NorthWest Biotherapeutics Inc (NWBO)

[ae kusterer]

My transcription machine generates alot of errors.Anyone have a machine that cab correct what I have below ? It's Les Goldman's Big Biz interview published yesterday, 7/14/23 . Thanks if you are able to clean it up .

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So you're here to be treated and veryexcited. Our next guest His name is Lesgolden and has been a longtimecontributor. To the program is SenioSoyou're here to be treated and very excited.Our next guest His name is Les golden andhas been a longtime contributor. To theprogram is Senior Vice President andGeneral Counsel for NorthwestBiotherapeutics essentials and Web. Doyou hear me talking about them? almostconstantly because it's one of thosecompanies, which are DC Vax technology,and where they are in the clinical trialstory. Less Great to have you on today.Let's talk about this topic. Can you give usan overview the CBM is a horrible diseasetalk about that.
15:41
It is the most lethal or quickest growingkilling of any solid tumor cancer, and sono more cancers make up about 80% of allcancers with melanoma. So it's reallyimportant but But additionally, theplatform that we've developed, which isexplain the way it works in a couple ofseconds here for events, accordingrevelation that came from a presentationthat Dr. Monix Bosch T Chief TechnicalOfficer made an amazing conference justabout four or five weeks ago.
16:21
And what what we discovered with a studycalled proteomics, which is the study ofproteins.
16:33
We've been selling the genome for 20years that the genome is made up of cells,strands of DNA, which are made up of of,of various components.
16:50
Proteins are part of those components,many proteins in each strand, and eachprotein has as individual parts of it, thatare called peptides. And that's a very smallfragment of a protein, protein. And Dr.Ralph Steinman working at NYU as amolecular and cellular research doctor in1993 actually was the first person toidentify when until then nobody knewwhat had been good Excel even did forand and what we presented just about fouror five weeks ago, confirms that it's areally unbelievably bigger thing than evenour potential realized at the time, which isit is basically we're putting on today'sParliament's it's the artificial intelligenceof our immune system, which has evolvedover many, many years of humanevolution and what the dendritic cell doesit is and and Simon one, we Nobel Prize in2011. It usually takes 30 years from thediscovery, but it was so significant that hewanted just about 18 years 16 years.
18:13
And and what it does and what I'm goingto explain to everybody I'm gonna giveyou just a little bit more background isthere are two components to making ourvaccine.
18:26
One is the the antigens, which is the samesame meaning as a peptide that you find inyour own tumor tissue. And we either getthe tumor tissue by operating it's going tooperate, or we do the same technique byby putting our invention into the tumor ifyou're doing the body what we do in thelab, but let's just keep it separate for asecond and talk about the the operableapproach. And if we've got time toapproach it, it's the same principle.
19:02
The dendritic cell is one of thecomponents of the vaccine.
19:07
The other component is the tumor tissueitself, treated in a proprietary way.
19:14
Which rates all of the peptides that are inthat particular use cases.
19:22
And in the lab, we do a blood draw to getthe baby dendritic cells and needs to befresh. So we try and get that done nearwhere the manufacturing facilities andexpose the peptides in the tumor tissue tothe to the dendritic cells, and here's wherethe magic starts. I mean, it's exquisite, it'selegant, it's non toxic, and it works prettywell based on the results we've got now.We've got our ideas about why it works.What happens because when they theydrink cells meet these peptides that were inthe tumor tissues. They select the ones tobe targets for the weapons of the immunesystem. Well listen to how this works.
20:17
They they choose the ones that are allrelevant to that particular cancer and theythey hold on to him on the surface of thedendritic cell.
20:32
And then we take the result of thatcombination which we we do what I justdescribed in the lab, where this selectionprocess of the dendritic cells occur, thenthat becomes the vaccine which weshipped in the doctor's offices and and thedoctors give a shot right in the upper armright near your lymph nodes. And thereason for that is the lymph nodes are theconference center of the immune system.And one of these AI type nobody everheard of it millions of years ago and saydeveloper, whatever. What do they do?They carry on their service, these varioustargets, many more than anybody can pickup in a lab. Because it's, it knows when itsees what was in the tumor tissue, what togo after. And it presents those to theweapons of the immune system andbecause it's elegant and complicated, I'mjust gonna focus on one of the bestweapons in the immune system called theT cells.
