David Talbot spoke at the London South East-Red Cloud Securities Global Mining Special. Watch the full video here.
LTH'S have to be very happy with the updates received this week. Couldn't really wish for more with regards to solid progress.
Avacta have a very bright and exciting future with multiple, non related, Multi billion £ opportunities;
2. LG chem
Each scope has a very real chance of generating a multi billion £ buy-out and in each case the technology is being validated by third parties (precision via the team of clinicians running the trial, Affimers via LG Chem and Affyxell via Daewoog + finance backers )
Avacta and it's cutting edge technologies is the real deal.
$2m bonus but lets keep focus on the bigger picture, which is that this deal is progressing towards clinic and could be worth $1b to Avata:
Avacta Group could earn anything from $1/2bn to $1bn from an extended partnership with LG Chem Life Science, the Massachusetts-based subsidiary of the South Korean LG Group.
The windfall stems from additional drug development programmes utilising Avacta’s Affimer® XT technology.
The foundations were laid in December 2018 when the companies agreed to develop Affimer® therapeutics in several disease areas potentially worth over $300m to Avacta.
Now the drug development partnership is being extended to include Avacta’s Affimer XTTM technology, which can be used to control the time a drug spends in the circulation.
The expansion of the partnership includes an undisclosed additional upfront payment, plus near-term pre-clinical milestones and longer-term clinical development milestones totalling $98.5m for two therapeutics to be developed using the Affimer XT technology.
LG Chem has the exclusive rights to develop and commercialise, on a world-wide basis, Avacta’s Affimer PD-L1 inhibitor with Affimer XT serum half-life extension.
The new deal also provides LG Chem with rights to develop and commercialise other Affimer and non-Affimer biotherapeutics combined with Affimer XT half-life extension for a range of indications and Avacta could earn up to $55m in milestone payments for each of these new products.
Avacta, which has operations in Cambridge and Wetherby, will also earn royalties on all future Affimer XT product sales by LG Chem.
Chief executive Dr Alastair Smith said: “LG Chem is a world-class drug development partner with excellent biologics manufacturing and clinical development capabilities and a pioneering vision to develop innovative therapies.
“The expansion of our collaboration to develop new therapies for patients with cancer and other diseases is another strong validation of the Affimer technology and its potential as a therapeutic platform to deliver a pipeline of new drugs.”
"The DE was obvious from the business update but everyone ignored it"
Perhaps, but then those that lived through the LFT know that when AS says 'DE shortly', or 'DE very shortly', that does not necessarily mean next week!
I'm not sure what else the market wants as it's all pretty much crystal clear via content of this threat.
Safety improved substantially Vs straight dox and activation status been known since PK of first dose.
Putting those points to one side, the actions from Avacta since first patient was dosed (3996, move to London, poster presentation, dropping the LFT, sale of animal div etc) coupled with high calibre NED appointments (CM) nail the theory that Precision clearly works.
Silence from AS is golden also. 100% sure if he had any doubt about performance he would be engaging with investors and ramping big time in order to raise further cash. He's clearly very confident in non dilutive finding post read out.
Very exciting Q3 about to commence
DE2 combined with those comments from Neil Bell (stating that in Q4 2021, i.e., in the early stages of the ava6k study, Avacta will have the data to "confirm the mechanism of action of ava6k" and "confirm that the results of the pre-clinal trials translates into humans".
Lead me to believe it certainly works.
5Mossman - is that short hurting? You need to try harder.
Primary Outcome Measures :
Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: Cycle 1, 21 days ]
Percentage of patients with Dose-Limiting toxicities (DLTs) of AVA6000 during the DLT period [ Time Frame: Cycle 1, 21 days ]
Maximum-tolerated dose (MTD) or Recommended Phase 2 dose (RP2D) [ Time Frame: Cycle 1, 21 days ]
Percentage of patients with Adverse Events (AEs) at RP2D AVA6000 dose level in tumour-specific expansion arms. [ Time Frame: Cycle 1, 21 days ]
Secondary Outcome Measures :
Maximum drug concentration (Cmax) of AVA6000 & Doxorubicin [ Time Frame: Cycle 1 and Cycle 2, 0-72 hours post dose (Dose Escalation) ]
Cmax (maximum plasma concentration) of AVA6000 and Doxorubicin after administration after Cycle 1 and 2 for 72 hours post-dose.
