Member Info for JohnnyB1

Thank you for your comments Chester, I really appreciate it.

Hopefully we will hear something soon.

This is the link to the Modi 1 ASCO abstract disclosures:-

https://coi.asco.org/Report/ViewAbstractCOI?id=420524

Amongst the names of Scancell employees and Principal Investigators from some of the Modi trial centres is the name “David Cameron – no relationships to disclose”. Having dismissed the former Prime Minister I did a search to establish who this is. I suspect that it is Professor David Cameron:-

https://www.ed.ac.uk/profile/david-cameron

It is worth reading the link e.g. “Internationally he is the chair of the Breast International Group, a Brussels-based umbrella group of 57 worldwide academic/not-for-profit breast cancer trials’ groups, and the vice chair of the steering group of the Oxford-based Early Breast Cancer Clinical Trialists’ Group. He is active in a number of current and past clinical trials in breast cancer”.

I found the following link from The ASCO Post (in 2020) that gives disclosure information at that time:-

https://ascopost.com/issues/november-25-2020/epov-david-cameron/

“DISCLOSURE: Dr. Cameron has served as an institutional consultant or advisor to Daiichi Sankyo, Eisai, F. Hoffmann–La Roche AG, Lilly, Merck Sharp & Dohme, Novartis, Oncolytics, Pfizer, Prima BioMed, Puma Biotechnology, Research Triangle, Roche, Samsung Bioepis Co Ltd (Korea), Seattle Genetics, Synthon, and Zymeworks; has received institutional research funding from AstraZeneca, Novartis, and Roche; and has been reimbursed for travel, accommodations, or other expenses by Novartis”.

A delayed "unknown" trade 333,333 shares @ 15.25.

Bermuda, Thank you for your in depth explanation, much appreciated.

Bermuda,

Thank you very much for that. I just wish that I had known about the bioRxiv site before. I got my information by reading the 2 vaccine subjects side by side which was not easy.

Scancell’s financial accounts for the year ending 30 April’22 show Grant Income of £965,000. This was grant income from UKRI to fund development and Phase 1 trial costs for Covidity. This was the last money received as the accounts for the 6 months ending 31 October’22 show Zero Grant Income.

On 26 May’23 Scancell put the following vaccine publication on its website:-

https://www.scancell.co.uk/Data/Sites/1/media/publications/papers/brentville-et-al-2023.pdf

It is an updated version of the following vaccine publication that Scancell put on their website on 22 June ’21:-

https://www.scancell.co.uk/Data/Sites/1/media/publications/papers/brentville-et-al-2021-preprint.pdf

The new item (received 13 April’23 and published 2 May’23) states “Work was funded by Scancell Ltd and grant from UKRI”. I suspect that the work in the earlier vaccine publication was funded by the grant from UKRI and the extra costs associated with the new publication have been covered by Scancell.

A lot of work has gone into the new publication. Here are some of the differences I spotted (as a layman):-

The earlier version only makes reference to the Alpha and Beta variants. The new publication also makes reference to the Delta variant.

The earlier version only made reference to mice. The new publication also refers to rats; it states “To confirm that T cell responses could also be stimulated in different species, responses were also analysed in immunised rats, These results demonstrated that T cell responses to RBD and N protein could be induced in rats”.

The new publication includes experiments performed by Texas Biomedical Research Institute. It states “In Vivo virus challenge model: SARS-CoV-2 viral challenge experiment [73] was performed at Texas Biomedical Research Institute (Texas Biomed; San Antonio, Texas, USA)”. This is the centre that also worked on the first Pfizer-BioNTech COVID-19 vaccine; it is worth looking again at the short video on this link:-

https://www.txbiomed.org/about/

So, why has Scancell spent more money on this new vaccine publication and all the associated costs?

We know Scancell is seeking a partner for Covidity. Maybe a new potential partner has requested this as part of their due diligence before committing to a deal?

