Member Info for inanaco

explained .... to be a Clinical trial investigator ... you have to have the "appropriate qualifications" ie oncologist in this instance

so Poulam Patel would already be listed as a site investigator ... on the application, if only one site starts on the trial he automatically becomes "chief trial investigator"

but a chief investigator over seeing multiple sites does not need to be so qualified ... the authorised health
professional,

Authorised health professional is defined as:
(a) Doctor
(b) Dentist
(c) Nurse
(d) Pharmacist

MHRA and HRA Position on Who can Act as a Chief Investigator
2004/1031 defines the following:
“chief investigator” means—
(a) in relation to a clinical trial conducted at a single trial site, the investigator for that site, or
(b) in relation to a clinical trial conducted at more than one trial site, the authorised health
professional, whether or not he is an investigator at any particular site, who takes primary
responsibility for the conduct of the trial;

considering the majority of the data the MHRA viewed at the time of the application and accepted was written up by ... Poulam Patel from the previous trials ...

your all most looking to find anything that creates confusion ....

As for your question regarding other bios, I have no idea what announcements were previously made

so you have accepted that your post was not a fair comparison

Are you suggesting that when they originally submitted the CTA to the MHRA they named Poulam Patel as the principal investigator then?

what has the Investigator got to do with it ... or is the investigator investigated as well ?

Scancell Holdings plc, the developer of novel immunotherapies for the treatment of cancer, is pleased to announce that it has received all of the UK regulatory, ethical and legal approvals required to initiate the Phase 2 clinical trial to assess the safety and efficacy of SCIB1 in metastatic melanoma patients also receiving the checkpoint inhibitor pembrolizumab (Keytruda). The UK arm of the study is therefore expected to start during the second quarter of this year, as planned.

received all of the UK regulatory, ethical and legal approvals required to initiate the Phase 2 clinical trial

so Oncologists here can "legally" dose ... process might change ie chief investigator .. but does the legal position ? i suspect not

Having considered the ethical issues related to patients awaiting enrolment into the UK sites, Scancell has decided to withdraw its IND application in the US to allow the UK arm of the trial to proceed.

"patients awaiting enrolment"

i suggest you email Scancell !

what you have not answered ...

did the other Bio Techs issue an "immediately" RNS prior to "first patient dosing "

because YOU introduced "other" bio Techs ... nobody else did

days prior to your Bio Tech investments that issued an RNS to say first patient dosing ...
Did they issue an RNS saying "starting immediately " or not
did Scancell back in 2010 only the "first patient dosing" is not on the scancell website as it was a regulatory RNS for the Plus market ........... but again did scancell issue prior the words "immediately"

that would be a fair comparison ....

for your "regulatory first patient dosing RNS"

it still may come .. but IMHO i don't think its now needed

Ruck ....
you post without saying anything ................
I bow down to your superior ability ...

patient dosing is not done by scancell .. heidhoncho ...

"immediately" .. maybe you can translate that

why don't you answer my questions knowlesi ???

explain to me Why Professor Poulam Patel, Chief Investigator, would not Dose ????? when he has stated

"There remains an urgent need for improved therapies in melanoma. Based upon our previous successful trial with SCIB1 alone we are excited to see if the addition of SCIB1 to current, standard treatment with pembrolizumab increases our anti-cancer response rate."

how do you know ? ... scancell does not have to tell you first patient dosed .. when they have told you its stating immediately

the Oncologists dose patients not scancell ..

they have the Legal authority to proceed ...

why would they NOT dose ?

1) Have? UK? trials started?, if so why no RNS, if not what happened to "coming weeks".........

word Immediately in RNS

2) Why weren't we told about? UK trial ? FDA situation sooner? .........

"Because you don't need to be and the Ichor situation is under NDA"

3) What happened to "monetizing of assess? in the near future?"?

cannot be answered at the AGM ... as that would be price sensitive RNS only

4) Why are deadlines? so rarely met?? ?(a nice to have :) )?

"how can you have deadlines relative only to self" please show where Scancell declared "this date is a deadline"

?5) What's happening with project blueprint

Moditope progrom is still active

6) ?Any update on situation with FDA/ichor

that is a Ichor FDA issue .... are you a shareholder in Ichor ?

?7) What's ?the ?situation with biontech - still ongoing? And similarly Can they expand on inanaco recent findings???

My discussions with Scancell on the science tells me all is ok ... what other data do you need ?

?8) Are NDAs still ongoing? Any change?

they are NDA ... how can that be answered ?

?9) Why are there similar bios (i.e. immatics) getting upfront deals but Scancell are not? What is the blocker? Have any offers been forthcoming since the last one in 2015???

Immatics have TCR in the clinic ........ Scancell does not its BioNtech that will carry the project further as far as we know.

?10) Funding - what's ?is the state of play there?

another price sensitive question that will only be answered via RNS

RNS
the trial is starting immediately ....

so what proof have you it has not ?

. Vaccination
with citrullinated peptides leads to a rapid increase in the number of pro-inflammatory CD4C T cells targeting the tumor
resulting in interferon release, which """ultimately flips""" the tumor
environment from anti- to pro-inflammatory and results in
tumor clearance

so you then have to research again ... but this time """ Immunoediting """

The principles of cancer immunoediting have set the foundations for understanding the dual host-protective and tumor sculpting actions of immunity on cancer and establishing the basis for novel individualized cancer immunotherapies. During cancer immunoediting, the host immune system shapes tumor fate in three phases through the activation of innate and adaptive immune mechanisms. In the first phase, Elimination, transformed cells are destroyed by a competent immune system. Sporadic tumor cells that manage to survive immune destruction may then enter an Equilibrium phase where editing occurs. The Escape phase represents the third and final phase of the process, where immunologically sculpted tumors begin to grow progressively, become clinically apparent and establish an immunosuppressive tumor microenvironment. This review focuses on important recent developments that have enhanced our understanding of each phase of the cancer immunoediting process, summarizes the discovery of new predictive and prognostic biomarkers and discusses development of novel and objectively effective cancer immunotherapies.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4388310/

put it this why Ray .. you can prove T cells . in fact your life today exists because of them ..

this is about "suppression of T cells" which is why Cancer enters the Escape phase ... then your in trouble

Even if that happened .................. all is not lost
1st ... run a trial with Yervoy suppress the suppression
2nd when its finished preclinical add Modi2
3rd ... Clonal expand outside the body with TCR therapy

i would word it like this .........

What we are not sure about is the "suppression signals" from the cancer may be higher than the TIL threshold to enter clonal expansion .... to tip the balance in favor of the CD4 killers T cells