Chimeric Therapeutics Limited (ASX:CHM) Chief Operating Officer Jennifer Chow presents on the company's chlorotoxin CAR T cell therapy for the treatment of glioblastoma.
Thank you so much, Clive, and thank you everybody for taking the time to let me introduce Chimeric Therapeutics (ASX:CHM)
to you today. My name is Jennifer Chow, and I'm the Chief Operating Officer.
A quick disclaimer slide.
Chimeric Therapeutics is committed to bringing the promise of cell therapy to life for more patients with cancer. We actually believe that drug development, or traditional drug development, has really focused on delaying disease progression, not on finding cures. And we are very much focused on finding cures. We believe that novel cellular therapies have the ability to do that. To bring the promise of therapy to life for more patients, our mission is to identify, develop and commercialise the most promising and innovative cell therapies that we can find around the world. And we believe that, by doing so, we can change the course of history for many patients with cancer.
In 2021, to be able to bring the promise of cell therapy to life for more patients, we're focused in three very specific areas. We're focused on accelerating the development of chlorotoxin, our CAR T cell therapy that is already in clinical trials for GBM patients. We're looking to identify the innovative science with transformative potential to enhance our pipeline. And we're establishing cell therapy expertise within our own company, so that we're uniquely able to move through rapid development into commercialisation.
A little bit more around chlorotoxin first and the development that we are focused on there in 2021. Chlorotoxin is first being investigated for patients with glioblastoma. Glioblastoma is, without a doubt, the most fatal of the brain cancers. Patients that are diagnosed with glioblastoma, unfortunately, rarely survive even the year that they're diagnosed. And today there are only three approved therapies for glioblastoma treatment, the last therapy being approved in 2009. We are very optimistic that chlorotoxin or CAR T, that's first and best in class, we believe will have the potential to help patients with glioblastoma.
Chlorotoxin utilises a very unique tumour-targeting domain that is derived from deathstalker scorpion venom. In preclinical studies, what we saw was that chlorotoxin was able to more specifically and broadly bind to glioblastoma cells when we compared it to other immunotherapy targets. We know as well from our preclinical work that chlorotoxin has an excellent preclinical safety profile. It targeted the cancer cells, but it did not target any of the healthy cells, setting us up for what we hope is a very good clinical safety profile. And we also know that, in preclinical models, we saw what was very promising from an efficacy perspective, where there was potent anti-tumour activity being shown in the survival of mice.
So, chlorotoxin right now is in a phase 1 clinical trial at the City of Hope hospital, just outside of Los Angeles. That phase 1 trial is really focused on patients that have recurrent or progressive glioblastoma. And our objective is, one, to establish the safety profile of chlorotoxin, but also to determine what is the right dose of chlorotoxin to be able to give patients to be able to move into a regulatory phase 2 trial. We anticipate that the trial will recruit somewhere in the neighbourhood of 18 to 36 patients, taking about two years. And we start with a very low dose of 44 million cells, and we'll be working our way up to a dose of about 440 million cells. Over the course of the trial, we also move from a single route of administration with chlorotoxin, where we just give the infusion intratumourally, to dual routes of administration with chlorotoxin, where we give both intratumoural administration as well as interventricular administration.
And you see on the right with the schematic that the very low dose, we actually were pleased to announce that we finished the dosing in that cohort in April. Just last week, we were also able to announce that the first patient in the second dose cohort for chlorotoxin has actually received dosing as well. So, really exciting for us now to be able to... We're moving into dual route of administration for these patients, and we're moving into higher doses as well. So, this was a really significant milestone we were excited to have been able to reach recently.
We also had some great news, and what we'll see is, next week, the first abstract for chlorotoxin that's been accepted by the American Society of Clinical Oncology for presentation. And ASCO, as the meeting is known, is without a doubt the preeminent cancer meeting in the world every year. And so we're very excited to have chlorotoxin being featured within that presentation as well.
With chlorotoxin, as we are focused on moving the patients through the dose levels in the phase 1 clinical trial, our team is preparing for accelerated development so that we can have rapid commercialisation of chlorotoxin. We're already putting into place the plans for a phase 2 clinical trial, which we believe will be a regulatory trial and enable us to get registration for chlorotoxin around the world. We believe that the trial will be somewhere in the neighbourhood of 75 to 80 patients, and we'll have it as a multicentre trial at global sites around the world. So, these plans are things that we're already beginning to work on to make sure that we're able to very rapidly move chlorotoxin through to development.
