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Why is anyone even responding to the ignorant bore?🤷🏻‍♂️ It adds nothing to anything.

Yeah, maybe we got a discount from KABI for the work they did on AVA004 for clinical trials.🤣🤣🤣

Particularly as the major shareholders are Russian. Oh dear. You couldn't make it up Laura, or should I say Laura Golovanovska.🤣🤣🤣

No reason at all but, completely unrelated, you are flogging an obviously dead horse so good luck with that!

There's a reason why I have you on filter, and a reason why I should NEVER dip into your pathetic sarcastic comments.

Wouldn't it be great though if it were Novartis or Roche in Switzerland doing the manufacturing of formulated AVA6000?!

Could indeed be KBI Biopharma, but Lonza is another, and bigger, CDMO services company: https://www.lonza.com/visp

Thanks Rambo.

Re the need for Phase 1b, it is pertinent to ask what the point of Phase 1b is.

I found this paper from 2016 which suggests to me that 1b is a fairly recent addition and refinement to the dose escalation study to find MTD, the purpose being "to better characterize the toxicity profiles of experimental agents or to study disease specific cohorts before selecting an appropriate dose and patient population upon which closer attention will be focused for the Phase II study [RP2D]".

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4976787/

One might argue that, with patients continuing on AVA6000 post-cohort and STS having been chosen for the clinical development already, a fair amount of Phase 1b is being done now (extended toxicity data studies) and the proposed still-called 'Phase 1b' will do the rest (larger, indication-specific patient population) and could easily morph into a straight Phase 2 trial if one of the two AVA6000 dosing regimens (i.e. the best at treating STS) were to be adopted as the 'RP2D' mid-study.

Frankly, I'd be surprised if Avacta didn't come clean and the next trial wasn't labelled as a Phase 2 in some way - Phase 1b/2 or straight Phase 2 - and I think that such a change would provide a big boost to the share price.

Bella, I see this: https://www.kbibiopharma.com/archive/avacta-and-selexis-partner-to-develop-cell-line-for-clinical-manufacturing but nothing about this company providing AVA6000 for our trial.

That and the RNS you cited (same news) are about AVA004, an Affimer PD-L1 inhibitor.

https://www.lse.co.uk/rns/AVCT/avacta-and-selexis-partner-to-develop-cell-line-aj9air2f8jmu5ks.html

Where did the idea that this company is also manufacturing for AVA6000 come from? I've not seen anything about the contract formulator for AVA6000, but I've not necessarily seen everything.

PL75 wrote "Lets up 1b to 60+, call it phase 2, bosh, approvals are instantly brought forward"

It seemed to me that the redesigned Phase 1b (1b/2, or whatever), as put forward since SD, was being designed to do several things:

1. Try a couple of dosing regimens (dosage and possibly frequency) to see which worked best for STS - Phase 1b-like.

2. Use doxorubicin as comparator - very Phase 2!

3. Gather data about doxorubicin that are not available in the literature.

Hopefully negotiations with the MHRA, FDA (and EMA) will lead to a, maybe bigger, trial that will indeed fast track AVA6000 to approval but I suspect it would be more expensive and, absence revenue from a licensing deal or two, would require a fund raise of some sort but from a stronger share price base when the results of Phase 1a are made known to the investment, scientific and media worlds.

Just some facts.

Avacta is the company, AVA6000 is the lead product. Loan repayments are quarterly, not monthly. Trial news due soon - good news or even better news. Many ways to raise further cash (all small biopharma companies need constant top-ups unti there is a revenue stream - it's normal!). Those % figures - just meaningless supposition.

All products used in human trials have to be manufactured by a GMP facility, so Avacta has had to contract that out.

To do that, I guess (don't know for certain but it seems sensible to do all this early), such hoops as stability testing (and analysis of degradation products) and purity of product (to BP, etc standard and characterised for impurities) have to jumped through as no company should be able to supply a product laden with toxic impurities that won't keep for more than a week without degrading to inert or, at worst, toxic chemicals.

🥱

It's never nice when you see your money wiped out with your investment so those who have lost out here have my sympathy.

