I have substantially bought #DDDD today

I have done extensive research into #COVID19 treatments companies listed on AIM over the weekend (Around 30 HOURS❗❗) and came to the conclusions DDDD is the drug which is most likely to have great efficacy and safety data 💥💥💥
#DDDD

The Microbiome Therapeutics company focused on using an innovative solutions for treatment in unmet 21st century ailments

Areas of focus

-Vaccines
-Oncology (Cancer)
-Respiratory illnesses inc
---SARS-CoV-2 #COVID19
-Irritable Bowel Syndrome
-Central Nervous System
#DDDD 💊

@Merck currently have signed 2 collaborations with #DDDD

1- To develop their KEYTRUDER®️ BLOCKBUSTER Drug in conjunction with #DDDD MicroRx Platform
(Initiated 2018)

2- To develop multiple novel Vaccines via Live Bio-therapeutics
(Initiated 2019)
#DDDD 💊

@Merk along with other very reputable high grade investment firms make up 70.9% of share holding.

This is a massive sign of confidence/validation of the project therapeutic area which they are innovators in
#DDDD💊

I myself have done vigorous research on the link between a healthy gut/microbiome and overall health.

Clinical researchers coming from the most prestigious Universities such as Harvard back up the thesis that ailments can be cured by cultivating the correct gut bacteria
#DDDD 💊

Here is a short video created by Cancer Research UK validating Gut Bacteria can play a vital role in reducing inflammation and CURING CANCER 💥
#DDDD💊

🚨A VERY INTERESTING WATCH- FOR YOUR POCKET AND HEALTH 🚨

Here is another Bio Chemist that hypothesises

The Microbiome is the central hub for health, energy and well being, validating the future to treating illnesses can be via the microbiome
#DDDD 💊

#DDDD + @Merck's collaboration are working with terminally ill patients who have advanced stage cancers

Generally, the most aggressive resistant cancers which unfortunately have limited treatment options and a significant mortality rate
#DDDD💊

Cancer Trial with @Merck

#DDDD PURE INNOVATION

Leading the way in the Cancer Microbiome field, improving one of the best selling drugs in the world💥

Ray Dalio
'It is so important to focus on hard assets and innovators in these markets, they are the real winners'
#DDDD 💊

Results thus far
3/6 of the First Patients indicate positive results.

This is SPECTACULAR for Stage 4 Cancer patients. 💥💥

When all hope is lost...
NSCLC- 🚨AFTER 7 FAILED CANCER TREATMENTS 🚨this treatment finally starts to offer light at the end of the tunnel
#DDDD💊

Now look at RCC top
This patient has shown consistent regression
One tumour COMPLETE DISAPPEARANCE
We are talking stage 4 Cancer with huge tumour regression😳

This is rare!

Can you see why @Merck have bought 7% of #DDDD and signed a $347m deal to create vaccines💥
#DDDD 💊

Thank you to @AIM_bagger for pointing out this is $347m per vaccine created

This equates to in excess of $1 BILLION in milestone payments plus Royalty payments on sales 💥💥
#DDDD 💊

I'm telling you this is INNOVATION!

I haven't even got onto their #COVID19 Potential treatment yet!
#DDDD💊

Why may #DDDD have an instrumental treatment technique that may assist in the FIGHT AGAINST #COVID19?

🔋🔋🔋🔋🔋
#DDDD💊

#COVID19 Background 🔬🦠

I have done extensive research into what is causing these severe #SARS_COV_2 cases

These cases are heavily linked to the immune system going into over drive creating #CytokineStorm
#DDDD💊

Cytokine storm= AN UNCONTROLLED RELEASE OF CYTOKINES By Macrophage

Cytokines such as Interferons and Interleukin play a role in the immune system over reacting, creating too much inflammation which then causes a range of other issues which spiral out of control
#DDDD💊

Where does #DDDD treatment come into play?

Cytokines wake up Neutrophils which excrete Neutrophil Extracellular Traps

As seen in the video NETS create inflammation which makes it increasingly difficult for Gas Exchange in the Lungs
#DDDD💊

Neutrophils also create
-Proteinaise
-ROS- 🚨Creates cell death and does not discriminate taking out both healthy and virus cells🚨
#DDDD💊

Notice how the video talks about positive data in mice models?

Is this video highlighting data from #DDDD?