To be honest I skimmed through this paper as it is over my head. I was expecting it to be an in depth write up of the Covidity trial. Instead I was reading about experiments in mice and rats, I genuinely thought that I had lost the plot.

I eventually worked out that it is an updated version of the following paper on Scancell’s website dated 22 June 21:-

https://www.scancell.co.uk/a-novel-bivalent-dna-vaccine-encoding-both-spike-protein-receptor-binding-domain-and-nucleocapsid-protein-of-sars-cov-2-to-elicit-t-cell-and-neutralising-antibody-responses-that-cross-react-with-variants-1

The extremely interesting thing about the updated document is that the affiliations now include the Disease Intervention & Prevention Program, Texas Biomedical Research Institute, San Antonio, Texas 78227, USA.

The Texas Biomedical Research Institute worked on the first Pfizer-BioNTech COVID-19 vaccine. I can recommend looking at their website and the short video in this link:-

https://www.txbiomed.org/about/

Hopefully not a dead parrot after all : - )

I’ve been thinking along the same lines.

Despite the numbers already dosed it is only Trish who has shared information. However, she has never given away any information that Scancell have not already RNS’d. Yes she gave percentage of tumour shrinkage (Firstly on 2 November’22 and then on later dates) but that was after Scancell’s RNS of 31 October’22 that stated “The first patient to be assessed has shown a partial tumour response at first radiological reassessment”.

I see that the ModiFY link details the timeline for the Scans and vaccines:-

https://modi-1-study.digitrial.com

There is a scan and vaccine in week 25 then every 12 weeks. Trish’s week 37 was 2 May’23. This ties in with what she said on the MM site on 20 March’23, she said “Next round of vaccines and scans are planned for early May. I'll let you all know how that goes”.

However, she has given no update on the MM site; instead we have just had the story in the press (and on the Clatterbridge Cancer Centre website). This story does not disclose any new information that is not already known and reflects the patient’s position as it was back in early February’23. It states:-

“Her tumour is now half the size it was when Trish started taking the vaccine in September last year.”

So while Clatterbridge (and I assume Scancell) were not happy to release this information in February’23, they were happy to do so earlier this month.

So, what has changed? I suspect (and hope) that more positive trial data has emerged from other patients that has made them now feel confident to do so. It is highly improbable that the first patient to get dosed in cohort 2 is the only one to get a partial tumour response. AIMHO

It is reasonable to assume that if the patient has now had a complete response and was asked not to disclose this she would be all too happy to oblige. I am not saying that this is the case because I have no way of knowing, but it would explain the thumbs up in one of the photographs.

I see it has also been liked by someone from Syneos Health. This is a link to their website:-

https://www.syneoshealth.com/insights-hub/syneos-health-podcast-full-service-commercial

Amongst other things they help emerging biotechs to bring their first product to market.

Syneos Health will also be at ASCO 2023.

Thank you for the link CW it gives a lot of information.

I see that they are no longer recruiting patients with high grade serous ovarian carcinoma (HGSOC) in the ModiFY trial. Lindy told us this was very popular so it must now be fully recruited.

There are now 11 hospitals open for the ModiFY trial. (Versus the 9 that were recruiting on the Clinical Trials website which was last updated 21 November’22).

The following 3 new sites have been added:

Mount Vernon Hospital

Royal Surrey County Hospital

Torbay Hospital, Torquay

One site is no longer showing: Christie NHS Foundation Trust, Manchester (I don’t know why, perhaps it was an ovarian cancer trial site?)

Another link to Trish's story. This time Liverpool Health Partners:-

https://liverpoolhealthpartners.org.uk/retired-nurse-given-lifeline-by-clinical-research-trial/

On 24 October’22 Scancell entered a collaboration with Genmab in respect of an anti-glycan monoclonal antibody (mAb) . We don’t know at what stage Scancell will start to receive milestone payments. Scancell have not disclosed this and searching the web tells me didly squat.

