Member Info for Steelwatch200

Thought the RNS slides from this weeks AGM, was all we could have expected. Confirmation that all is progressing prity much as planned / envisaged, in regards to the trial - Brilliant news.

It was great also that they are making this statement regarding the LG chem Partnership- 1 possibly 2 further milestone payments this year!!.

"Successful pre-clinical development of the PD-L1/XT asset will trigger further development milestones during 2022.
• Potentially first Affimer therapeutic to enter clinical trials

This is sounds as if all is progressing at pace on this front as well. The LG chem deal has massive potential for Avacta, & it looks like we may be in for some good news flow on this front over the next few months.

All imo, good luck all.

We are now mid way through the 18th week from the DE anouncement, enough time for ~6 conventional dosing cycles. As they have one eye on increasing the number of cycles traditionally given (which they seem to, see below) this may help to explain the time being taken & also why Christies seem to be recruiting 2 seperate patient groups ( perhaps some continuing @90% and some @120% ?)

From the conclusion of the case study in the anual report (also in the 2020 report) :-
"In conclusion, AVA6000 is expected to have the
following attributes:
• Improved therapeutic index relative to conventional
doxorubicin
• Increased intra-tumoural doxorubicin exposure
made possible through patients being able to
tolerate higher doses and/or increased number
of cycles of AVA6000 relative to conventional
doxorubicin
• Decreased systemic exposure of released
doxorubicin and its metabolites, resulting in
decreased exposure to tissues including heart and
bone marrow"

For me no news continues to be good news.

GLA

Getting busy!!

Clinical Research Fellow

Early Phase Clinical Trials (Cancer) & Experimental Cancer Medicine
Beatson West of Scotland Cancer Centre

The role offers an exciting opportunity to increase research capacity and deliver innovative early phase cancer clinical trials and translational medicine.

The post will be based at the Beatson West of Scotland Cancer Centre, Glasgow, and the post-holder will be a co-investigator on a portfolio of academically and commercially sponsored experimental drug trials as well as associated translational clinical research studies, with a particular focus on precision medicine as applied to experimental medicine.

The post-holder will work primarily alongside the early phase trials team and may include tumour-specific early phase trials led by other investigators in the Centre. The post holder will be involved in managing all aspects of trial patients, across a diverse range of solid tumours, through new patient consultation, consent & screening patients, reviewing patients at follow-up appointments, participating in regular safety review committee & dose decision teleconferences with other national and international investigator sites and study sponsors, and attending regular Regional and National Molecular Tumour Boards

The successful candidate will be able to gain experience in a broad range of experimental cancer medicine studies that may include administration of intra-tumoral novel immunotherapeutics; precision medicine; cellular therapies; clinical trial development, set-up, and delivery; and biomarker development as applied to clinical trials.

Interested applicants are encouraged to discuss the post with Professor Jeff Evans: J.Evans@beatson.gla.ac.uk

https://www.bmj.com/careers/job/152277/clinical-research-fellow/?TrackID=4

Agreed. But that was not the point being made

Its may be of note that Professor Jeff Evans (The Beatson West of Scotland Cancer Centre, NHS Greater Glasgow & Clyde, Principal Investigator) is one of the co-Leads of the PRECISION-Panc initiative.

On the 6/4/22 AS stated in the presentation that the Beatson Glasgow had started screening.

From the Precision-Panc web site:
"Precision-Panc Clinical Trials are delivered through the NHS and match people with pancreatic cancer to the trial most likely to work for them. "

" In Precision-Panc all registered patients have their genome testing using Glasgow Precision Oncology Laboratories bespoke panel."

https://www.precisionpanc.org/

https://www.beatsoncancercharity.org/about-us/the-beatson-west-of-scotland-cancer-centre/strategic-advisory-council/jeff-evans-profile/

gmcc. Totally agree Avacta's very very smart deal with William Bachovchin | Tufts University School of Medicine

Some of their patents listed :

https://patents.justia.com/patent/20220087971

GMCC. still no RNS for this 22m, 5 year funding package - when other AffyXell news has been.

Wonder why not?

22m definately news worthy

Thanks for posting gmcc.
=£3.7m almost RNS worthy, but yet more positive news.

Xellalent twitter posting by Little gunner last night....

LittleGunner (@LittleGunner5) Tweeted:
The realisation of what Avacta are achieving with AVA6K is great. Not everyone is there but hopefully with DE2 coming very soon, more will cotton on.

