

Some examples: we weren't told that Avacta submitted the FDA IND application until it had been accepted. We also know that the top brass at Avacta have knowledge of how the AVA6K trial is going, as AS said it would be "wholly inappropriate" to share that info at the last investor presentation. So there is information out there that we aren't being told (which is fine, i'm just curious to the actual rules).

So based on previous companies, do they RNS each time they send a drug from MRHA approval to begin clinical studies? Avacta did this for AVA6K, but will they do it for all new drugs? Or will they only RNS it, normally, once it has been approved for clinical trials? i.e., was AVA6K special because it was Avacta's first? Are there AIM examples that we can look at for examples on this?

Next question, again based on other companies, when are results from the clinical trials released to investors? Only at certain milestones (i.e., at the end of Phase 1a/1b) or whenever the company is confident in the results? i.e., how much leeway to they have on this?

Are there good comparison companies to Avacta (at least the therapeutics side) who are say 3 or 4 years further ahead in their pipelines that we could use as examples?

I agree Wiggly. I have previously speculated that the 2nd (and possibly 3rd) cohorts of the trial have already begun dosing. Yes, AS stated in the question session of the last presentation that such a milestone would be announced. However, it seemed off-the-cuff to me, and not cleared through legal. The announced timeline in that presentation implied that the last cohort (number 4) would be dosed early in the new year.

Perhaps things got delayed. However, in the RNS of Nov. 29th (announcing the FDA approval of the IND application) it states: "As previously announced in August 2021, the Company has begun recruiting and dosing patients for this study at several clinical trial sites in the UK, and continues to expect the dose escalation phase for this trial to complete by Q2 2022 ". Hence, at least until late November things looked on target. If they want to complete Phase 1a by Q2 2022, the final cohort would need to begin dosing in Feb or March at the latest, implying that the 2nd (and possibly 3rd) are already underway.

Nope. Says it pretty clearly in the article: "This technology is a turning-point in the pharmaceutical industry, comparable to the inauguration of recombinant dna technology (allowing the production of human-protein drugs such as insulin), or monoclonal antibodies in laboratory fermenters, more than 40 years ago. " Monoclonal antibodies aren't affimers, they have a long history of use (more than 40 years) in medicine.

Yes, I can imagine. But that is just for the UK, correct? Europe is desperate for LFTs as well. What is stopping them from selling there?

sorry agentb, that's actually not ironic. you made the same mistake as alanis morissette.

definition of irony: "the expression of one's meaning by using language that normally signifies the opposite, typically for humorous or emphatic effect."

Probably not directly, but in the 'phone call with M19', it was suggested that they had also applied for FDA approval, which was 45-90 days away (about 30-45 days ago). Once FDA approval is in the bag, then there will be a possibility of getting some of that pie.

Here is the reference for my 50% accuracy figure, from the Guardian in Dec. 2020.

"Government figures from the mass testing programme in Liverpool revealed earlier this month that the tests missed 30% of cases with a high viral load and half of positive cases that were detected by standard coronavirus tests."

This is what sets Affidx apart, it's real world and lab effectiveness should be essentially the same.

And that was with a brain tickler test, that was only ~50% accurate in the real word. Imagine what would have been acheived with an easy to use anterior nasal swab...

@IFA90, yeah, indeed AS said in the questions of the presentation that he would update the market as soon as possible, and gave an example that perhaps when the dose escalation started they would let us know. To me, this sounded like a more off the cuff statement than a planned strategy. But that is just a matter of opinion. I would however say that the AVA6K timelines have been quite accurate this year, and that 8 weeks after dosing 1st patient allows a lot of data to already be in hand when submitting the FDA application.

Quote from AS in the Sept. 30th presentation: "When will be be able to provide the market with an update, we've said consistently that it will be towards the end of the year, into Q1, that's the sort of time we'll have gone through *multiple* dose escalation cycles."

I've highlighted *multiple* as this was also emphasised by AS in the sentence. (you can find all this starting at 18 minutes in the Sept. 30th presentation)

Like many here, I've been waiting for an RNS stating that dose escalation has begun (i.e., that the 1st patient of the 2nd cohort had been dosed). However, from the sound of it, in late September, it was already planned to have been well under way by now. Since we haven't heard otherwise, it's reasonable to assume that things have continued to plan.