21:42
And what it does, is it hands off in theconference room in your lymph nodes. Itsays, Here's here are the targets for you togo after. And and identify and find these inthe in the body and then go attack themand kill and and not only does it presentthese targets we before we did this, wereally were maybe about 30 by 40 of theantigens out of 50,000 in the body thatneeded to be identified.
22:15
The dendritic cell, figures it out, mounts itoutside of the cell holds on to it, hands itoff to the T cell and the order to the T celland this is just one of the many weapons inthe immune system, all of which areorganized and given orders by the debititself. And if you've got to sign up, go getinvoice and and not only do the T cells,pick up all those targets and now gohunting for them in the body withoutleaving cancer cells. But they are alsoencouraged to multiply to chronal to createmore of them as they are loaded. And oneof the findings in this probably happenedstudies was that normally in the humanbody if you're healthy, you'd havesomething like between five and 20. Asyou measure the volume of blood of theseT cells.
23:16
After four months of the vaccine beingadministered, it's like halfway through theformer regime which is a six shots in thefirst year.
23:29
It was discovered that that the cloning ofthat original 520 It resulted in 400 400new T cells that multiply from the banksgo not only are they going after numerouspartners, but there's a whole bunch of themthat are doing the same thing. And thataccounts for the fact that everything elseon GBM has pretty much failed, addingjust weeks of toxic life. And we rexine isnon toxic, because this is nature's way ofhandling it and we're just re educating theimmune system by getting on the back ifyou will, of the dendritic cells andutilizing them to go tell the immunesystem that the killer cells, the T cells, allof it what to do, and amazing discoveries,how viciously they're doing it when itcomes to just following their orderssomehow, that tells you how it works. Andit's almost like before we had a black boxbased on Stein standards, invention, andnow we know how it works and why itworks and why it's better than anythingelse out there. So let's My question isbased upon it being a vaccine from yourown immune system or your own cells,can i Is it possible that this could thiscould be a therapy for other cancers?because the way it multiplies and such is Imean, is it specific to GBM? is it possiblethat it could go towards other cancers?
25:02
It we've already shown it to work in theTibetan and treatment Specialist programthat we are currently running in the UKand building up, but we made it work on15 different solid tumor cancer. Wow.Most of them blockbuster drugs, there'sless gold is
25:16
Most of them blockbuster drugs, there'sless gold
25:25
companies obviously some of theirspecialty, horrible, you're going to end upyour bio.com the stock symbol webservices. r Vice President and GeneralCounsel for Northwest Biotherapeuticsessentials and Web. Do you hear metalking about them? almost constantlybecause it's one of those companies, whichare DC Vax technology, and where theyare in the clinical trial story. Less Great tohave you on today. Let's talk about thistopic. Can you give us an overview theCBM is a horrible disease talk about that.
15:41
It is the most lethal or quickest growingkilling of any solid tumor cancer, and sono more cancers make up about 80% of allcancers with melanoma. So it's reallyimportant but But additionally, theplatform that we've developed, which isexplain the way it works in a couple ofseconds here for events, accordingrevelation that came from a presentationthat Dr. Monix Bosch T Chief TechnicalOfficer made an amazing conference justabout four or five weeks ago.
16:21
And what what we discovered with a studycalled proteomics, which is the study ofproteins.
16:33
We've been selling the genome for 20years that the genome is made up of cells,strands of DNA, which are made up of of,of various components.