#DDDD💊

To conclude

These 2 trials in both Cancer and #COVID19 represent near term exponentiation inflection points for this young innovative pharma

- #COVID19 Trials are expected to begin imminently

-Update/Readout from Cancer Trial progression is expected Q2 (This Q)
#DDDD💊

Director in the attached presentation highlights completion of enrolment for Part A of the P1/2 Cancer Trial in collaboration with @Merck on 16th March

https://www.4dpharmaplc.com/application/files/2015/8401/4673/4D_Pharma_plc_Chardan_MM_Summit_Presentation_16.03.20.mp4
#DDDD💊

Results on both oncology/cancer studies to be publish Q2 likely within the next 4 weeks IMO
#DDDD💊

Key take homes from today's RNS regarding Cancer Trial in conjunction with @Merck KEYTRUDER®️ drug, highlighted below

Phase 1 Success✅

Remember this is open label, so expect results as we progress

One to tuck away and in a couple of years likely to have 10 Bagged
#DDDD💊

UPDATE
MRx0518/ @Merck KEYTRUDA oncology/cancer trial

Phase 1 Demonstrated
-Excellent Safety Profile
-No Drug discontinuation due to drug side effects
#DDDD💊

UPDATE
MRx0518/ @Merck KEYTRUDA oncology/cancer trial

Out of the 12 Patients
-5 withdrawn from the study due to Cancer Progression Serious Adverse Events

This is due to the nature of the patient which #DDDD are trying to treat. (Stage 4 Terminally Ill)
#DDDD💊

UPDATE
MRx0518/ @Merck KEYTRUDA oncology/cancer trial

Analyse the data in 2 cohorts
Discounting the people that dropped out due to their own personal reasons, too soon into treatment

Mid case (Discount 3🔴)
5/9= PR 55%

High Case (Discount 5🟡🔴)
5/7= PR 71%
#DDDD💊

UPDATE
MRx0518/ @Merck KEYTRUDA oncology/cancer trial

By interpreting the data you can see a

55-71% of Stage 4 Terminally ill Cancer patients are showing PR (Positive Response) to the treatment💥
#DDDD💊

The study has recently been updated to add a series of further Exclusion Criteria's

This will ensure the larger cohort is more fine tuned to prevent these patients which unfortunately are ill to treat to be admitted

Improving the overall efficacy profile of the drug
#DDDD💊

UPDATE
MRx0518/ @Merck KEYTRUDA oncology/cancer trial

These findings show very encouraging signs that the treatment fills a large gap in the Oncology market

I anticipate efficacy data to become stronger as the P2 Trial progresses
#DDDD💊

UPDATE
MRx0518/ @Merck KEYTRUDA oncology/cancer trial

Due to the initial inflammation and immune response from the drug (Sudo Progression) the results can not be accurately distinguished until the patient has generally undergone 20 weeks on treatment
#DDDD💊

UPDATE
MRx0518/ @Merck KEYTRUDA oncology/cancer trial

Therefore with this analysis along with factoring in sudo progression.

I believe #DDDD will gain very significant statistical data on treating Terminal Stage 4 Lung and various other cancers in 12 months time💥
#DDDD💊

MRx0518 x @Merck KEYTRUDA 🚨US Market ONLY 🚨(so far)

44,000 Paitents pa
Price of
-MRx0518 $75,000 pa (est)
-KEYTRUDA $168,000 pa

Revenue for MRx0518 (ONLY)
$3.30 billion per annum

Market Expected to grow SIGNIFICANTLY from these levels

https://pharmaintelligence.informa.com/resources/product-content/every-new-cancer-drug-in-2017-cost-100000-or-more
#DDDD💊

4D commences Phase 2 #COVID19 Therapeutic Trial💥

MRx-4DP0004

-Excellent safety profile
-Reduces Lung Inflammation by down regulating neutrophils and eosinophils
- While Maintaining anti viral immune response

IMO I think this may drastically improve outcomes 💥
#DDDD💊

Following the placing today the BoD hold
-19.44% of the company

The placing has also generated substantial US Interest and has hinted at a near term listing on a US exchange 🇺🇸
#DDDD💊 https://twitter.com/AimHardy/status/1283731365247299584?s=20
#DDDD💊

Why I believe @4dpharmaplc are on the cusp of a multi hundred million pound licencing deal for IBD and IBS? https://twitter.com/AimHardy/status/1286223652451647489?s=20
#DDDD💊

Great Video 'Our Approach' highlighting @4dpharmaplc world leading innovative concept

Harnessing the bodies own Microbiome (Gut Bacteria) to solve genetic imbalances and malfunctions commonly referred to as diseases

https://www.4dpharmaplc.com/en/newsroom/video-and-audio
#DDDD💊

Are you excited yet?
#DDDD💊

Highlighted in this video is the autopsy findings of #COVID19 patients who have died

If is evident Cytokine storm and inflammation, which leads to Pneumonia and ARDS is a significant contributing factor to mortality (death)
#DDDD💊

@4dpharmaplc

MRx0004- Pre Clinical Indications shows it controls the Immune Response

To have the sufficient capabilities to deal with the issue but prevent over inflammation which can lead to ARDS and Pneumonia
#DDDD💊

Further comparative data highlighting the control and reduction of inflammatory cells

Untreated vs MRx0004
#DDDD💊

Further Data showing MRx0004 significantly reduces Lung Infiltration and Inflammation
Allowing the lungs to remain porous for gaseous exchange, eradicating the need for ventilation?

