The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
And we may have forgotten they expected to see AVA6000 MTD after approx. 4 cohorts…still haven’t found it after 7…AMAZING!!!!! No wonder plans have changed…
‘Phase 1a • Objective: Assess safety and tolerability of AVA6000; determine MTD and/or recommended dose for further development • Approximately 4 Cohorts to achieve MTD • 15 to 20 patients • Patient Population: Locally advanced and/or metastatic pancreatic, colorectal, non-small cell lung, breast, head and neck (SCCHN), soft tissue sarcoma, ovarian and bladder cancer’
https://avacta.com/wp-content/uploads/2021/09/Avacta-Group-plc-Interim-Results-Final.pdf
BV...'Whereas brtezomib (Velcade) couldn't be used as is because it lacks that free, or any, amino group so a version that has that free amino group had to be designed (by Bachovchin's team).'
Hence AVA3996...
From June 2021 Results:
Example: Velcade • Bortezomib (Velcade, Takeda Pharmaceuticals) had annual sales of $1.2bn (2018) • BUT – approval limited to multiple myeloma because of dose limiting toxicities, • AND - coming off patent by 2022. • Pre-clinical development of AVA3996 pro-velcade will be restarted using placing proceeds. Example: Taxanes • Taxanes, such as the generic Paclitaxel, are used to treat a range of cancers such as prostate, breast and cervical. • Paclitaxel has global sales of $2.96bn (2018) and is expected to generate revenue of $6.63bn by end of 2025. • BUT - significant toxicities, such as myelosuppression and peripheral neuropathy, limit the effectiveness of paclitaxel-based treatment regimens.
Ideal for pre|CISIONTM tumour activation to create safer and proprietary pro-drugs. Conservatively assume the pre|CISIONTM prodrug versions of these can achieve similar market sizes delivering 5-10% royalty to Avacta plus development milestones. Potential for a pipeline of pre|CISION pro-drugs, some of which have already been synthesized, with an addressable market of many $bn pa. Including but not limited to: • preCISION Velcade • preCISION Paclitaxel • preCISION Oxaliplatin • preCISION Gemcitabine • preCISION Capecitabine • preCISION PARP inhibitor • preCISION PD-1 Inhibitor • preCISION AKT inhibitor • preCISION Balixafortide
https://avacta.com/wp-content/uploads/2021/09/Avacta-Group-plc-Interim-Results-Final.pdf
The US has dosed 3rd Patient in C1 in the US...how many patients in a cohort?
Go ahead for UK just given so when will first patient be dosed and will UK Cohorts have same num ber of patients?
I think In parallel just means they won't have to wait for the US 2W trial to finish and then start the UK trial...the US will continue and the UK will start when ready and both will run at the same time for a period (assuming the US trial will finish first...
HI GMCC...nice to see you again...thanks for that post...couldn't agree more.
and this is why the AIM market was created so that PI's could get in on the early stage investment action which once was only available to II's..
'For investors in micro, small, and mid-cap companies, monitoring IP growth can help them spot early investment opportunities and bargain stocks. That's why IP valuation is an important stock investment tool.'
WelshFalcon...'Don't forget this phrase will encompass not only those 'warheads' currently approved and in use (with high toxicity and consequent restrictive dosing) but a whole host of 'warheads' where BP has invested large sums and which have failed due to toxicity issues.
The latter can be revived and their trials restarted. An opportunity for BP to recoup/capitalise on currently lost investments.'
Exactly, and the latter is an obvious target and could easily generate a deal or two...
Interesting RNS...it appears to answer a lot of the questions rolling around on here over the past few weeks...not all, but several.
B2HS2L...'I'd be interested to know the date the first patient was drugged, it may have been a while ago.'...Why? what will it help you with?...they said they would tell us when 3rd dosed (not drugged) and they have. They said 3rd because they probably knew this would be after the fundraise was completed. Keeping a bit of info up your sleeve for discussions with potential incestors was a commercial decision IMO...Avacta is a business and we have to appreciate that they won't tell us everything all the time.
