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The metastasised tumours are essentially the same cancers as the original ones and will have FAP present.

Good to hear Dr Tap throughout the presentation

Agreements with Caribou Biosciences, Harpoon Therapeutics and I-Mab have been terminated in the past two weeks by AbbVie, formerly Abbott, a very big pharma company.

https://www.fiercebiotech.com/biotech/abbvie-axes-caribou-car-t-deal-continuing-cascade-punted-cancer-pacts

Gearing up to establish a warchest for a licence deal with Avacta? We can hope!

Is this code for, like, 'Breakthrough'?😉😂

Too right DTW! All those highly respected clinicians now have absolutely no credibility whatsoever because they have thrown their lot in, and and their reputations away, by going all in with Alan, the LFT dreamer.

😂

How many early clinical stage biopharma companies have a revenue generating division?

How many early clinical stage biopharma companies wished they had a revenue generating division?

Therein lies the answer.

No posts on LinkedIn from Neil for 4 months now and only one short congratulatory comment 2 weeks ago and a few short congratulatory comments 3 weeks ago. Given how prolific he had been on LinkedIn, this doesn't look good and it upsets me to think that he or a family member may be ill or something equally demanding is occupying his time.

Let's all have a moment of silent contemplation concerning poor Eggy's dilemma. Times have changed and the little fella no longer has the wealth of options with which to, for some strange reason known only to himself, regularly attack Avacta about this and that and the other and, well, everything. Chin up little man, we share your pain. It'll all be over soon and then you can finally have that bath and ask your mum to put those Y-fronts in the washing machine (super hot, with bleach).

Neil Bell was Chief Development Officer, not Chief Medical Officer, so you got that wrong.

Where did you expect to be after 2 years Eggy? I mean, with your encylopaedic knowledge of all things pharma, pray enlighten us as to what Avacta has been doing wrong.

Admitted to trading from 8am today. Expect selling pressure.

Pharmaceutical production for human use has to be done in a GMP facility. Avacta doesn't have one, which is why production of AVA6000 formulation is currently outsourced (to Switzerland) for what are only small scale runs. I can't see Avacta building or buying a GMP facility just for AVA6000. For one thing they will want redundancy, so multiple contracts or a single agreement with one company that has multiple production sites, the important thing being production located close to distribution centres.

The same considerate HL that was pushing Woodford's equity fund all the way.

You might like to check this though: https://app.sharelinktechnologies.com/announcement/asx/3a1e3a498875724c9d5b70a79c6cea65

And look at this: https://wp-rac-2023.s3.ap-southeast-2.amazonaws.com/media/2023/08/clinical-1-1-1536x839.png

😵‍💫😂

Their drug, bisantrene, is being developed for leukaemia, so not competition.

Wiki overview: https://en.wikipedia.org/wiki/Bisantrene

February 2021 overview of the company: https://www.raceoncology.com/wp-content/uploads/2021/02/MST-Access-RAC-Initiation-18Feb21.pdf

Trials: https://classic.clinicaltrials.gov/ct2/results?term=Bisantrene

Bella, at the AGM, Alan made it quite clear that the next objective for Dx is to expand into the lucrative German market.

https://avacta.com/wp-content/uploads/2023/06/Avacta-AGM-2023-presentations.pdf (Slide 16)

Strategic Objectives 2023-24

Diagnostics Division

• Establish Launch GmbH

• Initiate first Coris/Affimer® product development

• Profitable revenues > £20M

Why do you think they'd make another purchase soon Bella? And what?

There is also Accelerated Approval

In some cases, the approval of a new drug is expedited. Accelerated Approval can be applied to promising therapies that treat a serious or life-threatening condition and provide therapeutic benefit over available therapies. This approach allows for the approval of a drug that demonstrates an effect on a “surrogate endpoint” that is reasonably likely to predict clinical benefit, or on a clinical endpoint that occurs earlier but may not be as robust as the standard endpoint used for approval. This approval pathway is especially useful when the drug is meant to treat a disease whose course is long, and an extended period of time is needed to measure its effect. After the drug enters the market, the drug maker is required to conduct post-marketing clinical trials to verify and describe the drug’s benefit. If further trials fail to verify the predicted clinical benefit, FDA may withdraw approval.

Since the Accelerated Approval pathway was established in 1992, many drugs that treat life-threatening diseases have successfully been brought to market this way and have made a significant impact on disease course. For example, many antiretroviral drugs used to treat HIV/AIDS entered the market via accelerated approval, and subsequently altered the treatment paradigm. A number of targeted cancer-fighting drugs also have come onto the market through this pathway.

More information on Accelerated Approval is here.

Same FDA page: https://www.fda.gov/drugs/development-approval-process-drugs

The astute pharma companies would have started a research programme using pre|CISION a year or so ago when it had become clear that It Works™. They can do this even though the tech has IP protection. What they can't do is commercialise it. Well, not without a massive court case, which they would lose.

So they will have already identified their past powerful cytotoxic agents with a free amino group (-NH2) that can be bonded to the acid (-CO2H) at the Proline end of 5140, consulted the archived lab books for activity data, pulled suitable compounds from storage, purified them, linked them to 5140 and started in vitro and animal model studies.

In short, by now they will have a good idea about how pre|CISION - the AVA6000 version with 5140, at least - works for them with their own research compounds and be in a position to negotiate licensing the tech with confidence. But they will also have been going through Avacta's IP with a fine toothcomb (and endless cups of strong coffee) to see whether there is any way they can circumvent the coverage. That won't be easy as the essence of the invention is just R-D-Ala-L-Pro-cytotoxin. FAP is a Gly-Pro-cleaving endopeptidase, so the invention is really the D-Alanine replacing the Glycine.

Avacta's core IP: https://patents.google.com/patent/US9737556B2/en ☕☕☕

Their own research compounds may have failed in clinical trials (so had specific patent coverage), not made it to trials because too toxic or there were better candidates (so had broad patent coverage for the compound family) or was in a compound family that was too toxic to do anything with (so may not have been patented - not a problem as anything that hasn't been publicly disclosed can be patented).

It should be noted that any dose that is tolerated in 2 week cycles would also be tolerated in 3 week cycles.

A study to test the safety and tolerability of dosing at less than 3 weekly intervals was always going to be needed before using that more frequent dosing in non-terminal patients. Avacta sense that they are still some way from MTD and have just brilliantly (their own idea or the FDA's suggestion?) supercharged Phase 1a to be able to rapidly up the escalations. It'll be interesting to see at what dose the fortnightly dosing study starts.

Exactly that PL. Alan was quite emphatic that C7 will be the end of dose escalations *for 3-weekly cycles*. Again and again he qualified it as the 3-weekly cycles. And, for sure, he can't be specific about something that the FDA have yet to rule on. His 'shortly' will be when the FDA give their decision to proceed. Again, I'll say that I'm sure Avacta is working closely with the FDA to get AVA6000 through trials and approved as soon as possible (study results willing) and hopefully that will utilise one or more of the FDA's schemes.