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Scancell cancer vaccines

Roger · 86 · 26229

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Online Roger

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I started so I'll finish   ;)

A new immunotherapy, 'Moditope', is at last going into trial after 10 years further work. 4 difficult cancers have been selected as the targets. Worth noting that at the pre-clinical stage, there was 'dramatic regression' of tumours. Hopefully there will be more news soon as the trial is intended to be active at 20 centres . . . .

"Modi-1 Phase 1/2 clinical trial open for recruitment. First-in-human clinical trial in patients with triple negative breast cancer, ovarian cancer, head and neck cancer, and renal cancer.

Early safety and immunogenicity data expected to be available in H2 2022

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer and infectious disease, today announces that its Phase 1/2 clinical trial with Modi-1 (ModiFY) is open for recruitment.

In addition, the UK's Medicines and Healthcare Products Regulatory Authority (MRHA) has approved a protocol amendment which is aimed at accelerating patient recruitment and shortening study timelines. The study is a first-in-human clinical trial in patients with triple negative breast cancer, ovarian cancer, head and neck cancer, and renal cancer. Modi-1 will be administered alone and in combination with checkpoint inhibitors (CPIs) in patients where the CPI is standard of care. As previously announced, the Company expects early safety and immunogenicity data to be available in H2 2022 and potential efficacy data in 2023.

Leading oncology clinical research sites and investigators across the UK have agreed to contribute patients to the ModiFY study. The first wave of clinical sites is now open for recruitment and in due course the Company expects up to 20 sites to be open and recruiting patients.

Modi-1, the first candidate in Scancell's Moditope® platform, consists of three citrullinated tumour-associated peptides exploiting the normal immune response to stressed cells, which is largely mediated by cytotoxic CD4 T cells. The peptides are linked to AMPLIVANT®, a potent adjuvant which, in preclinical models, enhanced the immune response of Modi-1 10-to-100 fold and resulted in highly efficient tumour clearance, including protection against tumour recurrence. AMPLIVANT® is the subject of a worldwide licensing and collaboration agreement with ISA Pharmaceuticals for the manufacturing, development and commercialisation of Modi-1.

Prof Lindy Durrant, Chief Executive Officer, Scancell, commented: "The opening of recruitment for patients into our ModiFY clinical trial is a major step forward for the Company. We are very excited about the prospects for Modi-1 based on the dramatic regression of large tumours in our preclinical models and look forward to accelerating recruitment over the coming months and analysing the early safety and immunogenicity data later this year."

Professor Christian Ottensmeier at The Clatterbridge Cancer Centre and University of Liverpool, commented: "As the principal investigator for this first-in-human clinical trial I am delighted to be working with Scancell to explore how this novel immunotherapy, Modi-1, could improve the prognosis for patients with hard-to-treat tumours."

Professor Kees Melief, Chief Scientific Officer, ISA Pharmaceuticals, commented: "This is an important milestone further cementing the product
"
''If you can't explain it simply, you don't understand it well enough'' - Albert Einstein


Online Roger

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This was posted on the Scancell BB today - a truly stunning pic  :o  (size wise - there's c. 70 trillion healthy cells in YOUR body)

Here's a killer T-cell attacking one ovarian cancer cell . .

?s=21&t=4rvCXzOMyCDzp-iD2mfmVA

Shows the potential of immunology when it can generate T-cells   ???   ???   :o

''If you can't explain it simply, you don't understand it well enough'' - Albert Einstein


Online Roger

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I see 25915 views on this thread so maybe it's worth persisting with an update . . .

After 10 years, Scancell finally has it's 'Moditope' vaccine in trial at an intended 20 hospitals. After safety and toxicity testing was passed without any issues, the first few Patients with advanced cancers, have been dosed.

Confidentiality is usually a condition of such trials, but one Patient, the first, has recounted her experiences on the Macmillan website :-

"Hi everyone, haven't posted in quite sometime but here's a little update on my immunotherapy journey following the recurrence of oropharyngeal cancer last year after 18 years of being cancer free.

So, last time I posted I was about to start Immunotherapy (Pembrolizumab) I was on that for around 6 months. Unfortunately it was only managing to hold the tumour at bay, it continued to increase in size very slightly at each scan.