Area under the concentration versus time curve (AUC) of AVA6000 & Doxorubicin [ Time Frame: Cycle 1 and Cycle 2, 0-72 hours post dose (Dose Escalation) ]
AUC (Area under the concentration versus time curve) of AVA6000 and Doxorubicin after administration after Cycle 1 and 2 for 72 hours post-dose.
Elimination half-life (t1/2) of AVA6000 & Doxorubicin [ Time Frame: Cycle 1 and Cycle 2, 0-72 hours post dose (Dose Escalation) ]
t1/2 (Elimination half-life) of AVA6000 and Doxorubicin after administration after Cycle 1 and 2 for 72 hours post-dose.
Renal clearance (CLr) of AVA6000 & Doxorubicin [ Time Frame: Cycle 1 and Cycle 2, 0-72 hours post dose (Dose Escalation) ]
CLr (Renal clearance) of AVA6000 and Doxorubicin after administration after Cycle 1 and 2 for 72 hours post-dose.
Objective response rate (ORR) [ Time Frame: Up to one year ]
ORR is defined as the proportion of patients achieving a best overall response of confirmed partial responses (PR) or complete response (CR), per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
Duration of Response (DoR) [ Time Frame: Up to one year ]
DoR is defined as the duration of time from date of first response to date of disease progression, as per RECIST v1.1
Progression-free-survival (PFS) [ Time Frame: Up to one year ]
PFS is defined as the time from the date of the first dose to the date of the first documentation of confirmed disease progression or death, whichever occurs first, as per RECIST v1.1
Overall survival (OS) [ Time Frame: Up to one year ]
Overall survival (OS), defined as the date of first dose) to the occurrence of death from any cause
Really great to read such significant commentary from Neil Bell.
I think some of the market lost confidence in the guidance from AS following his bullish LFT comments vs the outcome. I think AS was just really excited about the LFT but its very obvious he has cooled the commentary down completely. Neil Bell on the other hand was not connected at all to the LFT, is a very well respected professional in this area (he is not a CEO pumping the share price) and not tarnished by previous LFT. His comments (and any comments from AS IMO) should be held with very high regard.
This is looking great!!
I think this RNS will have caught quite a few by surprise. I certainly did not expect DE so soon after the AGM comments.
There could be a scramble to get back in. I hope those short will get well and truly burned.
Shorting a company trying to save lives. Disgusting.
Agree Bella. it is 100% working !!!
"The recommendation from the Safety Data Monitoring Committee to initiate dosing in Cohort 3 with 160mg/m2 of AVA6000 is an endorsement of the emerging safety and tolerability profile in the patients enrolled in this study to date. We look forward to providing additional updates as the dose escalation phase of the trial progresses."
Avacta had 1st PK data at the end of 2021/early 22 and the CEO stated the following during Vox interview;
Re Pk data;
‘That will tell us whether the preCISON platform is activating the drug in the tumour predominantly compared to healthy tissue”
Neil Bell, when discussing the trial during Q3 21, also referenced that Q4 21 would be highly critical as we would receive confirmation of the precision mechanism of action and at that point would move on 3996 (market at the time totally overlooked this and quite honestly continues to overlook what is taking place here)
Avacta know it works as do the safety committee. Activation is confirmed (a fact) and safety profile will be improved vs straight Dox.
Please listen to Alistair Smith on this link and give me a good solid response as to why you think Avacta don't yet know whether it works!?
I get that the primary objective of this phase is to test the safety and tolerability of AVA6K but the level of efficacy is going to be quite obvious based on tumor regression/progression (monitored via weekly/monthly MRI scans). As progression would see the dosing halted (read the trial continuation criteria) and as neither cohort has been cut short (we expected cohort 3 some time ago) it's reasonable to conclude that AVA6K is performing.
Now the multi billion dollar question is
Is the efficacy of Ava6k coupled with its improved safety profile sufficient to capitalize on the current straight Dox market (great efficacy terrible safety profile)
Each day this trial costs significant sums to Avacta and I'm sure they'd prefer to use those funds to drive the Affimer if AVA6K was a dud
Further to this point... They also would not be sinking funds into 3996 and a new FAPa detection method !
Additionally, it would be absolutely suicidal for Avacta to continue with the trial for this length of time knowing that AVA6K remained inert or that there was next to no clinical benefit being delivered.
Each day this trial costs significant sums to Avacta and I'm sure they'd prefer to use those funds to drive the Affimer if AVA6K was a dud.