Scancell Share Discussion Threads

[inanaco] 17/4/2024 07:41

i think we will get an RNS but only on monotherapy results

Professor Lindy Durrant, Chief Executive Officer of Scancell, said: "I am pleased to be invited to share this exciting data on SCIB1, Scancell's 'off the shelf' ImmunoBody® cancer vaccine, which has demonstrated positive efficacy data from the Phase 2 SCOPE trial for advanced unresectable melanoma. I am also looking forward to presenting early data from patients receiving Modi-1 as a monotherapy in range of hard-to-treat solid tumours, which has shown good T cell responses, safety and tolerability. Following on from AACR, there has been significant interest in the clinical development of therapeutic cancer vaccines, and I am excited to demonstrate the progress Scancell has made in this class of immunotherapies."

[inanaco] 16/4/2024 19:47

reprint

08/4/2024
09:09 chester18

Posts: 3,221

Price: 10.25

Strong Buy

RE: Modify trial4 Apr 2024 08:44
Additional to the late April Conference.

Immuno-Oncology Summit Europe 23rd & 24th April 2024.

Day 1 @ 14.45 Lindy Durrant

'Clinical Update on the DC Targeting Melanoma Vaccine, SCIB1 and Modi1 Vaccine Targeting Citrullination'

My presumption is that this will contain some new data, it doesn't say that it definitely will but 'Clinical Update' is a perfectly good clue for me.

[inanaco] 16/4/2024 16:33

a week away from the next conference

lets hope any update gets an RNS

have we heard about the proposed Doublet in renal ? that was about 10 weeks ago from interims

Modi-1 to be assessed in renal cell carcinoma in combination with double CPI therapy in the ModiFY study pending protocol amendment by the MHRA

[inanaco] 15/4/2024 16:25

size of head 4

another gaff


""FDA Their guidance is no law, they basically can do (almost) whatever they want.""

except its guidance is approved by congress ....

[sci102] 15/4/2024 16:18

At bare minimum they would have to discuss this with the FDA. Their guidance is no law, they basically can do (almost) whatever they want. But I don't think I've heard anyone from the company highlighting it the past year or so that I've been around.

[bermudashorts] 15/4/2024 15:45

Are you absolutely certain? - only that would make the reply from Scancell more than a little misleading and I have always found Richard Goodfellow to be completely frank and open in his responses.

Regarding your 393 - I really don't know. I believe the FDA have granted accelerated approval to other cancer therapies based on a surrogate endpoint of durable ORR but as it's a combination trial they'd be looking for the improvement in ORR over and above the CPIs. I suppose it depends on whether the FDA are prepared to accept a prespecified level of improvement for approval. Also given that Scancell will want to license after the phase II stage they may not want to go down that particular road and may want to look at one of the other expedited programmes.

[inanaco] 15/4/2024 14:41

ouch Size-of-head 4 gets a knock out blow ...... the seismic shock must surely send in the control rods

[sci102] 15/4/2024 14:38

It doesn't :) it's just they can't use it.

[bermudashorts] 15/4/2024 14:25

Sci

Way back in December 2015 when Scancell were planning their original US combination trial I emailed Scancell's CEO (Richard Goodfellow) on this very subject.

My question:- 'When SCIB1 is being used/trialled in combination with another treatment does it still retain Orphan Drug Status? '

Richard's reply:- 'The study would not have any influence on Orphan Drug Status'


So I'm not sure.

[sci102] 15/4/2024 14:11

What about accelerated approval, do you think they have a realistic chance of getting it for first line?

[sci102] 15/4/2024 14:07

You can't just do whatever you want with the designatikn, it needs to be trialed for exactly what is given for (this includes combinations). You can't just get orphan drug status and then use it on a subset or superset. See examples

[sci102] 15/4/2024 13:59

The designation stands. But for them to use it the development needs to align with the designation. They are not trialing below stage III if that continues to be the case in phase 2/3 in combination with CPIs they will not be able to use it even if the trials are succesful. Different indication. They might apply for a new one though.

[bermudashorts] 15/4/2024 13:51

Sci102

Thanks for the link. So they applied for metastatic melanoma, stages 2b to 4 inc. - there is no distinction between whether the treatment is in the resected or unresectable population so long as the patients have stage 2b to 4 metastatic melanoma. This has been the setting for all of the SCIB1 trials, including the current study.

I'm confused, I don't understand why you think the FDA orphan drug designation for SCIB is/was invalid.

[sci102] 15/4/2024 13:38

By the way Bermuda, do you have any comments on whether scancell can use the orphan drug status assuming they stay on the current development path and whether you think it will get accelerated approval for first line?

