Member Info for KonarA

@Berm I must have missed it.. when was cohort 4 given the green light?

In October they announced that Cohort 3 (modi + cpi) was recruiting. By feburary I was expecting 8 week results for this cohort, so was surprised when in the Feburary update lindy said "These results allow us to proceed with the monotherapy expansion cohorts and into the cohorts in combination with checkpoint inhibitors as planned." My reading of that at the time was that the Checkpoint inhibitor recruitment hadn't actually progressed since the October, as there was no specific mention of having treated any cohort 3 patients and the wording of "proceed into" suggested "yet to happen"

Yes according to that poster Cohort 3 was fully recruited and dosed in Feburary, but hadn't yet reached the first evaluation stage. By now they should have evaluated all cohort 3 patients and be ready to progress to cohort 4. Cohort 4 being particularly significant as they will be the first patient to receive a full dose of Modi 1 + Checkpoint inhibitors. This should "in theory" see the most benefit.

also important to remember the stated purpose and design of the trial. They are trying Modi-1 in a number if indications, with and without checkpoint inhibitors and also in a neoadjuvant setting. The aim is to find out:
Does Modi-1 stimulate T cell responses in cancer patients?
Do these T cells remain active within the tumour?
Does the tumour regress?
What biomarker predicts response?
Which is the most relevant cohort to expand further?

In other words this trial is designed to inform them where best to target Modi-1 for late stage trials. They will be a LOT more informed about the way Moditope works in humans as a result of the trial. By identifying biomarkers that may predict the response, they may get far better "success" percentage.

yeah this was quite the revelation to me at the time. I had certainly had my expectation set previously that results would be seen in a similar time frame to mice, so was a recalibration for me.

But is it the abstract and poster that needs to be submitted, or just the abstract? Or can the poster only reflect what was in the abstract? Just trying to determine if the poster can contain updated data like numbers of patient's dosed and so on..

@Bermuda, just in addition to your 9:17, I would add the following...

The expectation on here seem to have been that Lindy would be doing a full Oral presentation at AACR, and the fact that she is "Only doing a poster presentation" is seen as some sort of disappointing negative. But of the roughly 6000 abstracts submitted for presentation, the massively overwhelming majority of them are poster presentations. A poster presentation is standard and par for the course for AACR.

I would invite anyone to download the Programme PDF on this link and assess for yourself just how many are "only poster presentations"

https://www.aacr.org/aacr2023_abstractpresentations040123/

Does anyone know if AACR have to pre-approve the poster, or if Scancell just rock up with it on the day? Just trying to get a gauge of how up to date the poster data can be.

For the same reason we always get selling after expectations have been set at an impossibly high bar.

@Bermunashorts 100% spot on as usual

@rigga you are reading this all wrong. It isn't a sales conference, it is a Science conference. The whole purpose of the conference is to share scientific knowledge and understanding between AACR members. It's provides opportunities to form scientific collaborations with fellow researchers and clinicians around the world. Lindy is not just stood in front of a poster hawking her wares.

@dalester i think the idea behind orphan drug designation is that the product can "only" be used to treat that specific illness, and without orphan status it would unlikely be business viable to produce. In the case of Modi 1, H&N is just one indication that it is targeting. I *suspect* (I don't know) that would make it ineligible for Orphan Status.

@bojo - No problem. I wasn't trying to dunk on you or anything, just saw it as an opportunity to make the point.

Its also worth remembering that it was a poster presentation in 2015 that prompted the engagement with Keith Flaherty and the plan to do a SCIB1 trial in the States. So plenty can come from doing an early poster presentation at something as big as AACR. It's why I rec'd your post the other day on possible outcomes of AACR - I thought they were much more likely expectations.

It's why talk of being selected for the official press release was way off mark. The event organisers reviewed our abstract and determined it warranted a poster presentation, they weren't going to then specifically pick it out as being press release worthy.

We are early in a phase 1. Its good that we are seeing positive results from the patient's dosed to date, but many more patient's need to be dosed and much more positive data needs to be collected before this takes centre billing.

Just in response to Bojo's "When the room starts to clear"

Scancell are doing a "Poster presentation" they are not doing a "Presentation". There won't be a room full of people listening to Lindy speak. There will be "whoever walks up to the poster and asks to speak to her".

https://en.m.wikipedia.org/wiki/Poster_session

Worth looking at this link to see what a poster session looks like.

It's great that we are at AACR doing a poster presentation, but the real excitement will be when we are actually doing a full presentation of some conclusions.

For me, the hope is that they will want to be able to discuss the latest data, and it's that which will prompt the need to release an RNS. This abstract looks to have been "True at the point of submission" which will have been months ago. We can tell that from the numbers of patients treated at the end of the abstract.

https://www.abstractsonline.com/pp8/#!/10828/presentation/10452

I can see the full abstract now

Looking at the titles of last year's abstracts held back for presentation, they were all trials that had reached conclusions. I think it will be highly optimistic to assume or hope that Scancell's phase 1 trial in progress would be select for the official press release.

@Chester I cannot fault the logic of why you expect an RNS.

One thing I am certain of, after many years invested in Scancell, is they rarely do what you expect them to do. For good or worse.