Member Info for inanaco

The issue was known and its not that difficult to understand is it Ruck ............ it was a Device issue ... not a Vaccine issue
we knew about the problem from RNS .. so why even post that ?

The US has effectively shut a US company ... makes no difference to scancell because we have the fall back plan "scientifically approved" ie CRUK and Scancells scientist have successfully adopted the Nanoparticle. delivery system.

so we run the phase 2 SCIB1 in the UK, open multiple trial centers and get the data ...that gives Ichor 2 years min to sort out the FDA because that is critical for them, meanwhile at least 2 trials Janseen and Scancell will continue to provide data on the Ichor gun in support of a future IND in the US. I will stress this is a "device specific " issue

"""Whilst there has been extensive dialogue between Ichor and the Agency, a timely resolution to the device-specific questions has yet to be agreed."""

which is what i mentioned in my posts the other day ...

so the delay is over ... data on Keytruda SCIB1 ... will start to feed through soon .. its the data that is important not the location of the trial centers, we gained a bit of Prestige in the US with the US leading the trials .. and IMHO that has not changed as they still are prepared to lead the trials. This is not a Scancell issue

yes the FDA approved Ichor back in 2007 .. and electroporation has been known since the 60's

Chester trigrid opens cell membranes of the muscle and any dendritic cell caught in the electric field ... this allows DNA to be inserted into the cell, once the Field collapses the cell then closes locking in the DNA which changes the cell dramatically

so like a virus .... which in itself is dead as its only DNA .. once it enters a cell ... it takes over the cell and then functions using its code ... rather than the original cells code, so a virus cannot live or replicate without a host cell ...

worse case scenario ... which Scancell and Ichor are aware of ...
Revert to Trigrid 1 in the US and Trigrid 2 in the UK

Electroporation Seen as Powerful Addition to Human Trials, Future Commercial Applications

May 14, 2007 10:00 AM Eastern Daylight Time
SAN DIEGO--(BUSINESS WIRE)--Ichor Medical Systems announced today it has received FDA approval to conduct a Phase I clinical trial of a melanoma vaccine to be administered to patients utilizing a novel delivery technology.

But if you are confident of FDA approval ... why would you ?

The Application Cartridge is a sterile, single-use component that houses the nucleic acid construct to be administered and a TriGrid electrode array for the electroporation procedure.

"""Compatible with pre-filled syringe format"""

so the current stock of SCIB1 remains compatible for 1 and 2 IMHO

if you look in the data you will find ....

"""" Vaccination with GX-188 by EP (GX-188E) elicits a significant E6/E7-specific T helper (Th) 1-polarized cellular immune response in all nine patients with CIN3. """"

E6/E7-specific T helper (Th) 1-polarized cellular immune response

what is that ?

that is a CD4 T cell that has been flipped to TH1 ... to cause Inflammation

Moditope .... CD4+Tcell flipped to TH1 via the adjuvant ... and to cytotoxicity

what i am trying to get across these "t cells" are natural ..its just the way they have been programmed which gives them the punch

so its not about the failure of T cells ... as they are capable of killing cancer hence Keytruda got approved

what its about is "programming" .... can you program effective T cells ...

In June 2018, Keytruda® (pembrolizumab) was approved by the U.S. Food and Drug Administration (FDA) under accelerated approval regulations for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 [Combined Positive Score (CPS) =1] with 14.3% of objective response rate.

approved with "14.3%" response rates

This is why i keep highlighting genexine ...

why would Keytruda have synergy with GX 188

and NOT

SCIB1 or 2

which is why i ask knowlesi why he puts Scancell into the high risk bracket .. when we already have proof of effective T cells

http://www.genexine.com/m62_view.php?idx=156&cate=1&year=

Knowlesi ........ you often talk about High Risk etc as reviewed by your good self ... so can you pass comment on Genexine ?

2018, targeting patients with HPV (Human Papilloma Virus)-induced recurrent, relapsed, and metastatic cervical cancer.

