Member Info for Rambo23

Bella these are the key players in the Dox market so take your pick......

Pfizer

Johnson and Johnson

Zydus Group

Cilla Limited

Sun Pharmaceutical industries ltd

Padagis

Reddy Laboratories Ltd

Cadila Healthcare Limited

NOVARTIS

Microbiopharm Japan Co.

Whoever has a prodrug version of Dox surely puts the others on notice.

Bella I believe at the last 2 funding rounds for Affyxell AVCT did not contribute cash to the raise and as a result the equity stake reduced on both occasions. However milestone payments due to AVCT from the same JV were then used to buy back equity at the last fund raise price. See 5th June 23 RNS. I think confidentiality is the reason a funding number was not disclosed. I don't read anything else into that. I'm pretty sure someone queried this before and ran some numbers but I don't recall who it was.

Bella all fair points. Don't forget to add to that list the fortnightly dosing is open to NON STS patients (a recent positive change) as well. Who wants to see the results of multiple indications which likely have bigger total addressable markets than STS only and with first line patients? This is massively positive and something is driving that or they would have left it as STS only. We know they have backfilled cohorts for months now just to get more data which adds value to the platform. Ticking boxes!

Nautikc17 - I saw that comment. That statement from Fiona could be correct but it doesn't clarify if she is referring to screening or first patient has been dosed. I think AS will RNS once the first patient has been dosed. Let's see what happens. No issues if they have dosed already but based on feedback I think we will see an RNS.

Estura - 3 weeks ago we were told in the RNS they were screening patients and we know this process only takes a few weeks all being well, so I agree the window for the bi-weekly dosing RNS must be close now.

Https://www.fiercebiotech.com/biotech/novartis-voyager-launch-another-gene-therapy-mission-100m-upfront-deal

I agree MB53/ DTW - Importantly progress on Points use of pre|CISION is likely to trigger milestone payments along the dev path so it will be good to see what transpires. JV partner milestones likely to come into play during 2024 as well all of which will be most welcome.

@BV and from the 'about' page......'Our approach centers on creating oncology medicines that unequivocally show early signs of clinical activity and will matter to patients. We intend to curate a balanced pipeline of medicines, either internally or externally discovered, with the potential to treat cancer with dramatic effect.'

@BV I agree and given this trial is not randomised, or using a placebo or vs a straight Dox arm this enhanced flexibility for the Oncologists to use their discretion here is a huge opportunity. Most P1A trails don't even get to treat first line patients.

Just incase anyone this am missed this point from last night and a key observation from JT and AVCT on question 2 which is worth re-emphasising....

'If it is possible to enrol patients earlier in their treatment journey then that is a decision for the treating oncologist.'

This has Dr Tap all over it allowing him (and other oncologists) to enrol first line patients knowing that clinical efficacy is more likely to be seen in patients that have not been heavily pretreated and it is much safer than straight Dox.

I find it hard to imagine Dr Tap or his team recommending the Straight Dox queue over the opportunity to take part in the AVA6000 trial given what they already know. This important change now increases the scope and opportunity for the Oncologist to maximise their discretion to treat first line patients for the first time with AVA6000 and provide better patient outcomes as part of fortnightly dosing. This data will be key!

@Smeeagainbruce..... Front runners must be Novartis and Lilly (now the latter have agreed to takeover PointBio the only company globally with a Precision license from Avacta, exclusively for radioglands). Takeda license for AVA3996 in the mix? I say let them fight for it.

The question then becomes....what is the cost of not owning this platform tech and letting your competitors have it? XXbn

Bein no offence but you posted 17 messages today and more than half engaging trolls. Filter them and let’s avoid the tit for tat it’s not positive.

CEO.....'Don't worry about funding'.

Buenavista thanks for the correction on Ovarian. In the Dec presentation it was part of 'other' as per below. Breast definitely not been on the trial so far.

'Cancer types in Other category include (n=1 each): non-small cell lung cancer, prostate cancer, transitional cell cancer of the urethra, ovarian carcinoma, lung cancer (not other wise specified), esophageal cancer'

@Jiveturkey just replying to your 26/12 10.08 post....

In response to your second point I agree with what you have said. My observations are initially Breast and Ovarian along with STS were going to be the 3 indications initiated first. This changed to STS likely due to cost and speed to FDA approval. I don't think we have seen any patients on the trial with breast or ovarian so why not? Is that random based on patient recruitment at the time? Possible.

