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I’m going for the big RNS tomorrow morning, then Avacta into meeting with II’s.
Last chance at these levels…
You watch Sujood turn up later.

Listen to this from Jaykay on twitter dated 31/12/21 but the clip is from a month before trial started.

How confident does AS sound and again PK by end of 2021.

They know it works….

https://twitter.com/jaykay_jayk/status/1476880737609596931?s=46&t=-S3zm3HZYPDYdVd5isJqtw

Point missed earnings prediction down 35%. They need Avacta now
https://m.investing.com/news/point-biopharma-global-earnings-miss-revenue-beats-in-q3-2943228

So FDA won’t grant a IND if FDA raises concerns or questions related to the proposed clinical trials, including concerns that human research subjects will be exposed to unreasonable health risks.

After 3 dose escalations and double the legal amount of Dox in a patient they grant Avacta ODD.

It works………

Page 25
An IND is a request for authorization from the FDA to administer a product candidate to humans for further research of the drug candidate’s safety and/or efficacy. The central focus of an IND submission is on the general investigational plan for the drug candidate and the protocol(s) for human studies. The IND also includes results of animal studies or other human studies, as appropriate, as well as manufacturing information, analytical data and any available clinical data or literature to support the use of the product candidate. An IND must become effective before human clinical trials may begin. An IND will automatically become effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns or questions related to the proposed clinical trials, including concerns that human research subjects will be exposed to unreasonable health risks. In such a case, the IND may be placed on clinical hold requiring delay of a proposed clinical investigation, and the IND sponsor and the FDA must resolve any outstanding concerns or questions before clinical trials can begin. Accordingly, submission of an IND may or may not result in the FDA allowing clinical trials to commence.

We had Clovis worried and were on their radar.

AVA6000 binds to and is cleaved by FAP in the tumor microenvironment to deliver active doxorubicin to the tumor.

Page 20

https://www.annualreports.com/HostedData/AnnualReports/PDF/NASDAQ_CLVS_2021.pdf

1. Avacta Life Sciences Ltd. has two therapeutic platforms (pre|CISION and TMAC, short for “tumor microenvironment activated drug conjugates”) that are being used to target FAP and other ligands. The pre|CISION platform can be used to generate prodrug forms of chemotherapeutic agents that are inactive in the circulation. The TMAC platform is being used to design activated drug conjugates to help concentrate the delivery of chemotoxins to the tumor microenvironment.
AVA6000 is an FAP activated doxorubicin prodrug that is using the pre|CISION platform. AVA6000 binds to and is cleaved by FAP in the tumor microenvironment to deliver active doxorubicin to the tumor. At least one clinical trial (NCT04969835) is evaluating the safety, pharmacokinetics, and efficacy of AVA6000 in solid tumors.

POINT Biopharma Global Inc. is developing PNT6555, a D-ala-boroPro based FAP targeting radioligand. POINT Biopharma has disclosed that it intends to develop PNT6555 in multiple tumor types and will commence work on a phase 1 clinical study in 2022. PNT6555 is being combined with an alpha-emitter (225Ac) and beta emitter (177Lu). In addition, POINT Biopharma is supporting the PNT2004 program that is developing other FAP-targeted agents. POINT Biopharma has also entered into an exclusive licensing agreement with Avacta to use its technology (pre|CISION) to develop a range of FAP-activated radiopharmaceuticals, including a prodrug of doxorubicin that is a substrate of FAP.

GLA

Imagine this scenario:

In a large office in Jersey Dr Alistair Smith turns up with Dr Fiona McClaughlin and Neil Bell to meet Heights Capital.

Meeting starts:
AS: Can we borrow £50 million at 6.5 % pa to help bring our Fap activated drug to market and buy a diagnostic distributor that’s cash generative and will help us expand our diagnostics arm.

Heights Capital.
But we had Clovis here last month they have FAP 2286 in Phase 1-2 and have turn over of $150 million and are close to bankruptcy, why should we give you a £50 million pound loan with no income coming in.

AS: Well this is the data we showed the FDA in May and have just received ODD approval, and here is the trial data to date with 2 x extra dose escalations.

Heights Capital :
Where do we sign can we convert to shares…..

Avacta must be sitting on gold mine to be able to raise £50 million in the present market.

GLA

I have feeling, Presentation to II’s next week by Capital Access Group will be the science day.
Big RNS data release on the morning of the presentation. Avacta talking II’s through data results then a recorded posting for PI’s later in the day.

