Telix Pharmaceuticals Limited (ASX:TLX) Chief Business Officer Dr David Cade talks about the company's late stage molecularly targeted radiation (MTR) portfolio for oncology and immunology applications, major milestones achieved during 2020 and significant value events anticipated for 2021.
Thanks Clive and always a pleasure to be here. Thanks for the introduction. Next slide, please. We'll go to our disclaimer slide and then pass the disclaimer slide. Yeah, great. All right.
So look I'll open with a simple description for those who may be less familiar with the company. That I think summarises nicely how Telix's Technology works, essentially Telix develops molecularly targeted radiation. What we call MTR drugs, that use a targeting molecule to carry a radioactive payload to the site of a cancer cell, as most would appreciate radiation oncology is a fundamental task of cancer care, but it traditionally involves using an external beam of radiation that we aim at the patient to destroy their cancer cells. But differently with an MTR drug, we actually use a drug to carry that radioactive payload in a very precise kind of way. And so I think it's fair to say that the advantage of this, unlike the conventional radiotherapy payload approaches is that we deliver a systemic therapy that is able to hit the microscopic disease, that often may be missed with the conventional approaches. And so we can see there on the right side, with a low dose or with the use of a diagnostic radioisotope, we can use a PET scanner to image the patient's cancer with extraordinarily high accuracy. Whereas if we use a higher dose or if we use the therapeutic isotope we can treat that patient. And therein lies the elegance of this approach, it's really seeing the disease and then treating that same disease. So it's a great powerful form of personalised medicine.
So if we go to the next slide. Telix, it really is a radio pharmaceutical company with a broad late-stage portfolio of MTR assets that run across prostate, renal, glioblastoma, which is a form of brain cancer and hematological blood cancers, as well as a number of high value, rare disease applications, which I'll talk about in a moment.
I think it's important to note that, Telix's most proximal to market product is the company's prostate cancer imaging product, which is now known as Illuccix, which is presently got a regulatory submission in 17 countries underway, including the United States and Europe. So Illuccix is expected to commence receiving those marketing authorisations in the second half of 2021. Just looking back over 2020, the company completed the acquisition of a radio pharmaceutical production facility in Europe, and a number of other important transactions, including our strategic partnership with China Grand Pharma and the acquisition of TheraPharm. And I'll go into a bit of detail on these various accomplishments in a moment as well as the three major inflection points for the coming year, 2021 later on.
Moving onto the next slide. So looking at the companies clinical trials, next slide, this summarises Telix's growing pipeline of both imaging and therapeutic products. I don't think I'll delve into all of the specific detail here, but I will highlight three salient points. The first of those is the Telix's prostate cancer imaging product, which was called TLX591-CDx, but now has the brand name Illuccix, is the company's most proximal to market product. This product, which is really the new standard of care, or will be as soon as it gets to the market for prostate cancer imaging, has got a total addressable market in the US and Europe of about US$900 billion. So I think it's worth reviewing the progress of that product in a little bit more detail in a moment. The second point is the Telix's has a fast following renal cancer imaging agent known as TLX250-CDx, it doesn't have a brand name yet. This asset is nearing completion of its phase three development, in our trial known as the ZIRCON Trial and the assets being granted, breakthrough therapy designation by the FDA. So we'll review this in a little bit more detail later on as well. And then thirdly, I think it's worth highlighting the Telix continues to augment our portfolio in urologic oncology, particularly prostate cancer, including some new products that we believe extend the reach of our core technology into different clinical applications, such as radio guided surgery and image guided surgery, which are new fields. So these developments really closely aligned to Telix's objective of building category leadership in urologic oncology.
Moving on to the next slide. I'll now move through the various clinical programs in a bit more detail. I will start with prostate because that's our largest program.
Next slide please Clive. So this is a snapshot summary of where we're at with our FDA submission for the prostate cancer imaging agent, Illuccix. Our new drug application was accepted by the FDA for filing back in December and it's now proceeded to what we call a substantive review. No major issues have been identified during this initial period and the FDA has informed the company that they don't intend to conduct, what's called an advisory committee meeting. So that's a positive step. We see a relatively streamlined pathway for this product, from which Telix is seeking indications for imaging of prostate cancer, really from the early stages of the actual pre-treatment stages in high-risk men that have just been diagnosed, all the way through to the latest stages of advanced prostate cancer. So very broad indication for this product, that's obviously subject to final label approval by the FDA. So we're ready for a product launch from a manufacturing and distribution perspective. And I think we expect approval reasonably for this product in the second half of the year.
Just moving to the next slide and the European submission. We have filed in 14 member countries, other than now we included that in our European submission, which includes the UK. Again, it's a very broad indication that we are seeking for the imaging of recurrent prostate cancer. And we're also seeking various temporary authorisations in a number of EU Member States, similar to the national authorisation that we got last month from the Czech Republic, obviously a smaller market, but a very sophisticated market. And we're anticipating the company really is on track to receive marketing authorisation in Europe, on a country by country basis, from about the third quarter of this year.
Just moving onto the next slide to. Just to give you some further color, obviously we won't be stopping with the United States and Europe, even though they're very big markets for this product, of course, being an Australian headquartered company, it'd be remiss of us if we didn't file with our own TGA, so we've done that. And we expect, really subject to TGA's review and approval of our product dossier, that we should have an approval in Australia for Illuccix around the middle of this year as well. In Canada's obviously a very important market, will be a slightly smaller one than the US, we've had our new drug submission accepted by Health Canada, with a very broad label as well. So again, another territory that's well on track for approval prior to the year end. I won't go into all of the others, but we've got submissions going on in Switzerland, which is an important country and some substantial activity in Japan as well.
