Shining a (Blue) Light on Bladder Cancer: Photocure’s Impact

February 10, 2025

From how it enhances detection to its role in shaping future treatments, Anders shares expert insights on Photocure’s patient-focused innovations and its impactful partnership with BCAN. Don’t miss this inspiring conversation about how collaboration is driving progress and hope for the bladder cancer community. Listen now!

Transcript

Voice over:

This is Bladder Cancer Matters, the podcast for bladder cancer patients, caregivers, advocates, and medical and research professionals. It’s brought to you by the Bladder Cancer Advocacy Network, otherwise known as BCAN. BCAN works to increase public awareness about bladder cancer, advances bladder cancer research, and provides educational and support services for bladder cancer patients and their loved ones. To learn more, please visit bcan.org.

Rick Bangs:

Hi, I’m Rick Bangs, the host of Bladder Cancer Matters, a podcast for, by, and about the bladder cancer community. Today is the second in a series of podcasts that we’ll be doing in observance of BCAN’s 20th anniversary, which we’re celebrating all throughout 2025. In this anniversary year, BCAN is launching a Partners in Progress podcast series in which we’ll highlight the commitment of BCAN’s pharmaceutical company partners to creating better todays and more tomorrows for bladder cancer patients and families.

Today, we’re featuring Photocure, The Bladder Cancer Company, as February 2025’s partner in progress. Photocure’s mission is to deliver transformative solutions to improve the lives of bladder cancer patients and shape a future where bladder cancer is seen as manageable. While we’ll be talking today about imaging including blue light cystoscopy, it’s important to remember that different approaches to diagnosis and surveillance have different results in patients and your results may vary.

Joining us today on Bladder Cancer Matters is Anders Neijber, Photocure’s chief medical officer. Anders joined Photocure in August 2021, bringing over 25 years of experience in uro-oncology and pharmaceutical leadership. He has held key roles within the industry throughout his career, a board certified urologist with an MD, PhD and an MBA. Anders previously served as an assistant professor at Robert Wood Johnson Medical School. Welcome to the podcast, Anders.

Dr. Anders Neijber:

Thank you.

Rick Bangs:

So, we’ve seen some major and exciting changes in bladder cancer treatment in recent years. And that includes the addition of blue light cystoscopy to the diagnostic and surveillance arsenal. So, from your perspective, what makes this recent movement particularly groundbreaking?

Dr. Anders Neijber:

Yes, there has been really a remarkable innovation in science and technologies the last decade. It’s been driven by the needs for earlier and better diagnostics, and improved management and outcomes of cancers, including bladder cancer. So, a lot of research and development efforts have gone into, for example, non-muscle invasive bladder cancer, the area where we have our product. There are recently several new treatments in development, also using different mechanism of action and actually showing quite promising results. Such developments and innovations have led to three novel FDA-approved therapies, an immunotherapy, a gene therapy, and a drug targeting, an immune receptor that are now available for treatments in the US.

These therapies are often referred to as bladder-sparing treatments for patients with the most aggressive high-grade disease, also referred to as BCG-unresponsive non-muscle invasive bladder cancer. That is patients who are not responding adequately to the initial treatments. So, the bladder-sparing treatments really aim to delay and avoid cystectomy, taking out the bladder, so preserving the bladder function as long as possible. And more patients now have this option. However, not all treatments work well for all patients.

So, this highlights the importance of getting an accurate and early diagnosis to allow for more informed decision-making and treatment planning. And it’s really important to find the right patient for the right medication. So, there is a new emphasis on personalized therapy or precision medicine in bladder cancer. And this also includes then patient selection and therapy response monitoring, et cetera. And here, the diagnostics, and the innovation in diagnostics is really important.

Rick Bangs:

Yeah. And these are some huge areas of improvement, particularly since my diagnosis. So, this is wonderful. So, let’s talk about blue light cystoscopy. Can you share the backstory? When did Photocure begin working in the bladder cancer space? And what motivated your company to focus on this area and cystoscopy in particular?

Dr. Anders Neijber:

Yeah. So, Photocure was established in Norway, 1997, so 28 years ago. And was based on basic research in photodynamic therapy at the Radium University Hospital in Oslo, Norway. Photodynamic therapy is kind of an imaging agent, so photosensitive agents that can be activated by light. Photocure actually had a long R&D period with development projects for bladder cancer, but also for some other oncological indications. These products were eventually licensed out to other companies for commonization. So, we had companies like Galderma, GE, IBSEN, who took over these compounds. But this is before my time at Photocure.

