preCISION = novel
junior biotech behaving irrationally = not novel
If you’re still harping on about “how AIM is treating #AVCT” you have not understood the typical route a biotech takes. Regardless of the index.
Some facts:
A British biotech with x2 preclinical drugs just sold for $1.5B ($1.1B of that upfront).
Avacta requires x3.25 just to reach this market cap.
It sits on half a decade of clinical data which is proving the platform; the FDA removed the lifetime dose for AVA6000 for the first time in the agency’s history (for a P1 drug) and has just said Phase 2 SGC can be pivotal.
AVA6103 is 14 weeks into trial.
This year is proving to be the hottest year for biotech M&A since 2019.
It’s therefore safe to say AVCT has quite a lot going for it as we head into H2(!)
Those craving the signature of ANY deal are plagued by PTSD. The same bunch will sell the potential far too early due to their inability to separate the past from the future.
We’re delighted to welcome Dr. Patrick Vink to Avacta’s Board as Non-Executive Deputy Chairman and Senior Independent Director.
Patrick brings decades of pharma leadership at a key time for our pre|CISION® pipeline.
https://t.co/fccvdJ5vv4 #AVCT
We are thrilled to welcome Patrick to the Board at #AVCT. His deep sector experience building companies and navigating finances, operations and deals on both sides of the Atlantic will be critical for us at this time.
#LetsDoThis#HopeWithoutCompromise
Peak risk for #AVCT was 14 weeks ago when their Gen2 PDC (AVA6103) entered human.
Since FPI, indications have been added, directors have purchased stock and the company has released ‘platform validating’ data.
Risk:reward is now heavily out-of-sync for @avacta’s proprietary IP.
Well done @sandyradders excellent explanation of what we heard at the AGM. We were first introduced to Fapi-Pet scans by Avacta about 3+yrs ago, I’m pleased to see there has been a lot going on in the background. #avct
As has been mentioned before, it was a very upbeat AGM.
During the informal discussions afterwards, Chris answered every question with her customary thoughtfulness and courtesy.
But there are questions… and then there are questions.
One discussion centred on whether FAP expression changes during treatment. Chris became visibly animated because this is a critically important question for the pre|CISION platform.
Previous analysis had already provided important information that has been fundamental to the platform’s development. FAPI-PET takes this a step further by providing a comprehensive, whole-body assessment of FAP expression.
As Chris explained, one limitation of conventional ADCs is that targets such as HER2 are internalised into tumour cells. As treatment continues, HER2 expression can decrease or even be lost. The FAPI-PET data presented so far suggest something very different with FAP. Even as tumours shrink, FAP expression appears to persist.
That is a very important finding. If confirmed in larger datasets, it has the potential to become a game-changing differentiator for the pre|CISION platform and have important implications for AVA6103.
Chris said after the AGM that a lot would become clearer once the BIO data were released. It did.
The inference is that if FAP remains present while tumour cells are being killed, then the activation mechanism for pre|CISION doesn’t disappear as treatment progresses.
Conventional ADCs can run into the issue that the antigen they’re targeting changes over time. If the activating enzyme (FAP) persists instead, there is a scientific rationale that repeated dosing continues to activate drug in the tumour microenvironment.
As Chris said during the BIO presentation:
“The FAPI-PET results are critically important. The fibroblasts aren’t dying. And so the enzyme is still there. So dose 1 versus dose 8, it looks like you’ve got just as much FAP present even though you are killing off the tumour cells. It’s such an important finding for the whole platform, and especially as we’re looking at AVA6103 as it moves into the clinic.”
#AVCT
It is clear the relationship @coughlin582 has built with the FDA since her appointment as CEO of #AVCT will serve shareholders very well. Not just for AVA6000 but for AVA6103 and beyond.
A biotech on the cusp of deal(s) and - inevitably - a takeover.
Well done team @avacta.
“Avacta has terminated the AVA7100 Affimer® Drug Conjugate program, originally designed to optimize targeting by pre|CISION® in low-FAP tumor types”
Huge platform validation #AVCT
#AVCT
Trial design (and costs) must be locked down before quantum can be agreed. Now resolved. No confirmatory (and expensive) Phase 3 required for AVA6000 in SGC.
AVA7100 terminated due to how good AVA6000 has proven in the low FAP environment.