🚨Potentially significant treatment to prevent ARDS + Death in Patients with #COVID19🚨
#DDDD💊

I have now discussed the positive effects of inflammation reduction but what about actually killing the virus?
#DDDD💊

COVID19 paitents are seen to have depleted levels of CD4 and CD8

https://www.cell.com/immunity/pdf/S1074-7613(20)30183-7.pdf
#DDDD💊

MRx0004 has been shown to slightly elevate the circulating levels of CD4 and CD8 in the lungs
#DDDD💊

“All disease begins in the gut”

Amazing research in the relation between the Microbiome+health

Not everyone will change their diet!

Therefore @4dpharmaplc is exquisitely poised to assist in the therapeutic ailment of modern day illness+disease
#DDDD💊

Further Data from the Merck KEYTRUDER ®️ Collaboration In Oncology (Cancer) Treatment is showing to be very encouraging!

Clinical benefit increasing
25% ➡️ 33-42%

Why is this early data massively encouraging?
#DDDD💊

The patients @4dpharmaplc have recruited are patients with no therapeutic options available meaning there is a DESPERATE need for a treatment

Remember my previous tweet when analysing the data this combination is shown to yield even higher clinical benefit %’s
#DDDD💊

Thread🧵

Here are my thoughts on the clinical validation results of KEYTRUDA with MRx0518 and how this early data is showing revolutionary results for therapeutic treatment

This very well may be the start of a multi billion industry 🚀📈💥 https://twitter.com/AimHardy/status/1298515350275981318?s=20
#DDDD 💊

I will now go into further favourable data which suggests MRx0004 is perfect for the fight against COVID19
#DDDD💊

MRx0004 has shown in studies it boosts and maintains Tregs- control the immune response to self and foreign particles (antigens)

importantly Th1- T cell that promotes cell-mediated immune responses and is required for host defence against intracellular viral pathogens
#DDDD💊

MRx0004 increased FoxP3+ T A MASTER REGULATOR ensuring the body maintains an optimal balance of immune cells, to prevent lung damage while killing viral pathogens🤯💥
#DDDD💊

The aforementioned just disclosed in conjunction with my early analysis of MRx0004 signifies all the relevant biomarkers for the successful treatment of #COVID19 💥

MRx0004 potentially may yield PHENOMENAL results (which are expected towards the end of the year)📈🔥
#DDDD💊

Now taking a look into MRx Platform for CNS diseases such as Parkinson's Disease

Here is a video highlighting

🚨'Parkinson's occurs due to the death DOPAMINE producing neurons'🚨
#DDDD💊

Both MRx0005 and MRx0029 have stimulating properties which
-Reduces neurological inflammation💥
-Protect Dopaminergic Neurons💥
-Increases Dopamine💥

Dopamine is the neurological pathway which allows movement
#DDDD💊

MRx0004 #COVID Trial🦠

Although it is not a pleasant statistic to report on

Hospital admissions are exponentially rising and will continue to rise into winter

This will accelerate Trial recruitment (90) with potentially a read out by Jan IMO
https://www.england.nhs.uk/statistics/wp-content/uploads/sites/2/2020/09/COVID-19-daily-admissions-20200923.xlsx
#DDDD💊

6 Cohorts for their Phase 2 Treatment IN DIFFERENT SOLID TUMOURS

SIMILAR EFFICACY SEEN when compared to @4dpharmaplc Treatment!!

