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Violindog - correct, the FDA wouldn't clear the IND. From memory, they wanted more data from Ichor re. the electroporation device.
Crumbs - sorry!
Dalester,
Good post and I agree with most of your comments, but I don't think there was any issue with patient numbers on the original SCIB1 trial. It was a phase I/IIa trial and was powered to achieve the aims of the study which were safety, dosing levels and to find out whether SCIB1 warranted further development. Patient numbers were fairly typical for such a study and sufficient to achieve the objectives of the study.
So the problem wasn't low patient numbers for that phase I/IIa study, it was that Scancell didn't follow up with a larger randomised study in a timely manner. Remember, in 2016 the intention was to commence an 80 patient US based trial with Keith Flaherty as princiapal investigator. Had they gone ahead, that study would have been completed over 5 years ago now and Scancell might have been in a very different place.
ASCO abstracts have been published today and below is link to Scancell's Modi1 abstract. Really good to see no evidence at all of raised levels of anti-CCP antibodies which are associated with RA and other autoimmune diseases. Looking forward to seeing extra detail on the poster when it appears on Scancell's website.
https://meetings.asco.org/abstracts-presentations/221736
Chelsea,
I'm hoping that the next RNS will be to announce completion of recruitment to cohort 4 and permission to expand the combination arm of the trial at the full dose. We know that back in Feb 3 patients had been recruited to cohort 3 and they were screening patients for cohort 4. It obviously depends on whether the screened patients met the eligibility criteria, but this news may well come before ASCO.
I know we are all keen to receive updates on patient's responses, but completion of cohort 4 signifies the end of the dose escalation phase of the combination study and then it really will be full steam ahead for the whole trial. It will also mean that they can open the neoadjuvant arm of the study to recruitment. An important and significant point in the trial - IMO.
BOJO,
Sorry have only just seen your 9.45 post.
This has to be viewed in the context of Prof. Ottenmeir's role. As Principal Investigator he is bound by the terms of his contract with Scancell and does not have autonomy over unpublished results. His duty is to report results back to Scancell, he can't simply take it upon himself to start divulging new, previously unpublished trial results. He will also be fully aware of Scancell's disclosure obligations and the potential ramifications of leaking or disclosing of results. His contract is highly likely to allow for publication in peer reviewed journals etc., with prior approval from Scancell.
So I believe that the point I was making yesterday still stands - Prof. Ottensmeier won't be releasing or divulging updated/current trial results in his presentation as the cut off date for submission was back in February. Updated results would have to come from Scancell via RNS.
A few quick responses to various points raised today:-
Defender - Think it would be overly onerous to produce 6 monthly financial statements based on the calendar year as well as the interims and annual report in line with the financial year. We were told in the interims at the end of Jan that the cash runway was to Q1 2024 and assume this remains the position.
Genmab milestone payments - Scancell are trying to license other glycan mAbs and will be (or intend to be) negotiating terms with other companies. The triggers and levels of milestone payments agreed with Genmab are therefore commercially sensitive and must surely remain confidential. Scancell will issue an RNS as and when milestones are paid.
ASCO presentation - as discussed previously with the AACR presentation, these abstracts need to be submitted months in advance. From memory the ASCO abstracts submission deadline was end of Feb/March and we have already had top line results from completion of the monotherapy dose finding arm of the study. (see RNS of 21st Feb). Scancell may well use ASCO as an opportunity to provide a fresh update via RNS, but for clarity, the poster being presented by Prof. Ottensmeier will relate to the results detailed in the 21st Feb RNS. Hopefully he'll expand on those results, perhaps with more detailed immunogenicity data.