However, on 3 October’22 Oxford Bio Therapeutics also entered into a separate collaboration with Genmab in respect of one of its mAbs:-

https://www.labiotech.eu/trends-news/oxford-biotherapeutics-antibody-agreement-genmab/

I have used “way back machine” to look at Oxford Bio Therapeutics web site. You will see that as at 7 September’22 (BEFORE their Genmab deal) (Note: Date of web page screenshot is showing in top right of page) their OBT700 mAb is showing as “Preclinical” on their “Internal Development Pipeline”:-

https://web.archive.org/web/20220907054338/http://www.oxfordbiotherapeutics.com/pipelines-692929.html

Again using “way back machine” you will see that as at 19 November’22 the same OBT700 mAb is now showing as partnered with Genmab on their “Externally Partnered Pipeline”. Significantly it has progressed from “Preclinical” to “IND-Enabling”:-

https://web.archive.org/web/20221119163338/http://www.oxfordbiotherapeutics.com/pipelines-692929-692486.html

I think Genmab aren’t wasting any time and it would be fair to assume that Scancell’s mAb has also moved to “IND-Enabling”. I am not medically trained but a quick google tells me “IND-enabling studies are assays that aim to measure a new drug's safety for initial use in human clinical trials. These IND studies provide detailed information about each drug's dynamics, kinetics, and toxicity potential.”

Hi Crumbs,

I do not know if Trish is receiving Keytruda in the photograph, as I do not have the medical knowledge, but it is a very interesting point.

If that is the case it would fit in with something Trish said on the MM site on 21 February’23 (under the topic “Immunotherapy – Cancer Vaccine Trial). She said:-

“I'm seeing the oncologist next week to discuss what to do moving forward. I think he wants me to have a PET Scan next to get a more accurate picturThe 3rd cohort has commenced now and they are having immunotherapy combined with the vaccine. I'm not sure if that may be the next step for me too”.

If tumor shrinkage stopped at (or slowed down a lot) at a 55% reduction, might Scancell move a patient from monotherapy to Modi 1 in combination with a checkpoint inhibitor (CPI) (pembrolizumab or nivolumab)?

It is also worth mentioning that Cohort 3 is 3 patients with squamous cell carcinoma of the head and neck (SCCHN).

I see Trish's story is now showing in The Guide Liverpool. It is the same story as a few days ago but it also has another photograph:-

https://theguideliverpool.com/clatterbridge-cancer-centre-clinical-research-trial-offers-a-lifeline/

I was looking again at the Poster for AACR 2023:-

https://www.scancell.co.uk/Data/Sites/1/media/publications/posters/aacr_modify-study-poster_march-2023_final-corrected.pdf

I just noticed that Cohort 2 has a median age of 71 and an age range of 62 to 81. This effectively tells us the 3 patients are aged 62, 71 and 81.

There is one head and neck squamous cell carcinoma (SCCHN) patient in this cohort, Trish who is 62 (as we all know she has had a partial response).

There are also two high grade serous ovarian carcinoma (HGSOC) patients in this Cohort, one of whom has stable disease (at their first 8 week scan).

That to me (as a lay person) is pretty amazing that a 71 or 81 year old high grade serous ovarian carcinoma (HGSOC) patient has stable disease after 8 weeks.

The article in the Liverpool Echo does not disclose any new information that is not already known and reflects the patient’s position as it was back in early February’23. It states:-

“Her tumour is now half the size it was when Trish started taking the vaccine in September last year. Trish, who has a new grandson, George and another on the way, said: "The progress has been amazing”.”

So, why has she spoken to the newspaper now rather than 3 months ago?

If everything ran to schedule I calculate that Trish probably had her 6th dose on or around Tuesday 2 May’23 (* see below). I do not know when her next scan is due except that it is "early May".

Maybe she has now had that scan and knows the results? (She does say "The progress has been amazing”).

