Press Release

Cold Genesys Announces Clinical Results at American Urological Association (AUA) Annual Meeting 2017

SANTA ANA, Calif., May 15, 2017 – Cold Genesys Incorporated (“Cold Genesys”), a late-stage immuno-oncology company, today reported interim clinical data from the Phase II trial (BOND2) evaluating Cold Genesys' investigational oncolytic virotherapy, CG0070, in patients with BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer (NMIBC) at the American Urological Association (AUA) Annual Meeting in Boston, MA, during the Next Frontier Plenary session.

“The interim results are very exciting,” said Dr. Gary Steinberg, The Bruce and Beth White Family Professor and Director of Urologic Oncology at University of Chicago Medical Center. “No new drug has been approved in this space for nearly two decades. CG0070 has promising potential to fulfill the unmet medical need in BCG-Unresponsive NMIBC patients.”

A total of 45 of 67 enrolled patients had evaluable six-month data in this on-going clinical trial.  Of the 45 evaluable patients, there were 24 CIS only (Carcinoma In Situ), 12 CIS with Ta or T1 (CIS concurrent with papillary tumors), and 9 Ta or T1 (papillary only). Overall six-month Complete Response (CR) was 46.7%. Considering six-month CR for pathologic subsets: the CIS only group contained 14 CRs (58.3%), the CIS with Ta or T1 group contained 4 CRs (33.3%) and the Ta/T1 group contained 3 CRs (33.3%).

Arthur Kuan, Interim CEO of Cold Genesys, said, “We are very pleased to announce these top-line interim clinical results from our BOND2 study that has been fully enrolled. Long term follow up data will be provided towards year end 2017. There is an unmet medical need for a bladder sparing treatment for patients with BCG-unresponsive NMIBC. Removal of the bladder is not only a complex surgery, but also life-altering, often associated with at least 28% to 45% surgical complications and up to 8% mortality within six months of surgery in the elderly population. These interim results are encouraging and provide guidance for us to focus on CIS patients in the anticipated registration trial. Additionally, the trial provides insight to locally accessible cancers, where we will focus our development efforts.”

For more information, please visit: https://clinicaltrials.gov/ct2/show/NCT02365818

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
information@coldgenesys.com