SAN DIEGO, Oct. 13, 2016 /PRNewswire/ -- OncoSec Medical Incorporated ("OncoSec") (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, today announced that new clinical data from the Phase II Investigator Sponsored Trial led by the University of California, San Francisco (UCSF) to assess the combination of OncoSec's investigational intratumoral therapy, ImmunoPulse® IL-12, and Merck's KEYTRUDA® (pembrolizumab) in patients with unresectable metastatic melanoma and a low likelihood of response to an anti-PD1 alone will be presented at an oral poster presentation at the upcoming Society for Immunotherapy of Cancer ("SITC") Annual Meeting to be held on November 11-13, 2016, in National Harbor, MD.
In August 2016, OncoSec announced the publication of a research assay in the Journal of Clinical Investigation that can be used as a predicative biomarker in melanoma patients. The assay shows that patients with a low frequency of CD8-positive inflamed tumors (that are PD-1 high and CTLA-4 positive) would pre-dispose them to low response rates to PD-1 inhibitor therapy alone. The Company is using this biomarker assay to pre-qualify patients in this ongoing combination study based on quantification of these type of CD8 cells. In the trial, patients deemed to be likely low responders were treated with a combination of systemic pembrolizumab and intratumoral ImmunoPulse® IL-12 during the trial period. This presentation will provide an interim update of 15 treated patients.
The key endpoints of the study include: best overall response rate (ORR) by RECIST v1.1 and immune-related Response Criteria (irRC); safety and tolerability; duration of response; 24-week landmark progression-free survival; median progression-free survival; and overall survival.
Eligible patients were concurrently treated with pembrolizumab and ImmunoPulse® IL-12 during the trial period.
Details of the presentation are as follows:
Abstract Title: Phase II Study of Intratumoral plasmid Interleukin 12 (pIL-12) with Electroporation in Combination with Pembrolizumab in Stage III/IV Melanoma Patients with Low Tumor Infiltrating Lymphocytes (Abstract #203921)
Lead Author: Alain Algazi, MD, Clinical Instructor, Department of Medicine (Hematology/Oncology), UCSF
Poster Number: 466
Date and Time: November 11, 2016 at 12:15 pm EDT (Oral poster presentation to be defined)
Location: Prince George's Exhibition Hall AB, Gaylord National Resort & Convention Center
For more information about this trial, please visit:
https://clinicaltrials.gov/ct2/show/NCT02493361?term=pIL-12&rank=3
About the SITC Annual Meeting
The Society for Immunotherapy of Cancer (SITC) is a non-profit medical professional society of influential scientists, academicians, researchers, clinicians, government representatives, and industry leaders from around the world dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. Currently, SITC has nearly 1,600 members representing 17 medical specialties and are engaged in research and treatment of at least a dozen types of cancer. The 31st SITC Annual Meeting & Associated Programs will take place November 11-13, 2016 at the Gaylord National Hotel & Convention Center in National Harbor, MD. For more information, please go to http://www.sitcancer.org/2016.
About OncoSec Medical Incorporated
OncoSec is a biotechnology company developing DNA-based intratumoral immunotherapies with an investigational technology, ImmunoPulse®, for the treatment of cancer. ImmunoPulse® is designed to enhance the local delivery and uptake of DNA-based immune-targeting agents, such as IL-12. In Phase I and II clinical trials, ImmunoPulse® IL-12 has demonstrated a favorable safety profile and evidence of anti-tumor activity in the treatment of various solid tumors as well as the potential to initiate a systemic immune response. OncoSec's lead program, ImmunoPulse® IL-12, is currently in clinical development for several indications, including metastatic melanoma and triple-negative breast cancer. The program's current focus is on the significant unmet medical need in patients with melanoma who are refractory or non-responsive to anti-PD-1/PD-L1 therapies. In addition to ImmunoPulse® IL-12, the Company is also identifying and developing new immune-targeting agents for use with the ImmunoPulse® platform. For more information, please visit www.oncosec.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as "will," "can," and similar references to future periods.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on management's current preliminary expectations and are subject to risks and uncertainties, which may cause our results to differ materially and adversely from the statements contained herein. Potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, the following: uncertainties inherent in pre-clinical studies and clinical trials, such as the ability to enroll patients in clinical trials and the risk of adverse events; unexpected new data, safety and technical issues; our ability to raise additional funding necessary to fund continued operations; and the other factors discussed in OncoSec's filings with the Securities and Exchange Commission.
Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. OncoSec disclaims any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
Contact
Sophia Ononye, PhD MPH MBA
Associate Director, Investor Relations and Corporate Communications
OncoSec Medical Incorporated
855-662-6732
media@oncosec.com
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