focusIR May 2024 Investor Webinar: Blue Whale, Kavango, Taseko Mines & CQS Natural Resources. Catch up with the webinar here.
THIS:
“ It’s very rare (unprecedented as far as I’m aware) that a company can be so specific in the recruitment of patients in a phase 1 study. There are massive forces in play behind the decisions that have been made (FDA/BP) and the two weekly has the feel of a phase 2/3 efficacy study.”
🔨💅👦
I saw Wyndrum’s original post. 🙏👌👏👏👏. I don’t think AS is going to have an easy time of it. Not sure how he’s going to enjoy being reminded he doesn’t own the company, and he is answerable to shareholders. I’m guessing not many ‘science’ questions are heading his way.
Bring popcorn 🍿.
“ An FDA encouraged t/o before the end of the year....in my opinion.”
WTF? WTAF?? WTAFFOAFFB???
The FDA is a safety & regulatory US Government Agency. It doesn’t advise companies, or anything else, on business development matters. That would be seen as gross market manipulation. It simply cannot do this. It has no means, ability, or authority to interfere like that.
“ Trinity Delta view: The proprietary pre|CISION platform is key to Avacta's investment case, hence updated data that continue to support key hypotheses for AVA6000 are reassuring. Future efficacy data from studies planned to start in H224 will be key, and could also help to more broadly validate pre|CISION. The recent £31.1m fundraise (March 2024 Lighthouse), which provides a cash runway of c 24 months ie into early 2026, will be used to advance the therapeutics pipeline, in particular AVA6000, and should cover a number of value inflection points in AVA6000's development. Our valuation and forecasts are currently suspended; our last published valuation was £672m (equivalent to 237p/share).”
MATML74 THANK YOU FOR THE CORRECTION 🙏
Sorry for the inadvertent FUD. I hope Avacta give the explanation about the cardiac event in an RNS supporting the presentation, as they did in science day. I hope it doesn’t mislead anyone else. Doxorubicin without cardiotoxicity. Holy grail.
Matml74: I will look at the science day. But I took DLT in
“Two DLTs were observed of grade 2 cardiac failure (120 mg/m2; LVEF decrease 61 to 39%) and grade 4 neutropenia/ thrombocytopenia (200 mg/m2)”
To mean:
“Dose-limiting toxicity (DLT) Toxic effects that are presumably related to the drugs that are considered unacceptable (because of their severity and/or irreversibility) and that limit further dose escalation. DLTs are defined before beginning the trial and are protocol specific.”
Suggesting the myocardial dysfunction was drug related. A big error if Avacta have got it wrong on their poster. Excellent news if you’re right tbh.
40 patients, spread across different cohorts, doesn’t fit well blended together and presented as simple percentages. The treatment and dataset of each patient can be presented. It would be very helpful to know the dose to cardiotoxicity timescale, for example.
Evening BV. From the 3rd Feb 2022 RNS:
“Avacta Group plc (AIM: AVCT), a clinical stage oncology drug company and developer of powerful diagnostics based on its innovative Affimer® and pre|CISION™ platforms, announces that the first-in-human Phase I trial (ALS-6000-101) of AVA6000 Pro-doxorubicin will advance to the next dose cohort following a positive review of the safety data from the dosing of the first cohort.
Avacta's Safety Data Monitoring Committee (SDMC), comprised of clinicians currently recruiting patients, has completed its review of the safety data from the first cohort dosed with AVA6000 at 80mg/m2 in the ongoing Phase I trial. Following this review, the SDMC has recommended that the clinical trial continues as planned and escalates to the next dose of AVA6000 at 120mg/m2.”
So my thought was if cardiotoxicity had occurred immediately, or very soon after, the C2 120mg/m2 trial; could it have been taken as the MTD at that point? But because it didn’t, the subsequent cohorts proceeded. Agree no MTD found. This one off incident was just ‘bad luck’.
You were saying? 👌
Without wishing harm on anyone, thankfully it looks like the cardiotoxicity at 120mg has been a late event. If it had occurred immediately, would this have been the MTD? Or would further, more cautious, dose escalations have taken place.
And we’ve got to remember this is a P1a study. Powered and designed for safety only. Everyone has to be very very careful extrapolating these results to prove efficacy. It’s reassuring that efficacy is being suggested, but not proven. In saying that, another point worth thinking about is that all of the patients have already had other chemotherapies, if I’m reading it right. A median of 3 drugs? So cancers already effectively selected to show drug resistance. So if there has been an effect here, it’s impressive.