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.
SAN DIEGO, CA, June 2, 2011 — OncoSec Medical Incorporated (OTCBB: ONCS), which is developing its advanced-stage ElectroOncology therapies to treat solid tumor cancers, announced today that one of its clinical trial advisers will present results from an ElectroImmunotherapy clinical trial for melanoma at the 2011 American Society of Clinical Oncology Annual Meeting to be held June 4-8 at McCormick Place, Chicago, IL.
Dr. Adil Daud, a clinical trials adviser for Oncosec Medical, and Clinical Professor, Hematology/Oncology, University of California, San Francisco, will discuss trial results from a long-term, follow-up study of melanoma patients treated with DNA IL-12 delivered via electroporation. Dr. Daud will lead the following poster session:
Session: Developmental Therapeutics – Clinical Pharmacology and Immunotherapy
Discussion: “Systemic immune responses induced by intratumoral plasmid IL-12electroporation in patients with melanoma”
Monday, June 6, 8:00 AM to 12:00 PM
Location: McCormick Place Hall A
More than 30,000 cancer specialists from around the world will gather at the 2011 ASCO Annual Meeting to discuss the latest innovations in research, quality, practice and technology in cancer. This meeting will be the platform for the release of important scientific abstracts — highly anticipated research news for many people, including patients, caregivers, and the general public. ASCO is a professional oncology society committed to conquering cancer through research, education, prevention and delivery of high quality patient care.
OncoSec’s ElectroImmunotherapy consists of a DNA-based cytokine delivered using electroporation. Consisting of a DNA plasmid (manufactured circles of DNA) coded to produce a specific cytokine such as IL-12, this DNA immunotherapeutic is injected into locally targeted tumors and surrounding tissue and followed by electroporation. This results in significant uptake of the agent by cells in this area of tissue. The DNA plasmid instructs these cells to “express” the protein it was designed to produce, such as IL-12. After the immune system detects the immunotherapeutic agent, it produces significant amounts of immune agents such as macrophages and killer T-cells that are able to kill cancerous cells.
Cytokine immunotherapeutics such as IL-12 have been directly injected in the form of proteins and have been shown to induce innate immune system responses capable of killing cancerous cells. Unfortunately they can also cause toxic side effects as the immune system perceives the proteins to be foreign. When DNA IL-12 is injected, the IL-12 produced by the body does not induce this unwanted immune response but has been shown to induce an immune response against cancer cells.
In these Phase II trials OncoSec will employ its in vivo electroporation device, or OncoSec Medical System (OMS), to enhance the potency of the DNA IL-12. The OMS consists of a pulse generator and handheld applicator with a sterile disposable array. The system delivers nano-second electrical pulses that increase cell membrane permeability, resulting in significant cellular uptake of the DNA plasmid and subsequent gene expression (i.e. production of the coded antigen). OMS can increase gene expression by 1000-fold and immune responses by 100 times or more compared to an un-enhanced delivery of a DNA plasmid.
Oncosec Medical (OTCBB: ONCS) develops novel ElectroOncology therapies that combine its proprietary electroporation delivery technology with a chemotherapeutic or novel DNA-based immunotherapeutics. Targeted local delivery of these agents is designed to achieve selective destruction of cancerous tumors while sparing healthy normal tissue, resulting in improved functional, cosmetic and quality of life outcomes. These therapies have achieved validating safety and efficacy data in early and late stage clinical studies of over 400 cancer patients. OncoSec’s clinical programs include three Phase II clinical trials. More information is available at www.oncosec.com.