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I found a couple of bits of the interview confusing.

8 minutes in Lindy says “if you just had the double checkpoints at the moment you would expect about a 50% response rate i.e. your tumour starts to disappear, but in combination with our vaccine we are up to 86% of the tumours are disappearing at the moment”

We know 11 out of the first 13 patients responded. This is 84.62% and the RNS 17 January’24 rounds this figure to an 85% objective response rate. So when Lindy says “we are up to 86% of the tumours are disappearing at the moment” is she:-

1. Accidentally giving us the response rate on more patients than the initial 13 patients or

2. Was it just a simple mistake and she meant to say 85%

Confusingly (To me anyway) Lindy goes on to say:-

“……….. that was on 13 patients, we now need to expand that study to 43 patients and we are hoping to see at least 27 patients responding giving us a response rate of at least 70%. If we can get above 70% that would be a significant improvement for patients with metastatic or really end stage melanoma”

I found that confusing because 27 out of 43 is 62.79% not 70%.

Georgina Long is one of the “panel of international key opinion leaders” for iSCIB1+ Phase 2/3 Registration Clinical Trial named in the RNS 24 July’24.

She is also a Study Chair in the NADINA Clinical Trial and this is showing promising results. This is a Stage 3 trial in resectable, macroscopic stage III melanoma-

https://clinicaltrials.gov/study/NCT04949113

Both the iSCIB1+ (for unresectable melanoma) and the NADINA trials involve the use of Ipilimumab and Nivolumab.

The following link shows that the NADINA study was supported by Bristol Myers Squibb (not surprising given that the trial uses Ipilimumab and Nivolumab), a grant in Australia from the National Health and Medical Research Council (NHMRC), investigator grants from the NHMRC and funding from Nicholas and Helen Moore and Melanoma Institute Australia:-

https://www.esmo.org/oncology-news/neoadjuvant-ipilimumab-plus-nivolumab-results-in-longer-efs-than-adjuvant-nivolumab-in-resectable-macroscopic-stage-iii-melanoma

Others have said on here the possibility of Bristol Myers Squibb getting involved with the iSCIB1+trial. But that aside it is also certainly a possibility that Scancell could also get other grants and funding (Like the NADINA study has).

The RNS 24 July’24 names the panel of international key opinion leaders in the treatment of Melanoma. This names 2 people in the UK, 1 in the Netherlands, 1 in Australia and 5 in the USA.

Scancell’s website names 5 people in the SCOPE Clinical Advisory Board (I do not know when this was added to the website, I only spotted it a few days ago). Two of these (Dr Heather Shaw and Dr Pippa Corrie) are the two UK members of the Panel named in the above RNS:-

https://www.scancell.co.uk/scib1-iscib1

Interestingly, if you click on “Prof. Poulam Patel” it states “Patel is the UK co-ordinating Investigator for the SCOPE clinical trial”.

Obviously the existing trial is based in the UK but why say “UK co-ordinating Investigator” rather than simply saying “Co-ordinating Investigator”. Maybe the Phase 2/3 SCOPE-2 Trial will take place in UK, USA, Netherlands and Australia. (AIMHO)

I agree Chester, it would certainly fit in with the RNS 7 November'22:-

https://www.lse.co.uk/rns/SCLP/licenses-vaccitech-technology-to-advance-modi-2-5arpm4twcqxzkuu.html

"Company expects to initiate a Phase 1 clinical study with Modi-2 in 2024"

I see that Scancell put the ASCO Poster on their website yesterday. (The poster Lindy was referring when she said “We were also overwhelmed by the interest in the poster, which is the most significant response I have seen in my career.")

https://www.scancell.co.uk/annual-meeting-of-the-american-society-of-clinical-oncology-asco-31-may-4-june-2024-chicago-illinois-usa

I may be wrong but I interpret from the following that Redmile do not expect a Nasdaq listing.

When Redmile’s 3% CLN’s were originally issued Scancell’s Circular 12 October 2020 stated:-

“No conversion can occur prior to the Redemption Date, save for in the event of a takeover offer being made to shareholders of the Company or upon a Nasdaq listing.”

This has now changed, Scancell’s RNS 2 July’24 states:-

“The 3% Unsecured Convertible Loan Notes may now also be converted into ordinary shares at the election of the noteholder prior to maturity having previously only been convertible on the redemption date. The conversion price of 13 pence per ordinary share remains unchanged.”

