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Thanks noix and Tatty. I was busy yesterday getting a backgrounder document on Destiny together (patents and pipeline so far) and came across the QIDP and Fast Track designations for XF-73 on the Destiny website's Pipeline page.

Basic info about QIDP and Fast Track: https://www.fda.gov/drugs/ind-activity/fast-track-designation-requests (lots more detail available by searching the FDA site for QIDP)

I agree, it all looks very positive but puzzling (so far for me also) why the long delay between Phase 2 and starting Phase 3.

Now onto XF-73 development history.

These are the trials so far, all completed:

Phase 1: Study of the Safety and Local Tolerability of Intranasal Gel Formulations of XF-73: https://classic.clinicaltrials.gov/ct2/show/NCT01592214 (Trial carried out by NIAID. Last update posted 5 September 2016)

Phase 1/2: Study of the Nasal Decolonisation of Staphylococcus Aureus (SA) and the Safety and Tolerability of XF-73 Nasal Gel in Healthy Subjects: https://classic.clinicaltrials.gov/ct2/show/NCT02282605 (Last update posted 7 October 2016 - Results: https://classic.clinicaltrials.gov/ct2/history/NCT02282605?A=2&B=3&C=Side-by-Side#StudyPageTop )

Phase 2: Effect of Exeporfinium Chloride (XF-73) Gel on Nasal S.Aureus in Patients at Risk of Post-op Staphylococcal Infection: https://classic.clinicaltrials.gov/ct2/show/NCT03915470 (Last update posted 16 October 2023 - Results: https://classic.clinicaltrials.gov/ct2/history/NCT03915470?A=10&B=12&C=merged#StudyPageTop )

There has also been this Phase 4 trial: Study to Assess Eradication of Nasal Carriage of Staphylococcus Aureus (SA) With Mupirocin (Bactroban 2% Nasal Ointment): https://classic.clinicaltrials.gov/ct2/show/NCT02284555 (Last update posted 1 March 2016 - Results: https://classic.clinicaltrials.gov/ct2/history/NCT02284555?A=2&B=3&C=merged#StudyPageTop )

So your 'working through' is just a conspiracy theory? One step away from being binned for BSing...

What are you saying the working through is Bella? I may have missed you being explicit about that.

That previous posting has been officially sanctioned.

Ophidian

Let's all spare a thought for the Oph.

A snake on his donkey waving his sausage angrily at anyone who will pay attention.

😢

If X, formerly known as HC/HCI/Heights/whatever, didn't act like kids in a sweet shop but waited a couple of weeks before starting to sell, do you think the share price would rise and X would actually get a better return?

I'm seeing an ask price of 0.00p. I am very interested.

How do people join then? Is it by invitation?

What is the link to the Telegram group? I can't remember whether I joined previously. If I did I was either kicked out for disagreeing or got bored with the format and posters. Trying to access it would tell me which.

Relatedly, is its possible to find a Telegram group from within Telegram or Google?

Yes it was a typo

@Pharma3, I doubt AS's integrity would allow him to accept a Nobel Prize nomination. His skills lie in identifying opportunities and putting great teams together. The true recipient of a nomination would be William Bachovchin and his team at Tufts University.

Btw, I'd grab the offer of a £100bn takeover with both hands and both feet. At £350 per share I'd be using champagne or the washing up.

Oxford Nanopore and bioMérieux SA," a world leader in the field of in vitro diagnostics", today announced that bioMérieux is making an immediate £70M investment in Oxford Nanopore (ONT), taking a 3.5% stake with the option to increase that to 9.9% over 5 years by buying on the open market. ONT shares closed yesterday around 190p, bioMérieux are paying 238.08p per share.

Oxford Nanopore are shares up around 20% to 122p.

This just shows what confidence from a big company can do.

Details: https://www.londonstockexchange.com/news-article/ONT/biomerieux-makes-investment-in-oxford-nanopore/16173131

"The dox arm was for comparison of efficacy though not to determine concentration of doxorubicin in tumors. Tumors are so heterogenous that that data is meaningless and reason the data doesn’t exist."

Pretty sure AS said they intended to get human in vivo data from that Phase 1b design.

@Timster, yes AS said there was no data on dox concentrations in human cells in the published literature. My point was that in vitro studies can be done on rodents, dogs and human cells but, unless in an authorised trial, only in vivo studies on rodents and dogs, so...

in vitro rodent cell data ---correlated to---> in vivo rodent cell data

in vitro dog cell data ---correlated to---> in vivo dog cell data

in vitro human cell data ---guesstimate---> in vivo human cell data

Not saying it would be a reliable method, it's just an idea for a possible way to derive in vivo human cell data.