I'd never heard of Ovoca Bio unti I saw yesterday's disastrous RNS. Immediately I knew I'd never ever have invested in this company, and for these reasons:

1. There is only one drug candidate in the pipeline, so the company is a binary play: win big or lose everything.

2. The trials by Ivix were done in Russia. I would never trust anything coming out of Russia. They have a culture of lying: of lying openly, blatantly and straight-facedly. It's called 'vranyo' and it is done for personal progression.

3. Ovoca Bio is based in Ireland and I would never trust an Irish company. Their flavour of lying is called 'blarney'.

I see some are claiming that they've bought more OVB shares at this knockdown price as the SP will be going up again. Don't believe them. (Have they bought or are they trying to get others to buy and thereby raise the price so that they can sell their holding at a better price?) In any case, this company is a dog and is dead in the water. There may be assets in the form of a cash pile but that will dwindle away into the directors' pockets. This company has no product and no future.

Monkeysponge is, of course, a trader. Best to ignore.

Oxygen wrote "First patient dosed in the AVA 6000 P1 Trial : 11th August 2021, Share Price then was 125p . Two years and numerous positive updates later, yet we’re 15% down. You can argue the science all day long but to date you can’t argue the investment case. Tomorrow may be different, we hope so !"

Would you care to hazard a guess as to how much of that 125p was LFT expectation? No? I thought not.

When would pricing be decided in these instances? Avacta is not a charity! It is a tightly financed microbiotech!

@GTW and RD (all others are green binned so I've no idea what they wrote or even who they are except the last, the sealion), to agree with you, doxorubicin has a unique chemcal structure that defines it as doxorubicin. The hydrolysis of peptide bonds - cleaving them by adding an OH from H2O to one and the remaining H of H2O to the other is standard biochemistry.

The doxorubicin cleaved off AVA6000 is pure doxorubicin and nothing else. AS said so and it is true. End of.

For comparison, imagine a world where doxorubicin, water, eggs, bacon, waffles all consisted of chemicals that had random structures or the same chemicals but behaved differently... How would reality function? That would be SEALION WORLD.

@JT, I see that you are now suffering from lower case syndrome...

Whoever signed off the LSE website upgrade needs to be sacked. All lowercase text is one thing but the thing that REALLY gets me is that all line feeds (text to appear on the next line) are converted to a double spaced line feed (blank lines in between). This totally fecks up any attempt at presenting foramatted information in an easily assimilable way. Urgh!

Anyway, I digress...

As proposed in recent presentations, Phase 1b would definitely be a Phase 1b/2 trial and a fast track route to approval if the FDA decree it a pivatol study. Off-label use of a licensed product is the responsibility of the prescriber and the same would be true if limited approval were to be granted by the FDA. It's a good question as to whether 'off-label' prescribing of a limited approval drug would be allowed, ethically or legally. My guess is that Bill Tap and/or Lee Cranmer would make a judgement call and break down the ethical barrier. We can only hope!

@PL75, we are still in Phase 1a until Avacta announces that we are not. Phase 1a involves end of life patients as it is essentially a safety, tolerability and PK/PD study, no matter what it appears that it has morphed into. Phase 1b/2 will, if the intended protocol is submitted and approved, involve patients who would normally be given straight doxorubicin as the first line treatment and then we will see what efficacy AVA6000 has in comparison with the doxorubicin standard of care.

A Post Office account is calling you Roger. A name you know and trust.

@Rorydinho, look at the trial protocol to see in which part, 1a or 1b, each SOM is used. I'd guess that these have some value in 1a but they are totally unregulated - different dose levels, different number of cycles, different cancers. However, as I said, useful supporting annecdotal evidence, particularly if a terminally ill patient (i.e. all standard of care lines of treatment have failed to halt diseaase progression) survives for many months beyond prior expectation, up to a year and beyond.

Ignore the dose expansion part of the current trial protocol. It is intended to rewrite Phase 1b, making it very much like a Phase 2 trial (hence I call it Phase 1b/2) with standard of care doxorubicin - six 3-weekly cycles of 75mg/m² straight doxorubicin as the control arm. If AVA6000 outperforms that then it's as good as approved to replace doxorubicin for STS. Just needs the dosing regimen (dose level, frequency and maximum administrable) to be worked out.

Check out the Science Day and AGM presentations and slides and the Vox interviews on the Avacta website: https://avacta.com/investors/investor-resources/