Innovating Bladder Cancer Care with CG Oncology

July 2, 2025

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’m 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, produces this podcast.

Today, we’re featuring CG Oncology as June 2025’s Partner in Progress. CG Oncology sees a world where bladder cancer patients can benefit from their innovative immunotherapies to live with dignity and have an enhanced quality of life.

Today, we’ll be talking about CG Oncology’s lead product and development, Cretostimogene, an investigational, intravesically delivered oncolytic immunotherapy in development for the treatment of non-muscle-invasive bladder cancer. It’s important to remember that Cretostimogene is an investigational candidate and its safety and efficacy have not been established by the FDA nor any other health authority.

Today’s guest is Dr. Vijay Kasturi, chief medical officer at CG Oncology and responsible for medical affairs, clinical, and translational development. Dr. Kasturi is passionate about bladder cancer and has seen a loved one suffer from the disease, as well as treating patients with it professionally as a CG medical oncologist. He brings more than 25 years of experience establishing and executing global and regional strategies that have brought innovative new treatment options to patients.

Dr. Kasturi, welcome.

Dr. Vijay Kasturi:

Hi, Rick. It is a pleasure to be here today. Thank you for having me.

Rick Bangs:

I want to start with getting a feel for when you started in the bladder cancer space and what motivated that?

Dr. Vijay Kasturi:

Well, it’s been a number of years right now. I’ve been a medical oncologist in genitourinary cancer for almost 27 years, and working in bladder cancer has been very personal to me, having lost my father to this disease. He had high-risk non-muscle-invasive bladder cancer and went through the progression to muscle invasive and then more advanced disease, and I’ve been by his side as a caregiver during that process.

So I’ve seen firsthand how difficult bladder cancer is to live with and its impact on a person’s quality of life. And then as a genitourinary medical oncologist, I’ve treated hundreds of patients with this disease and have even given BCG as well as gemcitabine and interferon into the bladder myself. I’ve found that treatment options for patients which are tolerable and durable and give people a longer-term remission outside of cystectomy, especially in non-muscle-based bladder cancer, have been very limited. And that’s why I’m really passionate about bringing forward new treatment options for patients and made the decision to go into the pharmaceutical industry after spending most of my career as a treating physician.

Rick Bangs:

Excellent. Could you tell us a little bit more about the work that you do at CG Oncology?

Dr. Vijay Kasturi:

As CG Oncology’s chief medical officer, I play a critical role in overseeing the clinical development of Cretostimogene Grenadenorepvec, as well as the medical affairs for the company. I’m responsible for the overall medical and scientific direction of the company. I lead an amazing team of people who work on a wide range of projects intended to ultimately improve bladder cancer patient outcomes, and these projects can range from planning clinical trials and enrolling patients by recruiting investigators, including both community physicians as well as academic physicians and practices, and also ensuring access for patients in underserved areas for these clinical trials. We also analyze the data that’s been generated and then present that data with our investigators at urology conferences and ultimately publish that data as well.

Rick Bangs:

So clinical trials are really important. Could you tell us more about them and the status of Cretostimogene in the development process?

Dr. Vijay Kasturi:

Clinical trials allow patients to access novel treatments for bladder cancer, which may be more tolerable and durable than currently existing options. To this effect, we have carefully designed our clinical development program to address the different stages of bladder cancer, especially non-muscle invasive bladder cancer in this space.

So Cretostimogene has been studied in clinical trials, which have so far included more than 400 patients with non-muscle invasive bladder cancer. Our program includes two phase three clinical trials, BOND-003 and PIVOT-006. BOND-003 is for patients who have high risk BCG unresponsive non-muscle invasive bladder cancer, where options for providing a tolerable and durable remission are very limited. PIVOT-006 is for patients with intermediate risk non-muscle invasive bladder cancer. Intermediate risk is characterized by recurrences, which are very common in this space, and options outside of BCG are very limited for patients. In fact, BCG is recommended not to be used by the EUA for intermediate risk disease due to the significant shortage we have been experiencing in the U.S. of BCG.

At CG Oncology, we also have a phase two trial, which is earlier in the development cycle called CORE-008. This evaluates the safety and efficacy of Cretostimogene in high-risk non-muscle invasive bladder cancer, specifically in patients with BCG-naive disease, and also in patients who have been exposed to BCG and have recurred or those that have recurred more than 12 months after their last dose of BCG. So technically people who don’t qualify as BCG unresponsive by the FDA’s strict definition of having recurrence within 12 months of prior BCG.

Across these trials, we are able to cover essentially a large number of patients who suffer from non-muscle invasive bladder cancer. One of the key distinctions for our Cretostimogene clinical trials is that we allow patients to have had prior chemotherapy with agents such as gemcitabine and mitomycin in addition to BCG, for example, in the BOND-003 trial. In addition to these trials, we also have an Expanded Access Program or EAP for Cretostimogene in North America for patients who are unresponsive to BCG and meet certain program eligibility requirements.

