Member Info for noix

Splodge
The other important point to consider is that most if not all of the other 7 patients in the trial were unfortunately so ill that they either didn't reach or get through the radiological assessments at week 9 to get into the study proper.

Splodge
Apologies for the incorrect name spelling in the first post, so I've corrected it in this one and added the second part of Dr Stevenson's comment :

He added, "We believe that, while this is a small study, these efficacy and safety results in such a difficult-to-treat population are notable. To achieve these results while maintaining a very clean safety profile is to our knowledge unparalleled, and particularly significant in oncology where there is all too often the unfortunate trade-off between treatment and quality of life, and patients often elect to interrupt or stop treatment completely due to adverse side effects."

Slodge
Have you a medical background and if so why do you not believe that the MRx0518/Keytruda trial is not ground breaking.
I remind you of this comment in the rns announcing the results from 4D Pharma:

" Dr Alex Stevenson, Chief Scientific Officer, 4D pharma, commented, "The disease control rate observed in part A of the study, at 42%, far exceeds the 10% threshold for success agreed with our partner MSD for the cohort expansion phase, boding well for the outcome of the ongoing Part B of the study. This is ground-breaking for the microbiome in immuno-oncology. Considering the advanced stage of disease of the patients in the study, end of line patients who have previously failed on a checkpoint inhibitor and have little to no remaining treatment options, these results are very promising."

morning trek
Hope you don't mind me popping in here and apologies to all for the o/t.
Interesting events at the double double Diamond share and if you want to air your thoughts perhaps the CSH board would be a good place.

My reading of the deal is that although it's a merger with a SPAC ie LOAC, in effect it was a placing subject to the LOAC shareholders agreement. Whale, their largest shareholder is on board. The "placing is being underwritten by the two 4D directors to the tune of approx. $2 million and Steve Oliveira (South Ocean Capital) up to $5 million. The bonus is that subject to regulatory clearance, it gets 4D onto the Nasdaq without going through the process of a formal listing. And in terms of the share price increase, over and above the premium that LOAC were paying (£1.10 vs a closing price of 93.5p) the deal was the catalyst for the rise. The deal was the deal if you like and up or down any share price movements between then announcement and closing of the deal, is part and parcel.

crusty pete
"I would have thought that it would be fairly obvious to the "patient" whether it is "C" or "D"...... :0)"
With respect you have missed the point. There are many IBS sufferers whose symptoms alternate between C and D. Hence a treatment that addresses both types with the same dosage is a major step forward in this sector. 4D are saying that Blautix does this and that's why they see it as a one stop therapy for doctors to prescribe.
Guys we live in a free speech country - just - but can we please cut out the mystic meg predictions for thye share price because it brings nothing to the party. I'd have thought that people would have learnt that lesson 2 weeks ago.

It presumably doesn't always work out this way but as a layman, one would hope that the part B results are in line pro rata with the Part A. As has been posted both here and on other boards, the Company gave an update shortly before last years SITC2020, so I would expect one this year, just prior to our presentations on 14th November.

Apologies, less haste etc.
I'd better clarify this:
"We passed the Phase 1 stage for all 12 patients in Part A MRx0518/Keytruda and they progressed to the full treatment cycle,"
Unfortunately 5 of the patients in the Part A trial were so ill, they did not pass the radiological assessment and had to be withdrawn. This had nothing whatsoever to do with the safety profile of MRx0518 which matched placebo.

This is how a Phase1/2 study works.
Phase 1 is centred on safety and tolerance of the drug. Dosing is usually gradually increased to the optimum determined for efficacy and then if that stage is passed they move onto Phase 2, centred on the efficacy of the treatment but of course always keeping a careful watch on the safety angle.
We passed the Phase 1 stage for all 12 patients in Part A MRx0518/Keytruda and they progressed to the full treatment cycle, the results of which were announced in August.
In June they started enrolling the 120 Part B patients for the Phase 2 proper.
This is an excerpt from the rns after the frist patient passed the safety phase and progressed to phase 2 in part A of the trial:
"Update on MRx0518 Phase I/II combination study with KEYTRUDA® (pembrolizumab)

The first patient participating in the combination phase I/II study of MRx0518 and *KEYTRUDA® in collaboration with Merck & Co., Inc., Kenilworth, NJ., USA and 4D's strategic collaboration with MD Anderson has completed Cycle 1 of Part A of the study with no dose limiting toxicities. This study is open-label and will recruit up to 132 patients with metastatic cancer across multiple cancer types (non-small cell lung cancer, renal cell carcinoma, bladder cancer and melanoma) who have failed prior anti-PD-1 therapy. Part A of the study will enrol 12 patients with the primary outcome measure to assess safety and tolerability. Patients will continue on therapy with follow-up assessments including the anti-tumour effect of the combination. Recruitment is progressing as expected and we anticipate completing Part A before the end of 2019. At this point, Part B of the study, which has a primary endpoint to assess the clinical benefit of the combination, will commence."

