Chimeric Therapeutics Limited (ASX:CHM) CEO and Managing Director Jennifer Chow provides an overview of the company, discussing the company's cell therapy portfolio, growth since 2021, clinical studies pipeline and key milestones.
Chimeric Therapeutics is a clinical stage cell therapy company. We were listed on the ASX in January of 2021, just over a year ago today. And at the time we had one asset that we were developing in one disease area. Today, a short 12 month later, we now are developing seven assets across 10 different types of cancer. Rapid growth in just 12 short months.
Our portfolio is diversified and innovative. We use first and best in class NK and T cell derived therapies that are both individualised or autologous and allogeneic or off the shelf. We have an extensive clinical development program where we have two current clinical trials. We're planning two IND submissions to the FDA for approval to start two more clinical trials in 2022. And by 2023, we plan to have eight clinical programs in place.
Recently we've seen encouraging early signals in our lead asset, our chlorotoxin CAR T, promising early data in recurrent progressive Glioblastoma patients. One of the most fatal brain cancers that exists. And we're doing all this with a team that has proven cell therapy experience. Our small management team is industry leading with over 40 years of cell therapy experience.
So Chimeric's mission is to bring the promise of cell therapy to life. And what does that really mean? It means that what we're doing is we're looking to develop therapies that have the potential or the promise to cure cancer. And we were really excited recently within the past couple of weeks, when one of the institutions that we work in collaboration with, The University of Pennsylvania, published data that actually shows that patients that receive this type of therapy 10 years ago are still cancer free today. And so you can see at the top right hand side, Dr. Carl June from that institution saying, “we can now conclude that CAR-T cells can actually cure patients.” It's that type of outcome, cure of cancer, that Chimeric is looking to bring to more patients.
Our strategy to do that is pretty simple. We're looking to develop the most innovative cell therapies with the most curative potential for patients by leveraging a team of cell therapy pioneers and experts, and focusing on bringing those therapies to patients rapidly and maximising our asset value.
Today, this is our pipeline looks like all of our assets in our pipeline are novel designs, first in class assets or highly differentiated assets. On the left hand side, you see our assets that leverage T Cells and they're autologous or personalised. Which means that we're using a patient's own cells to make their therapy. We have both chlorotoxin, which we licensed from the city of Hope and our CDH17 CAR T from The University of Pennsylvania. On the right hand side, you see our NK Cell derived therapies, which are considered allogeneic or off the shelf because they use cells that have been donated by a healthy donor to make our therapies here. And you can see here, we have an extensive development program using the NK Cells from Case Western University.
I want to start by giving you a little bit more information about chlorotoxin, our lead asset. Chlorotoxin is an autologous CAR T therapy. So it's individualised therapy that uses T cells. It is a first in class asset, which means we are the only people making it right now. The only people with it in development. It's unique as it uses a 36-amino acid peptide derived from deathstalker scorpion venom as its tumor targeting domain.
What you see in the middle on the right is some of the preclinical data that had us decide to take this asset to a clinical trial. Chlorotoxin had extremely broad recognition in binding of Glioblastoma cells, much better than other immunotherapies that are being investigated in this area, like CAR 2, IL-13 or EGFR. And what we saw was potent in vivo activity with significantly improved survival in mice. So very promising pre-clinically.
That had us move into a Phase 1 clinical trial, which is currently underway at the City of Hope Hospital in California. The primary objective of the trial is safety and to determine a maximum tolerated dose and a recommended Phase 2 dosing plan. The trial, as you can see here is split across four different dose levels. We started in Dose Level 1 with a low dose of 44 million cells. And by the time we get up to Dose Level 4, we'll actually be giving patients 10 times that at 440 million cells. We also started with just one route of administration. Patients were receiving the cells through a catheter placed directly in their brain and it was intratumoral administration only in Dose Level 1.
In Dose Level 2, 3 and 4 as you can see illustrated here, we actually are giving cells to patients in two different ways. Intratumoral and intraventricular administration. This particular trial has completed both Dose Level 1 and Dose Level 2 with no dose limiting toxicities and we're now enrolling patient in Dose Level 3. What we've seen from Dose Level 1 and 2 is very early, but encouraging initial data. The safety was very promising as we saw no dose limiting toxicities. And generally the therapy was well tolerated by all patients. What we saw that we didn't expect to see so early on in such low doses was an efficacy or activity signal.
We've seen local disease stability in over 70%, five of the seven patients that were evaluable. We've also seen bioactivity, which is really important with this type of therapy. Bioactivity means that the cells, when they're infused into the brain, have stayed alive throughout the course of treatment with no signs of immunogenicity. So very early days for our data, but very encouraging.
