Beyond BCG: What Comes Next for Patients

April 13, 2026

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. I am also a survivor of muscle invasive bladder cancer, the proud owner of a 2006 model year neobladder, and a patient advocate supporting cancer research at the Bladder Cancer Advocacy Network, or as many call it, BCAN, producers of this podcast.

This podcast is the latest in a series that we’re doing in observance of BCAN’s 20th anniversary, which we’re celebrating throughout 2025. In these podcasts, we highlight the commitment of BCAN’s pharmaceutical company partners to creating better todays and more tomorrows for bladder cancer patients and families. And today, we’re featuring ImmunityBio as August 2025 Partner in Progress. Well, we’ll be talking today about ImmunityBio therapies, including recombinant BCG and ANKTIVA, which has the generic name, nogapendekin alfa inbakicept-pmln. It’s important to remember that different treatments have different results in patients, and your results may vary.

I’m pleased to welcome today’s guest and ImmunityBio’s Chief Medical Officer, Dr. Bobby Reddy. Dr. Reddy oversees clinical development and medical affairs, which included FDA filing and approval for ANKTIVA and BCG-unresponsive non-muscle invasive bladder cancer. He previously served as Chief Medical Officer at NantHealth where he oversaw education, outreach, and clinical development programs. Dr. Reddy practiced hematology oncology for 19 years, and holds a clinical faculty position at UCLA School of Medicine. His executive and medical oversight has produced over 100 abstracts at major medical conferences, and over 40 peer-reviewed publications in oncology in the past 10 years. Dr. Reddy, welcome.

Dr. Bobby Reddy:

Thank you. Thanks, Rick. Happy to be here.

Rick Bangs:

And we’re happy to have you. So I want to start with, when did you start working in the bladder cancer space and why did you make that choice?

Dr. Bobby Reddy:

That was around 2020, which we all remember as sort of a momentous year because of a global pandemic.

Rick Bangs:

Yeah.

Dr. Bobby Reddy:

But for me, it was a momentous year because we really started in earnest on the bladder cancer program, and one of the key reasons was the underlying mechanism. And so, our drug has a effect to proliferate and activate natural killer cells. And when we look around at the landscape of diseases, at least in cancers, one of the most profound examples of natural killer cells being important is non-muscle invasive bladder cancer and BCG. So, there was a natural underlying synergy that made it perfect sense for us to develop the drug in that space.

Rick Bangs:

Okay. So, what excited you about going with ImmunityBio?

Dr. Bobby Reddy:

Yeah. So, ImmunityBio is a unique kind of company in that we’re small but not too small, and we’re new but not too new. So, what do I mean by that? The company was created by Dr. Patrick Soon-Shiong, and he is the visionary behind the company. He’s the chairman of the board and the founder. He’s a pancreatic transplant surgeon by training, and when he was doing his transplants, he was looking to try to prevent islet cell rejection. And he developed a therapy for that, but it actually didn’t work, but it turned out that it was a fantastic drug for something else. So, it’s just the lesson in life about pivoting. And that drug became Abraxane, which is a chemotherapy that’s used in many diseases, most notably pancreatic cancer, breast cancer, and lung cancer.

And he then turned his attention to, well, what’s the next thing? What’s the next thing in terms of cancer therapies, particularly immunotherapy? And what we started to develop was what we call immunotherapy 2.0, and so what was exciting about ImmunityBio is going to the next level beyond checkpoint inhibitors. And so the idea was, what are the cells that we need beyond just T-cells? Can we get the innate immune system beyond just the adaptive immune system to come to this party? Can it come and help us eliminate these diseases in patients? And so, we’ve developed a whole slew of different products addressing each of those potential needs. So off the shelf natural killer cells that we can give to patients, vaccine platforms, and then of course the ANKTIVA or the nogapendekin, which is used to accentuate that immune response by activating and proliferating both T-cells and NK cells.

Rick Bangs:

Otherwise known as, starting a party, I suspect.

Dr. Bobby Reddy:

Exactly.

Rick Bangs:

Okay. So, what’s the vision for ImmunityBio and how does it translate into what patients actually experience in the clinic?