EAPs are intended to help patients who don’t qualify for a clinical trial or give early access to a drug such as Cretostimogene, which has proven efficacy and safety prior to its FDA approval. Or it can be an avenue for patients who do not live near a clinical study site to access Cretostimogene.

If people are listening to this podcast and are interested to learn more about the EAP, they should speak to their neurologist or seek additional information by emailing. The address is [email protected]. They can also visit the website www.clinicaltrials.gov. There’s a clinical trial number that is assigned to this trial, and that’s NCT06443944, and this can be entered on the website, clinicaltrials.gov. They can access the details of the Expanded Access Program through this.

Rick Bangs:

Okay. And they would use the field “other terms” on clinicaltrials.gov if you’re looking.

All right. So I’m curious, how does Cretostimogene actually work?

Dr. Vijay Kasturi:

Well, thank you for asking that. Cretostimogene Grenadenorepvec, and I think that is a mouthful, my apologies. It’s a part of the growing field immunotherapy, which focuses on harnessing the body’s immune system to fight diseases, especially cancer. So Cretostimogene is a oncolytic immunotherapy and it’s designed to work in two important ways.

Cretostimogene is specially designed to find, attack, and destroy bladder cancer cells. It does this by seeking out the special receptors that are on the surface of most bladder cancer cells. It then enters the cells and rapidly divides, forcing the cells to burst, and this destroys the tumor. Then the destroyed cells release signals that selectively trigger the body’s own immune system to eliminate many of the remaining bladder cancer cells.

The Cretostimogene molecule, the drug, also includes a protein called GM-CSF, which is also released into the tumor and causes an influx of more immune cells into the tumor. This dual mechanism of action thus ends up being highly tumor selective and minimizes any harmful effects on healthy bladder cells.

Rick Bangs:

Fascinating. So CG Oncology is BCAN’s 2025 Partner in Progress, and I think listeners would be interested in knowing how does CG Oncology partner with BCAN?

Dr. Vijay Kasturi:

First of all, the whole team at CG Oncology has tremendous respect for the important work that BCAN does to connect, to educate, and to rally patients in order to improve the lives of those with bladder cancer. Many of our team at CG have worked with BCAN in one way or another for decades, and we are very grateful for this partnership.

We see a relationship with BCAN as a two-way street. First, we are proud to sponsor programs that we know benefit bladder cancer patients. For example, the recent walks to end bladder cancer or the Clinical Trial Dashboard. We also rely on BCAN to inform us about patient data and insights and even opportunities to connect directly with patients at forums throughout the year. We take the information patients share to heart and it really helps shape our path forward.

For example, we had a PIVOT-006 intermediate risk clinical trial protocol reviewed by patient advocates from BCAN in a forum, and we took their advice in designing it to be as real-world and realistically feasible for patients as possible.

Rick Bangs:

So I think you’re in a great position to get your crystal ball out, and I’d like to hear what you see in the future for bladder cancer.

Dr. Vijay Kasturi:

Well, this is a great time of innovation in bladder cancer, which is very good for patients and those who love them, those who care for them. We are seeing many more companies commit to bringing forward new therapies and also a commitment to finding alternatives to the removal of the bladder or bladder-sparing therapies, as we call that.

At CG Oncology, we are really passionate about innovating in bladder cancer and leading from the front. It’s the only disease we focus on, and we’ve built an entire portfolio of trials to try to address the various stages of this disease. We plan to start our filing process for Cretostimogene for review and approval by the FDA later this year. We’ll be sending the FDA the clinical trial data from the BOND-003 trial, and this is again, for patients where BCG has failed them and whose cancer has become BCG unresponsive. We also look forward to completing our trial for patients with intermediate risk non-muscle invasive bladder cancer, and then to seek review and approval from the FDA for that within the next several years.

Rick Bangs:

Okay. So we’ll be watching and listening for that. That’s exciting.

Can you tell us if a listener wanted to learn more about Cretostimogene and CG Oncology, where would they go?

Dr. Vijay Kasturi:

Listeners can check our website at www.cgoncology.com, or if they’re familiar with the BCAN website, they can head there at bcan.org/cgonc.

Rick Bangs:

Excellent. All right. Any final thoughts?

Dr. Vijay Kasturi:

Well, I just really want to thank you for this opportunity, Rick. I’m honored to have this forum to connect with the bladder cancer community and share some information on Cretostimogene and CG Oncology, as well as our commitment to bringing forward an innovative bladder-sparing therapy for patients. I hope everyone enjoys the rest of the day.

Rick Bangs:

All right. I really want to thank you. This has been wonderful, and I want to thank you specifically for sharing CG Oncology’s bladder cancer story and for your part in creating better todays and more tomorrows for bladder cancer patients and families.

If you would like more information on bladder cancer, please visit the BCAN website, www.bcan.org. For more information on CG Oncology, you can visit www.cgoncology.com or you can head to the BCAN website. bcan.org/CGonc.

Just a reminder, if you’d more information about bladder cancer, you can also contact the Bladder Cancer Advocacy Network at 1888-9012226. 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, Kasturi.

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.