Chelsea,
I think both will do all they can to assist. Redmile in particular are about as well connected as it's possible to get and I'm sure will generously share/facilitate where appropriate. Having said that, they are invested in dozens of companies at any one time and I don't see them getting overly involved in strategy or the running of Scancell. Supportive from a distance is perhaps the best description. IMO
Chester,
Sorry, am being slow today and am not quite with you. I was simply trying to explain that the distinction between the roles of Principal Investigator (Ottensmeier) and the sponsor/funder of a trial (Scancell) might mean that it's acceptable for one to be involved with this media story, but not the other. So it could be that Scancell haven't commented because they can't and this is one instance where criticism regarding lack of PR isn't justified.
Although I can understand the frustration at the lack of any reaction from Scancell regarding this article, I think we have to be a little careful about reading too much into it.
As I posted the other day, I think this article originated from the Clatterbridge Centre. The clip below explains how their Communications Team work - worth watching to the end. I also posted that media coverage of ongoing clinical trials is fraught with ethical and practical considerations. The Clatterbridge Centre are independent - there is no conflict of interest as they have no financial vested interest in the outcome of the trial. Even so, they have to be very careful not to raise false hope or mislead in any sense and that the article isn't seen as an advert. This is even more of a difficult issue if the sponsor (Scancell) of a trial gets involved as it could be argued that there is a potential conflict of interest and the Ethics Committee (who must approve all advertising) may object, especially given the very early stage of the trial.
So it may simply be that Scancell haven't commented because good practice dictates that they shouldn't! Only Scancell and their advisors can make that call and I'm absolutely sure that if they could they would (or will).
https://www.youtube.com/watch?v=JwRSpLDOUe8
Rats,
Correct. Cohort 2 received the full Modi-1 high dose as a monotherapy. For clarity, the dosing levels and setting for each cohort are as follows:-
COHORT 1 -Modi-1v 80ug vimentin only peptides as a monotherapy
COHORT 2 - Modi-1 400ug all peptides (inc. enolase) as a monotherapy
COHORT 3 - Modi-1 low dose all peptides in combination with SOC checkpoint inhibitor
COHORT 4 - Modi-1 400ug all peptides in combination with SOC checkpoint inhibitor
As you can see, cohort 1 received a very low dose of only the vimentin peptides yet from memory 1 patient has been reported with stable disease from this cohort. It will be interesting to see whether cohort 1 patients are moved to the higher full dose and also to see any differences in response between the monotherapy and combination cohorts.
Violindog,
Trish was actually in cohort 2 and received the full Modi-1 dose.
WTP - an excellent spot and thanks very much for sharing.
FWIW my take on this article is that Crumbs and AB124 probably have called it right. I think the article is highly likely to have originated from a press release from the Clatterbridge Centre rather than from any other source or from the patient contacting the media directly. It's a win/win for Clatterbridge as not only does it raise awareness of the trial and help with recruitment, but it also raises the profile of Clatterbridge as a research centre . The contract between Scancell and Clatterbridge will cover publication and communication of trial updates/results and may well include a clause allowing such press releases. Media coverage of ongoing clinical trials is an area fraught with ethical and practical dangers and there are strict guidelines in place to ensure that the coverage doesn't lead to unreasonable hopes and expectations from the public and also that it doesn't damage the integrity of the trial. Prof. Ottensmeier will therefore have chosen his words very carefully.
Below is a link to a very similar article regarding a patient on one of Redx Pharma's clinical trials. The articles are very similar and you'll notice the mention of PA news agency. It will be interesting to see how this now develops. The Redx story ended up being covered by ITV News, the Independent, Telegraph, Daily Mail etc. I guess it all depends on what other news stories are about.
https://www.liverpoolecho.co.uk/news/uk-world-news/womans-stomach-sank-diagnosis-after-24884199
Interesting article below from Ben Schumann, Imperial College/Francis Crick which gives some background and context to the field of glycobiology . Some quotes from the article, followed by one from Scancell-
'perhaps no other field is as understated despite such a heavy clinical impact'
' Why is biomedicine still largely turning a blind eye to glycobiology? In my opinion – because they are difficult to deal with'
'glycotime” is rapidly gaining momentum in therapy and diagnosis'
'We (Scancell) remain one of only a few companies worldwide that has the capability to produce high affinity, humanised anti-glycan antibodies'
https://network.febs.org/posts/what-time-is-it-glycotime?channel_id=665-research
Cleanerworld - first and foremost, I was truly sorry to hear of the issues you're facing and sending you my very best wishes and hopes for your results coming back with a benign pathology.