Just moving onto the next slide. This is exciting for us in 2021, Telix will transition to being a phase three therapy company, and we're very happy with the progress we've made in working with the various regulators to design the companies Phase III ProstACT trial. That's the name for the trial.
This is an national multicenter randomised controlled trial for patients with metastatic castrate resistant prostate cancer, which is the main, really advanced form of prostate cancer. I think we've managed to really refine the design of his trial, based on a combination of key opinion leader input and regulator input, and what we've seen as sort of significantly shrunk the size and therefore the duration of this trial is going to take to complete. So the high level aspects of the trial are summarised here, but I think the key thing to really note is that the ProstACT trial is going to start in Australia in the second quarter of this year. And then I think during the course of the year, we'll progressively add European and US sites to the trial subject to of course regulators being satisfied with our submission. But this is important because this is one of our therapeutic program for prostate cancer. Is one of the three highest priorities for the company during 2021 overall.
So we'll move on from prostate cancer to our renal cancer program. And then again, next slide. So I mean, 2020 we made really significant progress with our Phase III ZIRCON Trial of TLX250-CDx. This doesn't have a brand name yet, it's still in development, of course, but this is the company's renal cancer imaging product. Not withstanding COVID-19, some of the prospect's figures talked about the impact on their business, this trials now recruiting patients at 36 sites around the world in 14 countries. And this trial really has quite a lot of momentum. So we expect to complete patient recruitment around the middle of the year. Now, the asset's been ground a breakthrough designation in the US by the FDA, meaning that in parallel to finishing the trial, we can work very closely with the FDA around the various manufacturing and product dossier related aspects. So really when these trials completed, the company will have a very expeditious pathway to approval of a second product. And so we really view this as a major de-risk for the company. We obviously expect that out prostate cancer imaging product will be successful, I talked about that. There's a significant unmet need for that product and there's a lot of anticipation for the product. It will be the new standard of care when it's launched, but having a second product launched shortly thereafter, we'll seek the big link to de-risk the business further.
Just moving on to renal cancer therapy, next slide. Yeah, this is our STARLITE trial, this is the Phase II trial of TLX250, and this is our renal cancer therapy product in the final stages of IMD filing. And we're expecting to start enrolling patients into that trial in May.
Just move on to the next slide Clive. This is the last of our traditional programs, our Glioblastoma's program.
Next slide. IPAX-I is our Phase I trial of TLX101. This is our Glioblastoma candidate, which is for the most deadly form of primary brain cancer and we presented some data late last year that I think, it was a snapshot of the progress that we've made on this trial. And while it's an early trial, it's a Phase I study, it's reasonable to say that we've collected some very encouraging data.
And you can see on the right there, on the right of this slide. There's a very significant anti-tumor response in a patient that's still alive about 24 months after diagnosis. So very good survival in this patient population. This is obviously just an anecdote from the trial, but it's encouraging data.
Moving on to the next slide. I think one of the really successful aspects of the companies that's collaborations and partnering capability, next slide. So we collaborate very widely with many companies and organisations, and a few notable partnerships are listed there. Mauna Kea and RefleXion are two that we've executed recently in radiation oncology and surgical oncology. But I think the cornerstone really is diagnostic imaging because that's where we believe, the fundamental of everything that we do is based.
Moving on to the next slide. I've alluded there, to the acquisition of TheraPharm that we completed three months ago. This is a relatively modest sized acquisition for Telix. It was only a €20 million acquisition, but it's worth emphasising that there's two parts to this acquisition. One is the therapeutic program based on besilesomab, which we think will have very shortly some preliminary utility in a rare disease known as amyloidosis, but with the potential to expand into other mainstream indications like multiple myeloma and leukemia. So this is a product that's got orphan drug designation in Europe, and we'll certainly be expanding that into other territories in the near term.
Just move on to the next slide. I think we're just about ready to wrap up here, but the last major topic, is our strategic partnership with China Grand Pharma, this partnership is really pivotal, I think, to building a footprint in Asia and it's a significant impact to Telix in terms of financial clinical and geographic impact, China Grand Pharma, we believe is a very strong partner for the greater China region for Telix's current imaging and therapeutic products. So as part of this transaction, it resulted in an upfront cash injection, the US$50 million through an equity investment and an upfront milestone payment to Telix. So it's really a partnership that's operationalised well, since October when we completed it. So this is an exciting collaboration that we'll achieve regulatory in clinical milestones together.
Next slide. So to wrap up, I think there's really in relation to Telix there's three key messages for 2021 are they are, we can articulate them. There's commence, complete, launch. So we're going to commence that ProstACT Phase III trial, that's our Phase III trial in prostate cancer. And this will see Telix transition to becoming a Phase III therapy company in urologic oncology, which is a very big milestone for us. Secondly, we expect to complete the Phase III ZIRCON trial for renal cancer imaging. We're going to complete enrollment around the middle of the year. And then with our breakthrough therapy designation, we have a very rapid pathway through the product approval. And then last of all is launching our first internally developed commercial product, Illuccix for prostate cancer imaging, 17 countries in which we have that product currently filed or being developed for market launch. So a very significant undertaking for the company and a major, major focus for the company right now. So commence, complete, launch, our three big things, they're the inflection points. That if we execute those in 2021, I think we'll be in a great position.
Next slide. So I think I'll leave it there Clive. And obviously we don't have time for questions today, but if anyone does have any follow ups, I'm always happy to address them as best as possible. Thanks very much. I'll hand back to you Clive. Ends