With chlorotoxin, we're also looking now at expanding chlorotoxin into other solid tumors. And first and foremost, we plan to expand into metastatic melanoma. Pre-clinically, we've started to build the evidence that you can see here that actually will demonstrate that there is an MMP-2 expression in melanoma, making it an ideal target or tumor type for chlorotoxin CAR T as well. With this, we plan to file an IND to the FDA to ask to be able to open a clinical trial by the end of this year.
Now, let me turn and tell you a little bit about CHM 2101 or our CDH17 CAR T. This also is a first in class T cell therapy that is individualised. So we make it again for each individual patient. It's a novel third generation construct and The University of Pennsylvania have been optimising this asset for over 10 years. We believe that this asset has broad applicability in gastrointestinal tumors, colorectal cancer, gastric cancer, neuroendocrine tumors as we move forward with it's development. CHM 2101 or our CDH17 CAR T showed remarkable pre-clinical data. What you see here on the left is the pre-clinical efficacy. And what we saw, as you can see by the green line, which is the CAR T, our CAR T therapy, is that tumor cells were completely eradicated with our CDH17 CAR T. And they never came back. There was no relapse in our pre-clinical models.
We were also, on the right hand side, able to demonstrate safety. So while we were able to completely eradicate the tumor cells, normal cells were actually spared. And so there was no toxicity in pre-clinical models shown. Bringing all this together, our plan is to move this into a Phase 1 clinical trial in multiple different tumor types, as quickly as possible. Our plan is to be able to look at this in a Phase 1 clinical trial with neuroendocrine tumors, colorectal cancer, gastric cancer, and esophageal cancer. Filing an IND with the FDA prior to the end of this year, to be able to start this clinical trial as well.
So now I'm going to go to the other half of our pipeline, which is our NK cell derived therapies. And our NK cell derived therapies all come off the backbone of our core NK platform shown here. That platform is a clinically validated, off the shelf platform that has robust and enhanced natural killer cells. It's been clinically validated already in a Phase 1 clinical trial and I'm going to show you how we're going to use this platform or repeatable technology to build out multiple different development paths very quickly.
From a first in class perspective, we believe that this platform is highly differentiated, and you can see the sum of the ways here from other NK cell platforms that are currently being developed. The clinical trial that's already been completed, was done at Case Comprehensive Cancer Center under Dr. David Wald, who invented this NK cell platform. The trial started in 2018 was completed in mid of last year and we anticipate we'll see results in mid of this year.
The trial included patients with both blood cancers and solid tumors, and you can see had a dose escalation from 10 million cells up to 15 million cells. So now with this clinically validated NK cell platform, we're looking at moving forward with multiple development paths. We're going to use the NK cell platform in combination right away. So that will be the first development path. We're then going to take the platform and we're going to further enhance it with next generation technologies. That will be our second development path. Parallel we'll be following our third development path, which is developing CAR NK products. We'll use our existing Chimeric antigen receptors, chlorotoxin and CDH 17, in the NK platform to build these CAR NK products. And then finally, we're already in discussions to further leverage this core NK platform through collaborations with other companies. So lots of development and lots of opportunity with this asset as we continue to move it forward.
What that gives us now is a pipeline that looks like this. Seven different unique assets are currently in development. Eight clinical programs are planned by 2023 and across 10 different disease areas, giving us lots of opportunity to impact patients with cancer as we move forward.
All of this is being driven by a very experienced team with lots of cell therapy expertise. Our management team has over 40 years of cell therapy experience working across more than 25 different cell therapy programs. And we're proud to have worked on the development of commercialisation of four of the five approved FDA CAR T therapies. So really enables us to move our assets through development towards patient access.
Our growth in 2021 has been incredible. We've gone from one asset, as I said, in one disease area, bringing in multiple new assets with multiple opportunities for development. As we look forward to the key milestones of catalyst in 2022, we'll be looking to complete the dose escalation portion of glioblastoma trial with our chlorotoxin CAR T. File an IND to be able to open a clinical trial in metastatic melanoma. As well as another IND to be able to open up a trial in gastrointestinal tumors with our CDH 17 CAR T. We're going to initiate the development on our next generation CORE NK platform and our CAR NKs. Solidify our manufacturing, our technical operations, particularly our vector that's required to manufacture these therapies. And then we'll look forward to seeing that NK Phase 1 data from Case Western as well.
So with that, I'll just highlight here for you. We believe that we have an innovative and diversified portfolio that has broad therapeutic focus across 10 different types of blood cancers and solid tumors allowing for extensive commercial opportunity in the future, we have an extensive clinical development plan with four programs by the end of this year planned, and eight by the end of 2023. We're already seeing early positive clinical signals in our data, in our glioblastoma data with chlorotoxin. We have world renowned partners in The University of Pennsylvania, City of Hope and Case Western. And an industry leading team of experts to drive our development forward, to get therapies to patients sooner.
So with that, I thank you so much for your time. I invite you to contact me at your convenience and I'll turn it back to you, Matt. Thank you.Ends