Chester - thanks, although Scancell have confirmed the partial response and patients with stable disease via RNS so I'm not sure it is anecdotal. Agree with your final sentence.
Crumbs - if that is the case, then no matter how good the intentions, they are misguided. I understand the desire to 'help', but when it comes to running clinical trials and dialogue with patients on the trial or potential recruits to the trial, Scancell do not need help and it is absolutely best left to the professionals. I'm assuming that their intentions are good because if they are fishing for information, then they're playing a dangerous game.
Chester - from your excellent summary below:-
'We have heard whispers of continued good results'
That is the second reference on this board today suggesting rumours of good results from the Modi-1 trial. Can you tell me what is the source for these whispers/rumours?
TF -
Ah OK - so when people say that a precedent has been set and they must have the 2nd scan results, the need for consistency stops there and they won't be requiring updates from subsequent scans. Seems inconsistent to me but thanks for clarifying.
Back on 15th April I mentioned that the next big scientific conference is ASCO in June and wondered whether Scancell might attend. Abstract titles have been published today and it's great to see that a Scancell abstract has been submitted and accepted and that the Principal Investigator for the Modi-1 trial, Christian Ottensmeier will be presenting it.
Modi-1, anti-citrullinated neoepitope vaccine, alone and combined with checkpoint inhibitors in patients with head and neck, breast, renal, and ovarian cancers: ModiFy phase I/II basket clinical trial—Report after completion of monotherapy dose-finding.
Presenter: Christian H.H Ottensmeier, MD, PhD, FRCP | The Clatterbridge Cancer Centre NHS Foundation Trust
Abstract: 2566
| Poster Bd #: 408
https://conferences.asco.org/am/dates-know
TF - if folk are suggesting that an RNS is overdue and have confirmed that they're expecting it because the first update has set a precedent and consistency now must be maintained by reporting the 2nd scan result, then logic suggests that they'll also expect an update after the following scan - ie. on a scan by scan basis.
WW - I have no idea whether the 2nd scan result for those patients would be considered worthy of an RNS in terms of the overall trial. Evaluation of data from 100% of available patients at the outset of a trial when you are making decisions about dosing levels and ongoing protocol is very different from evaluation of a subset of patients mid trial. In fact, publishing results from that subset could be misleading and it might be dangerous to make investment decisions on that basis. Raising questions about PR and IR is one thing, but I don't believe any of us have sufficient information to make any judgement calls whatsoever about the quality of dissemination of clinical trial results from Scancell. I'm happy to trust that Lindy Durrant and her team, in conjunction with the study investigators will update the market as and when they have the data and in line with industry guidelines.
Yet again we'll have to agree to disagree .
At no stage have Scancell raised expectations that they will continue to report on these 14 patients on a scan by scan basis in isolation as they continue through the trial.
WTP,
The suggestion that a clinical trial update has been delayed to allow time to get share options in place is an interesting one and I hope you understand the implications.
Of course the timing of the share options could simply be down to the fact that the Remuneration Committee have carried out an annual review as we're at Scancell's financial year end and there is no connection whatsoever with any of Scancell's clinical trials. Previous awards have been made at exactly the same time of year so this does seem likely.
1) Scancell are at their financial year end and the Remuneration Committee have met an carried out an annual review . Worth noting that previous announcements re. Chairman's options have been made at this time of year.
2) As you and wigwammer seem to be suggesting, Scancell have delayed publication of clinical trial updates to secure a lower strike price for the recently issued strike price.