Outside of GBM, we also believe that chlorotoxin has a lot of promise, and this really comes from what we've been able to see in our preclinical models. So, we are now also looking at developing and designing a phase 1 clinical trial to expand chlorotoxin into new disease areas. We are currently looking at melanoma, we're looking at small cell lung cancer, prostate cancer, and colorectal cancer as some of the areas that we believe chlorotoxin may also find and provide benefit to patients.
So, with that, we're looking outside of chlorotoxin now to also expand our pipeline. When we think about expanding our pipeline, focus is really on being able to bring value. And, for us, the reason to expand our pipeline is to bring more value to patients with cancer and to bring increased market opportunity to Chimeric Therapeutics. We know that there are over 19 million patients every year that are diagnosed with cancer, and over 10 million people that actually die of cancer causes every year. We believe that by enhancing our pipeline with additional innovative science and cell therapies, we have more potential to reach more patients and help more patients.
We also know that the global oncology market over the next couple of years will grow to be a $240 billion market. And it's only through enhancing our pipeline that we'll be able to increase the market opportunity for Chimeric to really be able to move into new disease areas. So, these are some of the reasons why we're also very much focused on finding additional innovative assets for our pipeline.
We are, as we're looking to build out our pipeline, focused on both haematological malignancies, as well as solid tumours. And when we're specifically looking at innovative assets to address solid tumours, what we're really looking for are assets that are able to overcome the challenges of solid tumours very much like chlorotoxin does. And, with solid tumours, there are really three big challenges that we look to overcome. The first is really about recognition. And so what we're trying to do is we're trying to find assets that are able to identify or have an antigen target that the CAR T cell can identify and then bind to. So, really something that can help us find that tumour cell. The second challenge we work to overcome and we look for assets that are able to overcome is what we call trafficking. And, very simply, what that means is it's the ability of the CAR T cell to travel through the body to actually reach the tumour cells. And sometimes tumour cells can be a little sneaky and they hide themselves, or they surround themselves with a stroma. So, we really need to find the assets that are able to get through that and reach the tumour cells to be effective. And then the third thing that we look for when we're looking at innovation and bringing new assets into our pipeline are assets that are able to overcome the immunosuppressive tumour microenvironments. For CAR T cells, it's extremely important that they're able to expand and persist so that they can continue to kill the tumour sites. And so we're really looking for assets that can overcome the immunosuppressive microenvironments that often exist within solid tumours and continue to expand and persist to be able to kill the tumour sites.
So, for us, we're looking to build out the pipeline. And right now I can tell you that we are assessing novel CAR designs to do so, allogeneic cell sources and alternative cell types. And we're really optimistic that, within 2021, we'll be able to build out our pipeline to create more value for patients and for our market opportunity. Finally, in 2021, we are also very much focused on being able to build and continue to build upon our cell therapy expertise. We know from our own experiences that cell therapies have some unique challenges in their development. There are an incredible number of scientific ideas when it comes to innovation in cell therapy, but very few of those ideas are actually able to make it all the way through to commercial approval. In fact, today, even in the United States, there are only five commercially approved cell therapies. And even within the team, the small team that we have right now at Chimeric Therapeutics, we've actually worked and led the development and commercialisation of four of those five approved therapies.
So, we believe we're really well positioned and we're building a team that has the expertise and the insight that is necessary to be able to address the new unique challenges that come with cell therapy, and be able to bring the innovations that we find through rapid development to commercialisation. So, for us, the year ahead, 2021, it's been incredibly busy already, and we believe it will continue to be incredibly busy. With chlorotoxin, we will continue to provide our phase 1 clinical trial updates as the trial continues to advance and progress. We will be defining the phase 2 manufacturing strategy as well as the clinical trial protocol for the phase 2 registration trial. And then we'll also be looking to move into that phase 1 basket trial, where we're going to look at chlorotoxin in other and new tumour areas.
We're also going to, as I mentioned, expand the pipeline with innovative cell therapies, and continue to establish the cell therapy expertise we believe is important to be able to continue to move our assets forward.
So, for us, we believe that the inspired focus we have very much on developing cell therapies for patients with cancer, the promising chlorotoxin CAR T therapy that we already have in phase 1 clinical trials, the pipeline expansion that we'll be doing in 2021 and the cell therapy expertise that we have and will continue to grow to be able to move our assets forward will really enable us to bring that promise of cell therapy to life for more patients.
We look forward to being able to continue to update everybody, and I thank you so much for taking the time to learn more about Chimeric today. Ends