I can only conclude that Redmile are not expecting a takeover or a Nasdaq listing. (If they were surely there would be no need to change the terms of the CLN’s so that they can now also be converted into ordinary shares at the election of the noteholder prior to maturity).

I suspect that there could be some sort of deal looming and Redmile expect the share price to go up (certainly before the CLN’s mature 10 November’27). This would also explain the appointment of Dr Florian Reinaud to look after Redmile’s interest. In the event of a deal and a rising share price Redmile would now be allowed to convert the CLN’s into shares at a price of 13 pence (They could also sell shares they already own, if need be, to stay below a 30% stake).

Sath did say at the Q&A following his presentation at Sachs 10th Annual Oncology Innovation Forum on 31 May'24 something along the lines of perhaps one day we will make the headlines in the financial press.

Separately, in my opinion the RNS is out by £100,000 of CLN’s. It is effectively saying Redmile start with £17.9 million 3% CLN’s, approximately £0.5 million is redeemed in cash and Redmile are somehow left with £17.5 million (rather than £17.4 million). I emailed Consillium 2 July but they have not yet replied.

I wonder if Dr Florian is behind the rise to just over 10 pence (One Florin = 2 shillings = 10 pence).

I look forward to the rise to £1.05 when Dr Guinea gets appointed :-)

Scancell’s science is certainly better than their maths.

At present Scancell have “August 2025 (£1.75m) in relation to the Nil Rate Unsecured Convertible Loan Notes and November 2025 (£17.9m) in relation to the 3% Unsecured Convertible Loan Notes”. I make that a total of £19.65m.

“As part of the agreement to extend the redemption dates, approximately £0.5m of the 3% Unsecured Convertible Loan Notes will be redeemed in cash on or around 5 July 2024”.

I make that a total of £19.15m CLN’s outstanding after the amendments (£1.75m plus £17.4m). However the RNS comes up with an extra £100k of 3% CLN’s resulting in an extra £100k in the total of CLN’s. It states:

“The total amount of the CLNs which remains outstanding following the amendments is £19.25m of which (i) £1.75m remains outstanding on the Nil Rate Unsecured Convertible Loan Notes and (ii) £17.5m remains outstanding on the 3% Unsecured Convertible Loan Notes.”

According to my calculations, looking just at the 3% CLNs:-

Under the existing arrangement £17.9m 3% CLN’s would in 12 months attract interest payable of £537,000 (In 12 months time there would still be £17.9m 3% CLN’s outstanding).

Under the new arrangement we have £17.9m. On 5 July’24 Scancell repay £500,000 resulting in £17.4m CLN’s outstanding. In 12 months time 3% interest accrued but not charged on £17.4m = £522,000

(In 12 months time there would be £17.4m 3% CLN’s and accrued interest of £522,000 outstanding).

Thank you Cleanerworld for posting the following link 3 days ago:-

https://www.sciencedirect.com/science/article/pii/s0142961224001819?via%3dihub

As a lay person the article is a bit over my head. However some things stood out to me:-

1. Starting with the obvious, the SARS-CoV-2 pDNA vaccine they are experimenting with is clearly Covidity.

2. I interpret they are looking at vaccine delivery methods. There are references to Gene Gun as the control of the experiment (It is worth noting that Texas Biomedical Research Institute were using a Gene Gun to deliver Covidity in their experiments).

3. Near the bottom of the article under a heading “Acknowledgements”, it states “Work on this project is supported by Wellcome Leap as part of the R3 Program”. If you google Wellcome Leap R3 Program you will find it is a $60 million project jointly funded with CEPI:-

https://wellcomeleap.org/r3/

It is interesting that despite appearing to have being set up to look at RNA vaccines it is looking at a DNA vaccine.

The RNS for the first patient dosed with iSCIB1+ in the SCOPE trial was issued on Tuesday 26 March 2024. That was 13 weeks ago today, so that patient has probably had or is about to have their first scan (due at 13 weeks).

I certainly wish the very best for the patient, Scancell and shareholders.

There is probably nothing in it and it is a bit above my pay grade to be honest. I am just wondering whether there is a possibility that the UK Government might help to support and accelerate Scancell’s Modify or Scope trials.

