Member Info for Sangijuelas1

A company called Yumanity who are partnered with Merck for Parkinsons had their IND put on hold last month.

So getting IND is an important step as FDA will have authorised the dose 4D put forward to start trials straight away in Parkinsons patients.

Yumanity are now openly looking for a buyer since the FDA decision.

I think you are out of your depth here calamari.

The 4D Parkinsons drugs are looking to deal with the symptoms rather than the causes.

Their LBPs can go straight into what is effectively a P2 as they don't need a P1 in healthy volunteers or to run a dose escalation stage.

Never mind, stay poor if that's your thing.

Merck has 2 partnerships with young biotechs for Parkinsons involving potential licensing agreements. One of these has just stalled due to FDA safety concerns.

So another reason why the 4D pipeline would be a good fit for Merck

The same day they announced positive top line data from their atopic dermatitis trial and a new clinical candidate in oncology so covering up the bad news with the good

If only we had the video of the fireside chat they did with Merck late last year to talk about the benefits of partnerships

It's not so much about shortcuts. More about not making mistakes and understanding FDA expectations.

I am sure if Merck had been helping Seres with their P3 candidate approval it would have been done by now.

But Seres screwed up as it was their first experience of going for an approval.

As I have said before, by going for the Biomarker data it will potentially create a new category.

Keytruda targets the PD1 biomarker. So is a treatment approved for people with that biomarker.

They are looking for additional biomarkers so you would combine PD1 biomarker with the Treg acquired resistance biomarker to provide a therapy for patients with both biomarkers.

The hunt for new biomarkers is a big deal in immunotherapy and other fields as it helps to make medicine delivery more accurate.

The trial has been going on for over 12 months.

Merck will have already seen the output.

I think we would have found out by now if results bad as they would have walked away.

They are involved in multiple Keytruda combo trials and they don't have time or resources to waste.

Evelo Biosciences started a trial with Keytruda for their live biotherapeutic around the same time as 0518 and that trial was abandoned in late 2020.

Seres started a trial in 2019 with Bristol Myers Squibb for their immunotherapy Opdivo and that was abandoned last year.

Merck are running the trial with 4D.

They will know what is expected by the FDA so will be guiding 4D along the way with any submissions.

It's basically getting another approval for Keytruda, but this time in patients who have developed resistance and have the Treg resistance biomarker.

That's a bit more like it

Why do people keep destroying these share discussion boards with pointless dribble about Ukraine situation.

If I want to know about that I go to the appropriate forum, whereas here I think it is better to keep the focus on Angle, which I don't believe is currently seeking approval from the Ukrainian regulator

If the 0518 readout is positive I don't think we will be around in 2 years time other than as part of Merck.

At least if it's not there is plenty to fall back on.

Took another look at the Parkinsons stuff yesterday and it does look very promising.

It's called providing perspective as most people have lost it

Crusty I bet you think your cash in the bank is zero risk

Better hope there's not a bank run

Micro RX platform with 9 drug candidates in pipeline discovered in 7 years

Blautix ready for P3 and talk of commercial manufacture in a US market conservatively estimated to be worth $2.4bn.

Partnerships in place with 2 mega pharmas in MSD and Pfizer and a mid market one Merck Kgaa

Massive opportunity for 0518 as combination therapy with other treatments including immune checkpoint inhibitors $56bn market. Next ICI collaboration likely to require upfront payment if the pharma wants to play with 0518.

Collaborations with top cancer research settings like MD Anderson and Imperial college.

Forthcoming trial for Parkinsons with a seat on the science advisory board of Michael J Fox Foundation and partnership with Parkinsons UK. Both collaborations will make patient recruitment a lot easier.

Funding in place until the end of 2022

Incredibly experienced board with heavyweights like Axel Glasmacher and Katrin Rupalla (check out their CVs)

Directors DP and AS own 10% of the company including further investments in the last placing at 110p

Vaccines collaboration with MSD with milestone payments potentially available of up to $1bn

A second generation oncology drug in pre clinical development already recognised for potential to make CAR-T therapies work in solid tumours (holy grail)

Manufacturing capacity in place for commercial production with 7 years worth of accumulated experience and expertise

With 2 partnerships in place with MSD and them owning nearly 5% surely the inevitable will be only a matter of time

Opportunity to buy into a company at the vanguard of the future of medicine.

Fickle UK investors fret about news when the news is already out there.

A Leader in the Microbiome space, which we know is such a focus of pharma attention given that the microbiome is the Number 1 project at the Merck Exploratory Science Centre.

Not just a leader with drug candidates for multiple conditions beyond Gastro intestinal illness but in the tech itself with several years accumulated experience of manufacturing a complex product.

At Microbiome Connect USA last year 4Ds head of manufacturing led a roundtable discussion with the FDA to highlight overcoming challenges in quality when producing live biotherapeutic products.

Seems like UK investors are just a big bunch of scardey cats that want to be spoon fed wealth without doing the hard graft of getting themselves educated about opportunities

So much negativity.

Not a few new drugs. A new branch of medicine.

For 34p you get

An immuno-oncology pipeline for multiple cancer types.

Gastro intestinal pipeline IBS and IBD

Respiratory disease pipeline for asthma

Neurodegenerative disease pipeline for
Parkinsons and Autism

Auto immune pipeline for rheumatoid arthritis and MS

4D is misunderstood by so many.

People look at the pipeline and see Blautix and as that has completed P2 they think it is the most advanced program.

It's not because they still need to run a P3.

Whereas 0518 is in P2 but if results are good it could get approved.

This is because it offers the chance to extend life in cancer patients who have exhausted all treatment options and are sadly going to die.

So the combo therapy 0518 /Keytruda could be made available to patients if the safety profile is good, the mechanism of action is clearly demonstrated and supported by biomarker data to show why it works in certain patients.

The ongoing approval would be conditional on future P3 trials but in the meantime it could be on the market.

Keytruda was made available following the results of P2 trials.

This is what people are not getting about this stock.

Easy 3 bag back up to placing price.

What are you waiting for?