16:50
Proteins are part of those components,many proteins in each strand, and eachprotein has as individual parts of it, thatare called peptides. And that's a very smallfragment of a protein, protein. And Dr.Ralph Steinman working at NYU as amolecular and cellular research doctor in1993 actually was the first person toidentify when until then nobody knewwhat had been good Excel even did forand and what we presented just about fouror five weeks ago, confirms that it's areally unbelievably bigger thing than evenour potential realized at the time, which isit is basically we're putting on today'sParliament's it's the artificial intelligenceof our immune system, which has evolvedover many, many years of humanevolution and what the dendritic cell doesit is and and Simon one, we Nobel Prize in2011. It usually takes 30 years from thediscovery, but it was so significant that hewanted just about 18 years 16 years.
18:13
And and what it does and what I'm goingto explain to everybody I'm gonna giveyou just a little bit more background isthere are two components to making ourvaccine.
18:26
One is the the antigens, which is the samesame meaning as a peptide that you find inyour own tumor tissue. And we either getthe tumor tissue by operating it's going tooperate, or we do the same technique byby putting our invention into the tumor ifyou're doing the body what we do in thelab, but let's just keep it separate for asecond and talk about the the operableapproach. And if we've got time toapproach it, it's the same principle.
19:02
The dendritic cell is one of thecomponents of the vaccine.
19:07
The other component is the tumor tissueitself, treated in a proprietary way.
19:14
Which rates all of the peptides that are inthat particular use cases.
19:22
And in the lab, we do a blood draw to getthe baby dendritic cells and needs to befresh. So we try and get that done nearwhere the manufacturing facilities andexpose the peptides in the tumor tissue tothe to the dendritic cells, and here's wherethe magic starts. I mean, it's exquisite, it'selegant, it's non toxic, and it works prettywell based on the results we've got now.We've got our ideas about why it works.What happens because when they theydrink cells meet these peptides that were inthe tumor tissues. They select the ones tobe targets for the weapons of the immunesystem. Well listen to how this works.
20:17
They they choose the ones that are allrelevant to that particular cancer and theythey hold on to him on the surface of thedendritic cell.
20:32
And then we take the result of thatcombination which we we do what I justdescribed in the lab, where this selectionprocess of the dendritic cells occur, thenthat becomes the vaccine which weshipped in the doctor's offices and and thedoctors give a shot right in the upper armright near your lymph nodes. And thereason for that is the lymph nodes are theconference center of the immune system.And one of these AI type nobody everheard of it millions of years ago and saydeveloper, whatever. What do they do?They carry on their service, these varioustargets, many more than anybody can pickup in a lab. Because it's, it knows when itsees what was in the tumor tissue, what togo after. And it presents those to theweapons of the immune system andbecause it's elegant and complicated, I'mjust gonna focus on one of the bestweapons in the immune system called theT cells.
21:42
And what it does, is it hands off in theconference room in your lymph nodes. Itsays, Here's here are the targets for you togo after. And and identify and find these inthe in the body and then go attack themand kill and and not only does it presentthese targets we before we did this, wereally were maybe about 30 by 40 of theantigens out of 50,000 in the body thatneeded to be identified.
22:15
The dendritic cell, figures it out, mounts itoutside of the cell holds on to it, hands itoff to the T cell and the order to the T celland this is just one of the many weapons inthe immune system, all of which areorganized and given orders by the debititself. And if you've got to sign up, go getinvoice and and not only do the T cells,pick up all those targets and now gohunting for them in the body withoutleaving cancer cells. But they are alsoencouraged to multiply to chronal to createmore of them as they are loaded. And oneof the findings in this probably happenedstudies was that normally in the humanbody if you're healthy, you'd havesomething like between five and 20. Asyou measure the volume of blood of theseT cells.
23:16
After four months of the vaccine beingadministered, it's like halfway through theformer regime which is a six shots in thefirst year.