Dr. Bobby Reddy:

The vision, as I said, it comes from our founder. And he’s a practical guy, he’s a surgeon, and he was originally from South Africa. And one of the things he talked to us early on and often continuously in the development processes, whatever therapies we develop, they have to be practical. And what does that mean? It means that it has to be given or it has to have the opportunity to be given to everyone. You can’t create a cure for cancer but it can only be given in very advanced, developed countries inside the hospital, inside a specialized center, like a bone marrow transplant center, for example. So, that was one of the things we were looking at with CAR-T therapies. Can we go beyond that? Can we move to a fully outpatient universe where people can be treated anywhere at any time at any place? And can we use the existing platforms and just make them better? We don’t have to reinvent the wheel. The wheel is a very, very good tool, but can we make it better? Right?

And so, what we were looking for, at least in the context of bladder cancer was, can we take what’s happening today in the office, in the clinic with the urologist and the patient, and can we just improve that? We don’t have to shake everything up. Can we use the same existing procedures, the same tools, but make them better? And that’s really what we’ve tried to do and I think we’ve accomplished that, at least with nogapendekin.

Rick Bangs:

Oh, that’s a great goal. Okay, so you have ImmunityBio, you have two agents that are used in bladder cancer, and they have a relationship to one another. The first is BCG, but there’s an interesting twist about this BCG that I want to discuss. And obviously, this is particularly important in general, but also important in light of the latest series of shortages. And your second agent is ANKTIVA, which we’ve already mentioned, and it’s new and probably unfamiliar to our listeners. So, let’s start with the BCG that you produce, and it’s something called recombinant BCG. So, can you tell us what that is and how it might be different from the BCG that many have had as part of their treatment?

Dr. Bobby Reddy:

The recombinant BCG is a modified strain of the existing BCG. So, what’s interesting about BCG, of course, is it’s Bacillus Calmette-Guérin. It’s a bacteria that was modified and developed to be used as a prevention of tuberculosis. And people would think, well, what does tuberculosis have to do with bladder cancer? And the answer is, a long time ago was recognized that when you use this bacteria in low doses to stimulate an immune response, that immune response isn’t just against tuberculosis, it can be against other things. And there’s been good data recently, like at the time of COVID, showing people who had childhood immunizations against tuberculosis had better outcomes with COVID. So, that immune response is real and it’s also long-lasting. And it makes sense, because getting tuberculosis is a very, very bad thing. And before the advent of antibiotics, it was almost universally fatal. And so for humans to survive, we had to develop strong, powerful immune responses to this kind of stimulus. And so, that immune response can then be harnessed and targeted in a different way against something like non-muscle invasive bladder cancer.

So, the recombinant BCG takes advantage of that strength but we modify the bacteria, because the problem with standard BCG is that number one, it’s hard to produce. That’s why we have a shortage. And number two, there’s a risk of systemic infection or sepsis, which something is called BCGosis, which is basically like having almost a tuberculosislike septic infection. And so, what’s happened with the recombinant BCG is it’s been genetically modified to knock out the urease gene and replace it with the gene from the listeria bacteria, and the gene encodes a lysin protein. So it’s a listeriolysin. So, lysin means to create holes, to lyse something. And so this lysin creates pores in the bacteria. And so the bacteria has holes in it, it’s not going to survive as long. But also what’s nice is, these little holes allow for those proteins to be chewed up in what’s called the phagosome, and these proteins then get more expressed.

So, it turns out that when you want to make an immunotherapy, it would be a good idea to have more protein expressed, and so therefore, we’re basically processing more antigen and getting a stronger immune response for the same amount of bacteria. And now, the bacteria is a little bit handicapped, so it’s not going to live quite as long because it’s got these holes, so it won’t live quite as long. And as a result, it’s much less likely to cause sepsis.

Rick Bangs:

Okay, so let’s talk about that development. So, where are you in the development lifecycle for recombinant BCG? And could you see it helping reduce the latest in this series of BCG shortages we’ve been experiencing?

Dr. Bobby Reddy:

Absolutely. I mean, that’s 100% our goal, that is our focus right now, because as we all know, we’re acutely aware that for 10 years we’ve had an on again, off again, but essentially ongoing BCG shortage in the United States. And of course, what’s interesting is there isn’t really a global shortage because in other regions in the world, there are other BCG strains that are available. And so we’re looking at, can we bring another one here to the US? From a development perspective, we’re very happy that the Food and Drug Administration has allowed us to open what’s called an expanded access program. So currently today, I’ll talk about the here and now and the future, to answer your question.

