Partner in Progress: CG Oncology

CG Oncology – Imagining a World Without Bladder Cancer

At CG Oncology, we see a world where bladder cancer patients can benefit from our innovative immunotherapies to live with dignity and have an enhanced quality of life. We are a late-stage clinical biopharmaceutical company comprised of more than 150 employees focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer.

“At CG Oncology, our team has spent more than a decade working toward one goal: reaching as many bladder cancer patients as possible with an innovative oncolytic immunotherapy that may offer a meaningful alternative to life-altering surgery. Our hope is not only to provide another treatment option, but to help patients live longer, fuller lives with more time for the people and moments that matter most, and with the dignity of a better quality of life.

This mission is deeply personal to me. Having experienced cancer in my own family, I understand the uncertainty, the waiting, and the constant effort to hold onto hope. That perspective fuels the passion and purpose our team brings to work every day as we advance cretostimogene grenadenorepvec and continue to demonstrate its clinical potential in NMIBC.

Together, we are united by a clear vision and a shared commitment: to deliver a bladder-sparing therapy that can make a real difference for patients and their families. I’m confident in the path we’re on and the impact we can achieve.” Arthur Kuan, Chairman & CEO

Committed to Bringing Forward a Novel and Innovative Bladder Cancer Treatment

Our lead product in development, cretostimogene grenadenorepvec, is an investigational, intravesically delivered oncolytic immunotherapy in development for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC).

Cretostimogene grenadenorevec is a part of the growing field of immunotherapy, which focuses on harnessing the body’s immune system to fight diseases.  Cretostimogene is designed to work in two important ways:

It 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 these 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. Click below to watch a video about how cretostimogene works in the body.

Cretostimogene monotherapy received FDA Fast Track and Breakthrough Therapy Designations in high-risk BCG-Unresponsive, NMIBC patients with carcinoma in situ (CIS) in December 2023. CG Oncology is working with the FDA to bring cretostimogene to patients with high-risk BCG-unresponsive NMIBC.

Advancing our Clinical Study Program

At CG Oncology, we are all in on bladder cancer, and so is our pipeline of clinical trials that advance new research into the potential of cretostimogene grenadenorepvec to impact multiple forms of NMIBC, including intermediate-risk (IR) and high-risk (HR) disease.

Our CG Oncology team holds a deep understanding of the pathology and progression of NMIBC and is motivated by the opportunity to potentially change how it is treated.

Cretostimogene has been studied in a clinical development program, which includes more than 400 patients with non-muscle invasive bladder cancer (NMIBC). This program includes two Phase 3 clinical trials:

• BOND-003 for high-risk BCG-unresponsive NMIBC
• PIVOT-006 for intermediate-risk NMIBC

CG Oncology also has a Phase 2 trial, CORE-008, evaluating the safety and efficacy of cretostimogene in high-risk NMIBC.

Additionally, CG Oncology has an Expanded Access Program (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 do not qualify for a clinical trial, or do not live near a study site.  Please be sure to speak to your doctor about an Expanded Access Program (EAP), or seek additional information at: www.clinicaltrials.gov, NCT06443944, or contact [email protected].

To learn more about CG Oncology’s clinical trials, including if they may be right for you, a family member or friend, please check out this one-page overview of the program, or visit BCAN’s clinical trial dashboard. You can also email our Medical Affairs Team here [email protected].

CG Oncology has also prepared some other useful resources that you may want to check out:

• Doctor Discussion Guide which is intended as a helpful tool to facilitate your conversation with your doctor, as you explore your treatment options and navigate your journey with bladder cancer.
• A Q&A  addressing some common questions you may have when you are exploring your care options.
• An overview of NMIBC risk levels and a glossary of bladder cancer terms and phrases to help you navigate conversations with your health care providers, Patients and Caregivers | Beyond the Basics of Bladder Cancer.

Cretostimogene is an investigational candidate, and its safety and efficacy have not been established by the FDA or any other health authority.

Click here to learn more about CG Oncology.