Member Info for jint

*AGM

TommyD_19

Rechecked notes from:

P2 trials will likely be U.K. and US trials.

US gov conversations are positive. U.K. government more frustrating.

Fruitsnveg, yes they stated they will be utilising the Casanova/Rockefeller University test which apparently has been licensed to the manufacturer they wouldn’t name, probably NDA’s in place. This admission came about after a period of sustained questioning about the tests to be employed.

In the past Synairgen and Casanova appeared to have had an active awareness of each other’s work in the field of interferons so it kinda makes sense that a collaboration comes to fruition that would suit both parties.

For those interested in the science side of Casanova’s assay test, here is the link to the filed patent application 22nd July 2021.

https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2022020569&_cid=P12-LO1QDW-62691-1

Wigster77

Your memory is correct, they intimated that they would be using the Casanova assay tests in reply to a question were they using Thermo Fisher for tests, to which they replied no.

They wouldn’t divulge the manufacturer of the test but added the the test was not currently on the market for general use.

At the time this appeared to me that the two had come to a mutual agreement that would benefit both in as much, a test that Synairgen require and for the unnamed manufacturer in-field use prior to general market release.

Wishing you a speedy recovery Doc.Daneeka.

Regarding the Universal trial numbers 300+ stated by P.Monk, was picked up by another AGM attendee, which I myself missed whilst busily writing my notes during the meeting however, noted the comment from conversations during the mingle with attendees and BOD post AGM.

Here’s hoping the proposed testing regime delivers for SNG001 in P2.

Doc.Daneeka,

Found in my notes, although latest Universal data was only presenting around 100 of the 1000 target, P.Monk said at the AGM that they would be analysing over 300 samples in the freezer already.

Doc.Daneeka

Apologies the source escapes me for the moment will have to come back to you.

Doc.Daneeka

I read the latest communication as Synairgen a collaborator, having received the results of circa 300 from Universal were now conducting their own analysis of the data to enable preparatory work for their planned Phase 2 trials.

Useful development for SNG001 testing requirements.

https://medicalcountermeasures.gov/newsroom/2023/bdpanel/#:~:text=WEB%20ANNOUNCEMENT&text=The%20BD%20Respiratory%20Viral%20Panel,)%20510(k)%20clearance.

Doc.Daneeka,

My recollection from the AGM is they envisaged starting the 3 x Phase2 trials (Covid, RSV, Influenza) simultaneously. They did state that the completion of the individual trials would naturally differ.

They also stated there is a possibility some patients will be enrolled on an ‘Open Label’ basis, these being known patients that turn up year on year with the same respiratory problems.

Perhaps Wigster77 or Doc83 can confirm my recollection of the simultaneous start.

Hi bobfraeberks,

Thank you for your additional input from the AGM.

It was a pleasure to meet you at the AGM and hope to meet up again next year along with others.

Trust you had a good journey home and applaud your effort which entailed a considerable journey.

ATB.

“The takeaway is that after 20 years of existence, we still need more data to bring this product to market. What an absolute disaster”.

In reality the dreadful period of Covid has brought on research in leaps and bounds i.e autoantibodies assays (Casanova), biomarkers, improved viral loading understanding . As someone remarked, probably SNG001 was ahead of its time waiting for the science to play catch-up (identifying correct targets).

The planned Phase2 trials involving stratification will make use of these new developments and to that end imo we’ll start seeing light at the end of the tunnel.

Wigster77

We can have a little side bet for a pint next year, 50 or 90 lol :)

Once again thanks to you both.

ATB till we meet up again.

**hit word limit :)

It was great to meet up again, pub gathering with both of you and other attendees was enjoyable and useful for exploring and exchanging view. Hope to see you all next year.

ATB.

Doc83 & Wigster77

Excellent recall of the ‘rumble in the jungle’ which was certainly tetchy at times.

On the few points you raise about any further info would be welcomed here’s my take:

1) Sprinter endpoints, they stated the ‘Discharge from hospital’ was required by the regulators.

