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Great work GMCC :

Data will be presented at International Society for Cell & Gene Therapy, May 2023 (AffyXell and Avacta) https://www.isctglobal.org/isct2023/home

After a relative fallow period during the pandemic, 2023 has seen a resurgence of M&A across drug-development. In fact in the past 2 months alone, there’s been a flurry of proposed deals - Pfizer’s $43bn purchase of Seagen, Merck $10.8m bid for Prometheus Biosciences, Inc. (75% premium), and GSK’s $2bn acquisition of Bellus Health (100%).

Other large Biotechs that also need to replenish their pipelines include Bristol Myers Squibb, Royalty Pharma, AbbVie, Biogen, Gilead Sciences and Viatris.

The common thread being that Big Pharma typically targets smaller firms progressing world beating new therapeutics through late stage clinical trials.

To me Avacta fits the bill, once its lead drug candidate AVA6000 (hopefully) enters Phase 2 trials sometime over the next 1-2 years alongside generating 1st sales in 2026.

Ok, so where do we stand?

Well the good news according to todays’ FY'22 prelims (re -£15.1m EBITLA on sales of £9.7m. Split £5.5m therapeutics & £4.2m diagnostics) is that everything remains on track. Plus with £41.8m of cash in the bank as at 31st Dec’22 - there should be ample capital for the foreseeable future.

Elsewhere Oct’22’s £24.9m acquisition of Launch Diagnostics Limited (FY’22 revs £4.0m) has bedded down well, with potential smaller bolt-ons possible in order to ultimately create a substantial in-vitro diagnostics (IVD) business.

CEO Alastair Smith commenting: “The outlook for AVA6000 and the pre|CISION platform as a whole looks very promising, based on the safety, pharmacokinetic and tumour biopsy data obtained to date. The next significant value driver for AVA6000 will be the initial efficacy data from the Phase 1b dose expansion phase in patients with soft tissue sarcoma.”

Chairman Dr Eliot Forster adding: “I firmly believe that our pre|CISION and Affimer technology platforms have the real potential to deliver an extensive pipeline of oncology drugs that will make a meaningful difference to cancer patients’ lives. The future prospects for Avacta are very positive indeed.”

Finally wrt valuation, broker Trinity Delta have (re 17th Jan'23) a risk adjusted NPV estimate for Avacta of 221p/share.

https://www.linkedin.com/posts/paul-hill-a5994116_avct-activity-7056508459814395904-cszK/?utm_source=share&utm_medium=member_desktop

Novartis to spend $10 billion a year on acquisitions
https://www.fiercepharma.com/pharma/novartis-ceo-looks-to-m-a-for-transformative-innovation-report

Updated
https://www.withpower.com/trial/phase-1-sarcoma-6-2021-6f477

Risks are now minimal IMHO Vs Rewards could be huge lol ..... Any day a huge RNS could be delivered and if your out then you will find it very difficult to get in !! Results next week .... AVA3996 / AVA6000 Updated ...Next news before results ? Something will drop before next week IMHO come on Sir Al

If you’re developing world beating new therapeutics, then its crucial doctors, key opinion leaders and healthcare professionals fully understand the drug's benefits, utility and safety profile.

In this context,
Avacta
(
AVCT
)
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is currently showcasing its second major pre|CISION based treatment - a novel proteasome inhibitor (AVA3996) - at the 2023 American Association for Cancer Research annual conference in Florida. One of the world’s premiere such events.

What's more, this commitment suggests to me the company is excited about AVA3996's long-term potential, and ticking off another important milestone along the road to fully commercialising the wider pre|CISION platform.

The AVA3993 pre-clinical data being presented demonstrates;

1) The release of the active proteasome inhibitor (AVA2727D) from AVA3996 is specific to the enzyme FAP, which is upregulated in most solid tumours.

2) In a head to head study, AVA2727D kills cancers cells (ex-vivo) as effectively as bortezomib (Takeda's Velcade), which is one of the approved proteasome inhibitors on the estimated $2.3bn annual market by 2026.

3) In 3 different in-vivo (mouse) cancer models (melanoma, sarcoma and colorectal cancer), AVA3996 was as effective as other related chemotherapies.

4) The significant toxicities associated with bortezomib observed in these in-vivo models were not observed in the case of AVA3996. Suggesting that the exposure to the raw drug had been reduced due to the tumour targeting of the pre|CISION chemistry in AVA3996.

CEO Alastair Smith commented: "We are delighted with the progress being made in the pre-clinical development of AVA3996, the 2nd drug candidate based on our preICISIONTM platform. The potential to apply a proteasome inhibitor to the treatment of solid tumours is very exciting. And, as can be seen from our poster presented at the prestigious AACR meeting, the pre-clinical data we are generating is very encouraging in that regard. We are focused on accelerating AVA3996 through to IND filing as soon as possible, so that it can follow AVA6000 into the clinic next year."
https://www.voxmarkets.co.uk/articles/avacta-reveals-more-development-progress-for-precision-treatments-0c4b990
Preliminary results are scheduled for Tuesday 25th April.

