Member Info for SandyR

Https://www.youtube.com/watch?v=cnQ6M05BiBY

Courtesy of Waterloo & Martyn from the other boards.

https://www.trinitydelta.org/wp-content/uploads/2024/01/ANGLE-Update-240130.pdf

TwoGood2Die,

You have posted a lot of misinformation on this board. As you well know, Parsortix has been widely used in multiple different cancer types.

AN gave this explanation in last April’s Investor Meet presentation in relation to how customer’s with lab accreditation can use Parsortix.

“So our clearance is in metastatic breast cancer, and if we wish to sell the system with a clinical label on it to hospitals, we must limit what we talk about to metastatic breast cancer. HOWEVER, there's a little bit of a nuance here, which is that the customer, if they are an accredited clinical lab, which in the United States, they pretty much all are, then they have the ability to validate their tests, their assays, in their own laboratory under their regulatory clearance. And it's perfectly acceptable for them to acquire our system and use it for prostate or lung or any other cancer that they feel they can verify and validate an appropriate test for in their lab. And so we are actually seeing strong interest in multiple cancer types. So we can sell the system for research use in any cancer type, and if we want to make a claim in clinical we're limited to metastatic breast, but it does NOT stop our customer base implementing across multiple different cancers. And of course we've got the large number of peer reviewed publications in multiple cancers showing the value of it”

TwoGood2Die,

You have completely twisted the context of my post. I did not suggest that AGL have not sold a single Parsortix machine to date to clinical labs.

What we do know is that the “Installed base of Parsortix® systems increased to over 290 with cumulative samples processed of 192,000 as at 30 June 2023” (Interim results RNS).

What we don’t know is how many of these installations are research related and how many are pharma customers. Some of these systems will be free issue for research purposes & to KOL’s. However, it is important to remember that part of AGL’s approach is to “get the leverage R&D”. So it is a symbiotic relationship. The benefit to AGL is that it provides an independent source of R&D and further validation of Parsortix in multiple different cancer types.

Apologies Sangi for my misunderstanding.

Sangi, it was the FDA’s recommendation that AGL limited their submission to MBC. This is what AN said about it in last April’s Investor Meet presentation:

“When we approached FDA initially, we suggested that we could have a pan-cancer clearance because the system does work, without modification, in all different cancers. They strongly advised us against that in the first instance, because they require detailed information on every single cancer and it would just make the whole process even more complex.”

As you know it took six years to get approval for MBC. So how long for a pan-cancer submission?

Hi BV, in response to your question “I missed the information that AS's latest view is to RNS once the 3rd patient In a cohort has been dosed. Which thread was this reported in please?” I can confirm that what Rambo & others say is correct.

I emailed Alistair at the end of last week and received this reply on the 19th.

“Thanks for your email.  All is going well with Q2W in the US and, as you noted, we said in the RNS associated with the data release that patients were being screened.  We will update the market when all three patients in the first cohort have been dosed.  That’s a more useful milestone than first patient dosed because it tells the market more about when the cohort will likely complete.

 

We are able to be more selective with patients for the Q2W as I mentioned in the data release presentation because of the great safety data. By doing so we can select patients that will have indications which are more likely to be in Phase 2 – and this will help us to make the right decision on which indication(s) to select.

 

Hope that makes sense.”

I appreciate AS taking the time to reply to me, but to be honest I think Avacta’s comms have been poor in this respect, as AS had previously stated that “We will keep the market updated at the start of each cohort…..” (Vox interview 5th April 2023).” I understand that the company are “getting on with it” but it does leave us in a bit of a news vacuum at the moment.

Well said BOJO. It was the FDA’s recommendation that AGL narrowed their application to MBC and it took a Herculean six year effort to gain that approval. It would have been an impractical logistical administrative nightmare to try and get approval for every single cancer type.

Bones699 is spreading total misinformation and falsehoods on the ADVFN board.

Tom, I’m sorry I can’t post the link on here and I don’t have premium, so I can’t DM you. I do also use ADVFN, I’m easy to spot on there, perhaps you could message me?