A bit more evidence for this was in the same presentation (on the same slide) AS stated that "We expect to go through approximately 4 cohorts, 12-15 patients, during the next couple of quarters, so that by the end of Q1 we will have a huge amount of data describing the PKPD, safety, and soforth for AVA6K."

He also mentioned in the same presentation (when discussing the Royal Marsden and other sites), "We will very shortly have 3 more sites online." If we assume 1 patient per site (minimum) that would put it at 4 patients, and that 4th patient is the 1st of the 2nd cohort (each cohort has 3 patients, i.e., a 3 by 3 study). Now, of course, only 2 more sites came online (as far as we know) after the presentation (Leeds and Manchester), or else that would have been the smoking gun. But i see no reason why it would only be 1 patient per hospital.

To summarise, AS planned to be well advanced in the dose escalation phase by now. So there is good reason to think that the 2nd or (and if we dream) 3rd cohort has already begun being dosed. If they want the data by the end of Q1, the 4th cohort would need to begin being dosed in Jan or Feb at the latest (assuming 3 weeks between doses).

Now, fold in the fact that they applied early for FDA approval of the IND, and you may start to think that things may be going well for AVA6K.

would love to see a 2nd one today, but given how poor the LSE chat board is maintained (i.e., time warps, delays, etc), i assume that this is just one of many errors.

Correct me if I'm wrong, but I believe that the AVA6k trial was initially recruiting patients with Stage 4 pancreatic cancer who were not responding to standard treatment regimens. Typical life expectancies of stage 4 pancreatic cancers are only 3-5 months (a terribly aggressive cancer), and likely less for patients not responding to standard treatment. If the study is expanding, it can only mean that the treatment is working, i.e., the patients are still alive and kicking. whoop whoop!

Yes, that's true, but when have Avacta ever missed a timescale?

Just a reminder that the initial pharmacokinetic (pK) data for the AVA6000K was already known at the time of the invester presentation on Sept. 30th. See Slide 15 of the presentation (https://avacta.com/wp-content/uploads/2021/09/Avacta-Group-plc-Interim-Results-Final.pdf), where it says pK data of cohort 1 avaialble at the end of Q3 (and the presentation was given on the last day of Q3 - it doesn't include a 'exp', i.e., 'expected', meaning it was already in hand). Presumably they needed to get this before they were allowed to dose further patients. Note that the next day, other hospitals started recruiting for the study. The conclusion is hard to ignore, the trial is going very well, and the initial pK data were positive, allowing them to expand the study. Since, they already have pK data on the first patient, and hopefully further patients will be dosed soon, I'm confident that there will be a public release of initial data before the end of Q4.

Not only that gmcc, 0%!!! survival in animals that just recieved dox. They may have survived the tumor, but not the side effects over 6 months...

ha, nice one, d0bs! i stand corrected.

injected -> injested

Hi Jimmy, yes, I stand by my maths (or math, as I am indeed a gringo). It's best to not work in percentages here, but in physical units. In the slides that AS showed yesterday (as well as in previous presentations) he showed the amount of dox in normal tissue and the tumor. For a 6 times higher dose than average, the resulting amount of dox in the tumor was 18 times. Hence, the factor of 3 in effective dosage. Apparently, as the chemo goes around the blood it doesn't get injected by other organs (or at least not as quickly) so it keeps circulating until it happens to enter the tumor.

Perhaps it was discussed yesterday, but I missed it.

One thing that I had previously overlooked regarding AVA6k in the animal model, was that the dose given was 6 times the normal dose. This led to 18 times more doxorubicin in the tumor compared to the non-pro-drug version. So, there is a factor of ~3 amplification of the amount of drug that gets in the tumor compared to the base case. The trial started with essentially the typical amount of doxorubicin (90%), however the effective dose for the tumor would be 3 times higher. The 2nd and 3rd doses would have been higher amounts, with again this factor of 3 in effective dose.

So my take away is that not only will this reduce unwanted toxicity to the body/heart, it is likely to work much faster than typical chemo due to the much higher effective dosage. By now, they may have seen a significant change in the tumor size. Perhaps this was one cause for AS's giddiness when discussing the trial.