Cold Genesys Announces FDA Acceptance of a Phase I/II Clinical Trial Using CG0070 Plus an Anti-CTLA-4 Checkpoint Inhibitor as a Neo-Adjuvant Immunotherapy for Muscle Invasive Bladder Cancer

SANTA ANA, Calif.

Cold Genesys, Inc., a late-stage immuno-oncology company, today announced that the U.S. Food and Drug Administration (FDA) accepted a Phase I/II Clinical Trial (NAOMI) using CG0070 plus an anti-CTLA-4 checkpoint inhibitor as a neo-adjuvant immunotherapy for muscle invasive bladder cancer, or MIBC. CG0070 is an oncolytic adenovirus expressing GM-CSF designed to selectively replicate in tumors.

This Phase I/II NAOMI trial is planned to evaluate the safety and efficacy of the neo-adjuvant combination of CG0070 plus anti-CTLA-4 in patients with 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.

“Based on our encouraging results in non-muscle invasive bladder cancer (NMIBC), we are excited to begin investigating this product in muscle invasive bladder cancer (MIBC),” said Alex Yeung, MBBS, CEO and Chairman of Cold Genesys. “This is an important milestone for Cold Genesys as positive results in this trial can theoretically increase 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. The rapid enrollment in our pivotal trial for BCG-failure NMIBC or the BOND II trial is also promising. To fulfill the requirements by the FDA in granting us the Pivotal BOND II trial, we have also initiated our new manufacturing and quality control processes, targeted for completion in the 2Q 2016.”

About CG0070

CG0070 is an investigational oncolytic immunotherapy based on a modified common cold virus 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 makes it an ideal agent to be developed for a variety of solid tumor types in combination with immune checkpoint modulators.

About Cold Genesys, Inc.

Cold Genesys, Inc. is a clinical-stage immuno-oncology company focused on the development of oncolytic immunotherapies to combat cancer. In 2010, Cold Genesys acquired exclusive worldwide rights to develop CG0070 from BioSante Pharmaceuticals. CG0070 is currently under investigation in a Phase II, single-arm, open-label, pivotal study (BOND II) for patients with high-risk non-muscle invasive bladder cancer (NMIBC) who have failed BCG therapy and refused cystectomy. In addition, Cold Genesys is exploring the use of CG0070 in combination with immune checkpoint modulators in different solid tumors.

For more information, please visit: www.coldgenesys.com.

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