I still cant get over how the deal with LG Chem is overlooked though

#AVCT have 3 big IPs:
1. PreCision
2. Affimers
3. TMAC

1/7 https://twitter.com/LittleGunner5/status/1516541173749497861?s=20&t=V6GehFvRJKi2zYg06HoJtQ

"Opportunity to develop safer better tolerated forms of these drugs."

"$56.5b with CAGR of 11.5%"

Wow

He sounded very confident about the trial / chances of sucess!!

GLA

LG Chem progress update soon, 7 months since this
“Avacta and LG Chem have a multi-target therapeutics development agreement to develop Affimer® therapeutics in several disease areas. As part of the agreement, LG Chem has the exclusive rights to develop and commercialise, on a world-wide basis, Avacta's Affimer® PD-L1 inhibitor with Affimer XT® serum half-life extension.
LG Chem has successfully completed certain pre-clinical in-vivo models in the PD-L1/XT programme leading to the selection of a pre-clinical candidate for further development towards the clinic and triggering an undisclosed milestone payment.
The partnership also provides LG Chem with rights to develop and commercialise other Affimer® and non-Affimer biotherapeutics combined with Affimer XT® half-life extension for a range of indications and Avacta could earn up to $55m in milestone payments for each of these new products. In addition, under the agreement Avacta will earn royalties on all future Affimer XT® product sales by LG Chem."

Point Bio poster has been uploaded on their web site.
They will be keen to see the data on the AVA6000 trial to assess their Avacta based- "Canseek" pipeline.
They may have been provided with early indicative data already.
GLA.
https://www.pointbiopharma.com/investors

Point Bio also presenting their FAPa targeted pre clinical test data for their PNT2004 (PNT6555) scheduled for clinical trial later this year.
Alot of crossovers and bodes well for Avacta, in térms of tumor retention and clearance.

https://eventpilotadmin.com/web/page.php?page=IntHtml&project=AACR22&id=269

FDA fast tracking new treatments that show gains - is this why FDA involvement in AVA6000 so important?

The FDA granted the Lartruvo application fast track designation, breakthrough therapy designation and priority review status because preliminary clinical evidence indicated that it may offer a substantial improvement in effectiveness in the treatment of a serious or life-threatening disease or condition. The FDA is approving Lartruvo under the agency’s accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease or condition based on clinical data showing the drug has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit. The sponsor is conducting a larger study, which is currently underway, to further explore the effectiveness of Lartruvo across the multiple subtypes of STS.

Lartruvo also received orphan drug designation, which provides incentives such as tax credits, user fee waivers and eligibility for exclusivity to assist and encourage the development of drugs intended to treat rare diseases.

Side effects
Lartruvo has serious risks including infusion-related reactions and embryo-fetal harm. Infusion-related reactions include low blood pressure, fever, chills and rash. The most common side effects of treatment with Lartruvo are nausea, fatigue, low levels of white blood cells (neutropenia), musculoskeletal pain, inflammation of the mucous membranes (mucositis), hair loss (alopecia), vomiting, diarrhea, decreased appetite, abdominal pain, nerve damage (neuropathy) and headache.

2016 approval

FDA approval after phase 2!!!
The randomized phase II clinical trial that provided the basis for the FDA approval of olaratumab for soft tissue sarcoma showed that targeting PDGFR-alpha had the same effect in patients as it had had in preclinical models. Results from the trial, which included patients with more than 25 subtypes of metastatic soft tissue sarcoma, were published recently in The Lancet. They showed that adding olaratumab to doxorubicin improved median overall survival by almost a year. The median overall survival was 26.5 months for those who received olaratumab and doxorubicin compared with 14.7 months for those who received only doxorubicin.

Hi Tony,
Difficult to predict figures esp with this news related stock, but it feels we will be better served long term, remaining as independant as we can.

I can see many positives and reasons for an almagamation with Point Bio, in short & long term
Some of my thinking :-
1. Common targets.
2. Nasdaq listing
3. Plenty of cash ($200m) to fund & deliver in-house, full drug development & release.
4. Both with strong links with Tufts uni
5. Both with strong links to Dr Bachovchin
6. Both with strong links to Matt Vincent (SVP Point & still a Director of Affyxell?
7. Both 5 & 6 named on Patent for tumor activated drug binder conjugates.
8. Direct Access to USA market & investors.
9. Slightly more protection from low ball takw over bids.

Would welcome any comments / corrections
ATB