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V-S

Avacta management has seen early Phase1B data and the information will be available under NDA rules, in a Data Room.

Isn't this the status quo for trials where there is a lot of interest from potential partners, or is it exceptional.

For LLP in response to his 550 dosing query

From Page 20 of the Panmure Liberum Initiation presentation:

"Of the 11 patients for whom data is available, two have received the maximum allowable dose of doxorubicin, based on the toxicity criteria for conventional doxorubicin.

The strong tumour response to FAP-Dox has resulted in Avacta successful in getting health authorities to agree to increasing the maximum allowable cumulative dose of FAP-Dox to the equivalent of 550mg/m2 of conventional doxorubicin;

an increase on the 450mg/m2 that is the standard of care.

A higher maximum cumulative dose enables patients to be treated with FAP-Dox for longer, potentially out to eight months, doubling the treatment time compared to standard doxorubicin.

Management believes that the maximum cumulative dose of FAP-Dox could be increased further based on the PK data."

Also

From ESMO Barcelona 09/2024

https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal_2/presentation/list?q=646p

A phase I trial of AVA6000, a fibroblast activation protein (FAP)-released, tumor microenvironment (TME)-targeted doxorubicin peptide drug conjugate in patients with FAP-positive solid tumors

Background

AVA6000 is a peptide drug conjugate, in which doxorubicin (dox) is bound by a linker that is specifically cleaved by FAP, which is overexpressed in the TME of many solid tumors.

Methods

The safety, pharmacokinetics (PK) and preliminary efficacy of AVA6000 was studied in a first-in-human, multicenter dose escalation phase I trial.

AVA6000 was administered i.v. q3w or q2w using a 3+3 design in patients with locally advanced or metastatic solid tumors categorized as high or middle range FAP (FAPhigh and FAPmid) based on published data.

AUC based dosing was used to calculate maximum safe number of cycles of AVA6000 (equivalent to cumulative dox dose of 550mg/m2).

See mention of

13.12.2023 - Investor Meet Q/A session as provided by the company, who have delivered significantly more Questions and Answers than were discussed at the end of the (above) presentation.

Question 14:

Can you map out a plan/path to commerciality including timescale and possible income projections for Ava6000?

Answer 14:

Please note: We cannot provide specific details of ongoing business development discussions not only because this is inappropriate from a market sensitive information perspective but also because it would actually jeopardise these potential relationships. The high level commercial strategy was set out at the AGM in June 2023; this strategy has not changed. (For reference, slide 11 here: https://avacta.com/wp-content/uploads/2023/06/Avacta-AGM-2023-presentations.pdf). The Company has the opportunity to commercialise both its specific assets, such as AVA6000 or AVA3996, and its platform technologies - pre|CISION and Affimer. It is strategically important for the company to continue to wholly own its lead clinical programme – AVA6000 – for now. Taking this asset into phase 2 not only adds value for shareholders by generating efficacy data but also maintains Avacta’s clinical stage status which is important for attracting specialist healthcare investors. Avacta therefore plans to take AVA6000 into phase 2 and will then consider partnering this asset to take it to market and to broaden its applications into other cancer indications. There is potential to partner AVA3996 or any other undisclosed pipeline assets at a preclinical stage. More importantly in the short term is the potential to partner the pre|CISION platform. This means potentially licensing the platform to a third party to use in combination with their own cytotoxic agent. Such a licensing deal would be expected to be narrowly focused on a specific agent or agents. The clinical data published on December 13th 2023 plays a pivotal role in generating business development discussions and accelerating those that are ongoing.

*This means potentially licensing the platform to a third party to use in combination with their own cytotoxic agent. Such a licensing deal would be expected to be narrowly focused on a specific agent or AGENTS.

The initial reason for Q2W dosing was as per last post.

However subsequently the "single-agent data is important in partnering discussions as it is likely to increase interest from partners who may be interested in FAP-Dox as a combination treatment with an existing chemotherapy that has a two-weekly schedule."

From RNS 28.09.2023 - Interim Results for the Period Ending 30 June 2023:

In light of AVA6000's continued strong clinical progress, the Company has reviewed its clinical development strategy with the aim of accelerating a pivotal Phase 2 study in STS which could lead to the first regulatory approval for the drug.

The excellent safety profile of AVA6000 opens up the potential to dose patients more frequently, as well as with higher doses or more cycles of treatment. In order to determine the recommended Phase 2 dose, the Company will initiate a short fortnightly dosing study in place of the much longer multi-arm Phase 1b efficacy study previously envisaged. 👍

Yes, that's a lot more like it Buena

Perhaps it's the first quarterly report in a year when Avacta will be trading on Nasdaq by year end.

Thus all quarterly reports present and correct for 2025. 😉

Meaves you thinking Coris has been 'mothballed', - no real intent to find a buyer now Launch is sold.

I'm talking about impressions, and a Coris sale doesn't seem imminent.

