OncoSec Medical Announces New Phase II Trial in Head and Neck Cancer Using ImmunoPulse
Multi-center Study to Expand Pipeline Beyond Skin Cancers
SAN DIEGO-- OncoSec Medical Inc. (OTCQB: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, has initiated a Phase II trial in squamous cell carcinoma of the head and neck (SCCHN) using its proprietary ImmunoPulse platform. The multicenter study is scheduled to be initiated in the first quarter of 2015, with the University of California San Francisco, under the direction of Dr. Alain Algazi as the first site of enrollment.
The study will enroll patients with treatment-refractory metastatic and unresectable SCCHN, regardless of HPV status. Eligible patients will receive up to nine cycles of IL-12 ImmunoPulse at six-week intervals and will be followed for clinical response and safety. The first stage of the study will enroll 20 patients with measurable disease. If three or more objective responses are observed, an additional 11 patients with measurable disease will be treated, for a total of 31 patients. The primary endpoint for this study will be best overall response by RECIST 1.1.
Dr. Mai H. Le, Chief Medical Officer at OncoSec, stated, “Similar to melanoma, recent data suggest that in SCCHN, tumor-infiltrating lymphocytes [TILs] are required to achieve responses to anti-PD-1 drugs such as pembrolizumab. We believe that as a single agent, IL-12 ImmunoPulse has the potential to convert tumors from a low to a high-TIL state.”
Dr. Robert H. Pierce, MD, OncoSec’s Chief Scientific Officer, said, “In addition to the clinical endpoints, this study is designed to test the hypothesis that intratumoral IL-12 electroporation will enhance the infiltration of TILs and the generation of a gene expression signature, which has been shown to correlate with response to anti-PD-1 or anti-PD-L1 mAbs in a variety of solid tumors. In essence, we are looking to see if we can convert non-responders to responders.”
Worldwide, SCCHN affects approximately 500,000 people and is the cause of death in up to 300,000 people. There are few treatment options for SCCHN, and with high recurrence rates in locally advanced disease, prognosis is generally poor with a five-year survival rate of less than 50 percent. ImmunoPulse with intratumoral plasmid IL-12 (pIL-12) is currently under clinical evaluation for metastatic melanoma. Based on data presented at ASCO 2014, there is reason to believe that the biological mechanisms at play in metastatic melanoma also have a role in SCCHN, thus providing a strong rationale for the evaluation of IL-12 ImmunoPulse in this indication.
Punit Dhillon, CEO of OncoSec, said, “We believe ImmunoPulse has the ability to demonstrate efficacy beyond skin cancers and into new solid tumor indications. Head and neck cancer represents an opportunity for IL-12 ImmunoPulse to deliver on the promise of this technology to another area of unmet medical need. It is another indication where we believe ImmunoPulse is a rational combination therapy with checkpoint inhibitors and has the potential to greatly expand the number of patients who can benefit from treatment.”
About Squamous Cell Carcinoma of the Head and Neck
Worldwide, there are approximately 560,000 new cases of head and neck cancer diagnosed and 300,000 deaths each year. Incidence rates are more than twice as high in men than in women. Oral cavity cancer is the most common type of head and neck cancer with 240,000 cases diagnosed every year, while cancers of the larynx, pharynx, thyroid and nasopharynx are less common.
Currently, the main treatment options for head and neck cancers are surgery, radiotherapy and chemotherapy. The types of treatment used will depend on the site and disease stage as well as on the patient’s overall health status.
In locally advanced head and neck cancer, chemoradiotherapy is an important option. However, due to high recurrence rates, patients with locally advanced disease tend to have a poor prognosis. For patients with advanced (metastatic) or recurrent disease, treatment options are limited. Despite the introduction of chemotherapy treatment in this setting approximately 30 years ago, patients with advanced (metastatic) or recurrent head and neck cancer still have a poor prognosis, with median survival of 6-10 months. There is a clear medical need in head and neck cancers for more effective treatment options to minimize toxicity and improve efficacy.
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.
Source: OncoSec Medical Inc.
Released December 9, 2014