No additional FAP testing required (pre trial) owing to this finding.
Critical for platform. Consider the additional implications for AVA6103 and beyond.
Remarkably the PFS in SGC has still not be found. Language around TNBC (‘still maturing’) suggests it too has not yet been found. Remarkable.
Data pre-FDA lifting dosing limit and post an important data point for those looking to partner AVA6000. Interesting but unsurprising to hear that flagged.
FDA validation enveloping preCISION from every angle.
Deputy chair to be independent in keeping with US listing trends.
Heights now representing <3.5% market cap.
Over 12% of TVR turning out for what was a procedural and irrelevant AGM means no 90%+ squeeze out takeover via the back door will be happening.
AVA6103 over 4 months into trial. Serious cumulative doses of EXd will now have been administered. BOIN structure remains unappreciated.
An historically cautious CEO now talking to ‘platform validation’. If you think she is talking platform validation on the basis of AVA6000 findings alone, I’ve a lovely bridge to sell you.
It works. Both of them.
Epic news out from #AVCT this morning. This is completely lost on the market.
No this is not the 'Advance to Go' card in Monopoly & collect £200 but simplistically it is a big green light to proceed on a pathway to approval.
Have we just leap frogged, Fast track, Breakthrough Therapy Designation and Accelerated Approval in one move via a Special Protocol Assessment....
In clinical terms Avacta have just been told their Phase 2 Salivary gland trial is registrational ie to seek approval, will not require a Phase 3 (huge cost and time saving) and the only trial end point will be Progression Free Survival (PFS)!
AVA6000 is the first drug ever to have its lifetime limit removed in a Phase 1 trial. No wonder it is being fully supported by the FDA for SGC.
With median Progression Free Survival still to be determined on the trial (a positive thing) but likely knowing it already exceeds the standard of care benchmark and we now have the benchmark set to beat in the phase 2 trial the path to approval is set.
Well done to all those involved not least the selfless patients!
PARTNER INBOUND
Numerous #AVCT interviews given over the past two years have the CEO saying a single drug is not a platform.
“You need to do it twice.”
That doesn’t mean just developing a drug. It means getting another drug into clinic. Into arm.
I.e. Avacta needs to show it can demonstrate safe delivery with a second drug, before it can call itself a ‘platform’.
This is because the technology in AVA6000 does not work with most drugs.
If you took the Gen1 (6000) tech and attached Exatecan, it would not work, it would NOT prove a platform.
It works with doxorubicin as doxorubicin does not need to be forced to hang around for longer (extended release).
The technology in Generation 2 (a modified capping group and a modified linker) extend the release of Exatecan.
It is this technology which needs to be validated. Not any technology from 6000.
We have half a decade of proof Gen1 tech works.
We have 3 month of proof the platform works.
Yesterday the CEO tried to shoe horn “platform validation” into an interview, based on 6000 data.
If you can’t see the discrepancy here, you have not been listening.
She is implicitly speaking about AVA6103 data. She has 3 months of that, which is why she was able to say she expects the platform to be validated (with a massive grin).
😁
Can’t wait to see what makes up AVA6207 (we know the Exatecan piece). The timing will tell us a lot about how the AVA6103 trial is going - it’s certainly going much faster than the AVA6000 trial #avct
Selection of a warhead for AVA6207 - a drug which is largely based on the tech used in AVA6103 - is only logical alongside proof the platform is working.
#AVCT will select AVA6207’s first warhead in H2.
That selection event is as important for AVA6103 as it is for AVA6207.
Ava6103 is able to tune the turnover rate of its FAP substrate. Many perhaps don't appreciate that they have slowed down the reaction by the order of 10^6 times. From milliseconds to around 12 hours. What would be expected to take 3-5 years done in 6 months. #avct
⚡🇬🇧 Rupert Lowe: “We must ban foreigners from claiming benefits and immediately deport migrants who cannot financially support themselves.”
“Those billions saved? Slash taxes for the British workers and families who actually keep this country running.”
Restore Britain
“What a difference a year makes.”
Congratulations to Chris and the Zeus team.
A year ago the conversation was dominated by the CLN. Today it feels as though it is being proactively managed rather than managing us.
Shareholders are recovering well from PTCLND (Post-Traumatic CLN Disorder).
Looking forward to the next chapter.
#AVCT