Member Info for nursesteve

Good point about that being the market for standard dose. The latest cohort is getting 250mg 3-4 times as much as the standard dose. Could multiply the value of the market by at least another billion!

54retiresoon is probably in the right share to live up to his name!

What lovely chickens! Lol

Understandable bullish comments.

The market size for doxorubicin is currently over a billion USD (worldwide per year) and projected to grow to 1.7 billion by 2030. See https://www.marketresearch.com/Global-Industry-Analysts-v1039/Doxorubicin-33571007/ the market cap of Avacta (from this site) is approximately £331 million.

Dr William Tap mentioned in Feb that if we have a version of doxorubicin that works better than the current version, then overnight, that becomes the new standard of care! Credit to 54retiresoon who said the real value is restarting the patent clock (on this and other chemo drugs).

How long can big Pharma ignore this? Bidding war likely???

Thanks for the useful link Neutronic.

In the January RNS it was stated that “at the highest dosing levels in cohort 4, equivalent to more than double the normal dose of doxorubicin, the typical drug-related cardiotoxicity of doxorubicin was not observed.”
I take this to understand ‘an equivalent to more than double the normal dose’ to mean it delivers active therapeutic doxorubicin at the tumour site (in cohort 4) that has the same effect as more than a double dose of normal dox. - This without the usual side effects.
I could easily imagine active dox being concentrated at the tumour sites in much higher concentrations than simply a doubling - especially at the higher concentration that were announced today.

Spot on 54retiresoon. Even the current market for doxorubicin vs the company market cap must make it an attractive TO target for big pharma. Even without looking at the added value of the other drugs in the pipeline, the Affimer platform or the diagnostics side! I’d expect to see a few TR1’s soon!

The strong buy recommendation I posted yesterday by British Bulls does seem very timely!

Great news - 250mg is well outside what are the usual maximum dosages recommended. A lot of hope for cancer sufferers and excellent for shareholders too! The usual dosage of doxorubicin is 60-75mg every 21 days. With a maximum lifetime cumulative dose of 550mg. See :- https://reference.medscape.com/drug/doxorubicin-342120

For what it’s worth British Bulls have issued updated guidance that it’s the right time to buy.

See https://www.britishbulls.com/m/SignalPage.aspx?lang=en&Ticker=AVCT.L

I’ve just submitted my question(s) -

Hi Alistair and the whole team,
I’m very pleased to be fully invested in Avacta in both my SIPP and ISA. The questions that I would like answered either on the day or via RNS if market sensitive is regarding recent announcements and updated guidance from the FDA regarding fast track/accelerated approval of oncology drugs (referring in particular to Project Optimus - the initiative to shift from maximum tolerated dose to dose optimisation and dose selection). Given the excellent data announced in January regarding the reduction in patient reported adverse side effects (a criteria the FDA specifically mentions as a key consideration in the new guidance) the company would seem to have a moral duty to try to speed along wider access to AVA6000.
Has the company considered reviewing their decision to continue further cohorts aimed to find the maximum tolerated dose of AVA6000?
Would AVA6000 meet the criteria for fast track approval?

Thank you for considering my question(s) and keep up the excellent work!

Hope that it gets a reply. GLA

Wiggy here’s an opportunity for you to ask the company about the implications (if any?!) of the recent FDA publications for fast track approval of novel cancer drugs. (I’m on a cruise then so might not be able to tune in live myself but I’ll certainly be reviewing the presentation afterwards).

“In January 2023 the Company announced that it had completed the fourth dose escalation cohort that has received an EQUIVALENT DOSE OF MORE THAN DOUBLE THE NORMAL DOSE of doxorubicin. The safety and tolerability data are very favourable and the Safety Data Monitoring Committee has recommended that the study proceed to higher dose cohorts to determined a Maximum Tolerated Dose (“MTD”). Additionally, analysis of biopsy data has indicated that the active chemotherapy, doxorubicin, is being released from AVA6000 in the tumour tissue at THERAPEUTICALLY RELEVANT LEVELS confirming the tumour targeting potential of the pre|CISIONTM platform. The Phase Ia dose escalation study is expected to complete in the middle of 2023 and the Phase Ib dose expansion study to commence shortly afterwards.

