Good evening. It's actually a pleasure to be here and presenting you about Candel. Candel is a clinical-stage biotech working on the development of Viral immunotherapy to treat difficult-to-treat cancer. I'm going to be making some forward-looking statements during my presentation. Candel is based largely on two platforms: an HSV platform and an Adenoviral platform. The Adenoviral platform is CAN-2409. That's our most advanced clinical-stage asset. It's developed for several indications. Probably the most advanced is prostate cancer, where we've recently unveiled phase III data in December, positive phase III data. We are poised for a BLA submission at the end of 2026.
This asset is also in development in non-small cell lung cancer in patients that are refractory to Checkpoint inhibitors and in pancreatic cancer. We have fast-track designation for each one of these indications. The second asset in the clinical development is CAN-3110. That's a classical oncolytic virus. It's a replication-conditional asset and is in development in recurrent high-grade glioma. We have a discovery platform that is much earlier on in development. We have three preclinical assets, experimental assets, let's say, that have been presented at different conferences. We are poised to develop these in the clinic later on. Let's focus first on CAN-2409. This has been dosed in more than 1,000 patients.
It's a locally delivered replication-defective adenovirus. It works in combination with a Pro drug. You inject the virus into the tumor, and then you give Valacyclovir, that is an oral metabolite, small molecule, generic, for 15 days after the injection. You can do repeated courses. We have treated patients with two to three courses, depending on the indication. Interestingly, it's extremely synergistic with radiation. This is what we've leveraged in the prostate cancer indication. We have very clear evidence of monotherapy activity. What you see there is a scan of a patient treated in neoadjuvant settings with non-small cell lung cancer prior to resection. You see a decrease of almost 50% of the tumor volume. The phase III trial is the most advanced one.
I'm also going to share with you some data in the non-small cell lung cancer and pancreatic cancer. This is an image instead of the effect of CAN-3110. I told you this is a classic oncolytic virus developed in recurrent high-grade glioma. Also for this, we have a fast-track designation and orphan designation. This is an extremely challenging indication where patients have a median overall survival of less than six to nine months. We have clearly demonstrated in two different cohorts a median overall survival of at least 12 months with single injection. We are now building up on this evidence, adding some different administration up to six injections in the cohort C that is undergoing.
We are going to be able to share some data before the end of the year as one of our catalysts. Enlighten, this is the discovery platform, newborn from the past four years at Candel. This is a new one-of-a-kind platform that enables the data mining using artificial intelligence of publicly available data set for the design of Viral immunotherapies to be combined with either Checkpoint inhibitors or, for example, cellular therapies in, again, difficult-to-treat cancer. This is our pipeline. It is really focused on what we call value creation. You can see the assets in their stage of development.
We're going to focus today in the presentation on CAN-2409. As I mentioned before, CAN-2409 is a replication defective adenovirus. It encodes a thymidine kinase gene. This phosphorylates the Pro drug that is orally administered. At the site of the tumor, this creates a formation of an intercalating metabolite that gets inside the DNA chain and blocks the DNA replication. This sends the cells in what is called an immunogenic cell death with release of tumor antigen and immunization, really, and activation of the tumor microenvironment. Really, the therapy is not the virus, but it's the immune system that gets activated through the release of the tumor antigens in the context of an inflamed tumor microenvironment.
This results in both a local decrease of the size of the tumor, obviously, and local activation of the immune response. These CD8 T cells that get activated at the site of the tumor are able to then get out of the tumor, patrol the tissue, the patients, and also affect peripheral metastases. We have very clear evidence of that both in animal models, but also in patients with non-small cell metastatic cancer, where we see responses in uninjected lesions. We do not need to inject all the lesions. We do not need to inject all the tumor because the immune response has that effect on peripheral lesions. The first focus is prostate cancer.
This is an incredible opportunity from the point of view of the significant amount of need, especially in localized prostate cancer, where therapeutics have not been developed for the past 20 years. The need for this is, and the reason for this is that designing a trial in prostate cancer takes some guts. It takes a long-term follow-up for the patient, almost 10 years follow-up. We've been very lucky at designing this in collaboration with the FDA, agreeing on what our endpoint is, and really being able to design this trial. The opportunity from the financial point of view is a multi-billion opportunity because this patient population of intermediate to high-risk prostate cancer that you see in the rectangle is the highest one.
Prostate cancer is extremely diffused in men. We have an aging population in which we think that this is going to increase over time even more. 50% of the patients with intermediate and high-risk prostate cancer will undergo Radiation therapy. We synergize CAN-2409 with this treatment. You see that some of the value proposition. From the point of view of the patient, this is, again, even a more significant amount need because patients normally, after having Radiation therapy, after having surgery, and around 30% of these patients will undergo recurrence of the disease. At this point, they will have to be treated with Androgen deprivation therapy and Salvage chemotherapy in some cases.