2) Test sets for the new company sponsored Phase2 trials, question was asked is Thermo Fisher going to be used, they stated no, they were going to use tests/assays developed by Casanova but manufactured by a company they refused to name. They stated the test kits were not generally available.

I took this to mean that it was a small run of test kits being supplied to Synairgen for their required purpose.

To this end Synairgen need/see these kits are what they require and the Manufacturer (licensed Casanova IP manufacturer) require in field use.

Over a long period it appeared that Casanova’s work on autoantibodies and Synairgen’s SNG001 had mutual benefits for both.

Furthermore, it was mentioned bio markers would be utilised along with high viral load readings. RM went on to say that high viral load readings don’t in themselves necessarily mean that the patients own INF response is lacking but it gives a marker to test further for those whose INF response is not as it should be, that’s likely where they’ll step in with SNG001 intervention.

3) Regarding patents 6years 8months remaining which I mentioned albeit this can be extended via a SPC (supplementary protection certificate) but does require authorisation in each territory that it’s applied for.

RM then replied for biologics they can apply for Governmental exclusivity which can protect for up to 10-12 years for the U.S and up to 8years in other jurisdictions.

In the post AGM chat I asked RM wouldn’t it be preferable to have the SPC protection as opposed to Governmental exclusivity. He replied if there was only one choice between the two he would choose exclusivity. As there is always a risk of having to fight the infringement risk.

I must admit I’d never heard of GE for biologics previously but to be fair I’ve never looked :).

4) For some reason I had the number 90 for trial participants but couldn’t swear on it so will bow to the info you heard.

My feelings regarding AGM, I was full of apprehension travelling up to the venue as I didn’t know what to expect or even if there’d be a Q&A session. I feel it was a good session that allowed attendees feeling/thoughts to be aired. Overall I remain on the median line, neither negative or overly positive. I do however feel they have a plan going forward which on the face of it looks positive.

Last years AGM whilst positive with PT’s here we go, with hindsight I feel we were looking for anything to cling onto post that dreadful day in February, probably the same for the BOD too.

It was great to meet up again, pub gathering with both of you and other attendees was enjoyable and useful for exploring and exch

Thx Jackman59 thought I’d heard correctly regarding starting.”

Doc.Daneeka, as you can appreciate trying to take notes whilst digesting the info can be taxing, at least for me:)

Hopefully Doc83 and Wigster77 will clarify any misunderstandings when they report here tomorrow after their long journey home.

Finally, they stated bio markers and autoantibodies testing for stratification has come on leaps and bounds since Covid.

Which certainly assists Synairgen in their Phase2 trials.

Also the subject of ILI patent life remaining was raised, that was when governmental exclusivity was mentioned by RM.

Post meeting I asked RM about governmental exclusivity (for biologics) as opposed to patent protection, he said if there was only one to choice he would go for governmental exclusivity.

Doc83 & Wigster77 good to catch up again, have a safe journey home.

I’ve done a quick summary, feel free to correct my interpretation or items I may have missed.

1) No comprehensive answer to company overview of timeframes, reading between the lines this will be dictated by the Phase2 element.

2) They are very focused on stratification for these Phase2 trials by both bio makers and autoantibodies.

It was encouraging to hear that they are going to use the assays developed by Casanova (patent applied for around the same time as our Covid application). The tests are produced by another company but not generally available yet, so early stages for them too.

3) From memory the Phase2 elements have will start more or less simultaneously but will probably finish at differing time and will be US and U.K. based (which makes sense).

4) We got the impression that PT’s are not a priority unless the organisers do all the heavy lifting and Synairgen just has to supply SNG001. Whilst appreciative I think the time taken to receive the ACTIV 2 data was a surprise to them. Synairgen’s limited resources will utilised for their own company trials.

5) Future funding I got the impression the Phase2 trials will be crucial for this area going forward.

6) They said they’ve taken on board criticism of communications, bearing in mind they don’t wish to dish out just fluff or words to that effect.

7) Simon Shaw when questioned about TFG he stated they were definitely not insiders.

Impression, still a long way to go therefore I shall remain on the median line neither positive nor negative, which I will say is much better than I was feeling this morning prior to the meeting starting.

Apologies for any typos.