What is the LW-02 Cartridge Therapy? Immunicom was actually formed in 2013. It actually was the byproduct of my wife who's a physician here in San Diego. And not only her experiences with her patients but also personal experiences that she had, people that she knew in the community, friends of hers. That really drove her to, looking for a solution and particularly for cancer patients.
That wasn't toxic, that wasn't gonna destroy the patient's lives. And there was actually a friend of hers, she was a single mother that worked at a local school district here and who got diagnosed with a metastatic breast cancer. And this woman, her name was Beon and Beon, had a son who was about to go to college, had a younger daughter who was autistic.
So this was a very difficult circumstance for her and her experience be, Beon experience was, the cancer as a disease is bad enough but the treatments were worse. And, as anybody who's been through this, People, you get sick from the treatments, you lose your job, things of that nature.
So my wife's attitude was, there has to be a better way. There has to be a way where we can help patients fight this battle. With cancer without without the treatments actually destroying the patient, much less the disease. And that really was the impetus of the company. And we started looking for methods and techniques by which we could do that. And that's really how the company came about.
So the approach that we've taken is to target, Soluble factors that are contributory towards a disease, whether it be elevated cytokine whether it be a anti angiogenesis, protein, a galectin, whatever the case may be. What we do is we will design molecules that will neutralize or bind to, let's say, a specific cytokine, if that's our target.
But instead of making it into taking our molecule and formulating into a drug, we actually stabilize it in a cartridge that we have. It's a proprietary cartridge, has this internal liquid matrix in there. And once the cart the molecule stabilize in our matrix, that cartridge attaches to an existing plasmapheresis apheresis machine, which, pretty much are available in every hospital clinic around the world. And the patient gets their blood and plasma filtered. And as the patient's plasma goes through our cartridge the specific cytokine or the molecule that we are targeting is the only thing that then gets bound in the cartridge.
Nothing gets put into the patient. There are no blood chemistry changes, there's no antibody reactions, nothing like that happens. No drug or chemicals added or put into the patient. So really what it does is it allows us to, to manipulate immune molecules. It allows us to manipulate other soluble proteins that are contributory towards a disease with without creating metabolic and other toxic side effects or contraindications.
So the approach that we take, one of the things. Really essential in, in, in our methodology is that going back to the premise of why, wife and I came, went down this path was that the treatment should not be toxic. We should not, the disease is bad enough when it comes to oncology and cancer, but the treatment itself should not be something that actually.
Toxic that causes the patients to battle the treatment more than the disease. So this approach where we can, externally remove something from the patient's system and do it in a way. That can actually affect other pathways that are bene that either immune is stimulating or actually anti-tumor, but do it in a manner where it's non-toxic where it doesn't cause.
Patients to have adverse events severe adverse events or side effects. That's where it really becomes a differentiator and something that we believe is required on the market. And the other thing about this is when you look at existing therapies, whether it be immunotherapies or whether the case may be usually, you've got about, 30, 35% of the patient population where it'll have a an efficacy or at least a target population that it can be used with.
And the rest of the population, it may or may not be addressable. And then even the patients that are able to receive it, about 40% of them. We'll develop toxicity may not be able to finish a course of treatment. The approach that immunotherapy takes with its with its platform, with this unique methodology on immune manipulation is really more for all comers is designed at least that you can treat patients, even end stage patients in a very safe manner. And that's really what we're shooting for.
The approach really works by, by decreasing the concentration, let's say, of a cytokine or a protein that is elevated by the disease. In this case, if the tumor cell or something of that nature is causing an excess ion, let's say of a receptor or a cytokine. In some cases, if you're treating the patient, for example, with an immunotherapy you will, you may get cytotoxicity with IL-6 or other factors.
So by targeting these factors that are either contributing to the disease or in some cases even toxicity with other drug therapies, by, by being able to safely control, lower their concentrations and keep them under. What we do is we allow not only existing therapies to actually work better without toxicity, without adverse events or side effects or lower adverse events on side effects, something more tolerable to patients. But the other thing it also does is that it actually allows, a different type of therapeutic approach potentially to even be contemplated.
Yes, actually the device does go through the same set of clinical trials that you would have for any, for example any therapy. When you look at our trials, they're designed with the same rigor, same controls. There's really nothing different. The only differentiation is that because we're not putting anything into the patient's body from a regulatory point of view, we go through a device approval pathway.
For example, in Europe where a class two B device in the US with the fda. We are a Class III PMA device. But it still requires trials just like you would for any type of other therapeutic product.
In the us this is still an investigational device. It has not been approved. We have been classified by the FDA as a breakthrough technology, a breakthrough device and that, what that really does is that helps us facilitate our interaction with the FDA In Europe we have received initial approval.
For advanced refractory triple negative breast cancer through the CE mark process. So we, we do have that indication approved in Europe. We have many other indications that are under trial right now that we actually. Are expecting that potentially, over the next over the next two years, we expect quite a few more indications for this for ourLW-02 product to be able to bring to patients. At the same time, we have many other products in development also that would be expanding that approval basis.
That's correct, so essentially what we have is a platform and the platform. What I mean is we have this unique chemistry that we've designed, in our cartridge. And we have this specific types of molecules that we can then design very small molecules, not antibodies, and they can really go after any soluble target.
So we actually have a list of over 15 to 16 targets that we're working on right now that affect a lot of different aspects, not only from an oncological point of view of tackling. The the process against the tumor in many different ways, but also quite a few where those products are being designed to actually facilitate existing therapies and remove the barriers that are stumbling block for those existing therapies.