'More potent warheads'..
Avacta did mention in an kld presentation slide that Dox mfrs would be their target market for AVA6000...this has changed to them keeping it and now I suspect their new target will be mfrs of more potent drugs.
Timster...I'm not saying it doesn't hsppen just that it's not common for doctors to point patients to trials.
Yes side effects of chemo can be horrendous but the radiotherapy can be awful too.
Sorry to hear your SiL had such a bad time.
Kevin1977...I'm extremely sorry to hear about your friend. My advise is he should ask if there are any suitable trials available. If he doesn't feel comfortable with this route ( quite understandable) he should make sure his doctor gets him the fastest treatment possible. Don't let him be fobbed off. If he can't be treated quickly near to where he lives he should insist on going to other centres which can start treatment quickly and he should be prepared to travel. Speed is now priority. I wish him all the very best.
Timster...'He'd be given options of applicable trials from his physician when given the horrible prognosis.'
In my experience this is highly unlikely...doctors don't naturally point patients to trials. Patients who ask about trials may get pointed.
Thompi...thanks for your post...I'm posting it up again under a new heading just incase some missed it. It clearly explains why they are trying out a 2 weekly dose...it seems less could be more...
CC is referring to slide 13: Toxicities with AVA6000 Demonstrate a Dose Relationship
“And so this table then describes for you a critical observation, as it provides then our first evidence that using a lower dose, and potentially shortening the interval between doses to every two weeks could enhance the anti-tumour activity by delivering more drug, increasing the dose intensity but with little to no severe toxicity. There are examples of this kind of approach in the clinic. Probably the most relevant here is the taxane Paclitaxel in the field of oncology. When Paclitaxel is administered in some settings in an every three-week regimen at a higher dose it's highly toxic, it's effective. However, when it was moved to an every weekly regimen with a lower dose, the toxicity was minimised and actually enhanced the activity. This weekly regimen is used more in the clinic, both are still used. But this is the rationale for these new dose cohorts of every two weeks dosing and it's based on the observations in this slide.”
https://youtu.be/eqj0hhgmX6U?si=tER5X1gdtec3L9Cd
Hurst10...all these deals are for companies with more behind them than Avacta right now...be it sales, contracts, product pipelines in trial or commercialised. You're not comparing apples with apples.
Energyshares...yes I had read the Feb RNS and noted the plural tumour comment made by CC...
As AACR falls about 1 year from C5 dosing and will be through C7 and possibly beyond if they are continuing to dose those beyond the trial, I am hoping they will put some emphasis on OS.
The 2W trial has, IMHO, been introduced because of OS/observed tumour reductions/no MTD at 3 times normal Dox levels/limited side effects again at 3 times Dox levels.
Everyone knows Cancer is always a race against time...the longer the intervals between treatments the more chance the more chance of resistancy setting in which is the biggest problems combined with damage to other vial organs (heart being the major one in the case of Dox).
So...how will AVA6000 perform on a 2W basis...that's the next biggest factor in this very early stage SAFETY/DOSING trial and what new definitive data will they Post at AARC regading the 3W trial.
B2HS2L...No I was referring to OS...overall survival.
C5 first dose was April 23...
So my question is...are any of the patients still alive/in remission???? If so, this would be huge as they were all at end of life
B2HS2L...'IMO AACR info has to include Q3W data - cohorts 5,6, & 7, else why bother attending unless you are going to poster info that is publicly available from presentations.'
Sure it will. Even better if they are able to confirm patient(s) still surviving too...
'Monetising Diagnostics through divestment would also bring in non-dilutive funding, but may, in our view, be targeted for later in this period, giving management time to embed the acquisitions, and improve the sales and profitability trajectory. As usual in such situations, we suspend our valuation and forecasts; for context our last published Avacta valuation was £672m (equivalent to 237p per share).'