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Preclinical and Phase 1 Data of VTX-2337 Presented at 2013 ASCO Annual Meeting Shows Early Activity in Ovarian Cancer
June 3, 2013
Seattle, WA –June 3, 2013 –VentiRx Pharmaceuticals, Inc. in collaboration with the Gynecologic Oncology Group and the National Cancer Institutes Cancer Therapy Evaluation Program announced today that positive preclinical and clinical data of VTX-2337 in combination with Doxil® (pegylated liposomal doxorubicin) or paclitaxel in women with recurrent ovarian cancer were presented at the American Society of Clinical Oncology (ASCO) annual meeting. Results indicate that the combination of VTX-2337 and chemotherapy is well tolerated with no evidence of synergistic toxicities. Encouraging signs of efficacy provided the rationale for the ongoing randomized placebo controlled Phase 2 study of VTX-2337 in combination with pegylated liposomal doxorubicin in patients with recurrent or persistent ovarian cancer (GOG-3003, NCT01666444) VTX-2337, a Toll-like Receptor 8 (TLR8) agonist, demonstrated a clear additive effect to Doxil in a humanized mouse model of ovarian cancer. Data demonstrated that this combination provides an enhanced effect in stimulating a variety of immune pathways associated with anti-tumor activity.
A Phase 1b trial conducted with the Gynecologic Oncology Group (GOG) in 13 patients with recurrent or persistent ovarian cancer demonstrated that the combination of VTX-2337 with Doxil is safe and well tolerated (GOG-9925, NCT01294293). The study reported no serious or unexpected drug-related adverse events and no evidence of synergistic toxicities. Eleven patients were evaluable for tumor response by RECIST 1.1. One patient achieved a complete response and 63 percent of patients had stable disease. A separate arm examining VTX-2337 with paclitaxel in 7 subjects showed similar tolerability with 43% stable disease.
“Given the absence of clear molecular drivers in high-grade serous ovarian cancer, targeting the tumor microenvironment with an immunotherapy like VTX-2337 is a good option for this difficult to treat patient population. The preclinical and early clinical data confirm the potential utility of igniting the patient’s own immune system to help fight cancer” said Bradley Monk, M.D., St. Joseph’s Hospital and Medical Center, chair of the Phase 1b and ongoing Phase 2 studies.
“We are excited to be working with the GOG to advance the clinical development of VTX-2337 in ovarian cancer”, said Robert Hershberg, M.D., Ph.D., President and Chief Executive Officer of VentiRx Pharmaceuticals, “We see a strong scientific and clinical rationale for chemo immunotherapy using our novel TLR8 agonist in the setting.”
VTX-2337 is a Toll-like Receptor 8 (TLR8) agonist that directly activates multiple components of the innate immune system. This includes activation of human myeloid dendritic cells (mDCs), monocytes and natural killer (NK) cells resulting in the production of high levels of mediators known to orchestrate the integration of innate and adaptive anti-tumor responses.