Our most advanced candidate, CG0070, is a cancer-selective oncolytic immunotherapy which has completed a Phase II 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 CG0700 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.
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.
Phase II clinical trial for the treatment of NMIBC after BCG failure
CG0070 has completed BOND2, a Phase II study that examines the safety and efficacy of CG0070 oncolytic virus regimen for high grade non-muscle invasive bladder cancer (NMIBC) BCG unresponsive population. 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 will be 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 II clinical study for the treatment of high grade, non-muscle invasive bladder cancer (NMIBC) in the BCG-unresponsive patient population.
Combination trials for the treatment of MIBC and other solid tumors
CG0070 will also be investigated in NAOMI, a Phase I/II study, to evaluate the safety and efficacy of the neo-adjuvant combination of CG0070 plus anti-CTLA-4 in patients with muscle invasive bladder cancer (MIBC) who are ineligible for platinum-based chemotherapy. One of the primary endpoints is to evaluate the efficacy of this intervention to increase the expression of PD-L1 in the primary tumor with positive results theoretically increasing the chance to further use an anti-PD1 or anti-PD-L1 blocker as an adjuvant in MIBC patients, who usually are deficient in PD-L1 and prone to disease recurrence. In addition, in a separate IND accepted by the U.S. Food and Drug Administration, Cold Genesys is exploring the use of CG0070 in combination with immune checkpoint modulators in other solid tumors.