As the Company has stated, they see this as a one stop treatment for all tyes of IBS and as it will be the only product in the market that addresses both types, it can be confidently prescribed by doctors to those people that alternate between C and D.
Slide 10 on the webinar shows the comparitive with the other IBS products now to market at the same stage of their development ie Phase 2 trials :
https://www.4dpharmaplc.com/application/files/7216/0201/7566/4D_pharma_-_Blautix_BHT-II-002_Ph2_IBS_Results_Oct_2020.pdf

Michael
On the 15th October I posted this as part of a comment on the results, which was subsequently questioned by a couple of posters:
"As many of us have been at pains to point out, the market interpretation of the results was a mis understanding of the numbers. Had the IBS C and IBS D individual cohorts been of greater patient numbers the "not statistically significant" label would have lost the "not" and the market reaction would have been completely different.
Just to prove the point, the summary of all the results, including the example given by 4D to you, is as follows:
IBS C/D combined response rate of Blautix 24.1% vs 17.5% for placebo, so Blautix 37% better efficacy.
IBC C response rate of Blautix 25% vs 17.1% for placebo, so Blautix 46% better efficacy.
IBC D response rate of Blautix 23.4% vs 17.8% for placebo, so Blautix 31% better efficacy."

The Company in its latest response to you have said this:

". For the IBS-C FAS this was 25%/17.1% = 1.46 = 46% over placebo; for IBS-C/D combined FAS 24.1%/17.5% = 1.38 = 38% over placebo; in both EEAS groups the effect size over placebo was enhanced. This we believe is a clear and positive outcome, particularly in IBS where the margins for currently available therapies vs placebo are not dissimilar (and sometimes smaller)."

If those two posters disagree with the Company, I trust they are no longer invested.

Apologies, that 11am should have been 10am UK time, I'm on the continent but at 12 noon the bid/offer was 135/137.

I've been doing a bit of research on the sell off, which certainly caught me out. I was of the opinion that after the inital drop the price would hold steady in the 130-140p range, which it did for most of the morning. At 11 am people were buying and selling in the low £1.40's, only 18% off the previous close. So much so I bought a few more a little lower.
The real sell off started at 12pm - 7am New York time and by 3pm - 10am NY time we were down to 116/117, closing at 109. Folk can draw there own conclusions from that !

I can only look at the historicals but these things do take time and from memory the Company mentioned first news towards the end of this year for Part B.
In the Part A trials, the first patient had completed the first three week cycle at the end of April 2019 and first meaningful data was released to us at the end of November 2019, for the first 6 patients.

It's impossible say but it shouldn't be forgotten that the MRx0518/Keytruda trial is independent of the vaccines collaboration.
Not much has been said about costs, whether they are being shared or if Merck, or indeed 4D, are paying for them individually.
Given the results of the Part A study, the interest of other Pharma's with ICI's will have been aroused and I very much doubt if Merck will want to let it slip away either. They might possibly have first refusal. If the results of the Part B study even come close to emulating those of Part A, then there's a deal to be done. Oh to be a fly on the wall :)

If Merck decide to license a vaccine developed in collaboration with 4D.
They are jointly looking at LBT's by using the MicroRx platform to identify suitable candidates for novel vaccine development.

"Under the terms of the agreement 4D's proprietary MicroRx® platform will be paired with MSD's expertise in the development and commercialisation of novel vaccines, to discover and develop LBPs as vaccines in up to three undisclosed indications. 4D has the right, subject to certain conditions, to cause MSD to purchase $5 million in ordinary shares in 4D during the first 12 months of the collaboration. In addition to an upfront cash payment, for each indication, 4D will be eligible to receive up to $347.5 million in option exercise and development and regulatory milestone payments, plus tiered royalties on annual net sales of any licensed products derived from the collaboration. MSD will be responsible for development, manufacturing and commercialisation following the exercise of any of its exclusive options."

