Scancell Share Discussion Threads

[inanaco] 14/4/2024 10:33

wrong trial Mr Scientist .... they are talking of the registrational trial 2/3 not the current

as this is a seamless trial its set up to be a phase 3 with a phase 2 run in ... again listen to what lindy has stated if the data is looking good we will then expand it



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Sci10214 Apr '24 - 10:17 - 376 of 377
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A chance. Yes. Not likely because there are already good options as first line. By the way, They stopped accelerated authorisations the last few years unless phase 3 is already recruiting anyway because previously some companies delayed the phase 3 for yesrs since they already had the authorisation. Sorry but to say now that we will get authorisation after phase 2 when all we have is data on 13 patients is rampy at best.

[sci102] 14/4/2024 10:19

And at the end of the day, if you insist that it will, at least provide a couple of relevant examples ( not from 10 yea4s ago) and you will see that the circumstances were different.

[sci102] 14/4/2024 10:17

A chance. Yes. Not likely because there are already good options as first line. By the way, They stopped accelerated authorisations the last few years unless phase 3 is already recruiting anyway because previously some companies delayed the phase 3 for yesrs since they already had the authorisation. Sorry but to say now that we will get authorisation after phase 2 when all we have is data on 13 patients is rampy at best.

[bermudashorts] 14/4/2024 10:10

Listen from about 22 to 23 minutes in for the definitive answer. According to Lindy Durrant:-

'There is a chance that we could get early approval but only if we've already started that phase III'

So you're all right!

[sci102] 14/4/2024 09:55

Bye bye marcus

[miavoce] 14/4/2024 09:08

Hi Marcus - apologies, it was Sath rather than LD. I do however think that the commercialisation he referred to was a commercial deal, but I may well be wrong.

[marcusl2] 14/4/2024 08:14

Sci, we have established that you think that you know better than Scancell.

No point in me wasting my time arguing with you and I am leaving it at this.

"which gives us a route to commercialisation potentially at the end of phase II"
33mins

Overview:
Cancer drug approval has evolved as the understanding of cancer biology, and the ability to select patients for trials of targeted agents, has matured. The longstanding reliance on Phase III trials to prove drug efficacy and positive impact on patient survival may no longer be necessary, as early trials, particularly the expansion phase of a Phase I trial, may provide convincing evidence of a high response rate to a targeted drug in a patient population who has been poorly responsive to conventional therapy. If the new drug produces no safety signals of great concern, and if a validated biomarker for patient selection has been established and is readily available, accelerated approval may be achievable prior to completion of a randomized trial.

[inanaco] 13/4/2024 12:28

like i said Scancell will have PFS data by 2025 on at least 86 patients

what will also be interesting is the drop out rate ... will this efficacy inspire patients to stay the course

Select Important Safety Information
Serious Adverse Reactions
In Checkmate 067, serious adverse reactions (74% and 44%), adverse reactions leading to permanent discontinuation (47% and 18%) or to dosing delays (58% and 36%), and Grade 3 or 4 adverse reactions (72% and 51%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313). The most frequent (≥10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.2%), colitis (10% and 1.9%), and pyrexia (10% and 1.0%).

[inanaco] 13/4/2024 12:06

take a look at what 73% efficacy achieves with the FDA









The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint. A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.

Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.

[sci102] 13/4/2024 09:44

Name 2 please. (And then you'll see *why* they got a conditional authorisation after phase 2).

[marcusl2] 13/4/2024 09:40

It wasn`t Lindy. Have a listen to it Mia and tell me what you think.

There are examples of P II approval for increased efficacy so IMHO it`s not far fetched.

I think the most likely outcome will be a big deal or buyout before that but it is all about the data as we know. Roll on Q3/4.

[miavoce] 13/4/2024 09:21

Perhaps by commercialisation LD simply means a commercial deal that will provide upfront (large) and milestone payment to Scancell.

[sci102] 13/4/2024 06:31

And I'm telling you it is very far fetched. But let's look at the results of current trial first.

