Scancell Share Discussion Threads

[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
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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.

[bermudashorts] 15/4/2024 08:37

Sc102

I haven't checked the figures, but isn't resected melanoma is a much bigger market than advanced unresectable melanoma? Surely the incidence of resected melanoma is much higher?

[marcusl2] 15/4/2024 08:13

Cw
The GlycoCell Engineering Biology Mission Hub, the GlycoWeb BBSRC sLOLA, the anti-glycan antibodies of Scancell Ltd and other glyco-connected work at University of Nottingham

[markingtime] 15/4/2024 08:06

Quite.There is a negative value to his one-man echo-chamber.

[sci102] 15/4/2024 07:32

They applied for IIb-IV in the end, despite best result back then being in fully resected in particular. However they are trialing in "Advanced Unresectable Melanoma Receiving Either Nivolumab With Ipilimumab or Pembrolizumab" specifically with eligibility only stage III and IV. So along the current development path, orphan status does not apply as originaly designated. They could of course (and perhaps they have?) always apply for another.

[inanaco] 15/4/2024 07:00

The New scientist has it wrong again ....


scancell is first line stage 4


example of stage 4 Melanoma orphan status

"""UV1 also has FDA orphan drug status for the treatment of stage IIB-stage IV melanoma."""

but how is it that the adjuvant stage (first treatment to melanoma) is smaller than stage 4 ?

what idiot would work that out ?

let me think

Sci10215 Apr '24 - 06:24 - 384 of 384
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Something I had gotten wrong previously:

""""fully resected melanoma which is a smaller market."""""
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29318;‍♂️🤦205;♂️🤦‍ϓ4;️🤦‍♂️;

[sci102] 15/4/2024 06:24

Something I had gotten wrong previously:
SCIB1 did get orphan drug sratus but that was back in 2014 (I thought it was more recent). Back then, they were going after fully resected melanoma which is a smaller market. Also note that orphan status is given per indication and for a specific drug. So this is no longer valid for SCIB1 as first line and anyway not for iSCIB1+ which is a different drug also for first line and is addressed to an expanded population. They would have to go after the fully resected market again with SCB1 in particular to take advantage of orphan drug status.

[marcusl2] 14/4/2024 20:16

I agree Bermuda.

[supernumerary] 14/4/2024 20:11

But will it ever get to that stage? I fear that dealings with the FDA interfere with Lindy's continuous improvement programme...

[bermudashorts] 14/4/2024 16:38

marcus,

I don't think it will arise because if iSCIB1 does ever get to that stage, I'm pretty certain Scancell won't be the ones submitting the NDA to the FDA.