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CJ there is no dependency on C7 completion for the fortnightly dosing to start. AS confirmed this and stated he will RNS once the 3rd patient in cohort 1 has been dosed, the thinking here is this then gives a more reliable view to the market of when a cohort will complete their second doses. I think this is a good idea personally.
Smee interesting find. More ADC's deal being done. J&J are one of the top Dox manufacturers currently so you would think they might want to know about AVA6000 if they don't already. I'm yet to hear an argument why AVA6000 cannot displace much of the current dox market subject to approvals in time. Whoever has control of 6k becomes the eventual market leader as no one will want Dox over 6k if they knew the difference. Would any of you want Dox over 6k given what we know to date....Best Bid secures 6k and the platforms.
JT the conversation price is 118.75 but if we are below that price during the 10 day calculation period it means more shares will be issued (assuming they are not settled in cash) than if we were above that price during the calculation period. Therefore more dilutive than planned. This point has been raised with management many times to be addressed. This is why raising a few million when we were 150p or higher would have been positive and less dilutive if we then used that cash to pay back HCI at 118.75 instead of issue shares. I think this whole HCI bond can be dealt with and should be dealt with as it adds no value now. Make it go away in Q1 please and replace with a US investor
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.
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.
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.