Note that this kind of thing usually happpens when there are no other decent options. And for first line late stage melanoma there are options. We are not aiming to be the first to demonstrate efficacy for first line late stage melanoma, we are aiming to be the best option.

[marcusl2] 12/4/2024 21:17

"which gives us a route to commercialisation potentially at the end of phase II"
33mins

[sci102] 12/4/2024 16:55

Where does it say that it will be approved on phase 2 data?

[inanaco] 12/4/2024 16:53

In a double blind trial it is implicit that the assessment of patient outcome is done in ignorance of the treatment received. Such blind assessment of outcome can often also be achieved in trials which are open (non-blinded). For example, lesions can be photographed before and after treatment and assessed by someone not involved in running the trial. Indeed, blind assessment of outcome may be more important than blinding the administration of the treatment, especially when the outcome measure involves subjectivity. Despite the best intentions, some treatments have unintended effects that are so specific that their occurrence will inevitably identify the treatment received to both the patient and the medical staff. Blind assessment of outcome is especially useful when this is a risk.

[marcusl2] 12/4/2024 16:50

Maybe you know better than Scancell amigo. 33mins

[sci102] 12/4/2024 16:34

Very far fetched. Sorry.

[inanaco] 12/4/2024 16:13

Crossover studies

In crossover studies, the people in each trial arm receive that treatment for a time and may then have the opportunity to swap to the other treatment. This can mean all participants have all treatments and helps confirm which is the most effective. If the new treatment doesn’t work as hoped with the first group, the second group won’t cross over. You also won’t cross over if you are doing well on the first treatment.

that is why a cross over is important it allows us to treat "failed" checkpoint patients

you have full control of that cohort and proves up the vaccine by quite a margin

[inanaco] 12/4/2024 16:07

FDA



they don't agree with you either



Although the value of a DMC is well accepted in settings such as those described above, it is
important to recognize that DMCs add administrative complexity to a trial and require additional
resources, so we recommend that sponsors limit the use of a DMC to the circumstances
described in Section 2.1. There are several factors to consider when determining whether to
establish a DMC for a particular trial. These factors, discussed below, relate primarily to safety,
practicality, and scientific validity


Conflicts of interest deserve special consideration in choosing individuals to serve on a
DMC. The most obvious conflict is financial interest that could be substantially affected
by the outcome of the trial. (See Section 6 for further discussion. See also Department
of Health and Human Services, Financial Relationships and Interests in Research
Involving Human Subjects: Guidance for Human Subject Protection, available at
hxxp://www.hhs.gov/ohrp/humansubjects/finreltn/fguid.pdf.)
Investigators entering subjects into the trial have a different type of conflict of interest—
their knowledge of interim results could influence their conduct of the trial. An
investigator who is aware of early trends might change his or her pattern of recruitment,
or modify his or her usual way of monitoring the status of participants. We therefore
recommend that DMC members for a given trial not include investigators in that trial.
Individuals known to have strong views on the relative merits of the interventions under
study may have an "intellectual" conflict of interest and might not be able to review the
data in a fully objective manner; such individuals may therefore not be optimal DMC
members. We recommend that sponsors avoid appointing to a DMC any individuals who
have relationships with trial investigators or sponsor employees that could be considered
reasonably likely to affect their objectivity.

[inanaco] 12/4/2024 15:53

read the pdf .... does not matter what you think is correct ...

"employees of the sponsor) involved in the conduct of the clinical trial (e.g. investigators) should not
serve on the DMC."

ATB

[marcusl2] 12/4/2024 15:24

Scancell`s words not mine.

It is not far fetched if the data is good enough. Other companies have done it.

Most recently, IQVIA released a report finding that 25 of 59 (42%) novel drugs approved in 2018 were approved on the basis of only one trial. And one out of eight approvals relied only on Phase 1 or 2 trials, with no Phase 3 trials.

[sci102] 12/4/2024 14:18

To commercialise after just the phase 2 part of the phase 2/3 is very far fetched. A deal hopefully.