Clinical-stage biotechnology company CG Oncology has dosed the first patient in Phase II CORE1 clinical trial of CG0070 for Non-Muscle-Invasive Bladder Cancer (NMIBC).
CG0070 will be evaluated in combination with Keytruda (pembrolizumab) for treating patients with NMIBC unresponsive to Bacillus Calmette-Guerin (BCG).
A selective oncolytic immunotherapy, CG0070 is based on a modified adenovirus type 5 backbone that has a cancer-selective promoter and a GM-CSF transgene.
It kills bladder tumour cells through their defective retinoblastoma (Rb) pathway.
The therapy is intended to replicate inside tumour cells with dysfunctional Rb pathways leading to tumour cell lysis and immunogenic cell death.
When cancer cells rupture, tumour-derived antigens and GM-CSF are released and stimulate a systemic anti-tumour immune response.
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The open label, single-arm trial will enrol 35 participants to analyse the safety and efficacy of CG0070 plus Keytruda in NMIBC patients who have failed prior BCG therapy.
The complete response rate in patients through 12 months will be analysed as the primary outcome of the trial.
CG Oncology CEO Arthur Kuan said: “We are motivated to advance this crucially important programme, despite the challenges presented under the current global pandemic.
“CG0070, an oncolytic immunotherapy which has been administered to over 100 patients for the treatment of NMIBC, may potentially exhibit additional effect when combined with Keytruda, which earlier this year was the first therapy in approximately 20 years approved for this indication.”
Earlier, the company had entered a clinical collaboration with Merck relating to the investigation of CG0070 used along with Keytruda.
CG0070 has concluded a Phase II trial for treating high-grade NMIBC after BCG failure.
The candidate, along with immune checkpoint modulators, is being analysed for additional indications in Muscle-Invasive Bladder Cancer (MIBC) and other solid tumours.