But since 2021, Photocure has established its own operations in Europe and North America, with our blue light cystoscopy technology, also referred to as enhanced cystoscopy or photodynamic diagnostics. And it’s a combination product. It consists both of the light-activated imaging agents that was kind of FDA approved, but also a medical device, a cystoscope. So, we are collaborating with cystoscope manufacturers. So, you use this product in combination with cystoscopy or transurethral resection of the bladder tumor, also referred to as TURBT. So, where you with the cystoscope take out the tumors in the bladder, basically. Our technology makes cancer cells glow bright pink. And basically, you can easier detect the tumors and also thereby improve diagnosis.

This particular imaging agent accumulates in cancer cells, so it’s basically targeting the tumor. And it’s therefore sometimes referred to as an optical biomarker. It visualizes the tumor in real time during the cystoscopy and guides the surgeon during the removal of the tumors. It’s basically used in conjunction with conventional white light cystoscopy. The product or technology was approved by the authorities for marketing, 2005, in Europe and by FDA in 2010. So, the product has been used for approximately 20 years. And by now, there is a lot of clinical studies and data available, and including 20 years of safety data supporting the product.

There have been more than 850,000 procedures done. And there are more than 20 randomized clinical trials enrolling over 4,000 bladder cancer patients. So, there is a lot of evidence supporting the technology, I would say. And they have consistently showed clinical benefit, which is then reflected that the use of this technology is recommended by basically all major international guidelines.

Rick Bangs:

So, what inspired you to join Photocure? And how does your personal journey align with Photocure’s mission in oncology in general and bladder cancer specifically?

Dr. Anders Neijber:

So, yeah, I am a urologist by training. And I’ve been in the industry for quite a long time. But I started at Photocure in 2021, approximately four years ago. And there I’m responsible for medical affairs and R&D, so the medical function in Photocure, basically. We have people in Norway, Europe, and the US. As you mentioned, I have been a long time in the industry, basically working on different bladder cancer projects. And several of them actually developed to the market. It was, for me, inspiring to join Photocure, as its mission statement is basically to be focusing on bladder cancer and to deliver innovative, transformative solutions to serve the bladder cancer community and patients.

And also, the pace of development in the bladder cancer area has increased rapidly. And as a urologist and scientist, it’s really exciting to be part of this rapid development. There’s so much happening. There’s new data to consider all the time. And then also, to have the opportunity to collaborate with bladder cancer expertise all over the world is also very inspiring.

Rick Bangs:

Yeah. It’s just wonderful to see all the excitement people have about where we are versus the concerns people had about where we were. Not that there isn’t room for improvement, but it’s just changed so dramatically here. So, let’s talk about the specific segments of bladder cancer Photocure would address with its devices and agents. So, beyond the blue light, are there other devices or agents in your pipeline or any areas of focus? Anything that’s in clinical trials that you could actually talk about?

Dr. Anders Neijber:

Yeah. So, the area or a segment that we are working on is really the non-muscle invasive bladder cancer area. So, as you probably know, bladder cancer is classified into two main types, the non-muscle invasive bladder cancer and the muscle invasive bladder cancer. And the non-muscle invasive bladder cancer accounts for around 75% of initial diagnosis. So, the primary treatment of non-muscle invasive bladder cancer is surgical resection or removal of the tumors in the bladder, which I refer to as transurethral resection of bladder tumors, TURBT. And during TURBT, all visual tumors are removed. That’s the therapeutic goal. And then, also, you do disease staging and grading to have an accurate diagnosis for further treatments, I would say.

And to get this diagnosis, you take tissue samples, biopsies during the procedure. And then based on the pathology, you can stage and grade, confirm the diagnosis basically of the cancer. And that allows for a prognostic risk assessment, so it can classify this as a low or intermediate, or a high risk cancer. And that helps you with the decision-making for further follow-up and treatment. So, basically, to make an early and accurate TURBT and diagnosis is really crucial. This is where you can identify the more aggressive bladder tumors and really initiate appropriate therapy as early as possible. The challenge is that there’s quite a high variability in surgical quality. There are tumors left in the bladder after surgery, there is a high recurrence rate in this bladder cancer.

There’s also issues with delayed diagnosis or need for restaging, so reconfirming the diagnosis, et cetera. So, all of this has to be addressed, and that is basically to try to improve the quality of this procedure. And that’s where the use of blue light cystoscopy or enhanced cystoscopy takes place. So, that is with what our product does, basically. It’s used by the surgeon during the initial cystoscopy or during the TURBT resection in patients to improve the detection of tumors, and improve the quality of the surgery, and to make a more accurate diagnosis basically through these more targeted biopsies that can be done with enhanced cystoscopy.

Rick Bangs:

Yeah. I like the emphasis on the making the tumor visible, because otherwise you can’t see it. I’m assuming it’s going to be pink, is based on what you said.

