Member Info for Energyshares

Finding STS patients shouldn’t be a problem in UK

Royal Marsden

Sarcoma Unit is one of the largest soft-tissue sarcoma units in Europe

The Sarcoma Unit now registers more than 850 patients a year.

https://www.royalmarsden.nhs.uk/our-consultants-units-and-wards/clinical-units/sarcoma-unit/sarcoma-unit-research-and-clinical

https://www.royalmarsden.nhs.uk/our-consultants-units-and-wards/clinical-units/sarcoma-unit

This is why AVA6000 is going to be approved and the 2W trial and P2 is just a boxticking exercise.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9058915/

Thus, the prognosis of advanced STS remains dismal, and new drugs are needed

a median progression-free survival (PFS) of 8 months

AVA6000 Patient with 65% reduction has smashed this PFS.

Very interesting podcast on

FDA discussion on trial design and end points ,Project Optimus plus a mention on Accelerated approval.

30 mins apple podcast but well worth a listen.

https://t.co/8tIQiDIrzd

“We would like to apologise to our long term and very loyal supporters, many of you have supported us for years.

Under very challenging unprecedented market conditions at the moment,we have to raise at 50p to help keep the lights on moving forward.

Critically, this financing provides with us 12 months of cash runway.

I guarantee that the person doing our finances and myself will both step down if we need more in the next 12 months.

Again to our long term and very loyal supporters, I apologise again for this diabolical situation.”

( That was me telling my customers last night I put 50p on a Pie and a pint deal.

At least I apologised )

N. Kinnersley,

Avacta Grant/Contract, Paid consultant.

His company KK

Octa Consulting Services

Regulatory Authority Preparation

Octa provide consultancy to project teams on how to prepare for high-stakes meetings such as Regulatory Health Authorities, Due Diligence assessments or whenever the interpretation of data is key. We have provided in-meeting biostats contributions to key Regulatory Authorities, the list of which includes: FDA, EMA, German, Spanish, Swedish, Swiss, Australian, and Japanese. The disease areas most recently supported include Oncology, Haematology and rare respiratory diseases. Octa can provide Due Diligence assessments for collaborations or mergers as well as Quality Inspections or audits of CROs with regards to statistics and statistical programming activities.

Octa Consulting Services provide design, planning, implementation, and analyses of CDPs or individual clinical trials. From ‘First-in-Human’ studies to regulatory approvals, Octa Consulting Services will work with its partners to ensure a relevant and applicable evolution of the CDP. We have experience in a number of key disease areas including novel or orphan diseases. Octa Consulting Services work in both traditional designs (e.g. 3+3, SAD/MAD, parallel group Phase 3 etc) and also a range of adaptive and/or emerging designs such as the increasingly popular BOIN design in Phase 1.

https://octaconsulting.com/team

AACR

going to be interesting

Professor Paul Loadman

Pharmacokinetics ,Biopsy consultant

Nelson Kinnersley

Regulatory Authorities consultant.

Hope they help getting the SP back over £1.00 and beyond

Start getting LTH’s money back in the black.

Paul Loadman

Professor of Pharmacokinetics and Drug Metabolism at University of Bradford

P. Loadman,

Avacta Grant/Contract, Paid consultant.

G. Lahu,

ThinkQ2 AG Employment.

Avacta Grant/Contract, Paid consultant.

H. S. Jones,

Avacta Grant/Contract, Paid consultant.

N. Kinnersley,

Avacta Grant/Contract, Paid consultant.

F. McLaughlin,

Avacta Employment.

C. Twelves,

MSD, Eisai, Daiichi-Sankyo, AstraZeneca, Pfizer, Lilly, Novartis and Gilead Grant/Contract, Travel, Advisory boards and research funding.

Abstract

Abstract is embargoed at this time.

Why would they fly him out to AACR this has got to be AVA6000 trial.

“We have also successfully monitored low concentrations of highly potent metabolites and pharmacodynamic markers in small clinical biopsy samples as in a recent Phase I clinical trial.”

Drug metabolism and pharmacokinetics

ICT has an experienced Drug Metabolism and Pharmacokinetic (DMPK) Team, led by Prof Paul Loadman, who have worked on numerous contract research projects with industrial partners within efficient and well-resourced GCP laboratories. The team undertake analytical method development (LC-MS/MS) and a range of bioavailability and pharmacokinetic studies from simple evaluation of parent molecule in plasma to full ADME and tissue distribution.