This patient is the one that we want to avoid to have recurrence. We want to really treat. We want to avoid for them to have Androgen deprivation therapy that is, unfortunately, associated with very severe adverse events and is very poorly tolerated by the patients. This is the highlight of the data that we presented in December. You can see that the trial included 745 patients. They were randomized two to one to CAN-2409 or placebo on the top of standard of care radiation. All the patients had standard of care radiation. 50% of the patients received short course androgen deprivation therapy.
We have seen that we have achieved the primary endpoint with statistically significant achievement of the primary endpoint with a decreased risk of disease recurrence or death of any cause or Disease-free survival in around 30% in patients treated with CAN-2409 as compared to the placebo. This primary endpoint was supported by achievement also of key secondary endpoint. I want to highlight the difference in the nadir of PSA. PSA is one of the most sensitive biomarkers of recurrence in prostate cancer. We see a significant effect on that. It is really corroborating our data. It is also very interesting, the data that we have seen on the biopsies.
We've seen that after CAN-2409 treatment, there is a much larger percentage of patients that achieve pathological complete response, meaning absence of tumor at the two-year biopsy post-treatment. The safety of CAN-2409 has been confirmed in this trial as in other trials. Really, this is a therapy that, being locally delivered, very similar to a prostate biopsy, is associated with a very good profile of tolerability from the patient. They compare it very much to a prostate biopsy. This is the key data slides. You can see a complete separation of the curves happening after two years post-treatment and then maintaining and continuing over time. We have a median follow-up time of 15 months.
We will continue monitoring these patients in the future to evaluate other events and that. I have highlighted here again the pathological complete response. Really, the absence of tumor will translate over time in absence of peripheral recurrence, local recurrence, and also in a specific decrease of death by prostate cancer. In the next two years, we have a packed full of activities. We are ramping up our CMC activity to be able to prepare the commercial launch and the product for the commercial launch. We also are preparing all the activities with the KOL and the medical affair activities that are linked to the launch.
We are preparing this with a very interesting model that is partially externalized to avoid very, let's say, strong implication of resources from our point of view. Very briefly, the data on the pancreatic cancer, we shared this at the beginning of the year like a new data cut. Here, we're looking at a patient with borderline resectable pancreatic cancer. Again, enormous amount need. These patients have got a very short median overall survival between 12-18 months, depending on the data set. We have shown in a randomized trial that we can significantly improve this median overall survival. It is a small trial, but the signal is quite strong. We are really looking forward to the possibility to further develop this in the future in a larger phase II trial.
Finally, the data on the lung cancer in the lung cancer space, again, extremely significant amount need. Nowadays, the majority of the patients with metastatic disease undergo treatment with PD-L1 plus or Anti-PD-1 or PD-L1 plus or minus chemotherapy. 60% of these patients will recur and will have a median overall survival of 12 months. What we've shown is that just by adding two injections of CAN-2409 to patients that are non-responding to Checkpoint inhibitors, we can increase that median overall survival quite significantly. The data that I've put here is just the data related to cohort two in our trial that were really the patients that were progressing under ICI.
They had like a scan patient who were treated for 18 months on ICI, non-responding, evidence of progression, treated just with two injections of CAN-2409, median overall survival of 21 months. Doubling what was expected in this population. Extremely exciting, again, poised to develop a phase III trial at the right time. This is a very strong leadership with decades of experience, of years of experience in drug development. This is our key achievement in the past couple of years. We've been actually overachieving what we had promised. We have still one more clinical catalyst this year we're looking forward to share. I can stop here.
This is just highlights. The corporate highlights show you actually our cash and cash equivalent. At the end of December, we just yesterday released our thank you. That number is $92 million. We have enough to get us to submission of the BLA in 2026.
We've got a couple of minutes. Questions, want to be respectful of the next session.
Maybe I'll just throw one up to you, Francesca. In terms of the ongoing BLA submission process, what are sort of the near-term focus points for the company? Is there any additional data that needs to be generated to support the filing?
Sure. So from our point of view, we have a role in BLA because we have the fast-track designation. We are in continuous conversation with the FDA. We are putting together the clinical package. We have some conversation on what the structure of the BLA will look like. Because the study was run under an SPA, we know already that they have evaluated the endpoint. The next things are really related to CMC manufacturing. We are scaling up the product and the production. That is the next catalyst, all these conversations really with the FDA.
OK. In terms of the 3110 data later this year, how would you sort of frame that for folks? Obviously, this is a slightly different approach than 2409.
Yeah. So 3110 is super exciting, actually. We've seen a really transformative response in these patients. We see patients that are alive in five years of post-treatment. That is really unheard of. We're going to see the responses from the six injections cohort. We have already disclosed that we have some patients which we've seen like 18 months survival. This was a data cut of almost now nine months ago. We're going to see that. We're going to see more biomarkers really associated with response that will enable us to really do those selections for the future clinical trials.
OK. OK. Looking forward to that update. I think with that, we're at time. Please join me in thanking Francesca for the presentation.
Thank you.
Thank you for being.