Member Info for inanaco

Scancell has said on the 12th Feb that the data has been supplied by Ichor and Scancell to the FDA

FDA policy is a 30 day response

i cannot find on the FDA website anything that changes that 30 day

Bigger Picture

Pretty sure that we will have the SCIB1 combo FDA rns by the 12th march

16 weeks away from the estimated conclusion of the Collaboration with BioNtech

Modi 1 manufacture and tox studies ongoing, no reports of any other issues

Modi2 could be ready for manufacture in approx 16 weeks

Patent News

SCIB2 by others so not expecting RNS until trial starts (transparency point)

Bigger Picture

Pretty sure that we will have the SCIB1 combo FDA rns by the 12th march

16 weeks away from the estimated conclusion of the Collaboration with BioNtech

Modi 1 manufacture and tox studies ongoing, no reports of any other issues

Modi2 could be ready for manufacture in approx 16 weeks

Patent News

SCIB2 by others so not expecting RNS until trial starts (transparency point)

It removes another "mechanism of failure" in fairness this area was looked at years ago, however a second look is worth considering as

Karolinska Institutet is at the forefront of research in RA . and has collaboration with Scancell in Oncology, so it would be ironic for a scientist working in RA to induce RA via a cancer treatment

C7 David Evans has since admitted he stays clear of it as well ..... LOL

example

https://www.tandfonline.com/doi/full/10.1080/2162402X.2015.1137416

to make it simple it's about the diversity of cancer HLA types and the way Modi1 engages the majority

so SCIB1 is 45% of the population the mark 2 version will be about 95%

the mark two version immunobody SCIB2 is (from memory) 95% ...

so you can see the value in the ability to target so many HLA types in the ONE cancer TYPE with One vaccine

I agree C7 ... Ruck appears and silly season starts ..

ATB

I refer again to all my posts on SCIB1 ..........all based on Proven trials and proven Synergy between a T cell and PD-1

i will remind readers again Keytruda acts on the T cell .. not the cancer so it acts directly on the High Avidity C8's generated by SCIB1

Keyytruda is on the the current standard of care for melanoma ... how can we NOT be commercial if we increase efficacy ? the determining factor is by How much ! it's like a value scale

everything else is a bonus

C7 .......... Scancell is not in charge of the SP .. regardless what you might think

the SP reacts to Scancell not the other way round ....

the question is why it does not react ... because of competing ideology ...

scancell is at the forefront of Autophagy research, as such everything is "new" ....

yet the market expects the estimated time frames to be ... religiously met same as SCIB1 ...

Channel Tunnel got delayed ... LOL .. still works

Cross rail is delayed ......... will it work ?

you cannot keep blaming Scancell for what is an incredible difficult thing to achieve ..........

again if it was easy ... the 100.s of billions invested over the last 100 years would have cured cancer !!

opps !! SCIB1 has ......... with no side effects

But the game is "regulatory driven" you cannot speed up process

Ruckrover Scancell is not in Charge of the SP its ridiculous to post .............2) Having let the sp drop to this low level

posted this on the other BB ... of interest to some ..

Lindy's pre-clinical research data has translated into human data in both immunobody and moditope

I hope that you can appreciate that the outcome of a vaccine is the creation of Specific T cells with the correct functionality, these are natural in that no modification of a t cell is required ... I also hope you appreciate that the priming of those cells is done by Professional Antigen Presenting Cells, so the actual "drug element" only happens at the injection site and has no further involvement once initialised apart from subsequent boosters to encourage clonal expansion and to capture further T cells that respond to all epitopes of the vaccine. (some SCIB1 patients required 10 injections)

As such the immune response becomes nature's response .. what's very interesting is Moditope as in effect plays a Dual Role ... it does not lose its capacity to signal other T cells which is why it was so important that Lindy held back on the earlier Modi1 to add amplivant which is what drives efficacy, and potency of the vaccine as it switches the T cell to ""pro Inflammatory"" this actually suppresses the TH2 CD4 T cells which "down regulate" and these chaps are not desirable, if you are going to "reverse" the escape Phase

The modi1 vaccine "immunogenicity" is already proven and is being proved up by BioNtech

ie if the epitopes did not engage "NO TCR" would be in evidence and the BioNtech program would never have been initiated

""""Immunogenicity is the ability of a particular substance, such as an antigen or epitope, to provoke an immune response in the body of a human and other animal. In other words, immunogenicity is the ability to induce a humoral and/or cell-mediated immune responses.""""

so the next stage is Proving "breaking the immune suppression environment"

it works in mouse ... now prove it in humans

thought Val had done a deal worth 100 Taka with Bangladesh ...