Or is it all pump and dump here and I'm the only idiot who takes it seriously?

[inanaco] 15/4/2024 12:04

appreciate that melanoma caught early is 95% curable it has not spread simple surgery to remove

but if its size has gone past a certain depth . things become dire. it can become metastatic it does not mater what stage your at, its still metastatic melanoma which is why SCIB1 could treat all stages


Tumor thickness: The thickness of the melanoma is called the Breslow measurement. In general, melanomas less than 1 millimeter (mm) thick (about 1/25 of an inch) have a very small chance of spreading. As the melanoma becomes thicker, it has a greater chance of spreading.

google

[inanaco] 15/4/2024 11:45

Size-of-head 4 Apr '24 - 10:47 - 388 of 388
0 0 0
I guess they'll wait for iSCIB1+ data and then apply for orphan drug in first line with CPIs for stage III and IV or whatever the phase 2/3 looks like when they start it.

SCIB1 orphan status covers this indication why do you have to mention CPI ? do you have to inform them if you take paracetamol or steroids etc ?

its SCIB1 is designed for metastatic melanoma .. it does not matter what the stage is because the criteria is based on an indication of less than 200,000 "melanoma"

so effectively melanoma has orphan status ... and so will ISCIB1

[inanaco] 15/4/2024 11:05

Glymabs was a spin off from the University as such Scancell seems to get a look in at what they develop and is in a position to transition them to the clinic




as further research gets developed we clearly are in the best position bearing in mind that early research eats capital and is very high risk, which is why you need CRUK etc grant funding

only moditope was discovered in house the rest developed further in house glymabs and immunobody discovered by Lindy team but working for the UNI

if Scancell was to pay Lindy true worth ......... we would be skint ! what would GSK pay ? or even BioNtech we get clouded by the low share price .......

emptyend

Posts: 544

Price: 10.10

Strong Buy

RE: Probing the expression and adhesion of glycans involved in Helicobacter pylori infectionToday 06:57
This is actually a piece I find a bit concerning as a shareholder. It renews lingering questions in my mind about whether shareholder value is front and centre in the company’s activities, or whether the company is just a bolt-on to a venture which is publicly-funded pure science, being pursued for its own sake.

Of couse there is a symbiosis here, but the company itself should be ENTIRELY focused on developing intellectual property and monetising it for the benefit of its shareholders.

I’d like to think we would get RNSs soon that prove that is the focus, and not the science alone…..

[sci102] 15/4/2024 10:47

I guess they'll wait for iSCIB1+ data and then apply for orphan drug in first line with CPIs for stage III and IV or whatever the phase 2/3 looks like when they start it.

[inanaco] 15/4/2024 10:32

Bets been taken for "who gets the next ban" what will create the conditions for yet another meltdown ...

3 mile island
Fukushima
Chernobyl
Windscale

size-of-head D ?

[inanaco] 15/4/2024 10:26

Size-of-Head D ... reacts and is cooking ...

will the Stoker make a reply ?



Orphan drug status in the United States qualifies the development of SCIB1 for a 50% tax credit for clinical trials, a waiver of the prescription drug user fee for the drug approval procedure and a period of seven years of market exclusivity following drug approval by the FDA. During the orphan market exclusivity period, the FDA cannot approve a NDA (new drug application) or a generic drug application for the same product including the principal molecular structure features of the drug and for the same rare disease indication.

The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.


The American Cancer Society's estimates for melanoma in the United States for 2024 are: About 100,640 new melanomas will be diagnosed (about 59,170 in men and 41,470 in women). About 8,290 people are expected to die of melanoma (about 5,430 men and 2,860 women).

Google

[sci102] 15/4/2024 10:02

Hi Bermuda, orphan drug depends on prevalence, not incidence. Also, as you can see they applied (and got) from IIb to IV, but they are not trialing for that.

Edit (I had to enter a call): So for how long does fully resected remains as such, and what is the prevalence. I don't know the full answer but it does not matter since that's not what they applied for.

[inanaco] 15/4/2024 09:50

its a new power plant at size-of-head D

current head stoker Bermuda

[ruckrover] 15/4/2024 09:31

"The New scientist has it wrong again ...."What's the article? I find it hard to believe such a prestigious publication would have errors.

[marcusl2] 15/4/2024 09:05

So our Glymabs could possibly be used in infectious disease.

For any new deals on the Glymabs I wonder if Scancell will reserve the rights to infectious disease if that option ever materialises ?

With SC129 Scancell only retained rights to Car T as far as I know.