This ties in with the EU Directive 2010/63/EU, which requires that animals are not be used for scientific purposes where a nonanimal alternative exists.

A successful implementation of our proposed secondary reagents could save more than 760 mammalians per year in the UK alone.

Onwards Avacta so many shots on goal.

https://nc3rs.org.uk/our-portfolio/direct-replacement-secondary-antibodies-affimer-proteins

Interesting tweet by Natalie Cook
Ava6000 lead investigator Christie Manchester

We are working on new liquid biopsies that can hopefully make things even more quicker and efficient but not available outside of research studies at the moment but fingers crossed this is something that will be available to ALL CUP patients in the future.

https://twitter.com/oncocook/status/1590419267157037056?s=46&t=XeAOlLzqHPaSQuPj6Fh2hw

Drugmaker GSK said on Monday that its relapsed or refractory multiple myeloma drug candidate, Blenrep, had failed to meet its primary endpoint of progression-free survival in a recent phase III trial.

GSK stated the main goal of its late-stage DREAMM-3 study was to show that the treatment was superior to the standard of care currently on the market. However, Blenrep failed to do so.

I know something that will be superior to what’s on the market :)

https://m.youtube.com/watch?v=j4Zd-jIFioA

Agree and they need to start 1b ASAP

455 days into the trial.

Safety Committee have met 32 times to discuss AVA6000 and each time recommended the trial to continue and have increased the dose 4 times.

FDA approve IND application then 9 months later grant Orphan Drug Designation (ODD).

Send all the top management team to USA to present to AACR .

Keep adding to the board of directors with world class oncology experts and continue to recruit therapeutics staff,latest need a Pre Clinical Director.

Avacta board members keep repeating “Remarkably consistent data”and the “technology delivers a drug which is much better tolerated, enabling further treament cycles to be administered.”

Avacta take biopsies that wasn’t needed in phase 1a.

Decide half way through trial to keep AVA6000 in house and not licence it out.

Avacta select precision’s next drug AVA3996 before they tell the market if AVA6000 works.

Takeda buys shares in Avacta.

Spend 18 months developing a covid test and just as you receive Home Use Authorisation and have a second manufacturer complete TT with a world wide distribution partner in place ,then pull the test because it is not as sensitive on the latest variant. Which could damage the reputation of Avacta’s lead cancer trial AVA6000.

Buy Launch Diagnostics and raise £64million to complete purchase and state more diagnostic acquisitions to come.

Over subscribed placing by £13 million and don’t ask AIM if they could allow more shares to placed so phase 2 could be funded.

Move Therapeutics laboratories just 60 miles from Cambridge to London.

Then throw a opening party invite top oncologist in the country to give a speech about AVA6000 and then put a screen bigger than the one at the winning line at the Grand National with strap line: ‘Revolutionising the treatability of solid tumours’

I have never seen clues like this from any other company, Avacta could be on the cusp of something enormous.

Relaxed and chilled with my holding
GLA keep hold of those Gold Tickets…..

£13.4m cash to be returned to investors share dealing accounts.

How much of that will be invested into Avacta tomorrow.

My guess 25% from genuine LTH’s the rest probably traders accounts who will be looking elsewhere now the 30% discount opportunity has gone.

You haven’t been able to trade for 5 to 6 days :):):):):)

£13.4m cash to now be returned to traders

The massive VAR screen with ‘Revolutionising the treatability of solid tumours’
Had something to do with it….. :)

With oxygen leaving the gas has gone out :)

Has the Gas gone out

Here it is Vanilla,

From the horses mouth.06 Oct 2022 19:12
Professor James Spicer
Avacta
SCIENTIFIC ADVISORY BOARD.

442 days into the trial when a member of Avacta SCIENTIFIC ADVISORY BOARD

In a article for BMJ as role model. Published on:
24 Aug 2022.

Makes a comment like this:

If you're working in a small company that's only got one product, sometimes you need partners like us who have a portfolio of interests, who can really give the bad news that a drug isn't going anywhere.
We need to stop it, and that's explicitly an intention of early phase, Phase I trials. One major contribution we can make is to take a drug which is actually not doing what it should, to discontinue its development as soon as possible. Before too many patients are exposed to an ineffective drug, and before too much money is wasted trying to develop it.

It Bloody Works…….

https://www.bmj.com/careers/article/professor-james-spicer-professor-of-experimental-cancer-medicine-king-s-college-london