$5.7bn DEAL?!?!?

https://twitter.com/LRamseu/status/1312391912956010498?s=20
#DDDD💊

My thoughts and opinions on Blautix results for IBS https://twitter.com/AimHardy/status/1313802382732603398
#DDDD💊

Thread on the potential early revenue generation from US markets alone of MRx0518 which potentially may gain approval as early as next year

🚨$3.52 Billion per annum🚨 https://twitter.com/AimHardy/status/1319541051221250048?s=20
#DDDD💊

My thoughts on the earlier than anticipated NASDAQ Listing🇺🇸🔥 and how this will propel @4dpharmaplc to a MULTI BILLION 💰 Valuation

📈📈📈📈 https://twitter.com/AimHardy/status/1319179022899810304?s=20
#DDDD💊

@4dpharmaplc CEO Q&A revealing some
🚨very interesting🚨 aspects of 4D and why they are the World Leader in a new a evolving therapeutic division... 🌍💊

🔥🦠Live Bio Therapeutics🦠🔥 https://twitter.com/AimHardy/status/1319297760030453760?s=20
#DDDD💊

SUPER PHARMA's are still on the lookout for efficacious drugs to treat #COVID19 and are prepared to pay HUNDRED'S OF MILLIONS IN UPFRONT PAYMENTS💥

Similarly 4D's compound MRx0004 is currently in Phase 2 #COVID19 Trials with results expected Q1 https://twitter.com/AimHardy/status/1319314612110659585?s=20
#DDDD 💊

COVID Daily Hospital Admissions continue to rise

997 Admissions in a 24 hour Period (21st Oct)

Surely Clinical Enrollment for MRx0004 is expected to be accelerating with 90 Patients to enrol https://twitter.com/AimHardy/status/1308850423902670857
#DDDD 💊

MRx0004 specifically dampens the immune response...💥

Dangerously ill coronavirus patients are making
🚨"startling recoveries" 🚨
in spite of being at "death's door" after being given
🔥drugs that dial down the immune system🔥
experts have said
http://telegraph.co.uk/news/2020/10/2 
#DDDD💊

NASDAQ listing expected Mid January 🇺🇸

COVID Phase 2 Trial Results I expect shortly after (February)🦠

Can you imagine what US investors will do if MRx0004 follows suit with the aforementioned and is proven to significantly help #COVID Hospitalised Patients 📈 https://twitter.com/AimHardy/status/1319883086113476608
#DDDD💊

Blautix- What has sparked my eye?👁

The company have stated they are conducting further investigational work regarding their Phase 2 Trial

Specifically Bio Markers for “Sub Groups” and will announce results Q4, refining further/digging deeper than a specific cohort
#DDDD 💊

I believe 4D may have stumbled on an entirely different way of looking at/diagnosing the mechanism of disease with this study🚨

Each arm of Blautix in IBS C/D/M ALL generated very similar efficacy 23.4% to 25%

This efficacy across the board is far to similar to ignore
#DDDD💊

I believe there is a potential to categories specific IBS, primarily by using bio markers

I believe the further investigational work will show strong signals Blautix will cure specific Microbiome deficiencies leading to a Pivotal Phase 3 which will show v high efficacy
#DDDD 💊

Overview

10% of the Global Population is expected to have IBS

Blautix has shown to be 25% effective across the board for improving peoples outcomes for IBS

🚨That indicates the potential market for Blautix is effectively 2.5% of the global population🚨
#DDDD💊

Blautix is safe with No SAE

This leads me to believe even with 25% efficacy

🚨This could become the first line of Therapy routinely prescribed by GP’s👨🏼‍⚕️around the globe (potentially OTC Treatment)🚨

With an initial 6-8 week prescription to see if benefits are seen
#DDDD💊

11th Nov I hope you are ready

Why would you host a presentation with an associate professor from
🌍THE BEST CANCER HOSPITAL IN THE WORLD🌍
discussing your drug in
Pancreatic (Gastrointestinal) Cancer
💥🔥UNLESS YOU HAD SOME NEW GROUND BREAKING NEWS TO PUBLISH...🔥💥
#DDDD💊

MRx0518 is already showing great signs of Efficacy in Lung and Kidney Cancer...

Are we now going to receive news on a further application to treat Pancreatic Cancer?🔥📈
#DDDD💊

Thread

Update of MRx0518 at SITC and the subtle and early indications presented for the long term growth and validation of the MRx Platform®️ https://twitter.com/AimHardy/status/1326539660638605313?s=20
#DDDD $LBPS 💊

Thread

How MRx0518 has the potential to penetrate multiple indications of Cancer due to its efficacy and excellent safety profile 🔥 https://twitter.com/AimHardy/status/1327381385267585026
#DDDD 💊

BLAUTIX

💥COMPARABLE💥
to
🔥FDA APPROVED🔥
IBS Drugs

Could Blautix become the the initial first line of treatment offered 🌎Globally🌎 for IBS across all indications?
#DDDD 💊

BLAUTIX

Now directors have laid it out very clearly

YOU CAN SEE WHY Blautix IS GAINING SUBSTANTIAL INTEREST FROM MAJOR INTERNATIONAL COMPANIES IN THE SPACE

You only need to look at the deals which are being signed in the area
🚨(BUT NOT IN THIS INDICATION)🚨
#DDDD 💊

