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OncoSec Enrolls First Patient in Biomarker-Focused Pilot Study in Triple Negative Breast Cancer

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OncoSec Medical Incorporated (“OncoSec”) (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, announced today that the Company has enrolled the first patient into a pilot biomarker trial of ImmunoPulse™ IL-12 in patients with triple negative breast cancer (TNBC). ImmunoPulse™ IL-12, which employs intratumoral electroporation to enhance delivery of DNA-based interleukin-12 (IL-12), is designed to enhance tumor immunogenicity, leading to increased tumor infiltrating lymphocytes (TILs) and pro-inflammatory cytokines.

Previous studies have demonstrated that breast cancer patients whose tumors are associated with markers of inflammation, such as the presence of TILs, have better clinical outcomes. These data have initiated an effort by an international consortium to develop guidelines and recommendations for the routine evaluation of TILs for breast cancer. Further, preliminary data reported at the 2014 San Antonio Breast Cancer Symposium indicate that TNBC is responsive to cancer immunotherapies, such as anti-PD-1/PD-L1 checkpoint therapies. However, response rates in these TNBC patients, who were selected for study participation based upon TIL status, were only 18 to 33 percent.

“There is increasing evidence that breast cancer patients with tumors characterized by a ‘pro-inflammatory phenotype,’ including those with TNBC, have better responses to chemotherapy and experience longer disease-free and overall survival rates,” said Mai H. Le, MD, Chief Medical Officer at OncoSec. “We anticipate that ImmunoPulse™ IL-12 will drive a tumor-specific inflammatory response in TNBC patients. The goal with ImmunoPulse™ IL-12 is to increase the number of patients who will benefit from anti-PD-1 therapy. We are very excited to be working closely with our colleagues at Stanford University to evaluate the role of ImmunoPulse™ IL-12 in promoting tumor immunogenicity.”

Melinda L. Telli, MD, Assistant Professor of Medicine (Oncology) and Irene Wapnir, MD, Professor of Surgery (General Surgery), are leading this clinical trial at Stanford University Medical Center. Approximately 10 patients are planned for enrollment into this trial. The primary objective of the study is to evaluate the potential of ImmunoPulse™ IL-12 to promote a pro-inflammatory molecular and histological signature in tumor samples obtained from study participants. Secondary objectives include: evaluation of safety and tolerability; evaluation of local ablative effect (% necrosis); and description of other evidence of anti-tumor activity.

To learn more about the trial, visit www.oncosec.com. Additional details can also be found at www.clinicaltrials.gov.

Source: PR Newswire