Our most advanced candidate, CG0070, is a cancer-selective oncolytic immunotherapy which has completed a Phase 2 trial for the treatment of high grade non-muscle invasive bladder cancer (NMIBC) after BCG failure. Additional indications in muscle invasive bladder cancer (MIBC) and other solid tumors are being pursued with CG0070 in combination with immune checkpoint modulators.
We also expect to advance our first fully owned immune checkpoint modulator, CG0161, an anti-CTLA-4 antibody, into a clinical trial after current IND-enabling studies are completed.
Non-muscle invasive bladder cancer
Non-muscle invasive bladder cancer
Muscle invasive bladder cancer
Metastatic bladder cancer
Cancer-selective oncolytic immunotherapy designed for tolerability and potency
CG0070 is an investigational oncolytic immunotherapy based on a modified common cold adenovirus backbone that contains a cancer-specific promoter and a GM-CSF transgene. CG0070 was designed to work in two important and complementary ways. First, it replicates inside the tumor’s cells causing tumor cell lysis and immunogenic cell death. Then, the rupture of the cancer cells can release tumor-derived antigens, along with GM-CSF, that can stimulate a systemic anti-tumor immune response that involves the body’s own white blood cells. The scientific rationale and clinical profile of CG0070 make it an ideal agent to be developed for a variety of solid tumor types to be used alone or in combination with immune checkpoint modulators.
Clinical trials for the treatment of BCG-unresponsive NMIBC
CG0070 is being investigated in a global Phase 3 trial (BOND3) as a monotherapy for the treatment of BCG-unresponsive, Non-Muscle Invasive Bladder Cancer (NMIBC). Most patients with high grade NMIBC (Cis, Cis with Ta and/or T1, Ta or T1) who have failed BCG intravesical therapy (standard of care) usually have no other choice but to proceed to cystectomy. Cystectomy is a surgery associated with major morbidity, mortality and quality of life issues. Morbidity and long term tedious medical care will continue for the rest of the patient’s life. Most patients at this stage do not show signs of disease progression into the muscle layer or of metastasis, making surgery a very difficult decision. CG0070 could serve to provide a therapeutic alternative for this patient population in need. learn more>>
CG0070 is being further investigated in a clinical collaboration with Merck to evaluate the combination of CG0070 with the anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in a Phase 2 clinical study (CORE1) for the treatment of high grade, NMIBC in the BCG-unresponsive patient population. learn more>>
Combination trials for the treatment of MIBC and other solid tumors
CG0070 will also be investigated a Phase 1b study (CORE2), to evaluate the safety and efficacy of the neo-adjuvant combination of CG0070 plus OPDIVO® (nivolumab) in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy. The single-arm, multi-center trial will enroll up to 30 patients with or without pelvic lymphadenopathy and who show no evidence of distant metastases prior to radical cystectomy. Primary endpoints of the trial will be safety and pathological complete response rate. learn more>>
In addition, in a separate IND accepted by the U.S. Food and Drug Administration, CG Oncology is exploring the use of CG0070 in combination with immune checkpoint modulators in other solid tumors.