So, the here and now is under the expanded access program, patients can get access to this product today. We have information on our website, which can then lead patients and their doctors essentially to go and sign up for this expanded access program where they can get access to this for essentially any disease that requires BCG. So, not just BCG unresponsive non-muscle invasive bladder cancer for which ANKTIVA is used, but even upfront BCG naive. Other stages, let’s say, of bladder cancer in which BCG would normally be used. Since there’s a shortage either for induction or maintenance, recombinant BCG could potentially be substituted. So, this investigational therapeutic is available today, and there’s now actually, I think, just under 100 patients in the United States who are currently receiving it through our expanded access program.

Rick Bangs:

All right, and we’re going to come back and let people know where they can go to get more information on that, because that’s, I think, an important point.

Okay. So now your other bladder cancer product, which we’ve already mentioned, is ANKTIVA, and that’s administered with BCG, whether it’s recombinant or not. And ANKTIVA, as you’ve hinted at, it’s not chemotherapy, and it’s a unique agent and it’s being used in more than just the bladder cancer setting. So, what is ANKTIVA and how did it come to be?

Dr. Bobby Reddy:

ANKTIVA is really interesting, because the big topic of many of the last couple of meetings that I’ve gone to that are big cancer meetings, the big topic has been to talk about what we call bispecific molecules, or BiTEs. But what ANKTIVA is, it’s a bifunctional molecule, so it’s working in two ways at the same time. It’s an IL-15 receptor agonist, and what it does is the IL-15 has been mutated, so it has a greater binding affinity. And so the IL-15 will normally activate and proliferate immune cells, but now that it’s been mutated, it does that even more than a normal IL-15 molecule would do. So, it’s really got a greater potency.

The second thing is it’s actually two IL-15s in one molecule. So the technical term for this molecule, it’s not a small molecule, it’s a cytokine fusion protein. The cytokine is IL-15, and the fusion protein part is the IL-15 receptor alpha. And it’s hard to do this visually, but if you can imagine it’s like a Y, and this Y-shaped molecule, each end of the Y that’s sticking out has this IL-15 receptor alpha. And what that does is it holds the IL-15 in place, but it also presents the IL-15 to the immune cells in a very specific three-dimensional way, so that it will only bind to the immune cells we want and not the immune cells we don’t want. And that’s really, really important. So, what it results in is activation, so more activity of both NK cells and CD8 positive T cells or killer T cells and memory T cells, but also proliferation of those cells. So you get more function and more number of these cells, and the NK cells and the CD8 positive T cells are what kill cancer.

But because of that three dimensional structure, it will not bind to regulatory T cells. And so as a result, you’re stimulating the cells that you want as a patient, you want them to get in there and eliminate the cancer, but you don’t stimulate the suppressor cells, the immune suppressive cells. So, you can continue to get this ongoing immune effect to eliminate and hopefully long-term eliminate, control of cancer.

Rick Bangs:

Okay. So it’s selectively stimulating, which is what we would want it to do?

Dr. Bobby Reddy:

Exactly.

Rick Bangs:

Okay, great. Okay. So now ANKTIVA’s FDA approved. So, what patients would be eligible in the bladder cancer space for ANKTIVA? How would they get it? We said it was with BCG, so how does that actually work? And how safe and effective is it?

Dr. Bobby Reddy:

Sure. So the first thing is, as I mentioned earlier, we were looking for practical, right? And so the schedule of ANKTIVA is the exact same schedule as BCG. So, no changes in what patients have already experienced before if they had BCG, no changes from the office workflow. In fact, the way that it’s given is the same way as BCG. So, it’s just a vial of liquid that’s mixed with the other liquid, which is the BCG. You just take it out of the refrigerator, there’s no special freezers. It’s a regular refrigerator that every urologist’s office has. Anyone who can give BCG can give ANKTIVA. So, you just take these out of the refrigerator, you mix them together, and you put it into the bladder via a catheter. So the other advantage, of course, is it’s in the bladder and it’s not being taken up into the bloodstream. And so, we’re avoiding any of those systemic side effects that some of the systemic therapies may give you. So, that’s the delivery and the safety aspect.