I was extremely fortunate to be offered a place on the Modi 1 cancer vaccine trial, i was the first patient on cohort 2 and have had 3 doses to date. My scan results have shown a reduction in tumour size by 30/40% which is just amazing. I'm feeling really well and my swallow has improved significantly.

I have my next scan on 30th of Nov, I'll update you again after that and in the meantime I'm hoping and praying the tumour has continued to shrink.

I hope this gives some of you hope that there are so many incredible people working hard to help us all and that there are options out there for us.

Hope that everyone is staying as well as you possibly can be. Keep the fight going, there is light at the end of this tunnel. Stay strong.

Trish xxx
"

Modi 1 is addressing head and neck, triple negative breast and renal tumours and as a monotherapy in patients with ovarian cancer, where there are no approved CPI therapies. In pre-clinical trials, Moditope was literally melting advanced tumour loads . . . . .

The Patients on this trial have a very bad prognosis - this is amazing. Is a cure for cancer on the horizon? Maybe so . . . .
''If you can't explain it simply, you don't understand it well enough'' - Albert Einstein


Online Roger

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On the Scancell BB, we have a talented Poster who 'gets' immunotherapy in the full  :D

The science he recounts here is well above my understanding but some might get it. If nothing else, it shows that it's 'clever stuff', to put it mildly . . .

"So there are a number of things to think about when it comes to Modi-1. Firstly, it isn't a single therapy, but a three in one hit. Modi-1 consists of three peptides (short fragments of protein) from two seperate proteins. The first is vimentin, a cytoskeleton protein which is used by normal cells to maintain their shape and internal organisation. The second is from a protein called alpha-enolase. This protein is a key enzyme involved in a metabolic process called glycolysis which cells use to generate energy. In modi-1, two peptides come from vimentin and the third comes from a-enolase.

Now we look at the tumour. These are metabolically stressed - with low oxygen levels and nutrient deficiency. The cell is basically fighting to survive, so to do so the cells start consuming their own proteins in a process known as autophagy. Therefore the cancer cell starts digesting it's normally functioning proteins (including vimentin and alpha enolase) to survive, and in doing so generates energy for survival but also random fragments of protein.

These random fragments of protein can be modified by other enzymes found within the cell. In this case, the vimentin and enolase peptides are modified by an enzyme known as peptidylarginine deaminase (PAD). Now we get technical. PAD converts a peptidyl arginine to peptidyl citrulline. So think of it simply as the enzyme adding a red flag on that peptide in a specific place. PAD will do this without external input. Every time it sees an arginine it will convert it to citrulline i.e. adding a red flag.

So let's take a step back and look at the cancer cell. It is battling to survive, it has a need for a cytoskeleton and energy generation. Therefore there is no pressure to mutate either of these. PAD also has no external pressure to mutate either, it's happy doing it's job. But together, the cell is basically a red flag producing factory. Even better, it's producing three separate red flags.

So unlike a target that say an antibody, CAR-T or small-molecule would traditionally target, the cancer cell doesn't have a huge selection pressure to down regulate or mutate these. This presents a problem for the cancer cell as it cannot easily beat Modi-1.

Now the additional benefit here is that because Modi-1 targets three different peptides, even if the cancer mutated the vimentin/a-enolase and lost an arginine (meaning it lost a target for PAD to citrullinate), the likelihood of it mutating three separate sites on two separate proteins is probably minimal.

Fundamentally moditope is less about targeting individual proteins, but instead targeting metabolic pathways and their byproducts. This also has the benefit of it being patient agnostic (and quite possibly also cancer agnostic).
"
''If you can't explain it simply, you don't understand it well enough'' - Albert Einstein


Online Roger

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And announced on 25th October :-

"Scancell signs Commercial License Agreement with Genmab

Genmab granted worldwide license to anti-glycan monoclonal antibody generated via Scancell's proprietary GlyMab® platform, for the development and commercialisation of novel therapeutic products

Scancell to receive from Genmab an upfront payment as well as potential milestone payments of up to $208 million for each product developed and commercialised, up to a maximum of $624 million if Genmab develops and commercialises products across all defined modalities. Scancell will also receive low single digit royalties from Genmab on net sales of all commercialised products.