Perhaps she has gone to the Liverpool Echo with Scancell’s authority on the proviso that she does not disclose anything other than the partial response that has already been disclosed by Scancell.

* I came to this conclusion based on the following information that Patient “Y” posted on the MM site on 2 May’23:-

“Hiya - it's a 2 year treatment, with the vaccine being given 10 times; on day 1, and then weeks 4, 7, 13, 25 and after that every 12 weeks”.

The above correlates exactly with what we know of Trish’s timeline:-

DAY 1: 16 August’22 RNS First patient dosed in cohort 2

DAY 92 (Week 13 detailed above): 16 November’22 Trish had her 4th dose. Reported hearing completely restored.

DAY 175 (Week 25 detailed above): 7 February’23 Trish had her 5th dose.

20 March’23 Trish advised next round of vaccines and scans planned for early May.

DAY 259 (Week 37 i.e. 25 plus 12 detailed above) : 2 May’23 Patient X Trish should have had her 6th dose.

If Trish has had her scan (scheduled for “early May”) let’s hope that it is an improvement on the 55% reduction we already know about. Maybe Scancell will share that information with us soon?

I just read the following article (I looked back to see if it had been mentioned previously. I see that Cleaner had copied a link to it on 17 April’23 but no one had discussed it) :-

https://www.businesswire.com/news/home/20230416005028/en/Genmab-and-argenx-Enter-Partnership-to-Advance-Antibo

It states “Discovery programmes against two differentiated targets are underway”. I wonder if one of these targets is Scancell’s SC129 (specific for the sialyl-di-Lewisa glycan, a target for pancreatic cancer).

It reminded me of the recent Richard Goodfellow interview; 9 minutes in he mentions Argenx (I could be wrong but I get the impression that he is reading from notes to his right):-

https://www.youtube.com/watch?v=oGBn9pStUYs

RG says: “This is one of the most challenging things for any biotech company I think. I mean, everybody knows that the pharmaceutical business is a global business. Nobody is going to be interested in any product that is limited to a country or a region. Every biotech company’s ambition of course is to ultimately to have a global presence and have all the benefits of the margins that selling your own products can achieve. But there is a huge journey between starting up such a company and achieving that ultimate goal and very few companies do it. Most of them are American, there are some in Europe that are beginning to emerge after 20 years, a journey like Genmab and Argenx that are still finding it difficult to achieve it. So the only way you can move forward is, as Charles said, through collaboration, trying not to give too much away, always having to give something away, learning from partnerships, growing gradually, all the time being aware of the desire over time to increase shareholder value and you have to do that in stages. Those companies that can, shall we say, hold on to enough to achieve that shareholder value whilst in parallel using and leveraging the help and support of companies that are further down the road is the way to do it. It is an extremely hard balance to achieve”.

That is really good news Cleaner. All the very best.

I totally agree with EE's comments at 8.34. I do look at the MM site from time to time as an interested spectator. In doing so I have established the following information:-

If everything ran to schedule Patient X may have had her 6th dose yesterday. I do not know when her next scan is due except that it is "early May".

Scancell’s annual Confirmation Statement has been filed at Companies House today. This states 818,903,461 Ordinary Shares allotted as at 14 April’23.

https://find-and-update.company-information.service.gov.uk/company/06564638/filing-history

I think that this may be wrong.

Previously there were 815,218,831 shares in issue before Ichor Medical Systems exercised their option over 3,184,630 shares bringing the total to 818,403,461 (as confirmed in RNS dated 8 February’23).

I initially thought maybe RG had exercised 500,000 of his options from the 2,880,000 block listing (Detailed in RNS 17 April’23; which also states “At the time of this announcement, Scancell has 818,403,461 Ordinary Shares in issue”). However, this can’t be the case because the Confirmation Statement is dated 14 April’23 (Unless the Confirmation Statement is dated incorrectly?).