Advantages of working with the DMPK team at ICT:

* Excellent knowledge and experience in this area- expert opinion from leading academics

* GCP accredited laboratories and high quality research and reporting

* Projects are managed to meet commercial timelines and we ensure our partners are fully updated on progress

* Examples of studies include the analysis of complex metabolic profiles and the development of analytical methods for the PK analysis of highly reactive and potent molecules in the picomolar range.

We have also successfully monitored low concentrations of highly potent metabolites and pharmacodynamic markers in small clinical biopsy samples as in a recent Phase I clinical trial.

Look who Avacta is flying out to AACR

P. Loadman,

Avacta Grant/Contract, Paid consultant.

https://www.abstractsonline.com/pp8/#!/20272/presentation/11478

Are they taking him to talk about the biopsy samples to BP.

Bella read the RNS below:

We have a patient still going from 3rd Cohort

The 59 year old with 65% reduction in tumour.

That’s massive that’s why I’m still in…….

28 Feb 2024 16:41

RNS Number : 8447E

The SDMC approved dose escalation to 120 mg/m2 in a second cohort, 160 mg/m2 in a third cohort, 200mg/m2 in a fourth cohort, 250mg/m2 in a fifth cohort, 310mg/m2 in a sixth cohort and 385mg/m2 in a seventh and final cohort.

A 59-year-old male with the diagnosis of undifferentiated pleomorphic sarcoma, treated at 160 mg/m2 on a three-weekly dosing ("Q3W"), resulted in a Partial Response with a duration of greater than 6 months and a tumour volume reduction of ~65%. Treatment is ongoing, with high FAP expression observed in the tumour tissue and a favourable PK profile with reduction in AUC which permits dosing for 7 additional cycles (~21 weeks)

BITL

Sp crashes after every interview excited Puppy interrupting waffle and not invested why ?

Preliminary Results and AGM are now just weeks away usually April with results in June.

Gardiner and Smith have weeks to save their jobs.

If SP isn’t back above £1:20 then Smith could be moved aside.

Put him back in the Lab and dont give him access to Zoom or Microsoft teams so he can’t contact that idiot at VOX and do more damage.

Even if SP gets above £2.00

I expect Gardiner to be gone, we need an experienced Pharma CFO to monopolise this platform.

This is a good read on guidance.

FDA defiantly engaged with Avacta.

https://www.fda.gov/media/166431/download

I wonder if Simon Bennett has finished his induction.

He could be with Gardiner helping him with his X tables.

This dated 7th December is this the patent mentioned in Q&A

Avacta has filed a patent for therapeutic conjugates with extended circulating serum half-life, linked through a FAPa-cleavable linker. The conjugates have a minimum 48-hour half-life in vivo and do not contain cell-binding moieties with a Kd of 1×10-6 M or less

https://www.pharmaceutical-technology.com/data-insights/avacta-group-files-patent-for-extended-circulating-serum-half-life-therapeutic-conjugates/

It’s not just about Smith & Forster the biggest problem is Gardiner he is the one holding the purse he should be sacked with his options cancelled .

If PI’s keep their incompetence in the news ahead of the science other BOD’s should start to look at a motion of no confidence against at least Gardiner.

CFO / Gardiner has got to go…

1/5 of working capital lost by not taking extra at over subscribed 95p and leaving fund raise to last minute,Naive at the highest level.

CEO / Smith at minimum move him sideways so he can’t do any more damage, promote CC.

Chair / Forster hold for now don’t need too many changes at the top but card marked.

If we can get CC in as CEO and an experienced CFO to replace Gardiner who hasn’t got a clue the SP could recover.

The FDA tweets this, let’s hope C7 results are smashing tumours and patients start to get wind of what is available.

“It doesn't take long for the FDA to grant an Expanded Access request. Review times are fast and a “granted” letter is usually sent within one day for both emergency and non-emergency requests. “

https://t.co/E0R4f0zisR

“or we’ll be back here again or lower in 2 years time!”

Back in a year if No LD or partnership,They will need 2 years cash to get signed off next year.

Bella

If you was on £400k a year you would drag it out.

If BP come knocking game over..

Bella read title

I said summer T/O

By then they will have AACR data and phase 2w data and if any leaks of a licence deal or a partnership game on….

We are all here now for a T/O the quicker the better for me,after last weeks shi te show by BOD.

If a major pharma wants the whole platform to improve their top line with expiring patents of their top selling drugs.

A low ball offer of £3bn which is criminally cheap, could start a bidding war.

They’ll need to start making moves soon before P2 starts.

If news starts to leak of a licence deal or a partnership it’s time to grab the popcorn.

GLA