Member Info for B2HS2L

Just checked AI to see if Avacta has made an application -

Source Grok: Has Avacta therapeutics applied to the FDA for Fast Track status for AVA6000

No, there is no public evidence or announcement indicating that Avacta Therapeutics has applied to the FDA for Fast Track designation for AVA6000 as of November 24, 2025.

Eligibility Check: Fast Track requires a serious condition (e.g., advanced solid tumors) and potential to address unmet need (e.g., reduced toxicity vs. standard doxorubicin). AVA6000 likely qualifies, but companies must apply explicitly—it's not automatic.

Current Stage: AVA6000 is in Phase I (dose escalation completed; Phase Ib expansion ongoing as of March 2025), where Fast Track requests are common but not always pursued early if focusing on safety data first.

No Announcements: Searches of Avacta's website, press releases (2021–2025), clinical trial registries, and related news yield no mentions of a Fast Track application or grant. Recent updates (e.g., January 2025 Phase Ia data) highlight safety and efficacy but omit regulatory designations beyond ODD.

If Avacta applies in the future (e.g., during Phase Ib/II), it would likely be announced via press release, as with their IND and ODD.

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Priority Review Eligibility Timing:

Priority Review requires substantial evidence of superior efficacy/safety over available therapies for serious conditions.

Applications occur pre-approval, not during Phase I.

Company Focus: Avacta has prioritized ODD for commercial incentives in rare indications like soft tissue sarcoma.

No press releases or updates reference Priority Review, Fast Track, or Breakthrough Therapy designations.

If Avacta advances to later phases and applies (e.g., upon positive Phase II data), it would likely announce it publicly.

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No Breakthrough Therapy Application:

Breakthrough Therapy designation requires preliminary clinical evidence of substantial improvement over available therapies for serious conditions.

Requests are typically made after Phase I/II data, but AVA6000's early data (as of March/October 2025 updates) has not prompted such a request.

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Avacta playing a waiting game it seems.

Touk - 'One of the issues with decision makers is that they never learn from history.'

Why would someone who believed that tosh, start buying and selling shares, let alone buy and sell them so long?

A sure sign of intelligence is to learn from others mistakes.

'your analysing this down to the far end of a fart for what reason'

The object is to obfuscate, mislead, and prepare a platform with which to introduce deceit and doubt.

It's been happening for years, YEARS. Yet people still take issue with minute details thrown up in this line of stupidity.

Those with other targets to meet don't allow their time to be wasted by answering such tosh, because other questions follow.

I've already wasted too much time on this post, it's a very small fraction of what others are posting.

146 replies and they are still introducing the next doubt and false comment.

WAKE UP posters, - your time is being scammed.

End the stupidity. - Do Not Reply.

Also, from Grok:

CDX Trials in Cancer Research

In the context of cancer research and drug development, "CDX trials" most commonly refers to clinical trials involving Companion Diagnostics (CDx).

These are specialized trials designed to co-develop and validate a targeted cancer therapy alongside its corresponding diagnostic test, ensuring the drug is used only in patients whose tumors have a specific biomarker or genetic profile.

This approach supports precision medicine by enriching trial populations for likely responders, reducing failure rates, and accelerating approvals.

The model gained prominence with the 1998 FDA approval of trastuzumab (Herceptin) and the HercepTest for HER2-positive breast cancer.

CDx trials are not a distinct "phase" but a design strategy integrated into phases I–III of oncology drug trials.

They address the high attrition rate in cancer drug development (e.g., ~90% failure in non-small cell lung cancer trials from 1998–2012) by linking drug efficacy to diagnostic results.

Key Features of CDx TrialsPurpose:

To demonstrate that the CDx test (e.g., a next-generation sequencing assay or immunohistochemistry) accurately identifies patients who will benefit from the drug, while confirming the drug's safety and efficacy in that subgroup.

Diagnostic Role: The CDx is an in vitro device providing essential information for safe drug use—e.g., detecting mutations like EGFR in lung cancer for targeted inhibitors.

Regulatory Path: Co-developed under FDA/EMA guidelines; ~66% of FDA breakthrough therapy designations include a CDx.

By mid-2021, 46 oncology drug-CDx combinations were FDA-approved, with numbers growing (e.g., FoundationOne CDx covers ~60% of NGS-based indications).

Thanks Harrogate.

From Groc:

Spheroid co-cultures are advanced three-dimensional (3D) in vitro models used extensively in oncology to simulate the complex tumor microenvironment (TME). Unlike traditional two-dimensional (2D) cell monolayers, which often fail to replicate key tumor features like cell-cell interactions, nutrient gradients, hypoxia, and extracellular matrix (ECM) influences, spheroid co-cultures involve aggregating multiple cell types (e.g., cancer cells with stromal fibroblasts, immune cells, or endothelial cells) into spherical structures.

This creates a more physiologically relevant platform for studying cancer biology and testing therapies.

They bridge the gap between preclinical research and clinical trials, helping explain why over 90% of oncology drugs fail in human testing despite promising 2D results.

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From previous Avacta presentation:

..human tumors that have been grown in mice are called PDX models.

Reminder for those interested.

Cancer Detectives: Finding the Cures

The work of trailblazing scientists taking on the disease, exploring how their pioneering work is changing patients' lives right now.

This programme focuses on Professor Sarah Blagden, who is attempting to stop cancer before it even starts using immunotherapy / vaccines.

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How successful is trial so far.

How much does AI feature.

..and one of the validated payloads released was exatecan surely.

