On behalf of the OncoSec team, we’re thrilled to announce the first patient enrolled in the Phase II Investigator Sponsored Trial led by the University of California, San Francisco (UCSF) to assess the safety and efficacy of the combination of our investigational therapy, ImmunoPulse™ IL-12, and Merck’s approved anti-PD-1 agent, KEYTRUDA® (pembrolizumab), in patients with unresectable metastatic melanoma.
We were thrilled to participate in the Nasdaq Opening Bell Ceremony to celebrate our recent listing to The Nasdaq Capital Market. This marks an exciting and significant milestone for our company as we continue to build on our success and advance our technologies to one day benefit patients everywhere.
On May 27th, we proudly announced that our common stock has been listed on The NASDAQ Capital Market. We’re very excited to be following an upward trajectory and expect this milestone will bring several benefits to the company, ranging from appealing to a broader set of investors to increasing the visibility of OncoSec’s capabilities.
OncoSec Medical Inc. 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.
OncoSec 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.”
OncoSec Medical received authorization to CE mark its proprietary gene and drug delivery platform, the OncoSec Medical System (OMS) electroporation device, for use in the European Economic Area (EEA). SGS Group, an industry-leading inspection, verification, testing and certification company, supervised the assessment and certification process.
A CE mark verifies the OMS electroporation device has met all applicable directives of the European Commission (EC) and subsequently the laws and regulations of the European Union (EU) member states and therefore can be commercialized within the 30-nation EEA and Switzerland. The electroporation device applies short electric impulses to a tumor, causing pores to open in the membrane of cancer cells, significantly increasing the uptake of anti-cancer agents into these cells. The granting of this CE mark involved a comprehensive audit of the company’s quality system as well as thorough evaluation and testing of the OMS electroporation device to assure it performs safely and as designed. The CE mark affirms OncoSec’s commitment to product quality and development, and augments the notified body certification to the International Organization for Standardization’s (ISO) 13485 standard for the “design, development, manufacture, and distribution of electroporation devices,” which the company received in July.
Punit Dhillon, President and CEO of OncoSec, commented,
“The approval marks an essential regulatory milestone on the road to commercialization and further approval of the OncoSec Medical System. The CE mark shows that OncoSec has the capability to manufacture and develop a device that meets commercial regulatory requirements.”
Oncosec receives “Method and Device for Treating Microscopic Residual Tumors Remaining in Tissues Following Surgical Resection”) for the OncoSec Medical System (OMS) electroporation device platform from the State Intellectual Property Office of the People’s Republic of China. The issuance of this patent has the potential to expand OncoSec’s commercial opportunities for minimally invasive and surgical procedures to treat solid tumors in a very large market such as China.