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Ice cool

STS tumour type was always going to be selected for phase 1B based on the above incentives imo,

I disagree.

STS would not have been selected unless data for STS was the most positive. Too much at stake not to put best foot forward for phase1b. Odd is a bonus

Will be fantastic to hear Professor Udai discuss positive phase 1 data.

Rah.

Selection of a tumour type for P1b is - without doubt - the most reliable indicator AVCT know it is activating.

Not just activating but also delivering positive data re secondary measures.

I expect a lot of positive data/commentary concerning the secondary measures within the data read out.

Thanks GMC. He also went on to say;

What collaboration opportunities are you most excited about at the Innovation Gateway?
I’m particularly excited about working with small biotech companies.......

During August 2021 the AVA6000 Principal Investigator Professor Udai Banerji offered the following comment;

“I am delighted that the first patient has now received AVA6000 in the first-in-human study. This drug harnesses our understanding of the tumour microenvironment to enhance drug delivery – targeting potent anticancer therapies to tumours and potentially sparing patients debilitating side effects. It is fantastic that efforts are being made to discover and develop smarter, kinder treatments.”

Fast forward 13 months and we have Professor Udai Banerji as guest speaker at the opening ceremony for new Avacta HQ and giving a talk on localizing cytotoxic anti-cancer therapy.

I'm sure that somewhere in between these dates Professor Udai also made some comments about exciting on-going trials and named specifically Avacta and AVA6k (even though he leads 50+ at any one time).

I've tried to search for those comments as I would like to confirm the date. Can anyone share?

Phase 1b (Dose Expansion): The dose-expansion phase will comprise 1 to 3 expansion arms in specific tumour types to evaluate the safety and tolerability of AVA6000 at the MTD or RP2D when administered as monotherapy. The tumour types to be explored in Phase 1b, will be determined based on evaluation of the Phase 1a data and the protocol will be amended accordingly.

For Avacta to have selected STS so early into the Phase1a data assessment (80mg dose stage) they must have seen something in addition to safety and tolerability e.g.. they must have seen positive data related to the secondary measures. Not only did they select STS for phase 1b but they also initiated (and gained) ODD.

Is this not the single most significant clue that AVA6K activated at low dose and delivered positive efficacy (tumor response).

If there was positive efficacy data at 80mg it stands to reason that the efficacy at 200mg (while remaining safe + tolerable) is likely to be outstanding.

No wonder Avacta are so bullish in their actions and statements.

Good Sunday all

While dosing at 160mg AS said he was very confident that Biopsy data would feature within the data read out. At the same time he said he wasn't sure whether DE at 200mg would take place, thus I'm sure biopsy data was collected at 160mg (possibly prior also)

I think they will have collected biopsy data at each stage in order to showcase the data at each dose. For sure they will have biopsy data at 160 and would suspect 200 also

Biopsy data is the icing on the cake and the only way that Avacta would pursue it (and market that they were pursuing it) is if they were super confident it would be positive. Biopsy data provides undeniable confirmation of the mechanism of action.

Ice cool baby makes a solid point.

Avacta were VERY confident of obtaining biopsies during phase 1a and even reported that they would present the biopsy data as part of the read out....all while under the assumption that DE2 could be final.

I conclude that they have had the biopsy data for many months. It was very likely obtained to support ODD.

Slightly different

From the interns

Two US sites are now being initiated and may contribute to the Phase Ia dose escalation phase.

Vs

TWO clinical trial sites in the US are currently being prepared to join the ALS-6000-101 study.

Is this new information?

Following approval by the US Food and Drug Administration (FDA) of an Investigational New Drug (IND) application, TWO clinical trial sites in the US are currently being prepared to join the ALS-6000-101 study.

Why would the AVA6K lead investigator, 400+ days into clinical data, be guest speaker at the opening of Avacta new expensive HQ IF AVA6K WAS NOT WORKING!!!

A therapeutics research day is not a bad shout.

Clearly confident to call this one a few months back.

Some interesting language used here!

Bullish

Avacta is proud to be supporting World Cancer Research Day 2022. The World Declaration for Research on Cancer calls for the active involvement of citizens, entities, institutions and leaders to join efforts to promote research that can reduce the number of people who develop cancer, and to improve survival rates and quality of life among cancer patients.

Cancer is now projected to become the leading cause of death worldwide, with 21.6 million new cases per year predicted by 2030. This major increase in global cancer rates means that supporting research into prevention, early detection and a potential cure – including transforming the disease into a treatable chronic illness – is both vital and urgent.

Avacta Therapeutics is today working with world-class cancer centres to advance our Phase I clinical program for AVA6000, a pioneering FAP-activated doxorubicin therapeutic harnessing Avacta’s pre|CISION™ platform. This first-in-class precision medicine offers the potential to significantly boost drug efficacy and minimise off-target toxicity by targeting the tumour microenvironment – with the ambition to revolutionise the treatability of solid tumours and transform outcomes for cancer patients.

For more information about the initiative, and to sign the declaration, head to the World Cancer Research Day website: https://hubs.ly/Q01n36wY0

Yet Avacta is green....

RAH,

The only downside is it’s a shame AVCT will likely have to relinquish rights to 3996

They do have 8 other pre clinical candidates that with god data could also command $$$$ up front license fees.

Avata could also license the entire platform.

• preCISION Paclitaxel ($2.96bn sales)
• preCISION Oxaliplatin
• preCISION Gemcitabine
• preCISION Capecitabine
• preCISION PARP inhibitor
• preCISION PD-1 Inhibitor
• preCISION AKT inhibitor
• preCISION Balixafortide

If the data is as positive as we hope Avacta won't be raising at a discount to the current market cap, that's 100% fact.

BOD discussions and funding strategy currently unknown however, non dilutive licence deal looks probable based on comments from AS.

NASDAQ to fund phase 2 for AVA6K backed by good data, biopsy + FDA ODD would look like an achievable/realistic path forward.

Selling down a stake in Affyxell could be an option to release equity ? Anyone have an idea on current value of Affyxell ?

Placing with strategic partners to fund phase 2 could also be good option. I'm sure this option could be used to leverage licence deal terms (and vice versa, licence option can be used to leverage best value with strategic funding partners)

All funding options look positive to me.

Language used was clever. They avoided the need to mention the Clinical data (giving insight as to whether it was seen as positive or negative) by stating that the FDA CAN grant ODD based on pre clinical. Well of course they CAN but did they, while 300 days into clinical data with regulations that demand any clinical data be submitted?

Avacta also did not state categorically that they did not submit any clinical data. They could have made this clear imo, by stating that THEY DID NOT SUBMIT ANY CLINICAl data and ODD approval was granted soley on the pre clinical package. This in itself would be ODD as then why did Avacta not requested ODD prior to clinical trial start date (if pre CLINICAL was sufficient )

Further clever language used below which combines both pre clinical AND potential for something in addition:

"a reflection of the high quality of the preclinical data AND the potential benefit the pre|CISION platform can bring to cancer patients.

The head of licencing at Novartis most definitely heard of preCISION prior to the trial however let's just assume for one moment that the first he had heard of Avacta and preCISION was when he read the Avacta LinkedIn post re FDA ODD.

Do you think he liked the post and thought ;

1. I look forward to reading that data when it's fully released to the market or;

2. We need to immediately investigate this licencing opportunity prior to our competitors.