"Coris, based in Gembloux, Belgium, develops, manufactures and markets rapid diagnostic test kits, mainly lateral flow tests, for use by healthcare professionals."

However could be gone in an instant if the requirement for LFT's were to explode.

"....today provides a business update on progress for the first three months of 2025 and a review of upcoming milestones."

This is to show their intent to report quarterly as they would if listed on NASDAQ.

Quarterly business updates from now on.

Loving this - "We are very encouraged by the Phase 1 data from FAP-Dox (AVA60000)"

That's a turbo charged AVA6000 - in trials soon..

Gmcc

Ref the website tidy up you mentioned yesterday at 07:30

This morning I cannot find the file

https://avacta.com/wp-content/uploads/2025/01/Avacta-_Corp_Deck_Jan_2025.pdf

on the Avacta website.

However the file is archived here:

https://web.archive.org/web/20250124154340/https://avacta.com/wp-content/uploads/2025/01/Avacta-_Corp_Deck_Jan_2025.pdf

Yesterdays new file:

https://avacta.com/wp-content/uploads/2025/03/Avacta-Corporate-Presentation_March-2025.pdf

It has similar content to the January file.

Suggest comparison of file contents worthwhile.

LLP - another for the snippet list

Page 4 - "Our Mission: Extend the Therapeutic Index of toxic payloads that are effective against cancer through Peptide Drug Conjugates (PDC)"

++++

The following is a competing mission statement, presently found on the Avacta website at

https://avacta.com/investors/key-information/

"Our Mission is to improve patients’ lives and grow shareholder value by developing novel cancer therapies and powerful diagnostics using our proprietary Affimer® and pre|CISION™ platforms."

I'm saying it does not make sense to choose a partner without using the pressure point of competing offers available post successful trials.

If Avacta state what an attractive offer looks like, - and I don't see why they wouldn't, - it's up to potentials to meet the spec.

CC's Leerink presentation

"...we did disclose that with our divestment of the diagnostics division that we now have runway into the first quarter of 2026."

RNS 07.03.2025

"Avacta is also in discussions regarding the sale of its remaining and much smaller Belgian-headquartered diagnostics unit, Coris BioConcept SRL......Following the divestment of Launch Diagnostics, the Company's cash runway will extend into Q1 2026."

So there is certainly more runway to come IMO, - not a lot but a little.

LDA

"It assumes they are confident enough with the data now to seek partnerships".

++++

I feel the situation might now read that those companies with access to data via NDA are starting to make early partnership overtures to Avacta, - what kind of deal content does Avacta find attractive.

Avacta aren't going to take the first partnership offered. Currently It's potential partners showing interest in a deal.

Avacta's position may well be that these potentials are nowhere near as interested currently, as they will be when trial progress matures and successful progress is reported later this year. - That's the scenario we all hope for.

At that point, several BP will be clamouring for a response to various updated partnership offerings, mindful that their offer needs to beat a number of competing BP offers, with all potentials wanting a quick decision from Avacta.

At that point the experience and savvy of CC / SC and most especially SB will allow them to make a decision and earn their keep.

This is everyone's board and the 3 amigos plus friends are making it a shi* show.

Terminally boring.

This is everyone's board and the 3 amigos plus friends are making it a shi* show.

Find somewhere else to 'discuss' differences, - take it off line - we're not interested.

Bella - if your right then we can expect Coris sale by Friday pm.

Pedrol and others

Since when have you been licensed to provide financial advise Touk.

You've kept that very quiet - I'll have to give your missives a second reading.

Or perhaps not, cos you ain't

AstraZeneca in oncology

AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

That's the reason I'll be putting Astrazenica down as one of those BP most interested in a buyout.

Unfortunately many BP have similar oncology aims.

However, as AVA6000 costs 1/10th the cost of ADC's in development (source CC),

THAT is the reason BP will be wanting (no not wanting, - NEEDING) all the preCISION IP.

The news from AVA6000 / 6103 development continues to give no cause for concern.

For me, the following will mean that with time, offers for the platform will just keep coming from BP, and

SB / CC / SC just need patience to ensure Avacta gets the best deal.

Source: 08 Nov 2024 - Video presentations from R&D Spotlight: ‘Next Generation of pre|CISION® Medicines’

https://avacta.com/video-presentations-from-rd-spotlight-next-generation-of-precision-medicines/

10:13 on slide 'Cytotoxic technology delivers cytotoxic drugs directly to the tumor while protecting healthy tissue'.

Advantages

. Small molecule manufacturing and timeline/COGM (cost of goods manufactured)

CC, commenting on this bullet point stated "What that statement means and why that is important, is that the price tag for this drug (AVA6000), is one tenth of the price tag for an ADC drug. ADC's cost a lot of money in the clinic"

No wonder BP's are looking to their development / manufacturing spend on ADC's, and licking their lips on an apparent 90% saving. That's not small change.