The reason I ask is because I have noticed that Maria Kuofali. Programme Director, UK Vaccine Innovation Pathway has liked a couple of Scancell’s posts on Linked in recently (Including Scancell’s post 2 weeks ago confirming MHRA approval to add an expansion cohort to the ModiFy trial).

This is a link to Maria Koufali and the Vaccine Innovation Pathway:-

https://www.nihr.ac.uk/blog/how-the-vaccine-innovation-pathway-is-advancing-vaccine-clinical-trials/35506

This is a link to a message about the “Vaccine Innovation Fund, a pivotal component of the Moderna Strategic Partnership with the UK” she sent to her colleagues earlier this year:-

https://www.nhsresearchscotland.org.uk/uploads/tinymce/UK%20Vaccine%20Innovation%20Fund%20_%2014%2002%2024.pdf

The focus is clearly on the Scope and Modify trials. However, something else caught my attention on the pipeline slide 3 minutes 20 seconds into the video:-

https://www.proactiveinvestors.co.uk/companies/news/1049866/scancell-holdings-promising-cancer-vaccine-developments-for-advanced-melanoma-one2one-forum-1049866.html

If you look at the arrows for Modi 2 and SC134 (The antibody Scancell want to bring into the clinic themselves), these are both very deep into the Pre-clinical section and almost on the cusp of the Phase 1 section. These appear to indicate that they are very close to bringing into the clinic.

Modi 2: The RNS 7 November’22 states “This agreement will allow Scancell to formulate and manufacture Modi-2, with the aim of initiating a Phase 1 clinical study in cancer patients in 2024”. It is also worth noting that Scancell are doing a presentation on Modi 2 at the Immuno-Oncology summit on 7 August’24:-

https://www.immuno-oncologysummit.com/cancer-vaccines?utm_source=linkedin&utm_medium=social&utm_campaign=vjm_final_track_agenda_20240423

Hi Chester, I think it is the same company. In the RNS 12 June'24 Lindy refers to "a leading international biotechnology company" and also says "this is now the second anti-glycan monoclonal antibody generated via our proprietary GlyMab® platform to be evaluated".

This is Lindy's complete statement "We are very pleased to announce this agreement today with a leading international biotechnology company. This is now the second anti-glycan monoclonal antibody generated via our proprietary GlyMab® platform to be evaluated, the first now being developed under a commercial licence agreement. This provides further validation of the potential of our antibody platform to create novel, differentiated antibody products. Whilst the agreement is for an initial exclusive evaluation period, there is an option to licence, and we look forward to providing the market with any updates in due course."

This was posted by Scancell 5 hours ago on Linkedin. They state “Later today” but this is a bit premature as the presentation is tomorrow:-

Later today, Bubacarr G Kaira, Scancell Ltd Antibody Research Scientist, will be in London for Antibody Engineering & Therapeutics Europe. Run in conjunction with The Antibody Society, an international trade association for individuals and organisations involved in hashtag#antibody hashtag#research and development, this event is Europe’s leading antibody conference for accelerating next-generation solutions towards commercial success.

Bubacarr will present ‘Unlocking the Unique Potential of AvidiMAb® in Clustering and Signalling’ from 5:15 pm – 5:45 pm BST, where he will share strategies to improve antibody target binding avidity and enhanced functionalities. If you are attending, stop by to hear more, or reach out to commercial.enquiries@scancell.co.uk to arrange a meeting.

To find out more about hashtag#AntibodyEng: https://lnkd.in/g7cRV49

hashtag#CancerVaccine hashtag#Biotech hashtag#Innovation

This is what it says on the link to his presentation:-

Unlocking the Unique Potential of AvidiMAb® in Clustering and Signalling

Strategies to enhance antibody (mAb) avidity prove valuable in the context of prolonged target occupancy and/or enhanced clustering and signalling. AvidiMab® is an Fc-engineering technology used to create higher avidity GlyMab® (anti-glycan mAbs) and immune-agonistic mAbs such anti-CD40 and anti-4-1BB agonists. These AvidiMab®-modified mAbs displayed improved target binding avidity and enhanced functionality.

Bubacarr Gibril Kaira, Ph.D.

