Many cancer research and treatment companies create and utilize various methods of treatment. These may be a combination of existing techniques or a new technology developed by the company itself. At OncoSec, one of our treatment methods is ImmunoPulse: a system we’re testing for the treatment of late-stage skin cancer, including merkel cell carcinoma, cutaneous T-cell lymphoma, and metastatic melanoma. With pending announcements surrounding interim data from our phase II trial for metastatic melanoma coming up soon, we would like to review a bit of the description of our ImmunoPulse treatment option currently being tested.
The treatment of many cancer types can vary quite widely. Different cancers and stages denote slightly different methods of treatment. While the early stages of some cancers – especially skin cancer – can sometimes require only minor surgery, others can require highly damaging doses of radiation and chemotherapy. With immunotherapy, companies like OncoSec are hoping to increase the number of available cancer treatments that are less damaging to the body. One specific cancer that we’re targeting is Merkel cell carcinoma.
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.
Data Presented at 27th Annual Meeting of the Society for Immunotherapy of Cancer
SAN DIEGO – October 23, 2012 – OncoSec Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapies to treat solid tumor cancers, announced positive preliminary results from a Phase II multicenter trial investigating the use of ImmunoPulse in Merkel cell carcinoma (MCC) patients at the 27th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2012). The data suggest that ImmunoPulse, which locally delivers a DNA-based cytokine coded for the immune stimulating agent interleukin-12 (DNA IL-12) via electroporation, may elicit increased levels of IL-12 in the tumor microenvironment, which has the potential to result in a systemic immune response in treating aggressive cancers like MCC without serious adverse safety events.
The preliminary results were published in the Journal of Immunotherapy (35(9):721-791, November-December 2012) and will be presented in a poster titled “Intratumoral delivery of Interleukin-12 DNA with in vivo electroporation can lead to regression of injected and non-injected tumors in Merkel cell carcinoma: Results of a phase II study.” Dr. Shailender Bhatia, principal investigator and assistant professor at the University of Washington School of Medicine, is lead author and will be presenting the data.
This open-label study is evaluating the ability of ImmunoPulse to increase levels of IL-12 in the tumor microenvironment, in addition to the efficacy and safety of this treatment for patients with MCC. Preliminary results of this study have demonstrated that 100 percent (3/3) of subjects treated with at least one cycle of ImmunoPulse showed an increased level of IL-12 expression in tumor biopsy done three weeks post-treatment as compared to pre-treatment biopsy. Correlative analysis of limited samples demonstrated that at least one subject had increased CD8+ T-cells (also referred to as killer T-cells) in the tumors. Correlative studies of patient samples are ongoing.
Of the first five subjects enrolled, the overall response rate is 20% (1/5). One patient with baseline progressive MCC, despite multiple prior therapies (systemic chemotherapy, surgery, RT, IT interferon) has had a confirmed partial response (greater than 70 percent regression) that persisted for approximately eight months. The regression of injected as well as non-injected tumors, along with no new tumors over six months, suggest successful induction of systemic immune response from local intratumoral immunotherapy in this patient. This subject remains in the study and will receive a third treatment cycle.
Dr. Bhatia commented, “These preliminary results are encouraging, and we are looking forward to continuing our study of ImmunoPulse. We are pleased to see that a patient with progressive MCC, despite failing multiple other therapies, had a confirmed partial response with regression of even distant non-injected tumors. This creative immunotherapy approach to deliver DNA IL-12 directly into the tumors appears to be tolerated well and so far without any systemic side-effects.”
All five subjects treated at the time of this preliminary analysis had distant metastatic disease, and were eligible to receive up to two treatment cycles. Two subjects have withdrawn from the study with progressive disease, and only received one cycle of treatment. Three subjects completed the study and received both treatment cycles. To date, the treatment has been safe and well-tolerated, with treatment-related adverse events including transient grade 1 pain (n=5) and grade 1 injection site reaction (n=1) without any systemic or residual toxicity.
Punit Dhillon, President and CEO of OncoSec Medical, added, “These subset data are positive and validate the results seen in our previous clinical trial. Thus far studies have shown that the administration of IL-12 using electroporation safely results in efficient transfection of the agent and a marked increase in production of the IL-12 protein inside the tumor. These results represent the first human data for a gene therapy using in vivo electroporation in MCC patients, and is a positive step towards advancement of this program.”
About Merkel Cell Carcinoma
Merkel cell carcinoma is a rare and highly aggressive cancer, with approximately 1,500 new cases each year in the United States, in which malignant cancer cells develop on or just beneath the skin and in hair follicles. The majority of Merkel cell carcinomas appear to be caused in part by a virus, Merkel cell polyomavirus. If this cancer metastasizes to the lymph nodes, the five-year survival rate is about 50 percent. A patient with a small tumor (less than 2 cm) that has not metastasized to the lymph nodes may have a five-year survival rate of more than 80 percent. Current treatment options for these patients is surgery, radiation and chemotherapy; however, up to half of patients suffer a recurrence.