Member Info for Bermudashorts

Ray, I didn't read it in that way. I think Scancell would need to secure approval in another indication. No matter and no point really in worrying about it until/unless Scancell are able to take SCIB1 further in terms of clinical trials or a commercial deal.

Ray,

I think that may only apply if you are able to secure marketing approval for new therapeutic indications for the same drug within the 8 years of obtaining initial approval. So EMA approves SCIB1 for melanoma and then within 8 years Scancell apply for approval for another condition.

Could be wrong though.

Ray,

Thanks, will take a look

Inanaco,

In which case why waste the effort in replying in that tone? For once why not just agree?

In effect, Knowlesi raised an issue that SCIB1 wouldn't be protected in the European market in 2028 and you replied that it had 7 years of market exclusivity in the USA - do you not see the problem?

Under which section Ray?

Wild - Yes, as I clearly stated in my post, there are plenty of ways to extend patents and I'm sure Scancell will do so.

Inanaco - no need for such a defensive response, I did read Knowlesi's post and your reply which was incorrect. SCIB1 does NOT have orphan status in Europe and so your response didn't deal with Knowlesi's point regarding the expiry of the European patent at all.

Inanaco,

I'm sure there are plenty of ways in which Scancell can extend the patent life of ImmunoBody and for all we know they may already have submitted applications but Knowlesi is correct - he only mentioned the European patent and SCIB1 only has orphan drug status in the USA, not Europe.

Ray,

There are still some outstanding Moditope patent applications. Have listed them below.

EP3301447 European patent for the assay to test blood for T cell response to cit. peptides etc. - this has now gone to oral proceedings which have been rescheduled from June to Oct

EP3287787 European patent for Moditope nucleic acids (covering DNA vaccines and I think TCRs) - awaiting examination of latest set of amended claims

WO2020053304 - application to cover homocitrullinated peptides

US20180346537 - US Moditope patent - think again this is to cover nucleic acids & is awaiting response from examiner re. latest evidence from Scancell

US201615746077 - US enolase patent which as Konar mentioned earlier is about to be granted

Of course, there may be others that have been applied for but not yet granted and I have only looked at US and European applications. Highlights just what a long process this is with a huge amount of work going into each application.

Konar,

Yes, a perfect example of why it's perhaps best to wait until a patent is actually granted before making any announcements to the market. The letter from Kilburn & Strode dated 9th December - 'Request for correction/amendment of the text proposed for grant sent from 01.04.2012' explains why Scancell rejected the text intended for grant and submitted amended claims.

As far as I can see, It appears to be linked to the fact that the EPO had deleted the world 'comprising' from the claims as they believed it suggested that the patent covered the whole full length cit. alpha-enolase protein. Scancell reinstated the word as the very fact they were only covering peptides means that they couldn't possibly be claiming IP over the whole protein.

Ruck,

Yes agree - and also IMO, if you're discussing valuations, it's much easier to look at it in terms of market cap rather than sp.

immunotherapy

Knowlesi,

'Instead, we believe it is more important to consider the underlying strategy of the business – which is overtly one of navigating the business in order to deliver one or more ‘partnering’ relationships in whatever form they may take – and to consider the landscape of recent deal flow to determine a potential valuation range. Ultimately, we
believe Scancell’s value will be reflected by whatever partnering relationship it is able to secure, and on the basis of the current and recent landscape of dealflow within the sector'
and the growing intensity of interest in cancer immunotherap

We very rarely hear anything from Panmure Gordon these days but they still are Scancell's nomad and broker. This is the view of Dr. Mike Mitchell , the analyst covering Scancell on valuations of the company (taken from broker note).

'The rapidly evolving technology and regulatory landscape in the area of cancer immunotherapy means that we believe
ascribing a value to the company through the synthesis of a ‘starting set’ of assumptions (regulatory timeframe, partnering terms, expected royalty rates etc.) would inappropriately suggest that meaningful guesses can be made on these key drivers at this stage'

Inanaco,

Genuine question - what point are you trying to make about Keytruda? AFAIK nobody has denied that it's a blockbuster.

Excellent news.

Blood donations have recommenced for FDA analytical studies and patient enrolment has recommenced for the ovarian cancer study. Interesting insight into what's involved with these studies too.

https://www.londonstockexchange.com/news-article/AGL/blood-donations-recommenced-for-fda-studies/14585506

Ray,

We had very similar conversations on this bb when SCIB1 was in clinical trials with ridiculous valuations bandied around so perhaps the more cautious approach from some long term investors is understandable.

In answer to your question, I can't see Scancell ever having the resources, the infrastructure or the will to run a phase III trial. Even with a successful phase III under their belts, there's still a long way to go to securing regulatory approval and even if they managed to get that far, they certainly wouldn't be able to actually market and sell the product, especially in the US. So best scenario is for either the sale of the company or a licensing deal after a phase I/II trial and that's the investment case here IMO.

Right now though, forget £8 a share and phase III trials, I'd be happy to see 8p and commencement of any trial!

I hope that was tongue in cheek :)

Ray,

No problem and no criticism of your post intended at all.

Ray,

I'm not sure the latest research paper makes any difference to the prospect of Modi1 getting into trial.

The research being discussed by Inanaco was from research carried out in 2013/4 by the University of Oslo - it's not new and it's not from Scancell.

Ruck,

The prognosis for late stage ovarian cancer is still dire, with a 5 year survival of just 17% . If Modi1 is successful in a phase I/II against these hard to treat cancers then it's about as good as it gets for a small bio. So I think it should make money for Scancell shareholders, there should be a complete reversal of sentiment with an upward adjustment in market cap and I'm convinced there will be industry interest. Whether Modi1 ever gets to market and generates sales is another matter and will be down to whoever takes it on.

Of course, it all depends on Scancell actually getting the trial up and running and the mice data being replicated in humans.