So we have quite a few products on development, one specifically, that's probably the furthest along is our EN-06 products that targets a very specific cytokine are related to cytotoxic side effects with immunotherapies.
That's correct, traditionally, the way we go about tackling any type of a barrier whether it be immune suppressing or cytotoxic or creating adverse events is usually we'll design an antibody and then we administer that antibody and then, they do work.
Obviously those approaches do work. They are helping a lot of patients. But one of the challenges with those types of approaches is that actually a few challenges is one, you can develop re. To the antibody and to that approach. So it may work for a certain time. The other thing is it itself in many cases can be cytotoxic and have adverse events.
And then you have the issue of having to clear the antibody and metabolize the drug from the liver and clear from the kidney. Our approach doesn't involve all that, so we can go after that same target without having. To put I would call it a systemic burden without having to have, a drug or a chemical, process to the liver cleared from the kidney.
We can take that same approach to the same target that potential antibodies going after. And in many cases, we can go after targets. Antibodies are not very good at going after and yet be able to produce a therapeutic effect by filtering something out of the patient's plasma in the patient's blood.
So again, one of the unique things about this therapy is that we actually do not, we do not add any type of a drug or a chemical or a molecule into the patient's blood system. And this is where the technology is unique. This is where a lot of our patents actually also sit is even though we ourselves do have a molecule that's residing within our little cartridge.
The way that molecule interacts with the patients plasma is very benign. And part of the chemistry is to making sure that there isn't any, what I would say offsite binding, where we minimize, things that, non-target, things that are non-specific to what we're trying to target does not get captured.
And also the fact that nothing from within the cartridge, we minimize, leaching back into the patient and therefore trying to keep the product very safe. And we've done, over close to 1800 individual treatments in, primarily in Europe and Israel right now. And and we've been able to demonstrate a very high degree of safety for the product.
So all the patients that we are treating in our trials and in our trials so far have been focused in primarily in Europe and in Israel. And some patients actually in Istanbul, Turkey with one of the largest private healthcare systems there. All the patients that we've been treating are end state.
They are refractory, so they have failed all therapies. And part of that was the guidance we had received from the FDA when they gave us a breakthrough designation. They wanted us to focus on stage four cancers, but patients who did not have therapeutic options. So that's what we've been targeting is really cancers where or the stage of the patients.
They're no longer responding to any therapy. So obviously that creates a significant hurdle as you can imagine trying to, elicit some type of a benefit to the patient. But we have actually, and we've taken on some fairly difficult targets also in triple negative breast cancer, as and. Metastatic melanoma, metastatic lung cancer. So these are not necessarily easy targets but we are seeing very promising results. We are seeing good numbers in, in overall survival. Most of these patients, their survivability is measured in weeks. Maybe, single digit a month or two simply because of the refractory nature and where they are in their development.
And we actually have been able to demonstrate in some of these patients some pretty impressive survival statistics. The other key thing about our therapy, Is that because of this whole approach of not being toxic of trying to prevent, side effects and adverse events and that we've been able to demonstrate that we can minimize those types of things and that patients, the quality of life actually, of our patients, even though they're in stage and they're really in a really bad shape in many cases, the quality of life for our patients improves dramatically.
We have patients some patients who actually are even, they go back to work while they're receiving their therapy or they go back to normal daily activities like going for walks with their spouse or playing with their grandkids and or, or gardening or whatever their, hobby may be. These are things that patients who in a refractory stage, end stage, of their of their disease cycle, generally, you do not see them having these types of responses. So yes, we're seeing very promising results. We're seeing results promising results.
Also in the metastatic setting, we're seeing promising results about down to the cellular level. In some of the immunohistochemistry we. Showing activation immune activation that is in converting potentially some tumors from what you would, a cold tumor that's immunogenic cold. We have data, early data that shows that potentially we may be converting cold tumors into. Into maybe immunogenic hot tumors. So there, there's quite a bit of information that we're pulling together and and we're very excited and encouraged on where this can go, not just with this first product that we have, our LW two product but also with just the overall platform and the approach that, we can go after.
Now our LW two product, for example, goes after the soluble receptor for TNF Alpha. So it goes after TFR one and two. We have a product that's going after IL-6. We have products in development that are gonna go after VGF A, B, C, D and IL-1. It's a long list of targets that we can safely go after. Not only to treat patients from a potentially a monotherapy point of view, but really our target is to provide the oncologist and the patient with therapeutic options in existing standard of care where we can help and facilitate work with existing therapies to improve their responses, lower toxicity, and in many cases states patients give them an option that actually may not be available to.
Amir Jafri is the founder of Immunicom and has served as its President and Chief Executive Officer since its inception in 2013. Amir has over 25 years of experience in healthcare technology and devices. As a senior executive in Fortune 50 companies and his own startups, he has managed multi-billion-dollar products globally and is highly experienced with global regulatory environments.
He was COO at West Health Institute; VP/CTO, VP of R&D, and VP of Operations at Cardinal Health, managing products with $1B in annual revenue (NYSE: CAH); VP/General Manager Healthcare Division at Manpower Group, responsible for the healthcare practice nationwide across 35 locations (NYSE: MAN).
Before joining Manpower, Amir founded various healthcare startups that were subsequently acquired. He has successfully managed global businesses and has a track record of success in every business he has led. Amir serves on the Board of various healthcare technology startup companies and non-profit organizations. Amir received his Bachelor of Science Degree from Houston Baptist University with a double major in Chemistry and Biology and a minor in History. He attended medical school at the University of Texas but pursued an entrepreneurial and corporate path.