Thanks noix. I hadn't seen your post when I posted (yes, it took that long to research and write!) so I'll have a look at that announcement as well.

Thank you.

As regards patents, Bill Love's presentation slide 3 states 84 granted patents. The announcement on 3 February 2021 (https://www.destinypharma.com/2021/02/03/03-feb-2021-destiny-pharma-announces-brazilian-patent-granted-for-xf-73-nasal-gel/) states "We now have 84 issued patents from three patent families related to our XF platform that will provide strong protection to our XF-73 nasal gel product, alongside standard market exclusivity awards, in all major territories."

The granted US patents I have found are these 3 (representatives of the three patent families):

1) US7244841B2 (https://patents.google.com/patent/US7244841B2/en), priority 23/12/2002, US application 23/12/2003, expiry 23/12/2023 (this one is a joint assignee with Solvias AG)

2) US7977474B2 (https://patents.google.com/patent/US7977474B2/en), priority 23/06/2004, US application 22/06/2005, expiry 15/11/2027

3) US9326511B2 (https://patents.google.com/patent/US9326511B2/en), priority 23/10/2009, US application 23/10/2009, expiry 23/10/2029

4) There is also a WO patent application (not yet granted), which includes US coverage, from another family: WO2022180380A1 (https://patents.google.com/patent/WO2022180380A1), priority 23/02/2021, WO application 22/02/2022

Throughout these four patents, XF-73 is identifiable as 'Compound 10'. In patent 3) Compound 10 is also named as 'XF-73' (and other compounds are given their XF research codes). Patent 4) mentions only XF-73.

Formulation as a topical gel, cream, lotion, etc is mentioned from patent 2) onwards, initially for Compounds 1 to 51, then for 10 specific Compounds, and finally in patent 4) just for Compound 10. Such successive narrowing of the claimed chemical structures is normal as the most active ones and then the chosen one are selected.

So, in conclusion, there is patent coverage in the US (the most important market) beyond the end of this year with two granted patents until 15/11/2027 and 23/10/2029. And if the latest one, currently a World patent that covers the US and many, many other countries (see https://patentimages.storage.googleapis.com/72/f8/63/8203191d46c35a/WO2022180380A1.pdf) is granted then there will be coverage specifically for XF-73 until 23/02/2041, plus possibly a few years due to the vagaries of the US patent system.

For the FDA aspect, I'll look at this year's interims presentation (thanks for the link) and consult the website and RNSs.

Potential investor here. I used to work with one of the senior management team (a good guy and very intelligent; I have faith in him) and have been following Destiny Pharma this past year but, I must admit, with something less than half an eye. So yesterday's presentation was a real eye opener for me. I've not had time to look at the website, RNSs and published papers in anything like detail yet so I was wondering whether you on this BB who have been following DEST in detail could answer these simple questions:

- Until when does the XF-73 patent coverage last? The patent number of the key US or WO patent would do - I can easily find the date when it is due to expire.

- Has XF-73 obtained any of the FDA, EMA, MHRA or JHA goodies such as the FDA's Fast Track, Breakthrough Therapy, Accelerated Approval or Priority Review or their equivalents in the other regulatory authorities? I haven't seen 'pivotal' mentioned and the fact that XF-73 is going to have to go through Phase 3 trials means perhaps it is too early to apply for these (more clinical data required) but I'm surprised as the 4 USPs (sic) listed during the presentation would indicate that this antibiotic needs to be progressed as fast as possible for the whole of humanity's sake.

Any help would be gratefully received.

You seem to have a good handle on what studies have been done JT.

Do you know whether they have produced doxorubicin concentration data 1) comparing human and rodent (or canine?) cells in vitro treated with doxorubicin and 2) comparing rodents or dogs treated (in vivo) with doxorubicin? It may be an extrapolation too far but if there is concordance between in vitro and in vivo the killing levels of doxorubicin for rodents and dogs, the killing levels of doxorubicin in humans could be guesstimated from the in vitro levels - perhaps a better, or a supporting measure, rather than using the in vitro data alone?

Won't 'they', speaking for us all, be urging Avacta to float off Dx? That was Myles' line just a short while ago.

Quoted spread yesterday afternoon and this morning was 8.00/8.20. Has widened again now.