Needs a listing on Nasdaq ..... Funds to progress and true Value will be outed !

Unreal well Happy Arise Sir AL !

Might be old article ?

Mr Tap today ......

https://www.medscape.org/viewarticle/867872

https://meetingonthemed.com/company-presentations/

Don't Forget Affyxell 12th April ......
Jong Sang Ryu, Ph.D., CEO and Chief Security Officer
April 12 | 10:45am | Dark Horse Consulting Ballroom
Gimhae, South Korea
(Private)
AffyXell Therapeutics is a joint venture between Daewoong Pharmaceutical and Avacta Group, developing a novel cell and gene therapy to tackle diseases that come from the imbalance of immune system homeostasis. AffyXell’s platform (also known as AFX) was created by converging two proprietary technologies of its parent companies – Daewoong’s mesenchymal stem cell (MSC) and Avacta’s Affimer® platform. The immunomodulation function by MSC is further increased with the Affimer®, and the treatment developed by the AFX platform enhances restoring immunologic balance. AffyXell is developing pipelines taking this new therapeutic approach to lead in resolving fundamental causes of intractable diseases like immune rejection and autoimmune diseases

Nasdaq will give us the funds req'd or indeed a sleeping partner , lot's of way's to push this thru ... ?

That is one confident cookie

Some of you should apologise for Doubting GMCC !

Presenting 12th Apr & Big Reveal in May
https://meetingonthemed.com
https://www.isctglobal.org/isct2023/program/2023plenaryandconcurrents

Must admit haven't seen this before clearly we are not letting go AVA6000
Key Objectives 2023-2025
Complete the phase I clinical study for AVA6000 FAP-activated doxorubicin.
Leverage the AVA6000 clinical data to commercialise the broader preCISIONTM platform through licensing whilst retaining AVA6000 as a wholly owned asset.
Expand the number of fully funded partnerships and licensing deals for the Affimer® therapeutic platform.
Demonstrate safety and tolerability of the Affimer® platform by progressing the first Affimer® into the clinic as quickly as possible with partners and through in-house programmes.
Grow the Diagnostics Division through M&A to build a profitable European IVD business serving both healthcare professionals and consumers.

https://www.abstractsonline.com/pp8/#!/10828/presentation/2606

We have demonstrated that the pre|CISION™ substrate is exquisitely sensitive to FAP and is not cleaved by related proteases. The active AVA3996 warhead should therefore be released primarily following FAP cleavage in the tumor microenvironment.
Cancer cell lines were assessed for their sensitivity to AVA3996 in vitro: activity was typically 100-fold less than the active warhead or Bortezomib alone. Upon co-incubation with soluble FAP, potency of AVA3996 increased to similar levels as seen for the warhead alone demonstrating the masking effect of the pre|CISION™ substrate. A DRF/MTD study established the maximum tolerated dose in rats was around 6-fold higher for AVA3996 compared to warhead alone. This provides further evidence that AVA3996 can be dosed at higher levels than proteasome inhibitor alone, with the potential for greater tumor targeting and hence reduced systemic toxicity.
Ongoing in vivo and co-culture studies aim to further validate the efficacy and tolerability profile of AVA3996 to direct future development of this drug. In addition, the data supports wider utility of the pre|CISION™ platform to target therapeutics to the tumor while reducing systemic dose-limiting toxicities

https://www.abstractsonline.com/pp8/#!/10828/presentation/2606

We have demonstrated that the pre|CISION™ substrate is exquisitely sensitive to FAP and is not cleaved by related proteases. The active AVA3996 warhead should therefore be released primarily following FAP cleavage in the tumor microenvironment.
Cancer cell lines were assessed for their sensitivity to AVA3996 in vitro: activity was typically 100-fold less than the active warhead or Bortezomib alone. Upon co-incubation with soluble FAP, potency of AVA3996 increased to similar levels as seen for the warhead alone demonstrating the masking effect of the pre|CISION™ substrate. A DRF/MTD study established the maximum tolerated dose in rats was around 6-fold higher for AVA3996 compared to warhead alone. This provides further evidence that AVA3996 can be dosed at higher levels than proteasome inhibitor alone, with the potential for greater tumor targeting and hence reduced systemic toxicity.
Ongoing in vivo and co-culture studies aim to further validate the efficacy and tolerability profile of AVA3996 to direct future development of this drug. In addition, the data supports wider utility of the pre|CISION™ platform to target therapeutics to the tumor while reducing systemic dose-limiting toxicities.