Member Info for Bermudashorts

Rats

That's entirely possible.

'Cancer Vaccines: New Targeting Strategies, Brighter Prospects' article published today with good coverage for Scancell:-

'Novel off-the-shelf cancer vaccines

Lindy Durrant, PhD, CEO and CSO of Scancell, explains that the company has developed two complementary vaccine platform technologies, ImmunoBody and Moditope, that do not require personalized approaches. “The problem with personalized vaccines is that they can pose significant economic and technical challenges,” she says. “As opposed to off-the-shelf options, patients are required to provide a biopsy, manufacturing can take several weeks, and there are added costs to make and distribute them.”

Scancell’s lead ImmunoBody cancer vaccine, SCIB1, is delivered as a DNA plasmid. SCIB1 incorporates specific epitopes for proteins (gp100 and TRP-2) identified in patients spontaneously recovering from melanoma skin cancers. According to Durrant, SCIB1 has been showing promise in the company’s open-label Phase II trial of SCIB1 (and a related vaccine called iSCIB1+) in metastatic melanoma patients with immune checkpoint inhibitors: “In the first phase of the trial, we saw an 85% objective response rate in 13 patients, accompanied by meaningful tumor volume reductions.”

Furthermore, one patient achieved a complete response and currently shows no signs of detectable cancer. “We were very excited by our results,” Durrant declares. “Previous studies have indicated that an objective response rate of 50% was the best that could be achieved in a real-world setting for patients with unresectable metastatic melanoma.”

Meanwhile, the company’s Moditope platform focuses on activating CD4+ cytotoxic T cells. Most cancer vaccines target CD8+ cells to kill tumors directly, but as Durrant notes, “targeting CD4+ T cells could reverse the immunosuppressive tumor environment. Plus, CD4+ T cells can also be cytotoxic.”

Durrant explains that cancer cells often undergo unique post-translational modifications, resulting in the generation of unusual peptides. An example of such a modification is citrullination, in which arginine residues are converted to citrulline. The Modi-1 vaccination, which is being investigated in Phase I and Phase II trials for various tumors, contains citrullinated peptides that can activate CD4+ cytotoxic T cells, enabling them to kill tumor cells.

https://www.genengnews.com/topics/infectious-diseases/cancer-vaccines-new-targeting-strategies-brighter-prospects/

No not at all - I simply meant consider in view of my 15.23

GF123

You don't have to explain anything to me about your wealth, the size of your holding or your investment strategy. I'm sure like me you don't judge posts from others based on any of these factors but on the content. Anyway it's good to hear that we are allowed to have different views and hopefully you'll at least consider that there's a potential upside for Scancell if results from BNT111 are good.

GF123

My post was actually postitive so am slightly bewildered by your reaction.

What about if you owned shares in one company and the success of another resulted in increased interest and demand for your company's products? How would you feel about that because that is the correct analogy and that is the point I was trying to make.

By the way, I explained very clearly the reasons why I reduced my holding here (timelines extended) and it has proven to be absolutely the correct decision. I still have a decent sized holding.

GF123

Yes of course SCIB1 results are more pertinent to Scancell than BioNTech's, I wasn't suggesting otherwise. You don't agree with my final sentence, any particular reason why?

All focus is on mRNA personalised vaccines at the moment and huge amounts of cash are pouring into their developmment. You only have to follow the links in ee's post to see this and also how the UK is placing all of its eggs in the personalised vaccine basket at the moment - the NHS/BioNTech collaboration aiming to provide 10,000 patients for clinical trials in the next 5 years! That's a huge commitment using limited resources on as yet unproven, early stage vaccines. We hear much about the Government's commitment to the UK ife sciences sector, what a shame they couldn't have demonstrated this by also running a few studies using home grown innovation.

The point is that Scancell holders should want BNT111 to do well. Although BNT111 is an mRNA cancer vaccine it's not personalised. All successes from any off the shelf vaccines will attract attention (and funds) to the whole field and will help validate the non-personalised approach. This can only help Scancell and make for an easier development path for iSCIB1+. So fingers crossed for really good results from the phase II when BioNTech finally present them.

Botski,

No you're not being thick!

The responses being discussed here this morning relate to BioNTech's phase 1 trial of BNT111 and come from an interim analysis published back in 2020. The trial had several cohorts including 42 patients who had previously been treated with other therapies. Of those 42 patients, 41 had received previous checkpoint inhibitor therapy and 35 of those had received both anti PD-1 and anti CTLA4 (but not necessarily at the same time). The 17 patients discussed this morning come from this patient population, they had previously received CPI therapy but their cancer had progressed. ie. They had failed on CPIs alone. When subsequently treated with BNT111 plus anti PD1, 6 out of 17 patients showed a partial response.

