Scancell Share Discussion Threads

[inanaco] 07/2/2019 20:07

One other point ...

The Modi1 vaccine proves up the TCR ..

chicken and egg ...

would the TCR be worth more if the modi1 proved efficacy ... in phase 1 ?

no fiddling these patients as we know ...

[oldnotwise] 07/2/2019 20:03

Ivy, yes I think you're saying that Scancell have done their bit (and I agree that seems to be the case) so it probably unlikely there's going to be any great delay if delay at all.
:-)
ATB

[inanaco] 07/2/2019 20:01

possible ...

you are using the end of year ?

Operational and regulatory activities are underway in the US and UK for the planned initiation of the SCIB1 checkpoint inhibitor combination Phase 2 study in patients with melanoma and the new funds raised at the beginning and end of the financial year have provided Scancell with the cash to progress both this trial, and the continued development of Modi-1 towards the clinic.

but at that point we do not know if Lindy had sorted the hydrophobic peptide issues
so "continued development"

now we know they have ... current outlook .. now


Outlook


The funds raised at the end of the previous financial year and the beginning of this period have enabled Scancell to move towards obtaining regulatory approvals for the initiation of the SCIB1 checkpoint inhibitor combination Phase 2 study in the US and UK, in addition to funding the continuing development of our Moditope® products, Modi-1 and Modi-2, and the underlying platform technology.

Scancell's focus for the immediate future is to initiate the planned Phase 2 clinical study for our lead ImmunoBody®, SCIB1, and to advance our lead Moditope® vaccine, Modi-1, towards the clinic. A positive outcome from both or either of these studies should represent significant value to shareholders.

"""""" A positive outcome from both or either of these studies should represent significant value to shareholders."""""

that bit indicates its still on ...

I think they have a deal on the TCR ... and the numbers are coming into focus ..

Don't forget we still have the Homocitrulline and the Karolinska peptides to consider for TCR

and with Roche ... playing TCR .. who knows

[bermudashorts] 07/2/2019 19:49

Inanaco,

I think we are talking at completely cross-purposes here - I know they plan to commence the trial in H2 - although it may well slip over to Q1 2020. However, they are not funded to commence the Modi 1 trial - they'll need to secure additional funding to commence the trial......and that's why any post suggesting that trial may be more expensive (ie. split into 3 separate trials) is not helpful to anyone - least of all Scancell.

[ivyspivey] 07/2/2019 19:47

ONW,
Yes it will be a response based on both parties but I repeat my understanding is that following a recent review meeting between the two parties SCLP believes that Ichor are in a well equipped position to respond to these queries.
What the reaction of the FDA will be is in the lap of the gods.

[inanaco] 07/2/2019 19:39

Ivy ...

if you know so much why don't you answer questions on the science .. you could have easily stepped in on crumbs post this afternoon while i was away ...

i replied by saying 60% ... quick study 99% ....

The issue you have, even boom will agree with this, i have moved on .. significantly in my understanding

Now i am not interested in your Risk ... blah blah

why .. i actually did a risk assessment of SCIB1, now, i did not see any comment from you that warranted investigation ..

but you can't just post This is Risky as it means Nothing ...

we are all here to buy shares etc ... so everyone takes and evaluates that themselves

your problem is you force a message with no corresponding factual point ..

and when questioned you get defensive ...

[oldnotwise] 07/2/2019 19:36

Ivy 19543
it's probably not a case of Ichor answering independently. It will be a combined response from Scancell and Ichor due to the particular questions asked in the context of the particular trial, scancell's Biologic Agent delivered by Trigrid V2.
Completely agree however with your last sentence.
AIMO
ATB

[inanaco] 07/2/2019 19:31

Bermuda

still using commence ?


Modi-1


Modi-1 consists of two citrullinated vimentin peptides and one citrullinated enolase peptide. Vimentin and enolase peptides are highly expressed in triple negative breast cancer (TNBC), ovarian cancer, sarcoma as well as many other cancers. The Company has completed the key process development work to allow for the Good Manufacturing Practice (GMP) manufacture of the three Modi-1 peptides each conjugated to the Amplivant adjuvant molecule. A defined manufacturing process is a key component for CMC (Chemistry, Manufacturing and Control) regulatory submissions required to support the filing of a clinical trial application (CTA) in the UK, toxicology studies and supply of the Modi-1 vaccine for The planned Phase 1/2 clinical study is anticipated to commence in H2 2019.

[ivyspivey] 07/2/2019 19:30

Don’t say I know best as would never be arrogant enough to claim that.
However U think the vast majority in here know better than some

[ivyspivey] 07/2/2019 19:28

We know the questions that the FDA are asking primarily revolve around the Trigid 2 device and that Icnor really need to answer those independently.
My understanding is that there has been a recent review meeting between SCLP and Ichnor and hopefully the answers can be submitted in a timely manner.
Of course there is no guarantee that the FDA won’t come back with more questions so w await further news with interest

[bermudashorts] 07/2/2019 19:27

..............and that's exactly the issue and why I'm picking up on this. In April 2018 the placing RNS states:-

'The net proceeds from the Capital Raise, in addition to the Company's existing cash resources and anticipated tax credits, will be used to:

Commence the First-In-Human study with Modi-1 in patients with triple-negative breast cancer ("TNBC"), ovarian cancer and sarcoma planned to start in H1 2019;'

fast forward to Jan '19 and the wording has changed - they are now 'advancing towards the clinic'

[inanaco] 07/2/2019 19:26

Ivy Knows best ...