From the effectiveness aspect, in our FDA label, we showed a 62% complete response rate. And then more recently in our updated publication, which has now been submitted for the full 100 patients, when we submitted for the approval, we had 84 patients, but in the full 100 patients, we’re up to a 71% complete response rate at any time. But importantly, there’s durability. Because of this underlying mechanism of getting those memory T cells, what we see is very long disease control. Our median duration was actually not reached through 45 months in our FDA labeled population. So, it’s very exciting to see that. And that’s what we would expect with immunotherapy. It’s the same that we see with other types of immunotherapy, that once the immune system can be trained, it’s going to keep working, and that’s a nice advantage of having an immunotherapy.

Rick Bangs:

Yeah, and longer is going to be better there. Okay, so I want to go back, tell me which patients are going to be eligible for ANKTIVA.

Dr. Bobby Reddy:

Sure. So, we’re currently approved for BCG-unresponsive NMIBC CIS, with or without papillary disease. So, that’s the FDA label. We have trials ongoing for patients who have other phases of disease. And again, we’ll provide that website and links to those trials, but those trials are looking at currently BCG-naive, carcinoma in situ, as well as intermediate risk NMIBC. Because again, the mechanism should run across the gamut, but this is where it’s currently approved, which is the BCG-unresponsive carcinoma in situ.

Rick Bangs:

Yeah, you have to work through each of the contexts on the approval side. So, that’s great. All right, tell me what’s next for ANKTIVA in bladder cancer.

Dr. Bobby Reddy:

Well, as I alluded to, we have an ongoing very large phase three, global phase three trial in BCG-naive disease, and we’re hoping to finalize accrual in that trial next year and then have a data readout maybe by the end of the year, and that’ll be very exciting to hopefully move it earlier for patients. We think earlier would be better because when there’s a more competent and stronger immune system, we hopefully will get better responses and longer responses.

And then as I mentioned, we’re looking at the intermediate risk space, where what we’re doing is currently the standard of care is to resect that tumor and then these tumors come back and there can be this ongoing need for the patient to keep having these surgeries. And what we’re trying to do here is say, let’s just eliminate the surgery. So rather than giving, say, chemotherapy or BCG after the surgery, we’re going to give this before and see if we can have the immune system completely eliminate the tumor and therefore, avoid surgery. So, we call that an ablative approach. And the advantage, of course, would be for patients who have high operative risk, avoiding that anesthesia. And then of course, we would love for it to work and have a more durable response so that they can stay off this kind of carousel of having multiple surgeries over and over and over.

Rick Bangs:

A lot going on, which is great, keeping you busy, I’m sure. So, how do you use and engage patients in all of this, therapy, surveillance, survivorship, clinical trials? Where do patients enter into your ecosystem?

Dr. Bobby Reddy:

In every sort of point, we want to be able to touch patients and have them engage in the process. So at the early stage, it’s definitely in the clinical trial arena, finding the right patients for the trials and patients who are eligible, making sure they have access. And then of course, the patients who may not fit into a clinical trial, as I mentioned, we’ve done a lot with an expanded access program, to where we’re able to at least get these drugs to people who need them the most. We know that’s not a long-term solution, but that’s our short-term. While we build a long-term solution, we can do both in parallel, I think that’s important.

And then in terms of looking at the survivorship and the long-term outcomes, because of this underlying mechanism where there is durability of the response, we’re very interested in tracking that, because one of our fundamental beliefs is that we’d like to shift the paradigm and be able to save as many bladders as we can. We know that not everyone that’s a possibility, that some people, their disease is so significant, so severe or may progress that they’re going to need to have resection of their bladder. But if we can show that we can delay that successfully and safely, we’re living in a new time for bladder cancer where patients have multiple options, and that allows more freedom to try some of these bladder sparing therapies. So, that’s one of the things we’re very interested in, is tracking that. We’re joining in efforts with BCAN to be part of a registry to look at this as well. And I think these are very important and yet unanswered questions. And so, we’ve got to collect that data and see how it all fits together for the patients.

Rick Bangs:

Okay. So, I want to talk a little bit more about your partnership with BCAN, and you mentioned the registry. So, what’s included in your partnership?