23:29
It was discovered that that the cloning ofthat original 520 It resulted in 400 400new T cells that multiply from the banksgo not only are they going after numerouspartners, but there's a whole bunch of themthat are doing the same thing. And thataccounts for the fact that everything elseon GBM has pretty much failed, addingjust weeks of toxic life. And we rexine isnon toxic, because this is nature's way ofhandling it and we're just re educating theimmune system by getting on the back ifyou will, of the dendritic cells andutilizing them to go tell the immunesystem that the killer cells, the T cells, allof it what to do, and amazing discoveries,how viciously they're doing it when itcomes to just following their orderssomehow, that tells you how it works. Andit's almost like before we had a black boxbased on Stein standards, invention, andnow we know how it works and why itworks and why it's better than anythingelse out there. So let's My question isbased upon it being a vaccine from yourown immune system or your own cells,can i Is it possible that this could thiscould be a therapy for other cancers?because the way it multiplies and such is Imean, is it specific to GBM? is it possiblethat it could go towards other cancers?
25:02
It we've already shown it to work in theTibetan and treatment Specialist programthat we are currently running in the UKand building up, but we made it work on15 different solid tumor cancer. Wow.Most of them blockbuster drugs, there'sless gold is
25:16
Most of them blockbuster drugs, there'sless gold
25:25
companies obviously some of theirspecialty, horrible, you're going to end upyour bio.com the stock symbol webservices.



Are we? Are we to continue the research? Are we gonna do an FDA sort of archivists story there where we're getting close to this obviously exciting you suddenly get a million emails, asking when can we get this here in the US? So talking about that? Well, we think we do have this advantage during my program, and you may need to go to UK to initially get it made. But a recent license, we've got to use our, our facility that we built for, for commercial operation and it's been licensed to do that allow us to ship anywhere now in the world. So if you call our office if there is a bathroom, but you can still get a hold of that away at this point, but but more significantly, we are in the process of finalizing our applications. First one will be to MHRA, UK, which has a Specialist program even before we file, but we're getting much closer to being finished up 1.7 million pages long. It's got 27 modules. It's been double check now and to make sure that it's completely consistent. We'll be applying there will be applying them to the other places they gave us permission to do the trial. That was for different countries, including the UK, including Canada, including Germany, and we'll be filing in order in each of those places where commercial approval and then we will go into operation on a completely commercial basis. And I think the prognosis is very exciting. During that we've shown the positive results and compassionate treatment specialists program and we're also dealing with issues relating to our are not as high as we believe we deserve. value in the marketplace, because you're interested would rather see us not succeed. We're we're cheaper. We're more efficient. We're not in toxic, I mean, and I will have to add, it's already been shown that in combination with certain other products that have been produced which have no effect than solid human cancers. We enhance the result of of what we get when we put it in combination with others and and we'll be doing plenty of that as well. We also have a product of inoperable tumors where we take the magic formula for well, and and together with MD Anderson. In 2015. We ran a phase one phase two trial where we developed a MRI guidance or or good scan guidance of being able to take a very thin needle and inject it to find the mothership tumor in a given body and then put the stuff into the tumor with this very thin tube which is quite non invasive, but it can be guided by by by by just you know the things that you can scope and one of the ways you could do X rays or whatever. And we got very good results on that and then we got the same safety results, which is basically no kind of side effects. And we'll be developing that product as well with further trials. So there's a lot of activities wanting to have to move this first one which was our leap I am because frankly, these trials are cost a fortune. And for example, if you're gonna do CrossFit, you have to do a phase three trial for six, seven years and costs $800 million.
4:06
And unfortunately, it's a lot quicker and you can measure themselves much quicker in the air. So we picked TBM to be our lead. And we're getting we're getting near the end others are working with less last of all will you take this to the finish line or well this is just one of those risk aversion models where a bigger pharma company will come in and take it to the market you guys intend on taking the market yourselves once you get done?
4:32
Well, if you're asking for absolutely everything. That would be a really big menu. I think with our seven minutes without 90 sites and 73 doctors, we have a pretty established infrastructure for GBM, the fact that it works and other things I mean, I think it all depends who might want to team up what they want, might want to say and I feel good stuff. Les Coleman, thank you so much. It was
5:04
a big lesson tonight. Holy moly.
5:14