Member Info for RayPointer

Surely the crucial point is that the money will be used to develop Modi3 (assuming we win of course) and Mod13 will be owned by Scancell.
CRUK will most likely control the spending but who is the main benificiary?

How much will Modi3 be worth after 20 million spent on its development and testing? Nobody can answer that question at this point.

Remember that Lindy is leading this project and I am willing to bet that, for the first time in her career, she is leading a well funded project.

Some characteristics of memory T cells

1) Easy to convert memory to killers since they can connect to a wider range of APCs compared to naive T cells. This makes them easier to activate than naive cells.
2) retain memory of the anitgen
3) Long living up to 10 years as opposed to killer cells which are short lived -
the more doses of the vaccine the more memory cells
4) The exact mechanism of memory cell creation is still being debated.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1782715/
https://www.nature.com/articles/nature24633

SCIB1 exhibits a strong memory response.

"Immune analysis from the patients recruited earlier suggests that patients may benefit from up to two years continuous treatment to effectively delay or prevent recurrence.
Re-challenging animals with tumour cells after SCIB1 treatment resulted in 100% survival suggesting that ImmunoBody® induces a powerful memory response. Such an effect has not been observed with checkpoint inhibitors."

http://www.scancell.co.uk/news/regulatory-news/research-update-amendment

It is SCIB1 that triggers the immune response and that in turn creates the Memory cells.
A strong immune response seems to equate to a strong memory response.
Double trouble for the cancer!

Afternoon all

https://immuno-oncologynews.com/2018/07/20/survival-rate-of-melanoma-patients-with-brain-metastases-doubles-with-immunotherapy-use-study-finds/?utm_medium=desktop-push-notification&utm_source=Notifications&utm_campaign=OneSignal

It should be noted that patients with brain metastasis were specifically excluded from the SCIB1 Phase1/2 trial (the completed one).

Yes, I know and even after a successful Phase 3 trial, the drug still has to go through an approval process.

The FDA does have ways of speeding up the process

https://www.fda.gov/forpatients/approvals/fast/default.htm

But I can't see anywhere that states how much time can be gained by the different approaches.

Only if Scancell do a deal for SCIB1 or Immunobody as a whole.

Presently, Scancell themselves have no intention of entering any of their products into Phase 3 trials - too expensive.

Now Merck? who knows.
For the SCIB1/KeyTruda combo it would also depend on whether the FDA would allow a phase 3 trial after a phase 1/2 trial of only 12 months or so.

I obviously haven't got this yet so I will study this next weekend
Ta

Are we saying that for these particular citrullinated Modi-1 epitopes there are normally no T cells with the right receptors.

So, in the absence of the correct T cells Moditope cannot do its stuff.

So, along come Biontech with their platform for engineering specific T cell receptors.
Hey presto, moditope can now activate these engineered cells which go on to kill the cancer

Yes and what great names, Ira and Ugur.
Nice to have a pair of Orcs on your team

I totally agree that a high "level of understanding" is very important.
So, with the posts today, I for one, can then do my own research to better understand why BionTech have chosen Moditope to combine with their own platform.
With better understanding the risks and the associated mitigations are clearer.
Thanks Guys

damn you Inan
More reading for me LOL

Agreed Ruck.

6 months unlikely since we may already have passed that deadline.
1 year is the rough timescale indicated in the Hardman report so, yes, this is what Scancell/BionTech are aiming for.

But the study could take longer than expected. You have to be open minded on how long a scientific study takes. Lindy on the critical path again providing the support that BionTech will require.

Hi Ruck

Neither, it is just that we don't have a date for this.
It could take 6 months, 1 year or 2 years - who knows?
The timescales are dictated by BionTech's own studies.

You have to make your own mind up on the chances of success based on the science of Moditope and the interest both BionTech and Genetech are showing by being part of Lindy's team in the Grand Challenge.

ATB

Current plan

SCIB1 combo h2 2018
Modi1 h1 2019
SCIB2 combo h2 2019
Modi2 trial prep 2019

Grand challenge Autumn 2018
Biontech deal ???

h2 2019

Evening C7.
Didn't CH mention 3rd party input. This is likely to be the clinical teams in the US and maybe others.
The irony is that this may be the only IND that Scancell ever need to submit.

Hope you have recovered from last night's disappointment.

From Inan 1249

"Our competition is only other vaccine designers we do not need to compete with other inhibitors of suppression or immune stimulation because effectively we have synergy"

From

http://www.scancell.co.uk/news/regulatory-news/research-update-amendment

"Experimental data suggests that the high avidity T cells induced by ImmunoBody® vaccines increase expression of PDL-1 on the tumour cell surface, thereby making the tumours more sensitive to checkpoint inhibitor drugs. Re-challenging animals with tumour cells after SCIB1 treatment resulted in 100% survival suggesting that ImmunoBody® induces a powerful memory response. Such an effect has not been observed with checkpoint inhibitors."

Make your own mind up as to what is the senior partner in this trial - Keytruda or SCIB1?

The IND itself looks very straightforward

https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083533.pdf

until you look at section 14 and you see a host of other documents that must accompany the submission. Section 11 also looks like another potentially difficult section to complete.

It will be the completion and checking of these associated documents that are causing the delay.

This is the first IND for Scancell, probably the first for Lindy and maybe even the first for Sally.
So, it is no surprise that Scancell are making sure they get it right first time.
In contrast, a big pharma would probably have an experienced team devoted just to INDs.

The other point is that Lindy is on the critical path of just about everything of a scientific nature that happens in Scancell. For example, at the moment she is also leading the grand challenge, and remember she is also running Scancell's research, advising and helping on Nottingham Uni research and giving the odd lecture no doubt.

We do need to be patient

But didn't CH tell you what he is happy about in the reply to your email?
What more do you want?

ATB

Keiny

A small biotech on the aim market and the science showing "seemingly" good progress.
And no news!

Surely, for you, this is a sell?

https://biontech.de/partnering/

Biontech is a pretty impressive company to have a collaboration with!