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer and infectious disease, today announces a licensing agreement with Genmab (NASDAQ: GMAB), an international biotechnology company, to develop and commercialise a Scancell investigational anti-glycan monoclonal antibody into novel therapeutic products.

Genmab has been granted the exclusive right to develop and commercialise the Scancell antibody in multiple novel potential therapeutic products for any and all potential disease areas, excluding cell therapy applications. Scancell will be eligible to receive upfront and potential development and commercialisation milestone payments, as well as royalties on products sold.

The Scancell anti-glycan monoclonal antibody is a humanised antibody developed by Scancell, using its novel anti-cancer GlyMab® platform. This is one of five monoclonal antibodies currently in Scancell's antibody portfolio which provides a rich reservoir of potential products for its own in house clinical development and also for further deals.

Prof Lindy Durrant, Chief Executive Officer, Scancell, commented: "This license agreement with Genmab provides strong validation for our proprietary GlyMab® platform and our ability to utilise this technology to support the creation of novel, differentiated antibody products. Genmab is a leader in the field of antibody therapies for cancer and we are very pleased to be working with them to progress this novel antibody product through clinical development and commercialisation."

About GlyMab® Scancell is building a pipeline of differentiated anti-cancer monoclonal antibodies ('mAbs') that target sugar motifs rather than proteins. The Company currently has five novel mAbs in early-stage development and has the potential to use its unique methodology to identify many more mAbs against glycan targets in the future. All cells are covered by a dense layer of sugar structures, called glycans, which change when a normal cell turns into a cancer cell. These glycan motifs that are associated with tumour malignancies can be targeted by antibodies such as the Company's GlyMab® portfolio.

A robust portfolio of patents and applications, as well as know-how, surround the GlyMab® platform and generated drug candidates. The GlyMab® technology is part of Scancell's antibody portfolio, joining AvidiMab®, a technology that can be applied to all antibodies (regardless of the technology used to generate them), enhancing their potency and ability to directly kill tumour cells."

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Full summary here https://www.lse.co.uk/rns/SCLP/results-for-the-year-ended-30-april-2022-yetdif6auz7s3iq.html

DYOR - at 18.65p this share is cheap - if the trials go well, there is potential to be a 'multibagger' as they say . . . . still under the radar   ::)

ATB R
''If you can't explain it simply, you don't understand it well enough'' - Albert Einstein


Online Roger

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Moditope - the tumour melter - is in trial now. After the 1st scan on the the 1st Patient, 'Trish' wrote this Immunotherapy - Cancer vaccine trial in the Macmillan Online Community

"Hi everyone, haven't posted in quite sometime but here's a little update on my immunotherapy journey following the recurrence of oropharyngeal cancer last year after 18 years of being cancer free. So, last time I posted I was about to start Immunotherapy (Pembrolizumab) I was on that for around 6 months. Unfortunately it was only managing to hold the tumour at bay, it continued to increase in size very slightly at each scan.

I was extremely fortunate to be offered a place on the Modi 1 cancer vaccine trial, i was the first patient on cohort 2 and have had 3 doses to date. My scan results have shown a reduction in tumour size by 30'40% which is just amazing. I'm feeling really well and my swallow has improved significantly.

I have my next scan on 30th of Nov, I'll update you again after that and in the meantime I'm hoping and praying the tumour has continued to shrink. I hope this gives some of you hope that there are so many incredible people working hard to help us all and that there are options out there for us. Hope that everyone is staying as well as you possibly can be. Keep the fight going, there is light at the end of this tunnel. Stay strong. Trish 'xxx"

It appears that the 2nd and 3rd Patients have similar response . . .

Some slides on Scancell's recent AGM https://www.scancell.co.uk/Data/Sites/1/media/docspres/agm-presentationnovember-2022_final.pdf

On no.7, I noted these wonderful words - "VACCINE PORTFOLIO HAS MULTIPLE NEAR-TERM VALUE INFLECTION POINTS " Still under the radar at 18 pence !
''If you can't explain it simply, you don't understand it well enough'' - Albert Einstein