Study to Evaluate the Effects of ImmunoPulse in Combination with Anti-CTLA4, Anti-PD1 and Anti-PDL-1 Therapies
SAN DIEGO – June 11, 2013 – OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors, signed a Sponsored Research Agreement (SRA) with Old Dominion University (ODU) and the Frank Reidy Research Center for Bioelectrics. Under the agreement, OncoSec and the University will collaborate on nonclinical research focused on developing new technology related to electroporation and delivery of different agents into solid tumors by electroporation.
The first research experiment under this SRA will evaluate the effects of ImmunoPulse in combination with Anti-CTLA4, Anti-PD1 and Anti-PDL-1 in a melanoma mouse model. The study will commence this month and data from these experiments will be announced at a later date.
“Although results from ongoing Phase 2 studies have demonstrated ImmunoPulse is a potentially effective monotherapy for the treatment of skin cancers such as melanoma and Merkel cell carcinoma, OncoSec continues to evaluate opportunities where ImmunoPulse can be combined with other therapies to either improve its effectiveness or broaden the use of ImmunoPulse into other indications,” said Punit Dhillon, President and CEO of OncoSec Medical.
Mr. Dhillon continued, “The signing of this research agreement with ODU enables the company to determine which combination approaches are most effective and will help guide the company in the development of ImmunoPulse for its melanoma program and other solid tumor malignancies. The recent data announced at ASCO demonstrating the benefit of combining Ipilimumab (Anti-CTLA-4) with Nivolimumab (Anti-PD-1) for the treatment of advanced-stage melanoma, provides further support toward OncoSec’s efforts to expand the use of ImmunoPulse through the evaluation of different combination approaches to assess synergistic effects.”
The principal investigator of the study will be Dr. Richard Heller, one of the world’s leading pioneers in electroporation and gene delivery. Dr. Heller sits on OncoSec’s Scientific Advisory Board and has more than 25 years of experience in evaluating effects of electric pulses on biological systems.
Dr. Heller said, “We are excited to be collaborating with OncoSec. The combination of immune modulating agents to treat aggressive cancers like melanoma will further the scientific community’s understanding of these therapies. ImmunoPulse has continued to demonstrate a clear safety profile with promising clinical results, so we are looking forward to learn about the benefits of these new combinations.”
About Frank Reidy Research Center for Bioelectrics
The mission of the Center is to increase scientific knowledge and understanding of the interaction of electromagnetic fields and ionized gases with biological cells and to apply this knowledge to the development of medical diagnostics, therapeutics, and environmental decontamination. The objectives of the Center are to perform leading edge interdisciplinary and multi-institutional research, recruit top faculty and exceptional graduate students, support regional, national and international programs, and to increase external funding and institutional visibility.
Presentations on December 6 to Cover ImmunoPulse Therapy and Phase II Study of Melanoma Patients
SAN DIEGO – December 04, 2012 — OncoSec Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumor cancers, announced it will be presenting at the DNA Vaccines 2012 Conference at the Loews Coronado Bay Resort in San Diego, California. OncoSec is a Silver Sponsor of the conference.
The Company will conduct two presentations within the Cancer Immune Therapy Track on Thursday, December 6:
From 11:30 AM-12:00 PM PT, Richard Heller, Ph.D., director of the Frank Reidy Research Center for Bioelectrics at Old Dominion University, will speak on “Gene Electrotransfer for the Enhanced Delivery of Immunomodulating Agents.” In this presentation, Dr. Heller will present data on electroporation and delivery of plasmids for cancer immunotherapy, a technology used in OncoSec’s ImmunoPulse therapy.
From 12:00 PM-12:30 PM PT, Adil Daud, M.D., clinical professor of medicine and dermatology and director of the melanoma program at the University of California, San Francisco, will speak on “Clinical Studies of Melanoma Therapy.” In this presentation, Dr. Daud will be reviewing previously presented interim data from OncoSec’s ongoing Phase II trial for metastatic melanoma for which he is principal investigator.