Dr. Anders Neijber:

Yeah. It lights up, kind of. You can contrast it from the rest of the bladder surface a little bit. Well, and it improves the detection rate quite significantly and especially the very hard to see tumors, the aggressive tumors like the carcinoma in situ, which is an especially aggressive tumor. Those are easier to detect with this technology. But besides the blue light technology, we are working on some other development projects to improve our current product. There are a number of new technologies that can help us improve the current product. And then we also work with scope manufacturers. I told you that we are a combination product, so you need both the imaging agent and you need the device, the scope.

And we work with these scope manufacturers to develop the next generation blue light cystoscope, for example, a new flexible cystoscope that we’re working on. So, there’s continuous innovation also here. And especially, on the cystoscope side, there is a lot happening with improved digital imaging technology, like the resolution. We’re talking from full HD to 4K and so forth. The sensors are improving, the light source are improving. And also, very important, the imaging process software is constantly improving. And you can just look at the very rapid development that is happening in imaging in an iPhone, an ordinary iPhone. That is also what’s happening on the device side in our combination products.

Rick Bangs:

Wow. Yeah, I think people can relate in terms of their smartphone. The cameras are getting more and more high definition. The high definition part’s getting much, much better, so that certainly translates over pretty nicely. So, what does blue light provide to bladder cancer patients? I heard about that it lights up kind of pink, but how does it stand out from other treatments in terms of benefits, safety or approach?

Dr. Anders Neijber:

Yeah. This part of imaging technologies, and here in non-muscle invasive bladder cancer, you have blue light cystoscopy as well as radiology, who are the main imaging diagnostics. And they are basically the backbone of diagnostics and management of bladder cancer and are likely to play an important diagnostic role also in the future, despite other technologies coming around. And it will continue to be crucial to have an early and accurate diagnosis to improve outcomes in non-muscle invasive bladder cancer. Using enhanced blue light cystoscopy, you can get a more complete resection. You see the margins of the tumors better. You can make a better resection. You can also, with the targeted biopsies, gather more information for the diagnosis, the staging and grading that I talked about.

And the good part is also, the imaging agent was, regardless pharmaceutical and FDA approved, and has been now around for approximately 20 years. It has a very good safety profile. We know that it’s very safe. So, that part is really good. And then despite this, the technology with the device, that keeps improving the performance of the product. And with every new generation of cystoscope, it will keep on improving.

Rick Bangs:

Wow, that’s terrific. So, I think our audience would be interested in hearing about how Photocure engages patients throughout the development of blue light, either in the past or going forward. So, can you elaborate on the role of patient involvement in your clinical trials or any survivorship studies you’ve done?

Dr. Anders Neijber:

Yeah. As I mentioned before, we have done actually 10 clinical trials and as a sponsor. And then there are, of course, a lot of investigator trials that have been run as well. So, there are more than 20 clinical trials, basically randomized controlled trials run with this technology. Just during the sponsored trials that we were sponsoring, we enrolled more than 2,000 patients. And in total, we are talking about more than 4,000 patients that have been enrolled into clinical trials in many countries. But both throughout the trials and with other studies that we have done with this technology, we collaborate both with experts, clinicians, but also then with patients and patient organizations like BCAN.

And that has been an aim in Photocure to collaborate with these experts, and to stimulate research and awareness of bladder cancer, and also generate new evidence to help improve the patient care pathway in non-muscular invasive bladder cancer. So, just talking specific about studies, we are involved in a number of investigative initiated trials, some registries. We did just finish a sponsored phase three trial in 120 patients with a partner, a series to obtain approval for a product in China. So, that was a phase three trial, a regulatory trial, so I’d say.

We use the new technology, new devices with 4K definition, et cetera, in these new trials to generate new data and to continue to support the value of this technology. I can also just mention that we in the US have a big registry ongoing right now. We produce real world data from clinical practice. It’s called the Blue Light Cystoscopy Registry. And it was started 2019 and currently includes 23 sites all over the US. And has so far enrolled more than 3,500 patients. So, there is about 10 years of follow-up in this registry so far. We also generate new evidence in other registries and other studies continuously, that we are both publishing and distributing with healthcare professionals and urologists, to help them understand how to use the technology and how they can best help which patients, I would say.

Rick Bangs:

So, you talked about the registry in the US. If I was a patient and I was interested in blue light cystoscopy, how would I find a urology practice that uses it?

Dr. Anders Neijber:

Yeah. Well, you could go to our website, but you could also go to the clinicaltrials.gov website that FDA has. That’s where the study is listed. And then you have also all the sites. But otherwise, contact Photocure and we can help you find a nearby site. Absolutely. You can also visit the site blcprocedure.com to request information.

Rick Bangs:

So, you’ve been partnering with BCAN for a number of years. Tell us a little bit about that collaboration and any plans you have for future partnering.

Dr. Anders Neijber:

It has been a privilege to be a long-time partner with BCAN. I think it’s over a decade, actually.