The study is being conducted in seven major hospitals in Korea, including Seoul St. Mary’s Hospital, Asan Medical Center, and the National Cancer Center. Genexine and Merck & Co., Inc., Kenilworth, N.J., USA.adopted the Simon two-stage design, which mandates to see a response rate from at least 3 patients in Stage 1 out of maximum 15 patients enrolled. The response is defined as either complete or partial remission of cancer, indicated by the reduction of tumor size by a specific percentage. Genexine and Merck & Co., Inc., Kenilworth, N.J., USA.agreed to enter the Stage 2 earlier than planned after evaluating responses from 10 patients instead of 15, as the target response rate in Stage 1 was met including one of the patients showing complete response (CR). The study design allows enrolling total 28 patients for the Stage 2.

any issues have to be RNS'd ... even when the SCIB1 went out of date it was RNS'd so i don't think they would hold back information. Lets hope its because the FDA are very close to allowing the Full trial to start and it can be done Under Dr. Flaherty, as i am not sure how that would play if only a UK arm started

worth reading up on "nude Mouse"

Crumbs .. i just fine tuned your post .. highlighting its not all about the peptide ...
and these mouse models are actual human blood and actual human cancers grafted onto the mouse

MODI-1 vaccines have been extremely successful
in animal studies with transgenic mice expressing
human MHC II. Both vimentin and α-enolase peptides
individually have been shown to induce immune
responses against tumours in HLA-DR4 transgenic mice.
Since these mice are expressing HLA-DR4 (a human MHC
II molecule) we can effectively establish a ‘human’ tumour
model and investigate the interaction between human
CD4 T cells and human tumour in vivo. Vimentin peptides
induced a strong CD4 anti-tumour response leading to
the survival of 80% of transgenic mice. Vaccination with
just α-enolase also showed significant survival against a
number of tumour types including melanoma, and those
in the lung and pancreas. 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.

this process is step by step C7 .. its in the hands of Scancell

the only way to speed it up is when its in trial ... just like the Genexine result with keytruda moved up a gear on 10 patients rather than the trial of 15 because they got the responses required in 10 patients

that is the stand out of that Trial ... its going to be near identical to scancells

https://www.ncbi.nlm.nih.gov/books/NBK27098/

C7 ... its highly complex
An important feature of the binding of peptides to MHC molecules is that the peptide is bound as an integral part of the MHC molecule's structure, and MHC molecules are unstable when peptides are not bound. The stability of peptide binding is important, because otherwise, peptide exchanges occurring at the cell surface would prevent peptide:MHC complexes from being reliable indicators of infection or of uptake of specific antigen. As a result of this stability, when MHC molecules are purified from cells, their bound peptides co-purify with them, and this has enabled the peptides bound by specific MHC molecules to be analyzed. The peptides are released from the MHC molecules by denaturing the complex in acid, and can then be purified and sequenced. Pure synthetic peptides can also be incorporated into previously empty MHC molecules and the structure of the complex determined, revealing details of the contacts between the MHC molecule and the peptide. From the sequences of peptides bound to specific MHC molecules, combined with structural analysis of the peptide:MHC complex, a detailed picture of the binding interactions has been built up.

so its all about the "binding of the T cell" to the peptide .. just call it a Key and Lock ...

scancell programs keys and Locks ... the viral infection of a T cell transfers a "new" key ...

Blood that has been found to respond to Scancells Key (peptide) gets sorted by BioNtech and the Key extracted and then it can be transferred to a patient that did not recognize the peptide

so they get an instant immune "system" given to them ... because they dont just give 1 0r 2 t cells .. they clone millions

One other point Crumbs if we had been expecting a 100% response Lindy would not have bothered with the TCR route .. which solves the problem of patients not responding to any epitope ...

we just Viral infect T cells with the moditope TCR ... (highly complex) but could increase coverage of the Modi1 vaccine

SCIB1 has four epitopes from two melanoma antigens (three
from gp100 and one from TRP-2) engineered into its CDR
region.

that is why they put 3 epitopes in the vaccine Crumbs its a broader spectrum

indeed SCIB2 has i believe 16

quite an achievement ... all about "de-risking" the share, so when you see

""investigate the interaction between human
CD4 T cells and human tumour in vivo. """

our mouse model is quite advanced ... Studies that are in vivo (Latin for "within the living";