The SCIB1 results are from patients who have never received any prior treatment for their advanced melanoma - so an earlier, first line setting. As you have pointed out, 50% of these patients would respond to the CPIs alone and that isn't the case for the BioNTech study.

In other words, the two trials are taking patients from different patient populations at different stages of treatment and you're not comparing like for like when looking at the results.

Ray,

Agree Genmab is a strong possibility - Lindy did say they were interested in a second mAb.

Now corrected:-

'RNS no: 2949Y was released in error and should be disregarded. The full correct version of the announcement appears below.'

https://www.londonstockexchange.com/news-article/SCLP/scancell-appoints-dr-nermeen-varawalla-as-cmo/16592650

Konar,

Yes they seem to have copied the wrong text to the title. It appears from the title they've appointed a new CMO, Dr Nermeen Varawalla. Her linkedin shows that she has a long history of many roles within the industry including plenty of CRO experience.

https://issuu.com/somervillecollege/docs/somerville_magazine_2022_-_web/s/16393371

Clare

Hope you and yours are well - good to see you posting.

Just wanted to add another point to my 8.06.

It's interesting that the title of the RNS is:-

'Scancell Provides Update from iSCIB1+ Clinical Advisory Meeting'

So not SCIB1/iSCIB1+ but very clearly just iSCIB1+. Of course this could simply be an oversight but equally it could be that the decision has already been taken to go with iSCIB1+ and that only iSCIB1+ was discussed.

Well that explains why Scancell took such a large team to ASCO this year including Fayaz Master and Dr Robert Miller who will both of course be heavily involved in the planning and execution of the phase 2/3 study. FWIW my thoughts on the RNS below in no particular order.

1) Some huge names on that list - well worth a google starting with Jedd Wolchok who has played a massive part in the clinical development of checkpoint inhibitors. Full credit to Lindy for securing the services of such a highly profile group with a truly international reputation. It will be interesting to see whether they become study investigators (assume that's the intention).

2) So looks like the phase 2 part of the trial will be blinded with a pre-planned early interim review looking at overall response rate. Possible outcomes from an interim review would be potentially be to halt the trial for futility (assume extremely unlikely given SCOPE results), continue with current protocol, adjust protocol as required or even perhaps an early transition to the phase 3. It will also give Scancell some hard data to take to potential partners for the phase 3.

3) Assume the next step will be a pre IND meeting with the FDA - not sure whether they have to wait for full results from the SCOPE trial for that to take place, although I'm sure they'll be required for the actual submission of the IND. Wonder whether they may also discuss any of the FDA's accelerated programmes at that meeting.

4) Disappointing but not a huge suprise that timescales have slipped for SCOPE results.

Violindog,

Systematic Internaliser

Chelsea,

Yes it's well worth a read, especially the public markets section which very much highlights the issues raised in the FT article. Any AIM listed companies managing to get a funding round away on reasonable terms last year did well.

Food for thought from this article in the FT which highlights the importance (and difficulty) of attracting specialist life science funds such as Redmile:-

' The plight of the UK’s smaller quoted life sciences companies does not reflect the value of their intellectual property, says Ross. “The science side is fantastic, and that’s the real problem here: UK science is terrific and making lots of progress. Unfortunately, the UK biotech investment sector isn’t.”

https://www.ft.com/content/48d4b1f3-e1f0-46ac-9aa4-6ad549d75edc

burble thanks for your 12.56. this may already have been posted, but in case not scancell's abdullah al-omari is presenting at the immuno-oncology summit being held in august in philadelphia:-

11:25 am

modi-2, a vaccine targeting ****citrullinated self-epitopes, stimulates potent cd4-mediated anti-tumor responses as a therapy for solid cancers

abdullah al-omari, phd, scientist, t cell vaccine, scancell ltd.

stresses within the tumor microenvironment mediate post-translational modifications of self-proteins. ****citrullination is the conversion of lysine residues to ****citrulline which can generate neoepitopes and bypass self-tolerance. modi2, a ****citrullinated peptide-snapvax vaccine, stimulates strong th1 responses and anti-tumor immunity in three different murine tumor models. we propose the modi-2 vaccine formulation has potential for translation into clinic in several cancer indications.

https://www.immuno-oncologysummit.com/cancer-vaccines

Roses,

I believe RNS service is also affected with only a handful issued.

BOJO - Unless I'm missing something I don't think you can make any link between trial centres opening and adverse events.