Dr. Bobby Reddy:

Well, I mean, first of all, I think BCAN is great. We love the podcast and the work. I mean, I personally have taken part in several BCAN walks. I’ve been involved in the patient summits, which I think are just exceptional. It’s a great opportunity for people who might be, let’s say, a little bit afraid to ask questions. You can be in a peer setting with lots of other patients and you can get that group dynamic, which is really important.

And then of course, I absolutely love the think tanks, which is really, a brilliant concept to bring all the right stakeholders together, really for mutual kind of understanding, discussion and benefit, under one roof. As I said, I’ve been in the cancer business for quite some time across multiple other cancers, and it’s a really unique format, and I salute BCAN for that work. So, we’d like to continue doing these things and be part of that and it certainly fosters a sense of community that is absolutely critical if we’re going to move things forward and really succeed, because I don’t think that any one drug is the answer.

Rick Bangs:

No.

Dr. Bobby Reddy:

And certainly in the example that we have, it’s two different drugs that we’re giving. And perhaps it’s two or three or four, and we don’t know what the right combinations and sequences are. So we definitely have to work together, but at the end of the day, that’s how we’re going to succeed.

Rick Bangs:

Yep. Together we are better, I think, is something BCAN has always said. So, what are you hearing from urologists regarding this changing treatment landscape? When I was diagnosed, there were very few options, and now we have, as you’ve mentioned, quite a few options. So, what are you hearing from urologists about that?

Dr. Bobby Reddy:

Well, I think urologists are, I’m going to say, cautiously optimistic. Right? We now have multiple FDA approved options to treat non-muscle invasive bladder cancer. I think at least with the possibility of recombinant BCG on the horizon, and Merck perhaps getting another factory up and running, we can solve the BCG crisis, which is a really important step forward. So, I think urologists are cautiously optimistic. We know that in the advanced disease space, we’ve seen great strides with EV, enfortumab vedotin and pembrolizumab, so that regimen. Or other regimens, such as the NIAGRA regimen, using a checkpoint inhibitor in patients that have muscle invasive disease and being able to reduce that disease burden and in a neoadjuvant way, maybe increase the likelihood of being able to save bladders. And then the molecular testing, whether it be urine or blood, but testing and even now digital pathology, there’s a whole series of new ways to identify and risk stratify patients.

So, all of these things will lead hopefully to earlier diagnoses, which should lead to better outcomes. So I think it’s a really exciting time and it’s giving us more options, and so it’s important that we have those discussions with patients that they understand that they have options, and that it’s a really good time to be in bladder cancer. We want to end bladder cancer, but our chances look much better today than they did say, 10 years ago.

Rick Bangs:

Oh my gosh, yes. So, any final thoughts?

Dr. Bobby Reddy:

Well, first of all, again, I want to thank you for the opportunity. I think that we’re very excited about where ANKTIVA is a valid option for patients that hopefully can forego some of the toxicities that might be associated with chemotherapy, but also get that immunologic benefit that could last years and years and years, even after they stop taking treatment. I think that’s one of the things that excites me. I’m a medical oncologist by training and what’s really exciting, I always say I grew up giving chemotherapy, that’s really the only treatment we had. And then we transitioned into immunotherapy and cellular therapy. And I did train as a hematologic transplanter, so I’m familiar with that idea. And what’s really nice is being able to give a therapy, stop the therapy or complete the therapy let’s say, and two, three, four, whatever years later, your patient is still in remission. And that’s a very exciting promise and we’re hoping to deliver on that. So, that’s really where I think the field is going and we’re just glad to be a part of that.

Rick Bangs:

Yeah, that is certainly the vision and seems close to our grasp. So Dr. Reddy, I want to thank you for sharing ImmunityBio’s part in creating better todays and more tomorrows for bladder cancer patients and families.

Dr. Bobby Reddy:

Thank you, Rick.

Rick Bangs:

If you’d like more information on bladder cancer, please visit the BCAN website, www.bcan.org. In case people wanted more information on ANKTIVA and recombinant BCG, could you share a website that they can visit?

Dr. Bobby Reddy:

Absolutely. So our website is immunitybio.com, which is www.immunitybio.com, one word, immunitybio.com.

Rick Bangs:

Excellent. Just a reminder, if you’d like 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, Dr. Reddy.

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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, advance 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.