The DNA Vaccines Conference brings in an array of researchers from all corners of the world to present new cutting-edge discoveries in DNA vaccines that have never before been presented or published at any other meeting. For more information about the conference, please visit: www.bioconferences.com/conferences/dna/index.aspx
Data Presented at 6th World Meeting of Interdisciplinary Melanoma/Skin Care Centres & 8th EADO Congress
90 Percent Complete Response Observed in Basal Cell Carcinoma
SAN DIEGO – November 14, 2012 — OncoSec Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors, announced positive interim results from a Phase IV trial investigating the use of NeoPulse in skin cancer patients at the 6th World Meeting of Interdisciplinary Melanoma/Skin Care Centres & 8th EADO Congress. Data from the trial showed a complete response of greater than 90 percent in basal cell carcinoma patients and 70 percent in squamous cell carcinoma patients at six months.
The data was presented in a poster titled “Interim analysis of an open-labeled, single-arm multicenter study of electrochemotherapy in skin cancer” by lead author Paul Goldfarb, M.D., and coauthors Lennart Lofgren, M.D., Ph.D., Axel Hauschild, M.D. and Richard Heller, Ph.D.
Dr. Hauschild said, “Based on these interim results, NeoPulse appears to provide local control with the potential advantage of preserving normal tissue, and therefore warrants further exploration as an alternative or even adjuvant treatment in cutaneous skin cancers.” Dr. Hauschild is a dermato-oncologist and professor of dermatology at the University of Kiel, Germany, and faculty member of the 6th World Meeting of Interdisciplinary Melanoma/Skin Care Centres & 8th EADO Congress.
The primary goal of this phase IV cutaneous cancer study was to assess the ability of NeoPulse to control growth or recurrence of the cancer six months following treatment, equivalent to surgery as compared to historical controls, with respect to primary (new) tumors and locally recurrent tumors. The study was conducted at 15 clinical centers across Western Europe. A total of 88 patients were enrolled and received treatment. At the time of analysis, 69 of 88 (78.4 percent) patients were evaluable at the six-month follow-up. The complete response rate at six months among basal cell carcinomas was 92.8 percent and 70 percent among squamous cell carcinomas. Response rate of melanoma was not calculated since multiple tumors were treated with concomitant therapy. The treatment was well-tolerated. The most frequent treatment-related adverse events were pain, infection and insomnia; all were transient and manageable.
NeoPulse appears well-tolerated and able to achieve local control comparable to that of surgical resection. The potential advantage of the therapy lies with the preservation of normal tissue with improved cosmesis, avoiding the need for reconstruction in difficult-to-treat sites or those with significant innervation. Together with the possible reduction in cost associated with hospitalization for procedures involving extensive reconstruction, the approach warrants further exploration as an alternative in select cases of skin cancer.
Punit Dhillon, President and CEO of OncoSec Medical, said, “These data demonstrate how NeoPulse might serve as an alternative to surgery that selectively destroys cancer cells without harming normal, healthy tissue. The results of OncoSec’s skin cancer program have so far shown a positive outcome among the class of patients who would typically be subjected to disfiguring surgery. We believe that NeoPulse offers a potentially significant new treatment for a variety of skin cancers.”
About the Phase IV Study
This Phase IV study was designed as an open-labeled study to measure local control and pharmacoeconomic parameters for NeoPulse in primary or recurrent squamous cell carcinoma of the skin, basal cell carcinoma as well as recurrent metastatic melanoma. Patients with primary or recurrent histologically confirmed tumors with no evidence of brain mestastases were eligible for enrollment. Safety and local control were measured. Patients received local injection of bleomycin followed by electroporation. Concomitant therapy was permitted when warranted.
Surgical resection of skin cancers can pose significant challenges in achieving local control while preserving normal tissue and function without the risk of cosmetic damage. NeoPulse involves the combined use of electroporation with intratumoral injection of low-dose bleomycin to treat local tumors. An evaluation of the pharmacoeconomic benefits of NeoPulse therapy suggests it could afford healthcare savings in reducing the expense and complications of reconstructive surgery to address cosmesis.