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She is now listed Fiona M.
Just checked my LinkedIn and they are all still showing AS FMc EF SC
Just search Avacta then people
Having a bit of chill time I like to research Avacta and confirm to myself,I have stumbled across one of the rare unicorn shares that is fast growing, disruptive and has large market opportunities.
The FDA issued a guidance for industry, “Rare Diseases: Considerations for the Development of Drugs and Biological Products.”
This was issued just 3 days ago,reading through it was like it was written for Avacta.
I’m convinced Avacta will receive market approval for AVA6000 in 2024 and all I have to do is sit and wait and enjoy the ride.
https://www.fda.gov/media/119757/download
Happy new year
GLA
When the RNS was released on 4th December stating Avacta will present a detailed review of the AVA6000 clinical trial's Phase 1a data.
I thought we would receive on the 13th December:
What they had seen after 1st patient was dosed.
Details of data why FDA granted ODD
Details of what Safety Data Monitoring Committee (SDMC) was seeing and their reasons for escalating the drug strength on each cohort.
Details of early trial patient progress.
Details from all UK trial sites and their observations and patient enrolment and plans for UK sites moving forward.
Details of what they showed
Doctors William Tap (MSK) and Lee Cranmer ( Fred Hutch) for them to put their names to the trial.
Reasons why they presented this data before cohort 7 had completed.
Plans for peer review after C7 has completed.
December 13th
We received info about 5 patients in the USA part of the trial.
Although this info given was very good news, my question is why present after C6 and not wait until C7 has completed.
Reasons
To appease PI’s ?
Dought it, All though comms has been good of late they wouldn’t present just for PI’s
FDA communication ?
They are in close contact with FDA and communication would already be ongoing
BP licence deal or T/O ?
This to me has to be the reason for the trial update.
Once New year starts we could wake up any day to a 07:00am wonder dot.
Two dates for everyone’s diary
JP Morgan Health care conference
January 8-11, 2024
AACR
April 5 - 10, 2024
San Diego
Merry Christmas everyone.
Also gives over 65’s and patients with serious conditions that can’t be treated with Dox for cardiac toxic reasons a fighting chance ….
I agree they usually invest in seed capital JT, but a quick search on google you find they do invest in public companies.
My point was Shaun Chilton has a relationship with a few VC’s he was brought in for a reason and his experience will be vital in any future negotiations.
Also AS has access to all the VC’s who have invested in the Affyxell start up.
Optionality in deals
Optionality in funding
Venture-capital firms are jumping into the stock market , buying up battered shares in publicly traded tech companies at a time when they are investing less in the startups that have long been their focus.13 Oct 2022
Venture capitalists are in the business of investing money in businesses - small businesses, mid-sized companies and global enterprises - any company that shows potential for significant growth over the short term.
What is Avacta’s plan B.
I would have thought licence deals or a buy out would have come after P1a data.
Are they in talks ?
Have they had offers ?
Something happened in the summer after seeing the emerging C5 data.
Days before C5 completed they appoint Shaun Chilton.
Shaun Chilton at Clinigen
Clinigen business model:
https://www.clinigengroup.com/media/1652/8clinigen_business-model.pdf
Generates cash for Group investment (venture capital-backed )
Utilises unlicensed medicines supply and distribution infrastructure
Provides visibility of R&D pipeline
Commonality of client with early access
Transfer of patients from clinical trials to early access
On-demand’ identifies target medicines to acquire and revitalise
On-demand’ access identifies higher demand opportunities to develop, licence and commercialise medicines
On-demand’ helps identify geographies to internationalise commercial products
So this is another route to market for AVA6000 if Shaun can raise funds and leverage his contacts in venture capital and transfer of patients from AVA6000 clinical trial to early access like Clinigen they don’t need BP cash just yet, this could lead to a much stronger position in negotiations.
Just guess work but if Avacta can raise funds through venture capital if needed and show the market they can take AVA6000 through P2 and approval we will all benefit from a higher T/O.
Alongside his role as the CEO of Clinigen, Shaun was Non-Executive Chairman of C7Health, a disruptive, venture capital-backed medical technology and services business
Shaun has a track record of developing successful senior management teams and managing growth businesses and is passionate about Clinigen's mission to deliver the 'Right Medicine to the Right Patient at the Right Time'
With 25 year’s experience in the global pharmaceutical industry, Shaun has held a number of senior strategic, commercial and operational roles in the pharmaceutical industry and related service sectors covering the breadth of the product lifecycle.
GLA
We are aware of an account on X that is impersonating our CEO, Alastair Smith. We have taken measures to have it removed but please be aware that anyone claiming to be Alastair Smith on X is not genuine.
NY
Todays drop orchastrated by MM’s new investors mugged for stop losses
AIM is a 💩pot
Avacta my only holding on the 💩pot
Can’t wait for nasdaq
PI’s getting frustrated with AS and his promises of SP inflection points that never materialise.
Could Avacta’s II’s also start to want some SP growth after 3 years with large sums invested.
Is it time for AS to step aside ?
Who could replace him on the Avacta board or do they bring in fresh blood.
Shaun Chilton could do a very good job or after today’s performance Dr. Coughlin ?