London, UK., 28 July 2017: ValiRx Plc (AIM: VAL), the clinical stage biotechnology company, is pleased to announce that ValiRx has signed a licensing agreement with Mystic Pharmaceuticals Limited ("Mystic") of Dhaka, Bangladesh, under which Mystic has acquired a licence and access to certain patents and products owned by ValiRx.

recruit to what End ... ?

should have added

Missing from your post

"winning " lottery numbers

insufficient space to give you all the possible combinations ...

but i am sure you can mix then up to generate a few ...

anything that you are not sure of just ask ...

you are more than welcome to put info on SCLP on the SCLP BB .. and have a sensible debate

not sure why you are using SCLP to defend VAL... it makes no sense

the 9 patients you keep referring to are the dose escalation of Modi1 ... which has never been in trial

and comparing that to a phase 2 of 7 patients of the 401 ... which should have been 20 but as they found little of interest they stopped recruiting and never actually complete the trial as it was laid out in the trial protocol

"""The protocol details the dosing and testing schedules to be carried out on each patient for six months treatment, with a maximum of twenty patients to be fully enrolled, with recruitment staggered over a number of months to ensure patient safety.""""

now ....... Principle Investigator Dr Tsira Kortua on the VAL401 trial ........... No Report ???? strange

I have not mentioned Scancell but the trial Investigator (independent of Scancell) has reported ...

for the up coming trial ...

Dr Keith Flaherty, Director of the Termeer Center for Targeted Therapy at the Massachusetts General Hospital Cancer Center and Professor of Medicine at Harvard Medical School, commented: "The SCIB1 overall survival and progression free survival data generated to date go well beyond established norms for this group of melanoma patients. We have a lot of enthusiasm for validating these results in subsequent trials."

Prof Poulam Patel, Chief Investigator for the trial and Professor of Clinical Oncology at the University of Nottingham, added:Â "The whole field of cancer immunotherapy is undergoing a fundamental transformation. Although checkpoint inhibitors are continuing to deliver clinical results, the long-term benefits are seemingly only apparent in around a third of patients. Â Taking the brake off T cells with checkpoint inhibitors and pressing the accelerator with active immunotherapies such as SCIB1 may be an effective way of overwhelming the disease and increasing efficacy even further."

and just to highlight again have they produced any evidence yet of Goal 1 ...........

which is why in the 18Th Dec 2017 RNS

they set 3 Goals

·     To substantially raise the dosing level in patients in order to reach therapeutic levels and reduce disease progression;Â

·     To assess at what stage in disease development the compound can be most effectively deployed in subsequent, larger, outcome-oriented clinical trials; and

·     To determine which route and with whom to take the project to its next stage - by the Company or with a partner.

From Oct RNS .......... No efficacy Data

London, UK., 17 October 2018: ValiRx Plc (AIM: VAL), the clinical stage biotechnology company, is pleased to announce that VAL201 has now entered the concluding stages of its Phase l/ll clinical trial at University College London Hospital ("UCLH") involving patients with hormone-sensitive and hormone-resistant prostate cancer.

This stage of the trial follows approval received from the Medicines and Healthcare products Regulatory Agency ("MHRA") to escalate VAL201 dosing (announced by the Company on18 December 2017). In the intervening period, the Company has geared up the compound supply chain to meet increased demand for the drug, as a result of the higher dosage to be administered. UCLH has spent the period both screening and recruiting patients who are eligible to enter this stage of the study.

The current cohort has already received the escalated dose. This marks the point that VAL201 entered the concluding stages of the Phase l/ll clinical trial. The VAL201 compound has already demonstrated consistent safety and tolerability and signs of activity in previous patients treated with lower dosages.

UCLH continues to recruit suitable patients to complete the trial. Further results will be announced as they become available and have been verified.

Now they have stated

"""""The current cohort has already received the escalated dose. This marks the point that VAL201 entered the concluding stages of the Phase l/ll clinical trial.""""""

actually this is the concluding point of the Phase 1 part ................ as per the 3 Goals

·     To substantially raise the dosing level in patients in order to reach therapeutic levels and reduce disease progression;Â

·     To assess at what stage in disease development the compound can be most effectively deployed in subsequent, larger, outcome-oriented clinical trials; and

·     To determine which route and with whom to take the project to its next stage - by the Company or with a partner.

what i am not doing is Saying the trial has failed, i am just highlight exactly the data that is missing which is

"efficacy" to compete with current standard of care ... at phase 1

Then you can think about value drivers ................ because unless you have efficacy that has commercial value i struggle to see how you can market it as a produc