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I am so impressed with the tumour overall reduction in this case study...just think football to tennis ball,

Laptop to mobile phone

Cumberland sausage to chipolata (well almost!)

Regarding the time on the trial , the secondary outcome measures 5-8 are all for up to a year. Think they will want to keep going for as long as they can - data -data -data...

Hi BV.

Had just been doing the same calc- think your outcomes are correct for your assumptions.

Looking at what AVCT are saying is there has been a 74% reduction based on RECIST 1.1 methodology. So in the one organ 2 tumours are measured & combined length taken. The 74% is the reduction in this combined length.

The continued reduction is still very active and impressive.

"Unless you're talking percentage reductions?"

Which we are!!

65% to 74% of the original tumor size, is continued massive reduction.

eg. If the original tumor dia was 100mm

@65% reduction it would be 35mm

@74% reduction it would be 26mm

The move from 35mm to 26mm is a 26% reduction between scans - continued impressive performance.

Alastair

Does anyone have a view if these Gov proposals will place an additional obligation on Carclo's future pension reduction payments?

https://www.telegraph.co.uk/business/2022/10/09/pension-crackdown-risks-sparking-wave-bankruptcies/

Why have Avacta not updated the NIH clinical trial study data base for The Freeman Newcastle.???
They need to update the data base within 30 days of any trial sites status changing, as guidance note below.

In the interims they confirmed previous statements that the Freeman is recruiting.

"Having seen the first dose of AVA6000 administered at The Royal Marsden NHS Foundation Trust in August 2021, clinical trial sites have been added at the Christie NHS Foundation Trust in Manchester, St James' Hospital in Leeds, The Beatson in Glasgow and The Freeman in Newcastle and continue to recruit."

"Individual Site Status 30 calendar days after a change in status of any individual site"
https://clinicaltrials.gov/ct2/manage-recs/faq#fr_23

Update needed asap, to stay onside with the FDA approved study status.

Great trial summary - thankyou

Hi MrA,
You are right in saying the results will come when they come.
All I was putting forward a timeline that is perhaps shorter than the concensus, and one that would fit in with previous guidance, along with the results presentation as per livedata.
No ramping lather intended!

Given that AS at the agm, inferred that the next cohort may be at 150 and that the MTD may not be found.
It strikes me that the latest anounced cohort at 200 on the 1 Sept, may be a last ditch attempt to find MTD.
All the 4 primary outcome targets of the Ph 1a trial, are looking for MTD data and are only viewing the dose 1 up to +21 days.
It could be that this cohort is only one cycle, so the results could be as soon as w/c 26 Sept.
It may be their last shot at finding MTD, prior to agreeing on the RP2D.

From the trial design :-
Primary Outcome Measures :
1. Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: Cycle 1, 21 days ]
2. Percentage of patients with Dose-Limiting toxicities (DLTs) of AVA6000 during the DLT period [ Time Frame: Cycle 1, 21 days ]
3. Maximum-tolerated dose (MTD) or Recommended Phase 2 dose (RP2D) [ Time Frame: Cycle 1, 21 days ]
4. Percentage of patients with Adverse Events (AEs) at RP2D AVA6000 dose level in tumour-specific expansion arms. [ Time Frame: Cycle 1, 21 days ]

Does anyone have copies of old point pipeline schedules as the current one shows 2 "CanSEEK" programmes.
Have they paid up for the 2nd yet ?
https://www.pointbiopharma.com/our-products/pipeline

From Point's 2021 IPO. p92.
Preclinical Data and Next Steps We are currently evaluating development plans to advance our tumor microenvironment targeting technology prodrug platform, and plan to assess its application to PMSA targeting ligands. Avacta Life Sciences has recently received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) for its Clinical Trial Authorisation (CTA) in the UK for a Phase 1 study of its lead pre | CISIONTM prodrug, AVA6000 pro-doxorubicin, and we eagerly await the clinical data from their program as well as it may help us inform our own development plans.

https://sec.report/Document/0001104659-21-098307/#.YyF8Fzq2gC4.link

CanSEEK™
CanSEEK™ diagram
Toxicity caused by off-target delivery is a longstanding concern of cancer therapies.

Developed by Dr. William Bachovchin of Tufts University, POINT’s CanSEEK™ technology aims to minimize radiopharmaceutical toxicity caused by off-target delivery by only activating a radiopharmaceuticals' targeting moiety, such as its ligand, after it has encountered FAP-a in the tumor microenvironment (TME). FAP-a is highly expressed on a wide range of solid tumors, but in very low quantities or absent altogether in healthy tissues.

The intent of CanSEEK™ is to minimize the toxicity caused by off-target delivery. At first, CanSEEK™ prevents the radiopharmaceutical from bonding to receptors on cells. When the radiopharmaceuticals enter the TME, the radiopharmaceuticals targeting moiety is re-activated, enabling it to once again bond to receptors on cancer cells.

CanSEEK™ has the potential to make treatments even more precise, expanding their therapeutic index, and enabling the use of new, more powerful medical isotopes.

?POINT's CanSEEK™ has been sub-licensed from both Bach Biosciences and Avacta Life Sciences, which has branded the technology as pre | CISION™ (an Avacta trademark).

Point are raising $125m in a fully covered fund raise. This is to progress their current preclinical & clinical pipeline (this includes their Avacta "CANSEEK" programme).
Great news that they can now fund the milestone payments for us going forward. Potentially they have seen in our data room!!

Point bio sp on the move today.
Have they seen inside AVCT data room?

Thanks for posting Muck & Mr A for your post.
I have also been thinking for some time that the dosing cycle times at 3 weeks, may not be optimal and been constrained by study design constraints.
It would be great if the comprehensive data that is being currently collated, enables them to reduce the cycle times. It would definately have the result of condensing the timeline of the ph1b/ph2.

RAH

& Merck $218.44B cap

"For what it’s worth I do believe it to be material

If £165Bn AZ consider orphan status material and worthy of RNS then so should £300m AVCT:"

Great find thankyou for sharing.

From your link - Funding provided for trials !!

Orphan Drug Product Designation and Grant Programs
To assist with the development of orphan drug products, the OOPD has established multiple grant programs including the clinical trial grants program and the natural history studies grants program.

The clinical trial grants program provides funds to help offset the costs of clinical trials that will test the safety and efficacy of products intended to treat a rare disease. At any one time, there are typically 60 to 85 ongoing funded projects under this grant program.

Avacta front and centre of the affimer journey.

https://journals.biologists.com/jcs/article/135/14/jcs259168/276020/Affimers-and-nanobodies-as-molecular-probes-and

Great news today.
Next one IND - soon!
GLA