Press Releases

Nature Publication Co-Authored by Robert H. Pierce, Chief Scientific Officer, OncoSec Medical

Data Support Expanding the Application of Checkpoint Inhibitors with OncoSec’s ImmunoPulse Therapy

SAN DIEGO-- Research conducted by Robert H. Pierce, MD, Chief Scientific Officer at OncoSec Medical Inc. (OTCQB: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, was published in the November 27, 2014 issue of the journal Nature. The publication, titled “PD-1 blockade induces responses by inhibiting adaptive immune resistance,” presents research led by Drs. Paul Tumeh, MD and Antoni Ribas, MD at the University of California, Los Angeles (UCLA), with studies conducted by Dr. Pierce and colleagues at Merck Research Labs, during his previous tenure as Executive Director at Merck. The results provide OncoSec with supporting evidence that response to anti-PD-1 drugs such as Merck’s breakthrough drug KEYTRUDA® (pembrolizumab) is dependent on the presence of PD-L1 and tumor-infiltrating lymphocytes (TILs) in the tumor.

The study cohort consisted of 46 patients with advanced melanoma treated with pembrolizumab between December 2011 and October 2013 at UCLA. Patients underwent tumor biopsies before and during treatment. Immunohistochemistry (IHC) analysis was performed on the tissue samples for the presence of cytotoxic lymphocytes (CD8+ T cells) before and during PD-1 blockade. Pre-treatment samples of patients who responded to pembrolizumab (responders) showed higher numbers of CD8+ T-cells at the invasive margin of the tumor when compared to samples from patients who progressed during therapy (non-responders).

Based on results of this study, investigators postulate that the presence of PD-L1 in tumors alongside tumor-infiltrating CD8+ lymphocytes (TILs) – a phenomenon that has been termed “adaptive immune resistance”— is a potential biomarker for predicting response to anti-PD-1 drugs. Moreover, they suggest that combining anti-PD-1 drugs such as pembrolizumab with therapies that can induce a type-1 interferon-gamma response should be further investigated.

“These data make an important contribution to our understanding of PD-1 inhibition,” said Dr. Pierce. “Importantly, the correlation of low TILs with a lack of response to pembrolizumab drives home the need for new therapies that amplify TIL response in those low-TIL patients. We know that IL-12 drives a type 1 interferon-mediated immune response and augments TIL generation, supporting that the combination of ImmunoPulse IL-12 of and PD1 blockade will lead to enhanced responses in melanoma.”

OncoSec recently announced a combination Phase 2b trial in collaboration with the University of California, San Francisco, and supported by Merck, that will evaluate the combination of ImmunoPulse (intratumoral IL-12) with pembrolizumab. A link to this release, which was issued on November 25, 2014, can be found here.

Punit Dhillon, President and CEO of OncoSec Medical, commented, “Building on the pioneering work of Dr. Pierce while at Merck, we have focused the potential of ImmunoPulse therapy with IL-12 to enhance TILs in tumors to treat the larger population of cancer patients who are not responsive to anti-PD1 or other checkpoint inhibitors. We are very excited about the potential implications of a successful combination Phase 2b trial of pembrolizumab and ImmunoPulse.”

“PD-1 blockade induces responses by inhibiting adaptive immune resistance” was published in the November 27, 2014 issue of Nature, vol.515: pp. 568-571. To view or purchase the article, please click here.

About OncoSec Medical

OncoSec Medical Inc. is a biopharmaceutical company developing its investigational ImmunoPulse intratumoral cancer immunotherapy. OncoSec Medical's core technology is designed to enhance the local delivery and uptake of DNA IL-12 and other DNA-based immune-targeting agents. Clinical studies of ImmunoPulse have demonstrated an acceptable safety profile and preliminary evidence of anti-tumor activity in the treatment of various skin cancers, as well as the potential to initiate a systemic immune response without the systemic toxicities associated with other treatments. OncoSec's lead program evaluating ImmunoPulse for the treatment of metastatic melanoma is currently in Phase 2 development, and is being conducted in collaboration with several prominent academic medical centers. As the company continues to evaluate ImmunoPulse in its current indications, it is also focused on identifying and developing new immune-targeting agents, investigating additional tumor indications, and evaluating combination-based immunotherapy approaches. For more information, please visit www.oncosec.com.

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements 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. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include our ability to raise additional funding, our ability to acquire, develop or commercialize new products, uncertainties inherent in pre-clinical studies and clinical trials, unexpected new data, safety and technical issues, competition, and market conditions. These and additional risks and uncertainties are more fully described in OncoSec Medical’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 Medical 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.

Investor Relations:
OncoSec Medical Inc.
Jordyn Kopin, 855-662-6732
investors@oncosec.com
or
Public Relations:
Dian Griesel Int’l.
Laura Radocaj, 212-825-3210
lradocaj@dgicomm.com

Source: OncoSec Medical Inc.