CG Oncology Presents Additional Phase 2 Data with CG0070 in Combination with KEYTRUDA® (pembrolizumab) in Non-Muscle-Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Guerin

CG Oncology, Inc., a clinical-stage biotechnology company focused on developing oncolytic immunotherapies for patients with advanced cancer, announced interim results from the global Phase 2 study (CORE1) of CG0070 in combination with Merck's anti-PD-1 therapy KEYTRUDA^® (pembrolizumab), for the treatment of patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG).

The results (Session MP54-03) were presented at the 2022 American Urological Association (AUA) Annual Meeting. The preliminary data adds to that presented at the American Association of Cancer Research (AACR) earlier this year and continues to show both promising early anti-tumor activity and tolerability of CG0070 in combination with pembrolizumab for patients with BCG unresponsive NMIBC.

Summary of Interim Clinical Results

• As of the interim analysis, based on a data cutoff on April 28, 2022, 22 patients were evaluable for efficacy with a minimum of 3 months follow up.
• 91% of patients evaluable for efficacy (n=20/22) have achieved complete response (CR) at the initial 3-month timepoint. Of those patients evaluable for CR at additional timepoints, 87% (n=15) have also maintained a CR through 6 months, 80% (n=10) through 9 months and 75% (n=8) at the 12-month assessment.
• Treatment related adverse events were generally limited to transient grade 1-2 local genitourinary symptoms including pollakiuria, bladder spasm, dysuria, fatigue, nocturia, hematuria, chills, and immune-related adverse events including hyperglycemia and hypothyroidism.

About the CORE1 Study

Under a previously announced clinical collaboration with Merck (known as MSD outside the US and Canada) relating to the investigation of CG0070 used in combination with pembrolizumab, the goal of CORE1, which will enroll up to 35 patients, is to evaluate the safety and efficacy of CG0070 plus pembrolizumab for the treatment of NMIBC unresponsive to BCG.

More information about the study can be found at www.clinicaltrials.gov (NCT04387461).

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About CG0700

CG0070, a selective oncolytic immunotherapy based on a modified adenovirus type 5 backbone that contains a cancer-selective promoter and a GM-CSF transgene, destroys bladder tumor cells through their defective retinoblastoma (Rb) pathway. CG0070 was designed to replicate inside tumor cells with dysfunctional Rb pathways, causing tumor cell lysis and immunogenic cell death. The rupture of cancer cells releases tumor-derived antigens and GM-CSF, which stimulates a systemic anti-tumor immune response. In advanced clinical trials, CG0070 is a safe and efficacious agent in NMIBC following BCG failure. CG0070 is currently in late-stage clinical trials across a variety of solid cancers, as a monotherapy or in combination with immune checkpoint inhibitors.

About CG Oncology

CG Oncology is a clinical-stage biotechnology company focused on developing the next evolution of oncolytic immunotherapy for patients with advanced cancer. Our lead candidate, CG0070, is a selective oncolytic immunotherapy in a Phase 3 trial with CG0070 as a monotherapy for the treatment of BCG-unresponsive NMIBC, and a combination Phase 2 study of CG0070 with KEYTRUDA^® (pembrolizumab) in the same indication. Other types of bladder cancer are being evaluated with CG0070 in combination with OPDIVO® (nivolumab), and additional indications in other solid tumors are being pursued with CG0070 in combination with other immune checkpoint inhibitors. At CG Oncology, we aim to take the next evolutionary step in delivering innovative cancer care to millions of patients in need worldwide. Learn more at www.cgoncology.com.