Hi Tom, no criticisms from me. Your posts are informative

I posted this last night on the TG board. It’s a little bit more info regarding the DDR Inhibitors Summit - Brett Swansiger is a listed speaker.

https://ddr-inhibitors-summit.com/speaker/brett-swansiger/

Tom,

This may interest you. AGL have updated the Events page on their website.

They are a ‘Program Partner’ (whatever that means) at the LBX summit Feb 28th-1st March.

And a speaker at the Next-Gen Immuno-Oncology Conference, 7th - 8th March

https://angleplc.com/about-us/events/

https://events.marketsandmarkets.com/immuno-oncology-conference-london/speakers

https://lbx-summit.com/partners/

Bantham,

You have to look at in the wider context, which is that many AIM companies do not have joint brokers.

I haven’t got my head in the sand - I appreciate it is far from ideal that the company have felt compelled to undertake these cost cutting measures. But some of the conspiracy theories have been way off target.

It is a temporary cost cutting measure, to quote the old proverb - they are cutting their coat according to their cloth.

I emailed IG reference the departure of Jefferies. Ian replied that it is a cost cutting measure. Once the SP has improved and the time is right they can either reinstate Jefferies or engage another broker. To suggest any other reason is incorrect.

Hi Phantom again, I think we are looking at the lab business from different perspectives.. Because you also correct in what you say. AGL will need CLIA accreditation for specific purposes.

“Processing of patient samples for clinical purposes requires the laboratories to be accredited under the appropriate local regulatory regimes. In March 2022, the Centers for Medicare and Medicaid Services (CMS) issued a Certificate of Registration, under the CLIA process, to the Company's United States clinical laboratory. This is a key step towards achieving CLIA accreditation of the laboratory.”

Just out of interest, the below gives an indication of the outstanding stages in the accreditation process.
“Following a satisfactory CMS audit, including an inspection of the facilities and documentation on the validation of assays to be performed together with associated quality control procedures, a Certificate of Compliance will be issued. This will complete the accreditation process that permits the laboratory to process samples for patient management from the majority of the United States, with a small number of States requiring additional procedures which will be progressed separately.” (Source Chairman’s statement 29/9/22)

https://www.lse.co.uk/rns/AGL/interim-results-g8991xa6ady3qkg.html

Phantom, I understand what you are saying. But my point was that AGL don’t necessarily need CLIA lab accreditation to get pharma contracts for the labs. Hence me quoting AN saying that it “wasn’t a critical point”. I think AGL’s first pharma contract was in April 2021. Extracts from the RNS “The services cover the capture, harvest and analysis of circulating tumor cells (CTCs) and CTC clusters. Samples are being shipped from multiple study centres to ANGLE's clinical laboratories in the UK and United States for analysis using the Parsortix system……. ANGLE believes that there is a substantial business opportunity in providing services to pharma and biotech customers to support cancer drug trials. This contract demonstrates that our investment in clinical laboratories and a pharma services business, a key use of proceeds from our fundraising in October 2020, is already delivering….

https://www.lse.co.uk/rns/AGL/first-large-scale-pharma-services-contract-secured-yul6kl9hzdwjthv.html

I think there may be a bit of a misconception that AGL require full lab accreditation before customers will sign a lab contract. AGL already have four Pharma customers with “numerous others in discussion”. It is these discussions I am particularly interested in and am hoping AGL can close a deal on.

The CLIA Lab accreditation is required for the LDT’s. But, as AN has said previously - “the pharma services business, however, it doesn't need the accreditation it simply needs the clinical labs and that is already up and running.” AN also said something similar at the AGM - “to an extent [accreditation] it is not a critical point because the most important use of those clinical labs is the pharma services work and that is happening. It doesn't need the actual accreditation, it just needs the quality systems and controls to be in place which we already have”.

Lab accreditation would be good too of course.

Sorry, the link didn’t work on my previous post. Take 2 :) I have tried it again.

https://www.clinicaltrials.gov/ct2/results?term=Parsortix&draw=2&rank=6#rowId5

Some good news, especially as it is a clinical trial into colorectal cancer. It is sponsored by the Centre Hospitalier Universitaire de Nimes. It’s hot off the press, the first post on the clinical trial website was today.

https://www.clinicaltrials.gov/ct2/results?term=Parsortix&draw=2&rank=6#rowId5

Presumably we will hear directly from AGL about it shortly?