When we consider the fortnightly dosing and the recent protocol change to include first line patients & indications beyond STS it appears they are deliberately increasing the scope here and prioritising looking for efficacy data in multiple indications high in FAP not just STS, why? If we then consider that new indications won't require P1A and can start at P2 the first line patient data we are about to see is critical to supporting those steps and any deal.

Lastly in the interim presentation if you refer to slide 12 they specifically quantify the following indications...Colorectal, pancreatic, prostate, lung, breast, Esophageal and salivary. There was no mention of Ovarian although it is detailed on the FAP graph.why? Management haven't spent much time discussing the TAM/other indications. I can't help feel this is deliberately being held back until a more advantageous time ie further through the trial with more data. Previous versions of this slide didn't quantify the incidences of these indications but adding this detail is telling.

JT a question for you.....do you think a deal for example breast cancer be done now if we haven't treated a patient with it yet but we know it is a high FAP indication? Given efficacy in STS is so hard to achieve and as you pointed out the patient stories to date are about STS efficacy that is a very positive sign.

As for your third point I got a reply to my question from the company last week on this. I asked why cardiotoxicity and alopecia were not on the 'adverse events' slide 13 and if there was any negative changes. This wasn't overlooked but was left off make the presentation as concise as possible.

Now refer to slide 16 interims in Sept and you get these two points below....

'Significant reduction in the incidence and severity of the usual doxorubicin related toxicities(alopecia,nausea,myelosuppression,

mucositis) including the most serious (neutropenia, thrombocytopenia, anaemia).'

'• Despite administering the equivalent of approximately three times the normal dose of doxorubicin to patients in cohort6, the typical drug-related cardiotoxicity of doxorubicin is not being observed.'

My personal view is Cardiotox is still not an issue and the reason why they may have left off these two important side effects but low on the adverse effects slide is because it isn't an issue and they can discuss at a future date. Worth noting that at AACR only new data can be presented so I think they are holding things back.

@CJ62 as I understand it the company initiate and submit a change to the protocol to the FDA. The FDA then have a period of time to make any challenge. A lot of emphasis recently has been on the FDA issuing a formal approval to the change which I believe is incorrect. Happy to be corrected but it would explain why they are screening for fortnightly all ready and I think we will just get an RNS to confirm first patient dosing which must be anyway now.

@Yorkshirepragma - interesting article and where it all began. Shire Pharmaceuticals was born above a wine merchant in a sleepy Hampshire village and then got taken out by Takeda years later. A good idea has to start somewhere right. It feels AVCT is well placed for the next step up.

Donald - He has the Xmas period to get up to speed and then if it were me I would load him onto a plane for San Francisco and send him straight to the JPM Healthcare conference starting the 8th Jan.

ABC = Always be closing. The flight TV should only play the epic sales speech from Glenn Garry Glen Ross for the duration of his flight just so he is prepped.

@BV they only recently just told us they were screening for fortnightly dosing. This doesn't mean they have been screening for months does it. It usually takes a few weeks for this screening process to complete. I expect this stage to start anytime in the coming weeks and be delivered by mid year. Other practicalities are in play besides updating the protocols and other admin like making sure product is available etc etc.

Everyone should look closely at slide 11 from last week and specifically at the Arm 2 cumulative dose numbers vs the ARM 1 numbers for each dose. It is possible we may see DLTs at these frequencies and therefore not all cohorts will be required. Either way valuable data being captured with every patient. For clarity only 2 doses per patient are required to progress onto the next cohort even if they continue to receive treatment. I think many last week assumed the wording '12 weeks' meant it would drag on and on. Not the case to progress cohorts but the passing of time beyond the first 2 doses is needed to see the impact on the tumours just as we have seen in patient stories next week.

@Nanomat good post.

On that link I extracted this......'DNA uracilation is a novel therapeutic strategy that has demonstrated effectiveness and safety in pre-clinical models with no added toxicity when combined with standard-of-care anti-cancer drugs.'

'No added toxicity' - I read that last part as though you will still have to put up with the side effects from the standard of care drugs. One of which could be Dox. AVA6000 changes the game there as an example. The possibilities with Precision are enormous.