LL - there is this in the 27.10.2025 RNS:

Key Preclinical Findings:

The pre|CISION® dual payload technology demonstrated robust FAP-selective delivery and potent anti-tumor activity across multiple complementary payload combinations:

· validated dual payload release mechanism: Biologic and biochemical analyses confirmed simultaneous release of two independent payloads from a single FAP cleavage event. Modifications to the self-immolative linkers enabled tunable payload delivery kinetics, providing flexibility to optimize therapeutic profiles for different payload combinations. Strategic modifications of linker and capping group structures enabled optimization of compound activity.

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ie VALIDATED in 6207, so good for 6103 for release of exatecan only.

From Wikipedia - Crown Jewel Defence

https://en.wikipedia.org/wiki/Crown_jewel_defense

In business, when a company is threatened with takeover, the crown jewel defence is a strategy in which the target company sells off its most attractive assets to a friendly third party or spins off the valuable assets in a separate entity. Consequently, the unfriendly bidder is less attracted to the company assets. Other effects include dilution of holdings of the acquirer, making the takeover uneconomical to third parties, and adverse influence of current share prices.

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I would hope the board have actioned something that addresses this threat.

Avacta certainly need one.

What that action is and with who, we will hopefully will never know.

There are many PI's and many holders below 3% holding now.

So a hostile bid would not be out of the question, if your prepared to p'off the board.

IMO any takeover would precipitate an auction.

Only an idiot would predict the size of the winning bid in any auction.

Think old masters paintings, - it's who ,and how many, are on the end of the phone. 🤷🤷‍♂️🤷‍♀️

“Do not assume anything Obi-Wan. Clear your mind must be if you are to discover the real villains behind this plot. “— Yoda

Haven't stopped tittering this morning - thanks Thorn.

Sounds like something Yoda would say.

I'm looking for perspective with this programs content.

It's the first in a 3-part series.

Interested in anti-cancer developments other than pre|CISION ?

With much investment of time and money at stake, big pharma will know about this and other initiatives as well as Avacta's promising technology.

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Cancer Detectives: Finding the Cures

The work of trailblazing scientists taking on the disease, exploring how their pioneering work is changing patients' lives right now.

This programme focuses on Professor Sarah Blagden, who is attempting to stop cancer before it even starts.

Her pioneering clinical trials feature Trevor, a retired Navy veteran whose skin cancer has spread. Could Sarah's immunotherapy trial save Trevor's life?

Twenty six-year-old Ella has a genetic condition giving her a 90 per cent chance of developing cancer.

Ella hopes to join Sarah's prevention trial and live without fear.

Sarah hopes to bring together several recent breakthroughs in cancer research to create a world-first vaccine. 🧐 👓 👀

Apologies if posted before:

MedCity Life Sciences Companies to Watch 2025 Brochure

Sector insights

The London’s Life Sciences Companies to Watch brochure highlights 60+ companies positioned to be the vanguard of future healthcare and research.

https://medcity.london/resources/london-life-sciences-companies-to-watch-2025-brochure/

Downloading report reveals Avacta listed on pages 12, 35 & 38.

Hotlinked within the Association of the British Pharmaceuticals Industry report previously referenced is:

https://www.abpi.org.uk/media/news/2025/september/uk-tumbles-down-global-rankings-for-pharma-investment-and-research/

The following Big Pharma management have their say about the good and bad parts of the UK environment:

Steve Hopkinson, Vice President & General Manager, AbbVie, UK

Tom Keith-Roach, President AstraZeneca UK

Vani Manja, Country Managing Director and Head of Human Pharma, Boehringer Ingelheim UK & Ireland

Guy Oliver, General Manager, Bristol Myers Squibb UK and Ireland

Jordan Cummins, Chief Policy & Campaigns Officer, CBI (CBI = Confederation of British Industry)

Roz Bekker, Managing Director UK & Ireland, Johnson & Johnson Innovative Medicine

Johan Kahlström, Country President & Managing Director, Novartis UK & Ireland

John McGinley, Country President and Managing Director of Pfizer UK

Christopher Stokes, President and General Manager UK, Ireland & Northern Europe, Eli Lilly and Company

Kate Rowbotham, General Manager, Roche Products Ltd UK

Rippon Ubhi, UK & Ireland Country Lead & General Manager Speciality Care, Sanofi

Sharon Hall, Vice President and General Manager, Sobi UK and Ireland

Şeyda Atadan Memiş, General Manager, Takeda UK and Ireland

Nico Reynders, General Manager UCB UK & Ireland (UCB is a global biopharmaceutical company headquartered in Belgium. - In the UK, UCB is a leading investor, reinvesting around 25% of our revenue back into biopharmaceutical R&D.)

Https://www.soci.org/news/2025/9/pharma-r-and-d-why-the-uk-is-losing-the-investment-race

The UK is ‘losing the race’ for investment in R&D, clinical trials, and foreign direct investment, a report published by the Association of the British Pharmaceuticals Industry (ABPI) warns.

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Christopher Stokes, president and general manager UK, Ireland & Northern Europe, Eli Lilly, said the UK is currently an international outlier in life sciences competitiveness. “There is great potential here, but we must see bolder action to address some of these critical factors that influence inward investment decisions. Lilly has recently paused a potential investment in the UK while we wait for more clarity on the UK environment. We are keen to see urgent action to reverse some of the recent decline in competitiveness.”

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The UK is falling behind similar countries in how it values innovative medicines and said meaningful reform is needed, said Roz Bekker, managing director UK & Ireland, Johnson & Johnson Innovative Medicine. “With challenges such as the VPAG clawback rate and how the UK values innovation unaddressed, the UK’s global competitiveness, economic growth and most importantly, patient health outcomes, are at risk,” Bekker said.

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Seems to echo our thoughts about the unfavourable UK environment Avacta finds itself in, that we've discussed here in the past.

...and regularly claiming victimisation.

Classic Narcisism behaviour.

...and used ridiculous arguments in an attempt to drive sp down further.

We already know what to expect from you should sp drop over time in future.