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Without knowing what the issues are it's impossible to say whether it would make any difference whether Scancell use the first or second generation device. The FDA may have the same questions re. Trigrid 1.0.

No, to run a trial in the UK you need approval from the MHRA (Medicines and Healthcare products Regulatory Agency). The new 2nd generation Ichor device is already being used in trials in Europe and Ichor have also licensed out for use in Korea.

It would be interesting to know whether any current trials in the US are now using the new device - in particular this one:-

https://clinicaltrials.gov/ct2/show/NCT03532217?term=trigrid&draw=3&rank=5

Very disappointing and frustrating RNS this morning and note revised date for trial commencement is H1 - not even Q1. Suggests that the delay is more than just a couple of quick queries from the FDA.

Interesting article in The Times re. some fantastic Keytruda results presented at ESMO for head and neck cancer. Given the recent 'comments' on this bb regarding immunotherapy and checkpoint inhibitors, a few comments jump out:-

'Only 17 per cent had serious side effects on pembrolizumab, compared with 69 per cent with chemotherapy'

'Immunotherapies tend only to work for a minority of patients and in the study only a quarter responded to pembrolizumab. However, these patients’ tumours did not grow for an average of 21 months compared with five months for those on chemotherapy.'

'We’re used to seeing immunotherapy trialled in patients who have exhausted other options, but this trial has shown its true potential as a smarter, kinder and more effective first-line treatment for cancer, where it can have the biggest impact on a patient’s life'

Wonderful!

https://www.thetimes.co.uk/article/cancer-treatment-without-chemo-t0l56gc7l?utm_medium=Social&utm_source=Twitter#Echobox=1540225507

no problem - still impressed that you managed to spot Scancell's name in amongst all that text #eagle-eyed

Yes, just confirmation that Paul Chapman was receiving $$$ from all of those companies listed - to prevent accusations of conflicts of interest

I'm not sure it's evidence of any involvement in the study from Scancell. I may be wrong but it's simply a disclosure of all his financial interests.

Blimey how did you spot that buried in there?

Thanks for the link. Can you explain how the paper demonstrates Roche's respect for Scancell? Sorry if it's obvious but I can't see a connection but it's been a long day and am being slow tonight!

Just a quick response re. the NYT Tecentriq ( atezolizumab) article. I can understand your comments but you have to be very careful when comparing new therapies that you're comparing like for like.

You're absolutely right that Scancell have stated:-

'Pre-clinical data suggests that Modi-1 may be effective in up to 90% of patients with TNBC, up to 95% of patients with ovarian cancers and up to 100% of patients with sarcoma'

For clarity, they're not saying that 90% of patients with breast cancer WILL respond to Modi1 or that 90% of patients will survive. What they're saying is that the target peptides for Modi1, (citrullinated vimentin and enolase) are highly expressed in 90% of triple negative breast cancer patients. In other words 90% of patients are suitable candidates for Modi1 as are 95% of ovarian cancer patients and 100% of sarcoma patients.

If you go back and look at the Tecentriq results, you'll see that when you look at the whole group who received the combination treatment, the survival benefit over chemo alone wasn't statistically significant, but when you take the patients with high levels of PD-L1 expression on their tumour then they are. This is really good news for patients as up until now checkpoint inhibitors haven't had a great impact on breast cancer. However, only about 20% of TNBC patients have tumours with high levels of PD-L1 expression.

So you can see that the target market for Tecentriq is likely to be about 20% of patients whereas Modi1 would be 90%.

Hope that helps and makes sense!

Yes, congrats!!

Following on from the excellent article about BioNTech that you posted the other day, below is a video of Prof. Ugur Sahin (CEO) talking about their cancer vaccines.

https://grandchallenges.org/video/grand-challenges-spotlight-talk-i-ugur-sahin

Ruck,

In answer to your question and hopefully to put this debate to bed, I have no idea how much I know and I couldn't even begin to put a % figure on it. The reason I know that is that I don't know what I don't know and therefore can't know how much I know and how much I don't know. What I do know for sure is that I don't know more than I know by a country mile.