Part 2
"Dr Alex Stevenson, Chief Scientific Officer, 4D pharma
Slide 3 – Key takeaways
Thanks very much Duncan. Well to start off with what I’d like to do is to talk to you about the key takeaways from the study itself. So in
terms of what we set out to achieve in this study, we designed it to generate a meaningful signal of clinical activity in IBS-C and IBS-D and
therefore in the combined population and to provide the necessary data for us to develop a pivotal program for Blautix.
What we saw as you’ll see is that Blautix demonstrated an effect size relative to placebo that was comparable to pivotal studies of other
approved products with both IBS-C and IBS-D, but Blautix also demonstrated activity in the combined cohorts of IBS-C and IBS-D patients
as a result. Importantly, Blautix also showed a highly favorable safety profile, which is comparable to placebo. Interestingly, we also saw
preliminary evidence of enhanced activity in specific subgroups of patients. We won’t talk about that today, but that’s subject to further
investigation, and we saw a particularly strong signal in overall improvement of bowel habits across both major subtypes of IBS.
So where do we go next from this? Obviously, we are highly encouraged by the data that we’ve generated. We think it’s supportive of
progressing the candidate towards pivotal Phase III trials. We think the data we generated shows that Blautix has unique potential to
address all subtypes of the disease, including potentially IBS-M [mixed]. As you can see from the quotation at the bottom, you know many
in the clinical arena would consider the prospects of having a treatment that could equally benefit both IBS-C and IBS-D with a very strong
safety profile as particularly compelling. "

Sam Lee, Chardan
Great, this is Sam on behalf of Gbola. Congrats on the data by the way. Actually most of my questions have already been answered, but
maybe just a little bit outside the box thinking. With the data you’ve seen so far, is there any indications that you could potentially use this
to expand to IBD indications? Namely, all sort of colitis and Crohn’s disease?

Prakhar Agrawal, Jones Trading
Ah yeah, congrats on the data guys. So I had a question on the baseline characteristics of the patients. I know you’re going to be
presenting the full data set later in the year, but any colour there, specifically, what was the baseline let’s say mean abdominal score pain
for patients, just trying to see how this patient population compared to some of the other trials for approved drugs, and I had one more question.

Here's the full webinar transcript link:
https://www.4dpharmaplc.com/application/files/2616/0268/3162/09.10.20_4DP_Webinar_transcript_October_2020_FINAL.pdf

Krusty
I'd pencilled in a 35% rise if the market liked the results and a 35% fall if the market viewed them as bad.
The market couldn't make its mind up initally, from memory they came out of auction around the previous days closing price and with fluctuations in between, people were able to sell at around £1.40 at 9am. At 10am the shares were still just shy of £1.40 and they had fallen to £1.30 at 11am, which is when I bought some more.
I forgot this is AIM and very often if there's the slightest doubt in a company's results the traders and the shorters take over and that's where we are today. There was clearly the froth of expectation that took the shares to 5 times the recent placing price but as ever, the market over reacts, or do folk believe that the shares had 70-80p baked into the price for the Blautix result. However, I do agree that the market does the talking but within that market I find it instructive that the only move of major shareholders so far, is to buy more. They of course do not do short terminism, particularly given the nature of 4D's portfolio and the pipeline of news to come.
The Company has now put up the transcript of the webinar, which I find really useful, because it's much easier to digest the facts in written form and as such they also provide a good reference point. I'll post a couple of relevant comments in part 2, as I'll probably run out of space here.

bluetigeruk
Thanks for your reply and if I can start at the end this is what you said:
"I suspect the email you posted was written by someone in Financial PR."
With respect you do not appear to be following the thread and as such not paying attention to what the Company has stated. In the Investor Relation department's reply to Michael highbar's measured questions, everything is clearly layed out further down the thread. My original post on the subject, was in response to Michael's post on the matter, which he kindly shared with the board. I'm not a statistician so I'm not going to get into that particular debate, suffice to say I've laid out my arguments below and I have every condfidence in the Company and their interpretation of the results.
If you really believe them to be poor, then why don't you put your argument to the Company. They do respond to genuine investors and their replies, in my experience, are based upon not only the expertise of the IR department but, when necessary, the expertise of other personnel within the Company as well. If you think about it, it would be both damaging and irresponsible for a listed Company to submit information to investors that has not been reviewed and verified, particularly given the sensitivities of this particular subject matter.
Let us know how you get on.

Thanks for your kind words.
This is clearly a frontier area of medicine and one that the medical community is increasingly becoming excited about and I'm very happy to support 4D in what I beleive is going to be an incredible journey, although not without a few bumps along the way. Seres anyone :)
ATB