Tocilizumab the “anti inflammatory drug” to receive approval for treatment of COVID19

https://www.bbc.co.uk/news/health-55002339

“an encouraging result which SUGGESTS that OTHER MORE TARGETED ANTI-INFLAMMATORY DRUGS may help”

MRx0004 a LBP that SPECIFICALLY targets Lung Inflammation🔥
#DDDD 💊

4D are now 5 months into their P2 trial for MRx0518 x KEYTRUDA and have recently requested an FDA meeting for accelerated approval which is now planned for Q1 2021...
#DDDD 💊

With so little patient enrolment to date (Likely less than 100) why are 4D going for approval so early into trials?

Is the growing body of evidence showing large statistical significance/benefit for these desperately in need Stage 4 Cancer Patients?🤷‍♂️
#DDDD 💊

4D have shown some remarkable results already with 70%+ tumour shrinkage in a patient with Stage 4 cancer

You have to remember these patients are terminally ill after having exhausted multiple different treatments which all have failed
#DDDD 💊

Another encouraging update

MRx0518 shows most promise in Lung Cancer (NSCLC) and more efficacy as a monotherapy ALONE than an already approved drug which is actually approved for FIRST LINE OF THERAPY💥🤯
#DDDD 💊

Developing on why MRx0518 may be ground breaking for Lung Cancer 🫁

Observe this patient NSCLC

They had a STAGGERING 7 lines of therapy with no meaningful benefit before 4D's trial
Now they have seen a continued steady shrinkage of the Tumour 💥

Data- 8 months ago
#DDDD $LBPS 💊

This Stage 4 Terminally ill patient that had exhausted ALL other treatments STILL remains on treatment 18 MONTHS LATER using MRx0518💥🤯

STILL continuing Progression Free Survival and Tumour Shrinkage

This is HUGE

Now lets look at ORR...
#DDDD $LBPS 💊

Objective Response Rate is currently at 33%
However taking into account the ground breaking results just discussed, the current data is skewed due to patient withdrawal due to factors unrelated to MRx0518

ORR is likely to improve much further in NSCLC from here📈
#DDDD 💊

As shown on the graph the 2 other NSCLC participants withdrew before the first assessment at 9 weeks (This is the point you will BEGIN to see meaningful benefit)

The patients also did not discontinue due to drug related side effects
#DDDD $LBPS 💊

Therefore to date the ONLY patient within the NSCLC cohort which continued treatment up to the first meaningful assessment point shows VERY SIGNIFICANT clinical benefit

Adjusted ORR for NSCLC (Lung Cancer) is a HUGE
💥100%💥
🔥Continuing to show PFS 18 Months+ 🔥
#DDDD $LBPS 💊

Thread
Identifying similarities found between MRx0518 and Iova's TIL Therapy
A NASDAQ listed company developing similar very safe and efficacious drug pathways
The only difference $IOVA valued 3700%🤯(YES 37 TIMES) higher than 4D Currently https://twitter.com/AimHardy/status/1333888698602168322?s=20
#DDDD 💊

Commentary on $GLSI and likelihood of multiple near term value inflection point for 4D Pharma Q1 2021 https://twitter.com/AimHardy/status/1336766100391026689?s=20
#DDDD 💊

Incredible safety profile🔥

NO Moderate Side Effects atall (All mild)

All while yielding clinical benefit in terminally ill patients which have exhausted all other treatment methods

A effective treatment that shows the possibility to be stacked with many other combos
#DDDD $LBPS 💊

Information on how the Microbiome can enhance immune activation increasing efficacy of drugs.. in particular VACCINES 🔥

4D Pharma has a joint development agreement with @Merck valued @ $1bn+ specifically targeting vaccine innovation 💥
#DDDD $LBPS 💊

This one specific study highlighting the potential of
Live Bio Therapeutics (Microbiome)🧫
To reactivate the immune system in
-Elderly
-Antibiotic Resistant Patients

Improving efficacy of vaccinations to sufficiently generate Anti Bodies
#DDDD $LBPS 💊

There is now a large growing body of evidence in many arms of Therapeutics showing the vast potential of the Microbiome

Signalling this new arm of Therapeutics plays an important role in modulating and optimising the immune response in combatting disease
#DDDD $LBPS 💊

24min30sec
Discussing how Live BioTherapeutics can re engage an immune response to increase the efficacy of Immune Checkpoint Inhibitors (In this instance PD-1/PD-L1)

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