On a more serious note, IMO all anybody can hope to achieve is a basic level of understanding that is sufficient to make judgment calls on your own investment. Where that level is will differ for each of us.

Would highly recommend the following video. It's not specific to Scancell but gives a really good basic explanation of immunotherapy and the different approaches - easy to then look at Scancell's website and work out where their tech. fits in.

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

Rebster,

The standard trial design for a dose escalation trial is 3 x 3 - ie. 3 cohorts of 3 patients, with each cohort receiving a higher dose than the last. The VAL201 results to date published via an abstract by the principal investigator show that this was indeed the case for this trial (see link below).

Worth noting this sentence from the abstract:-

'The final planned escalation will be 5.0mg/kg, the maximum feasible single dose which may be administered.'

Up until now, the highest dose administered had been 4mg per kg and this sentence suggests that it's not possible to go beyond 5mg. It's therefore not unreasonable to assume that they intend to recruit a further cohort of 3 patients who will receive the max. 5mg dose and then part 1 of the trial will be complete. I assume they will then analyse the results before deciding whether to expand the trial to the full 50 patients.

I'm not sure why VAL don't make this information freely available - would be so much easier if they just issued a straight RNS to tell potential investors how many they have recruited and treated, at what dose and how many they plan to recruit to complete the trial.

https://oncologypro.esmo.org/Meeting-Resources/ESMO-2016/A-first-in-human-FIH-phase-I-II-dose-escalation-pharmacokinetic-PK-study-to-assess-the-safety-and-tolerability-of-VAL-201-in-patients-with-advanced-prostate-cancer-APC-and-other-advanced-solid-tumours

Excellent news

Lojuxta to be reimbursed in France

Joe Wiley, CEO of Amryt Pharma, commented: Following closely on from our recent approval with the NHS in England, where we have already started treating patients, we are now very pleased to be able to make Lojuxta available to adult HoFH patients in France."

Trashing approved drugs which have revolutionised cancer treatment, been prescribed for thousands and thousands of patients, achieved multi billion dollar sales and recently been recognised by the award of the Nobel Prize for medicine is a very poor trolling!

Troll away all you like but honestly, if you think adverse events for CI's are even remotely relevant or appropriate in this context then you seriously need to do some more research to understand the market.

Come on you're better than that. Immunotherapy and checkpoint inhibitors are have transformed the treatment of cancer and are the biggest breakthrough in the field of oncology for generations. Thousands and thousands of patients who had absolutely no other treatment options have been now been treated with CI's. Some sadly have had severe adverse reactions, some have not responded but many have!! I believe that side effects as a whole are less severe than for chemo and management of any toxicity is improving all the time. In any case, the toxicity profile of CI's is just one reason why SCIB1 has potential as a combination treatment.

The impact of CI's goes way beyond petty squabbles on bulletin boards. Scaremongering posts re. adverse events have no place here or on VAL. Indeed, VAL themselves have touted the idea of combining VAL401 with CI's so perhaps not a good idea to knock them.

............now showing on clinical trials register

https://clinicaltrials.gov/ct2/show/results/NCT02875340?term=val401&rank=1

Not at all, Valirx have never claimed that they have approval from the regulators or permission to commence a phase 3 trial.

You're right, VAL can't go into a phase 3 (not sure what you mean by escalation) without regulatory approval and you're also right in that the phase 2 results will be used to support that process.

The current situation is that phase 2 is complete and the clinical study report (CSR) has been or is about to be submitted to the local ethics committees in Tbilisi - thereby formally completing the trial. The CSR is a massive document and it's great that it has been completed. Nevertheless, the only regulators involved so far are the Georgian ones in Tbilisi regarding that existing phase II trial.

It definitely hasn't been passed by the regulators and doesn't have permission to progress to phase 3 as you claimed. It's a massive achievement for any bio to receive approval from the FDA/EMA for a phase 3 trial. It won't help VAL if expectations are too high because investors reading this bb believe that they already have it.

Thanks for your reply - so have FDA and EMA approved phase III trial?