There is also significant longer term potential to combine the two platforms to create next generation targeted ‘drug conjugate’ cancer treatments.
The platforms are also being developed through leading industry partnerships including LG Chem, Daewoong Pharmaceutical and POINT Biopharma.
The second pre|CISIONTM tumour targeted chemotherapy candidate for development was announced in January 2022 and is a proteasome inhibitor referred to as AVA3996.

The Company plans to generate additional Affimer® and pre|CISION™ drug development candidates in 2023, to further support its growing, innovative therapeutic pipeline”.

So candidates tolerated what equates to a doubling of the normal dose without experiencing dose limiting side effects and the company is working on what the MTD is.

I think anyone unfortunate enough to need Dox would be queuing up to take part in the next cohort.

Might be because they are targeting the American market Mikea01 ? as the poster presentation is at the American Association for Cancer Research (AACR) 2023 Annual Meeting, taking place at Orange County Convention Center, Orlando, Florida on 16 April.

This reinforces the wider value of Avacta’s proprietary pre|CISION™ platform as it again states - ‘data supports wider utility of the pre|CISION™ platform to target therapeutics to the tumor while reducing systemic dose-limiting toxicities’. It’s an multiple oncology drug market that can and is being targeted!

Then in amongst all the childish posting you get some relevant information worth consideration.

BetulaKapital Posted - Huge news from FDASat 04:38
FDA Issues Draft Guidance Aimed at Improving Oncology Clinical Trials for Accelerated Approval

https://www.fda.gov/news-events/press-announcements/fda-issues-draft-guidance-aimed-improving-oncology-clinical-trials-accelerated-approval

https://twitter.com/viveksubbiah/status/1639429237919690752?s=46

This could well be the pathway for accelerated approval for many of the oncology drugs AVCT have in the pipeline. I’d certainly think Alistair would be looking this very recently issued FDA guidance over.

Thanks for posting it BetulaKapital

Thanks for posting BetulaKapital. Seems this latest FDA guidance is very relevant to AVCT latest oncology drug and future pipeline

Malignant tumours do not typically regress on their own. If early trial participants demonstrated favourably responses then ethically it would be difficult to stop dosing them. This news from the FDA seems supportive to using such responses as evidence to fast track approval of AVA6000 as a monotherapy drug regimen and builds on FDA earlier approval of it as an investigational new drug IND.

Certainly market sensitive information if earlier participants have continued to receive the drug and continued to show favourable responses.

Or even an RNS from ALASTAIR ;-)

If trial participants have increased drug delivery to tumours then you might reasonably expect to see their tumours shrink. This news from FDA seems tailor made to support the research value of continuing therapy for AVCT trial participants. As in the guidelines the FDA specify that, -
Single- arm trial designs and response rate endpoints (with duration of response as supportive) have most commonly been used in oncology because response rate is a marker of drug activity since malignant tumors do not typically regress on their own, and response rate can be interpreted in single-arm trials for monotherapy drug regimens.

Worth a Monday morning RNS welcoming this news Alan?

The RNS containing the details of the second convertible loan note did contain this paragraph “To the extent the Second CLNs are not repaid, redeemed or converted on 28 February 2023, 50 per cent of the amount of the Second CLN can be redeemed at the principal amount plus accrued interest in cash. The remainder of the Second CLN shall be redeemed on 28 February 2024.” So I suppose we should have been expecting that Ben would repay this loan?
To me it’s great that Ben are now in a financially secure position to be able to make these payments. I expect that after this they will also aim to pay off the first loan note too. Looks like we might wait a little longer for dividends? Unless we see exactly how much cash is being generated above these repayments? As I expect Adam would have left some headroom available for operating costs if not an additional amount for the first dividend?

Those disappointed with the RNS today should just remind themselves of the 17th January RNS which stated that “The data being generated in the ALS-6000-101 study are providing detailed insights into the pre|CISIONTM platform which add significant value to the technology and confirm the potential of the pre|CISIONTM platform." That was very positive market sensitive information. Today is about getting that information out to the clinicians who perhaps don’t read company RNS’s. This is a small scale study and will need larger participation groups as it moves on.