Chris Heminway, Exec-Chair at Time To ACT, explains why now is the right time for the Group to IPO. Watch the video here.
Matml74, I think you may need to quote the full context of the TG note. I took it to mean that the Royal Marsden could potentially provide patients for further indications?
“Though sarcomas are a relatively rare cancer, if we get AVA6000 registered in this indication you can then broaden out into other indications such as breast and ovarian. With Bill Tap’s help in the US and the Royal Marsden we can ensure sufficient clinical trial patients. A successful P2 is critical.” (TG notes)
Hi Tim - “*I think* he stated phase 2 will be US only (could have imagined that).”
I think you are correct. It was mentioned by AS during the interims, approx 21:07 into the presentation. But listening to it again, I could have misinterpreted it?
AS said:
“So that phase 2 study will be in soft tissue sarcoma, we'll release more information on which subtypes and more detail on that phase 2 study when we can. But it'll be a study in Soft Tissue Sarcoma, and it will be designed to be a registrational study in the US.”
https://youtu.be/LKoI83jSpDM?si=7fOxHBYDPO9QLOT1
Not only do we have William Tap’s invaluable experience in navigating the complexities of the FDA, but Eliot Forster is also well versed with the processes (plus, of course, licensing and deal making).
Someone (I’m sorry I can’t remember who it was) posted a podcast featuring Eliot Forster. He has lived and worked in the US. During his time out there with Pfizer he went through three successful FDA submissions.
In the podcast he talks about “really getting a sense in particular of the FDA, we went through three submissions during that period we were out there, successfully fortunately, and got a flavour for the importance of US markets/regulations. And, indeed how Pharma is done there, which is kind of the same and different just because of scale in particular, but also processes.”
https://www.buzzsprout.com/1992308/13248337
I agree PL75 that it’s baseless “concern” the FUD about Neil Bell. And as Soleboy pointed out, he can hardly have dominated Science Day because he wasn’t there. AS briefly commented on his absence in the beginning of his Strategic Overview (about 5:33 into the presentation) - “I would like to just say Neil Bell unfortunately can't be with us today because of a personal issue so he would obviously otherwise be with us but can't be”. If I had to look for an inference from that comment, then I would assume ill health.
Incidentally NB is still showing as a member of the Therapeutics team and is still on LinkedIn: July 2020 - Present.
https://avacta.com/therapeutics/therapeutics-team/
Hi WeAreGroot, “Didn’t the TG notes also mention AS saying he hoped they would publish case studies with the data?”
Yes, your recollection is correct. This is from the TG notes:
“…….we intend to present the full pharmacokinetic data and clinical data later in Q4 including case studies if that is permitted……
We’ve had a patient in the P1a trial who has had a significant reduction in tumour volume which continues to shrink, this will be a great news story, and once all the phase 1 data is fully validated we will use that to communicate the huge potential of pre|CISION and Avacta. The press want stories about cures for cancer, safety trials are less interesting. A few months ago we had no hints of efficacy and did not expect to have them. We are now able to talk about safer chemo with dramatically reduced side effects and some hints of efficacy so we are starting to engage more with mainstream media.”
Another example today of how a potential deal could possibly be structured. There is so much “optionality” now for AVCT.
A collaboration between AZ & Cellectis. Upfront payment for Cellectis ($25m), equity investment by AZ in Cellectis ($80M) option fees/milestone payments, tiered royalties….
https://www.reuters.com/business/healthcare-pharmaceuticals/astrazeneca-signs-drug-development-deal-with-biotech-cellectis-2023-11-01/
We get good posts and then it sometimes just degenerates into embarrassing vitriol. Sometimes it can be amusing and other times it’s just excruciatingly bad. Today was one of those days. “We broke you then and we'll do it again”, seriously, that is just dreadful.
Is there anyone, please, with a greater medical/scientific knowledge than myself (mine is virtually zero) help me understand a point raised in the TG meeting notes.
I understand the definition of what a drugs “half-life” means - “Drugs with a longer half-life may take longer to start working, but their effects persist for longer, and they may only need to be dosed once a day, once a week, once a month, or even less frequently”.
The question asked at the meeting was-
“TG: How long before AVA6000 is cleared, what is the half-life? What is the FAP concentration?
FM: AVA6000 is eliminated in about 4 to 6 hours. Dox by comparison doesn’t hang around long. Dox has a short initial plasma half-life. When dosed Dox goes to the patients’ tissues very quickly. The maximum blood concentration is reached quickly and then there is a long terminal half-life.
A number of doxorubicin metabolites as well as the leaving group are measured. Because they are small they are measured in the urine.
Concentration of FAP is one thing but what’s important to pre|CISION is the ‘Activity’ of the enzyme because it has to be active to release doxorubicin. The presence of FAP alone does not mean there is activity.”
What is the significance (if any?) of the difference between the half-life times of Dox & AVA6000?
Icecool, I understand the scepticism but the notes are genuine. There was never going to be any sensitive information revealed, but it was important that the notes were vetted due to concern that other parties (TW etc) would create mischief. Albert has tried to put the issue to bed on Twitter. I’m not really sure there is much more he can say.
https://x.com/albertmay59/status/1717643833482133823?s=61&t=yGNoQ6Xj0Lw6rjPJMTuiZA
“Ive heard a rumour. AS is going to invite a select group of LSE posters to a Xmas knees up at the Weatherby Whaler.”
That made me smile RD. I have this image of the TG group being all refined and then us (not so select) lot turning up at the Wetherby Whaler Xmas knees up like a gang from the Bash Street Kids. Unruly, unkempt and wearing badges with “Twat” on as our proof of membership 😀
Yuyus, you are wrong. The TG meeting definitely happened. It perhaps got more attention than it would have done because Ophidian made a sly dig about it in a tweet because he wasn’t invited. But it did happen.
Credit to the Telegram group & Albert for organising and coordinating a meeting with AS. Collectively they hold a significant amount of shares.
I’m no big fan of Oph because of all the people he has had chucked off on there, but I understand he has left the group now.
Wonder if the uber rampers of two weeks ago get a twinge of embarrassment when one of their rampy predictions don’t materialise.
https://x.com/ophidian18/status/1712119518330310886?s=61&t=yGNoQ6Xj0Lw6rjPJMTuiZA
Poolbeg Pharma's scientific advisory board endorses influenza drug targets identified in AI drug discovery programme https://www.voxmarkets.co.uk/articles/poolbeg-pharma-s-scientific-advisory-board-endorses-influenza-drug-targets-identified-in-ai-drug-discovery-programme-f01045c
I’m going with JT’s 200 mg/m2. Based on the grounds that JT is much more knowledgeable than me 🙂 and also because AS said at the interims that they would be starting in the middle of the dose range. (Source Q&A session, Interims 28th September)
The phase 1a doses have ranged from 80mg/m2 (C1) - 385mg/m2 (C7). So 200mg/m2 sits almost in the middle and was the dose used for C4.