Rick Bangs:

I think so.

Dr. Anders Neijber:

Every year, we evaluate different opportunities to provide additional support where it can be beneficial. And actually, something that’s really exciting right now is that we are in an initial phase of starting collaborating on a unique BCAN sponsored real good evidence registry study, together with other industry partners in academia. The goal with that study would be to follow patients who receive new bladder-sparing therapies over time, also getting blue light procedures. So, this could become a really important and valuable project, where it’s an area where we still lack long-term data of these new medications. And that will therefore benefit patients going forward.

Rick Bangs:

So, what do you see in the future for bladder cancer care? From Photocure’s perspective, where do you see the field evolving and how does Photocure contribute to that evolution?

Dr. Anders Neijber:

Yeah. I mentioned the rapid innovation also in technologies. Not only in the science, but also in technologies. And there are a number of new technologies emerging that will be new tools for urologists. So, these are complementary diagnostic technologies that improve the performance, the diagnostic performance. And I don’t think it’s going to be like a single diagnostic method or test that will be sufficiently accurate to diagnose bladder cancer in the future. There’s going to be a need for several diagnostics. And they won’t be mutually exclusive, but they can complement each other, and enhance both the diagnostic accuracy and the prognostic performance.

So, having all of this information then will allow physicians to make better treatment decision. And also, as I mentioned, the enhance prognostic risk stratification, identifying which high-risk patients should get what kind of treatments, et cetera. So, this will really enable the trend towards more personalized therapy. In addition to, I’ve been talking about imaging diagnostics, such as blue light, et cetera. But there is also a lot happening with radiologic technologies, such as magnetic resonance imaging, MRI, and new tumor-targeted contrasts that are being explored.

They are already using this in prostate cancer, but there is also similar emerging contrasts being explored for bladder cancer. And then we have digital pathology with advanced imaging analysis. I talked about the rapid development in software and AI, that allows AI, for example, to interpret these digitalized pathology slides, and for improve diagnosis and prognostics also in the pathology area. And then we have the whole field of biomarkers, also sometimes refer to as liquid biopsies, where you can do molecular and genomic profiling of a tumor, using really sophisticated next-generation sequencing technology, genomics, biosensors, et cetera. And so, that is a very exciting area.

And some biomarkers have already been regulatory approved, and are increasingly being implemented clinically, and could potentially replace or postpone cystoscopies for monitoring patients. And then there are also some really exciting prognostic and predictive biomarkers starting to be used, that can identify patients who are responders or non-responders to different treatments. And then, of course, you have this whole area of artificial intelligence, which will have many different implications, also in bladder cancer.

Some of the first tools available are medical imaging analysis. So, I talked about digital pathology, but this can also be used for cystoscopy. It can be used to integrate information from several diagnostic, and further enhance this prognostic performance and treatment planning. And this is already happening in, for example, prostate cancer, where there is a tool that is even mentioned in the guidelines. So, it’s a very exciting time.

Rick Bangs:

Yeah, definitely. And layer on artificial intelligence, and it’s just that much more exciting. So, stay tuned. We’ll be looking forward to some of these advancements more. So, any final thoughts you’d like to share?

Dr. Anders Neijber:

No. As I mentioned, as a doctor and scientist, it’s an exciting time, but this will also be leading to improvements for patients. It will benefit patients. There will be new treatments, more effective treatments, better and earlier diagnostics, et cetera. So, I hope there’s still a lot to come.

Rick Bangs:

Which is wonderful. So, Anders, I want to thank you for introducing Photocure and blue light cystoscopy, and for creating better todays and more tomorrows for bladder cancer patients and families by being one of BCAN’s Partners in Progress. If you’d more information on bladder cancer, please visit the BCAN website, www.bcan.org. In case people wanted to get more information about Photocure or blue light, where can they go? And I think you mentioned a website that we may want to remind folks about.

Dr. Anders Neijber:

There is a website called blcprocedure.com, so BLC and then procedure.com. You can also go to the company website to find more information. And that is photocure.com.

Rick Bangs:

Excellent. Thank you. Just a reminder, if you’d more information about bladder cancer, you can contact the Bladder Cancer Advocacy Network at +1 888-901-2226. That’s all the time we have today. Be sure to like, comment and subscribe to this podcast so we have your feedback. Thank you for listening. And we’ll be back soon with another interesting episode of Bladder Cancer Matters. Thanks again, Anders.

Dr. Anders Neijber:

Thank you.

Voice over:

Thank you for listening to Bladder Cancer Matters, a podcast by the Bladder Cancer Advocacy Network, or BCAN. BCAN works to increase public awareness about bladder cancer, advanced bladder cancer research, and provide educational and support services for bladder cancer patients. For more information about this podcast and additional information about bladder cancer, please visit bcan.org.