Antibody Research Scientist

Scancell Limited

Hi TorquayFan,

I think you’re right, I was probably being over cautious. This is the very heart felt comment posted on linkedin by Peter Symonds, Laboratory Manager / Research Scientist at Scancell:-

“My father is a recently retired prof of oncology. Xmas day in our house was me and my sister's putting on smart clothes and visiting the patients too ill to go home for one day. At the time this was just how life was and it was far from unpleasant too. The poor juniors and nurses working the 25th always made a fuss of us and the patients were equally lovely. Only recently I've realised how remarkable it was and how few senior doctors these days would do the same. I've spent the majority of my working life with scancell helping to get these drugs to the clinic so every but of good news like this makes it worthwhile. Great news.”

His comments certainly demonstrate the hard work going on behind the scenes at Scancell. I feel confident that Scancell will update us on progress when the time is right.

Scancell have posted a link to today's RNS on LinkedIn. Someone from Scancell has made a comment against the article. I have not copied the comment here (in case this is not allowed?) but all I can say is that it certainly puts today's news into perspective and more than endorses moonparty's post.

Polly Brown, VP, Head of Business Development, Oncology R&D, AstraZeneca is one of the 5 panelists alongside Sath on the 11.40 am Panel:-

https://drive.google.com/file/d/1-WeggpKG_BTfijvY1diwnYZa00rKpXoK/view

It is well worth viewing her profile on Linkedin. She has been involved in a number of AstraZeneca’s deals recently including an agreement to acquire Fusion Pharmaceuticals, the acquisition of Gracell Biotechnologies and today a global licence agreement with Nona Biosciences.

This is part of a post she made last month:-

“When assessing external opportunities our teams at AstraZeneca always seek innovations that are underpinned by strong scientific rationale and that we believe have transformational potential for patients.

Together with our strong scouting effort, attending congresses such as AACR helps us to stay at the forefront of science innovations.

I hope to see colleagues new and old at AACR!”

I wonder if she saw Lindy’s presentation at AACR ?

It is worth mentioning that "Extensive preclinical testing" of Novavax's vaccine was done at Texas Biomedical Research Institute:-

https://www.txbiomed.org/news-press/news/novavax-covid19-vaccine/

The last we heard about Covidity on 1 October'23 was that the research team at Texas Biomedical was waiting for official approval to move into primate studies, hopefully followed by FDA human clinical trials:-

https://www.ksat.com/news/local/2023/10/02/new-type-of-covid-vaccine-showing-promise-at-texas-biomed/

Sorry it is 11.40 am. This is the Agenda:-

https://drive.google.com/file/d/1-WeggpKG_BTfijvY1diwnYZa00rKpXoK/view

Sachs Associates have posted the following on Linkedin:-

Scancell is a clinical stage immunoncology company that is leveraging its proprietary research, built up over many years of studying the human adaptive immune system, to generate truly novel medicines to treat significant unmet needs in cancer. Adaptive immune responses include antibodies and T cells (CD4 and CD8), both of which can recognise damaged or infected cells. In order to destroy such cancerous or infected cells, Scancell uses either vaccines to induce immune responses or monoclonal antibodies to redirect immune cells or drugs.

Scancell's lead asset SCIB1, a cancer vaccine being evaluated in first line unresectable metastatic melanoma and has impressive early clinical results as a monotherapy (88% DFS) and in combination with checkpoint inhibitors (85% ORR). The next data is anticipated in Q3 2024.

More Info @ https://lnkd.in/djZps36w

This is the link to the website:-

https://www.sachsforum.com/10oif-about.html

Sath Nirmalananthan and Brad Loncar, Founder, BiotechTV are among the “Confirmed Speakers and Chairs”.

Sath is one of the Panellists in the following 50 minute slot at 11.30 am:-

“Advanced Immunotherapies Panel:

Cell Therapies & Cancer Vaccines

Co-Chaired by: Kaveri Pohlman, Director, Biotechnology Equity Research, BTIG, LLC

Michael Rice, Expert Advisor, SVP, Cell & Gene Therapy, Lumanity

Panellists: Deborah Rathjen, Managing Director & CEO, Carina Biotech Limited

Niranjan Sardesai, Founder, President & CEO, Geneos Therapeutics, Inc. Polly Brown, VP, Head of Business Development, Oncology R&D, AstraZeneca

Sath Nirmalananthan, Chief Financial Officer, Scancell Holdings PLC

Upendra Marathi, CEO, 7 Hills Pharma Inc.”