Press Release

CG Oncology and Roche to Collaborate on Clinical Trial of Oncolytic Immunotherapy CG0070 as Part of Novel Combination for Various Solid Tumor Indications

IRVINE, Calif., September 22, 2021 – CG Oncology, Inc. announced today that it has entered into a clinical trial collaboration agreement to evaluate the combination of CG Oncology’s investigational oncolytic immunotherapy CG0070, with Roche’s atezolizumab, an anti-PD-L1 (programmed death-ligand 1) therapy.

The Phase 1/2 clinical trial will evaluate the safety and efficacy of this novel immunotherapy combination in patients with various advanced solid tumors yet to be disclosed. CG Oncology will sponsor the study and Roche will provide atezolizumab.

CG0070, CG Oncology's lead immuno-oncology candidate, is in an ongoing Phase 3 monotherapy study and has been administered in over 100 patients to date for the treatment of high-risk, non-muscle invasive bladder cancer (NMIBC). CG0070 is based on a modified adenovirus type 5 backbone that contains a cancer-selective promoter and a GM-CSF transgene, destroying various cancer cells, including bladder tumor cells, through their defective retinoblastoma (Rb) pathway.

“We are pleased to enter into this collaboration agreement with Roche,” said Arthur Kuan, CEO of CG Oncology. “We are excited to initiate this important clinical trial with our lead oncolytic immunotherapy, CG0070, in combination with atezolizumab to evaluate the potential synergy of these two immunotherapies in cancer.

Additional details of the collaboration were not disclosed.

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.

Contacts

Bing Kung
Vice President, Business Development
CG Oncology
(949) 354-4246
bd@cgoncology.com
or
Media
Kimberly Ha
KKH Advisors
(917) 291-5744
kimberly.ha@kkhadvisors.com