Scancell Share Discussion Threads

[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.

[bermudashorts] 12/4/2024 14:11

Inanaco,

You seriously think that patients on double blinded trials need two doctors and they're not told their scan results and that appointing a DMC is some frivolous unnecessary expense and you tell me to correct my posts! For clarity:-

1) DMCs are a routine element of large, randomised, multicentre clinical trials and the more serious the setting the more likely a DMC will be used.

2) Patients on a double blinded study do NOT need two doctors. The one doctor treats patients on both arms of the trial in exactly the same way and can ask the DMC or CRO to reveal which arm of the trial the patient is on if he needs to know for safety reasons.

3) The only difference for a patient on a blinded trial is that he/she doesn't know which arm of the trial they are on - in all other respects their treatment is exactly the same including being informed of the results of any scans.


I really am going to leave it here. I don't know whether the study will be blinded or not. None of us do and with data from just 13 patients it's not something we have to worry about for a good while.

[marcusl2] 12/4/2024 13:58

Scancell did say that they could potentially commercialise at the end of phase II in their phase II/III registration trial which will include the USA.

I would imagine that if the results look good in Q4 then a big partner will dictate what happens then.

Just a reminder that Scib-1 as a monotherapy is as good as Moderna`s data with checkpoint.

If our data continues to be as good we will beat Moderna hands down.

iScib+ with doublet could be the best game in town. We could then get the whole Melanoma market (USD 7.5 billion by 2032) Our patent runs to 2039.

Dr Jean-Michel Cosséry said that big pharma has cash and are very risk averse so do not mind waiting for the data and paying more.

[inanaco] 12/4/2024 11:43

you need to correct this post Bermuda

it conflicts with DMC guidelines

Bermudashorts12 Apr '24 - 11:03 - 7758 of 7761
0 0 0
No they don't - the same oncologist looks after the patient.

Re. the DMC - they will be experts and simply analyse and report back on the data. What Scancell decided to do with that analysis is up to them.

========================================================================

and stop propagating that a double blind trial is one that scancell can start and is preferred

It isn't and the costs would be completely disproportional to any advantaged gained
because stage 4 patients on a randomised trial should have a cross over option and be fully informed

efficacy drives the result ........... and that is patient scans and what patient would have a scan and not want to be told the result ?

[bermudashorts] 12/4/2024 11:43

What do you mean except in my trial?

[2tyke] 12/4/2024 11:42

Think this BB is the 'blind leading the blind's
Is that double blind ?
Well we've had great news of progress...efficacy...licence deal...funding...trials...you name it. The share price still drops.
........
Does that make sense in your world ? No ?
Well it does in mine !

[inanaco] 12/4/2024 11:17

double-blind study


A type of clinical trial in which neither the participants nor the researcher knows which treatment or intervention participants are receiving until the clinical trial is over. This makes results of the study less likely to be biased. This means that the results are less likely to be affected by factors that are not related to the treatment or intervention being tested.

except in Bermudas trial .......

[inanaco] 12/4/2024 11:14

Bermuda then you have destroyed your "double Blind" data set

and thats not what the guidelines say ..

While a DMC completely independent from the study sponsor would be desirable, this is not always
possible. Usually DMC members will be appointed by the sponsor, often in cooperation with the
principle investigator(s) of the study or the steering committee. Furthermore, the sponsor will not only
pay for the expenses of the DMC members, but often will also pay an honorarium to account for the
time DMC members have to spend. So there are some unalterable relations between sponsor and DMC
members, but when it comes to the appointment of DMC members possible conflicts of interest should
be taken into account. Potential candidates for a DMC membership should have no financial interest in
the outcome of the study. Thus, it is obvious that e.g. employees of the sponsor who naturally have an
interest in the trial outcome should not serve on a DMC. Besides financial interests other aspects
should also be taken into consideration when assessing a possible conflict of interest. For example the
planned authorship of DMC members in publications on study results might impact the independence
of the DMC and is a non-financial conflict of interest. Furthermore, in order to allow for an unbiased
assessment of study data and not to bias the further conduct of a clinical trial, any person (not only
employees of the sponsor) involved in the conduct of the clinical trial (e.g. investigators) should not
serve on the DMC. Another problem might arise in case a potential DMC member serves in parallel
on the DMC of a clinical trial in the same indication area but with a different sponsor. This constitutes
a conflict of interest that should be avoided.



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

[inanaco] 12/4/2024 11:09

the problem you have Bermuda is this

The Efficacy is so high that you do not need to influence the trial to inflate the data

and if you did how would you do it ?

they cannot predict failures to the checkpoints if they could the NHS would after all save itself £100k/patient

every patient taking SCIB1 in the previous trials produced a T cell response we even tried to use tests that would predict a response but they never got past scrutiny

[bermudashorts] 12/4/2024 11:03

No they don't - the same oncologist looks after the patient.

Re. the DMC - they will be experts and simply analyse and report back on the data. What Scancell decided to do with that analysis is up to them.

[inanaco] 12/4/2024 10:53

this needs to be done by MI6

[inanaco] 12/4/2024 10:45

one oncologist has to stay blind ...... with the patient

otherwise its not a blinded trial

your DMC committee has to un-blind to report how ? what data in a blind trial are they looking at ?

another oncologist report

[bermudashorts] 12/4/2024 10:41

I have no idea why you think blinding a study requires 2 oncologists per patient. As for integrity, a quick search of clinicaltrials.gov brings up nearly 2500 oncology blinded trials. If you think they're unethical then tell the FDA.

Will repeat one last time - Scancell may or may not run a blinded study but they need to do whatever gives them the best chance of approval.

[inanaco] 12/4/2024 10:38

not blinded

[inanaco] 12/4/2024 10:24

so you have doubled the attending oncologist's Bermuda

one that knows what the patient has

another that does not

meanwhile you are keeping the patient out of the loop while taking scans !

and your trying to maintain integrity

who is paying for this ?

[inanaco] 12/4/2024 10:20

Pharmaceutical industry trials most often maintain blinding until all participants have finished the protocol [2]. This practice reflects concern that debriefing individual subjects may inadvertently unblind investigators and those evaluating outcomes. Unmasking or bias could occur if unblinded subjects discuss their treatment and outcomes with subjects still on protocol, or relate their experiences to clinicians who work alongside the investigators outside of the trial. Sponsors may also be concerned that subject-by-subject debriefing can affect recruitment for longer-term open trials that frequently follow controlled trials. Open extensions also pose some of these risks to internal validity since they enable subjects and clinicians to correlate outcome with treatment, but are perceived as less threatening than unblinding subjects before investigators.

In other research, a non-blind physician uninvolved with data collection discloses actual study assignment to subjects when they finish their participation while keeping the investigators blind (e.g., Ref. [3]). Doing so may entail extra logistical complexity, including the involvement of different clinicians or sites to provide care in open extensions.