[ivyspivey] 07/2/2019 19:20

P7
Yes all of it is a considered gamble.But if you buy at low prices it increases the odds dramatically in your favour if you are patient and of course the fundamental story is good.
As always up to each individual which I always stress as could never be immoral enough to pretend their is not always risk.
Guess Panama and others guess many of us have a lot of experience of the real world and of people and who to trust and not to trust.
You can’t always be right but anyone who calls it as no risk and ignores balanced discussion is a huge Red Flag imo.
I understand enough of the science having worked a lifetime in pharma to know if it hangs together,I have spoken to many prominent scientists over those years as well as CEOs etc and have always found the real experts like Lindy never speak to score points over others and show huge amounts of humility rather than ego

[kreature] 07/2/2019 19:17

Nice £0.0000000005 bounce today.

[inanaco] 07/2/2019 19:16

Bounce .... ouch ! dead cats do that ...

[panama7] 07/2/2019 19:11

Ivy, that is all fair enough, I have no doubt if they do announce the IND has been approved and they give a definite start date that the share will bounce.

[inanaco] 07/2/2019 19:09

Bermuda the Funding RNS used the word commence


·    Commence the First-In-Human study with Modi-1 in patients with triple-negative breast cancer ("TNBC"), ovarian cancer and sarcoma planned to start in H1 2019;

now H2 ..

[bermudashorts] 07/2/2019 19:05

I don't need to argue with Scancell - they've never stated that they're running 3 separate trials unless I've missed an RNS.

Re. your 19533 - we all understand what a phase I dose escalation is but what are you referring to re. the use of the term commence? In what context and what is the point you're making?

[ivyspivey] 07/2/2019 19:04

Hi p7.
All about risk/reward and yes this could fall further if more delays but think they have enough cash for 6-9 months and must look to st least start a Combo trial before any potential raise.
I just can’t see them raising at this low level as think they only have 20% headroom and just would not raise anything like enough.
So my money is on they will announce something maybe the Bion Tech partnership as does it not end in June or something and it seems clear that so far it has gone well so must produce something.
I am having a very good run on my main share MTFB so that is perhaps making me feel protected,whatever if it all goes wrong it won’t change my lifestyle so happy to gamble.
One of my main themes is if you buy at a particular low point in an essentially sound Company with good fundamentals then you have plenty of options to trade/ hold or whatever.
This will rise to at least 10p again at some point and anticipate much higher but that in itself is an nice 50%.
Many of the stale bulls will simply not sell at anything below their average as they are too emotionally attached to the share so you can always get out before them.
Also panama I am not afraid like you to meet up with real experts and know a few folk in pharma that I can bounce ideas off so pretty happy with things here.
I can wait a long time as have a very good income so only deal here for a bit if fun but don’t get me wrong I like to make money as that is the only sign if being a successful trader.
Hope that does not come across as conceited but a long explanation anyway.

[inanaco] 07/2/2019 18:55

just to remind you Bermuda

Phase two is not a done deal !! until you pass phase 1 and scancell are looking for efficacy in the phase 1 study

which is why they can only use the term Commence

[inanaco] 07/2/2019 18:30

it's a factorial trial ..

you can argue with Scancell ..

its one product and one trial at phase 1 .. all the regulatory stuff relates to that part of the trial as it dose escalates to the estimated dosage of clinical efficacy

---------------------------------------------------------------------------------

From Lindy and Ruhuls article.. may mean nothing but they say 'clinical trials'... well we know of a 'trial' but 'trials' ?...

'Furthermore, CD4-specific
responses were also observed when these peptides were
tested in vitro using PBMCs from healthy individuals with
several HLA types. The results from PMBCs proliferation
assays suggest the citrullination-specific response is not
restricted to just one HLA type, hence the vaccine can be
used in a wider population. Clinical trials with MODI-1
are now being designed. '

[bermudashorts] 07/2/2019 18:25

Crumbs did not state that Modi1 splits into 3 separate trials - you did. Can you confirm whether or not you got this information from Scancell?

The use of the word trials rather than just trial is standard stuff - it's common practice ie. we are going to run clinical trials, we are planning clinical trials.

With the share price sitting at 6p and concerns around how they are going to fund the SCIB1 combination trial let alone just 1 Modi1 trial, it doesn't help anyone to suggest they're going to be running 3.

[panama7] 07/2/2019 18:10

Ivy, you don't have to answer but with everything that has gone on with this Company why did you decide to buy 50k before the trial has been confirmed. Everyday that passes without IND confirmation is not a good sign.

[inanaco] 07/2/2019 18:09

Bermuda ..

why repeat the debate ?

or do you fancey that ... 3 trials or one trial with 3 arms is a big technical problem for you to handle ?

scancell has called it Trials ...

not me .. argue with Crumbs

i did find the name of the trial design ... cannot remember it now

but for now "factorial Trial" will do ... take it or leave it ...