She has the experience and with the trial continuing in the USA a perfect executive to deal with the FDA.
Privately held CytoImmune Therapeutics, Inc. strengthens its team by appointing cell therapy veteran Christina Coughlin, M.D., Ph.D. as CEO
Dr. Coughlin joins CytoImmune from Rubius Therapeutics, Inc. where she served as the Chief Medical Officer and led the clinical development, translational medicine, and regulatory efforts in the allogeneic red cell therapy platform. Prior to Rubius, Dr. Coughlin was with Tmunity Therapeutics, Inc., where she served as Chief Medical Officer and was responsible for the preclinical and clinical development of autologous CAR-T and TCR-T cellular therapies. Dr. Coughlin has held other leadership roles in the pharmaceutical and biotechnology fields in her career including Chief Medical Officer at Immunocore, heading the development of the soluble TCR platform, and Oncology Asset Team Leader at Pfizer.
Avacta gave a big middle finger to British government and MHRA today after the way they have been treated over the last few years.
No mention of continued clinical trials in UK
2 week study recruitment in USA
Even the header of the RNS was changed to American version ALS-6000-101 Phase 1a Study Data
I wouldn’t be surprised if NASDAQ listing and de-listing from Wild West AIM was next.
Lots of new investors gained over the last few weeks and I wouldn’t be surprised if this SP decline was orchestrated to take out newbies with stop losses in place.
AS needs to give Vox a miss, every time he gives them an interview the SP tanks.
He should have had one of the main news channels lined up today for this fantastic news.
Come Avacta get some main stream media lined up.
Janet Munro is back
Novartis
Great news for patients.Congratulations to the Avacta team for the vision and execution. Best is still to come ….🤞
Thanks for tweet RAH
Well the company who has asked to see the data and cut off C7 after one cycle must be in a rush to do a deal.
Let’s hope it’s the first of many.
Encouraging to highly encouraging …..
Billy Tap you tease.
Dr. Coughlin will provide strategic leadership for the recently launched biotech and its clinical-stage pipeline of engineered NK cell therapies designed to improve outcomes for patients with cancer. Dr. Coughlin will join the company’s Board of Directors.
Dr. Coughlin joins CytoImmune from Rubius Therapeutics, Inc. where she served as the Chief Medical Officer and led the clinical development, translational medicine, and regulatory efforts in the allogeneic red cell therapy platform. Prior to Rubius, Dr. Coughlin was with Tmunity Therapeutics, Inc., where she served as Chief Medical Officer and was responsible for the preclinical and clinical development of autologous CAR-T and TCR-T cellular therapies. Dr. Coughlin has held other leadership roles in the pharmaceutical and biotechnology fields in her career including Chief Medical Officer at Immunocore, heading the development of the soluble TCR platform, and Oncology Asset Team Leader at Pfizer.
Plenty of experience as a CMO Avacta have a plan we find out tomorrow .
GLA
DTW
Most cardiotoxicity caused by
Drug to drug inter-actions
AVA6000 doesn’t have this problem.
As with most cancer treatments doxorubicin is rarely given in isolation. Most of the in-vivo studies involve cotreatment with other antineoplastic agents such as taxanes, platinum drugs, nitrogen mustard analogs, fluoropyrimidines, and vinca alkaloids, which can complicate the association of variants with a particular treatment.
More clinically relevant are the drug–drug interactions resulting in the cardiotoxicity from cotreatment with doxorubicin and trastuzumab or taxanes such as paclitaxel and docetaxel .
No one has done it:
Finding a way to maintain the efficacy and reduce toxicity has been one of the major areas of focus of anthracycline research.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3116111/
Wednesday 13th December 2023
One company has done it….
GLA
Wednesday is like Christmas Day for all of BP.
They have had their present early with Avacta telling them they have chemo without side effects which is a new paradigm shift in oncology.
But Wednesday they finally get to open the present with full instructions available.
Everyone needs to read the instructions to work out how best to use your new present.
GLA
Shaun has held a number of senior and executive commercial positions over more than 30 years in companies in pharmaceutical and pharmaceutical services industries. These include at Pfizer, Sanofi, Wolters Kluwer Health and KnowledgePoint360 Group (now part of UDG Healthcare).
Dr Eliot Forster, Chairman of the Board of Avacta Group plc commented:
"Along with my fellow Directors I am delighted to welcome Shaun to the Board of Avacta Group. He brings a wide range of highly relevant commercial experiences from successful healthcare businesses with similar ambitions for growth that we have in Avacta. I know Shaun will positively impact our shared thinking and I'm excited to have him join the company."
Dr Alastair Smith, Chief Executive of Avacta Group plc commented:
"I am delighted that Shaun has joined the Board of Avacta Group. He brings deep and extensive commercial experience to further strengthen the senior leadership of the Group as it executes its strategy across two divisions to build a major global healthcare business working to improve people's health and well-being through innovative oncology drugs and powerful diagnostics."
Shaun Chilton, Non-Executive Director of Avacta Group, commented:
"Avacta Group is building a high value, global business that is seeking to significantly improve people's health and well-being. I am excited to leverage my own broad experience of growing healthcare businesses and working with the other members of the Board to help guide Avacta to meet its very significant potential."