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 120 employees focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer.

“At CG, our team has spent over a decade developing a new immunotherapy for bladder cancer patients—something we hope will give patients another option, more time with loved ones, and the dignity of a better quality of life. I’ve been through the fight against cancer with both of my parents so I know what it’s like to sit with the fear, to wait for the unknown, and to try to hold onto hope. Together with my incredible team, I come to work every day with a sense of purpose and passion to deliver an innovative, bladder-sparing therapy for patients afflicted with bladder cancer. I’m confident that we will deliver on this mission and make a meaningful impact.” 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.

Podcast

Listen to a podcast featuring Vijay Kasturi, MD, CG Oncology’s Chief Medical Officer. In it, he talks about groundbreaking clinical trials underway for cretostimogene—an innovative investigational therapy targeting non-muscle invasive bladder cancer.

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

CG Oncology’s clinical programs have been carefully designed to address different stages of bladder cancer and tumor types. 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 may also reach out directly to JoAnn Horn, CG Oncology’s Clinical Site Educator & Liaison at 516-456-1415 or [email protected] to learn more.

Patients may also want to check out this 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.

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.