Press Release

Cold Genesys Announces Acceptance of Late Breaking Abstract at American Urological Association (AUA) Annual Meeting 2017

SANTA ANA, Calif., April 25, 2017 – Cold Genesys Incorporated (“Cold Genesys”), a late-stage immuno-oncology company, today announced that interim clinical data from the Phase II trial (BOND2) to assess Cold Genesys’ investigational oncolytic virotherapy, CG0070, in patients with BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer (NMIBC) will be presented on May 15 at 10:55 a.m. ET at the upcoming American Urological Association (AUA) Annual Meeting in Boston, MA, during the Next Frontier Plenary session. The presentation is titled, “Interim Results from a Single-Arm Multicenter Phase II Trial of CG0070, an Oncolytic Adenovirus, for BCG-Unresponsive NMIBC.”

“CG0070 not only selectively kills cancer cells, but also harnesses the power of the immune system to combat cancer,” said Arthur Kuan, Interim CEO of Cold Genesys. “We are committed to bringing innovative cancer care to patients with debilitating diseases by taking the next evolutionary step to deliver safe and impactful therapies.”

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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 BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC)

BCG-Unresponsive NMIBC patients have limited treatment options. Historically, radical cystectomy (surgical removal of the bladder) is the recommended treatment guideline in this setting. Other intravesical chemotherapeutic agents have been tried as first-line therapy, but results showed limited efficacy. In a pivotal Phase II and Phase II/III open-label study supporting approval for treatment of patients with carcinoma in situ (CIS) who are BCG-unresponsive and not medically eligible for cystectomy, Valrubicin demonstrated a complete response rate of 18% at six months and 6-8% at 18 months.

About Cold Genesys

Cold Genesys 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, multicenter study (BOND2) for patients with NMIBC who 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.

Media Contact

Arthur Kuan
Interim CEO
Cold Genesys Incorporated
(714) 884-3953