OncoSec Medical Announces Positive Interim Data from Phase II Study of OMS-I100 in Metastatic Melanoma

Favorable Safety Profile, Robust Response Rates Reinforce Potential of Novel Immunotherapy

SAN DIEGO – December 16, 2013 — OncoSec Medical Inc. (OTCQB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy to treat solid tumors, today announced positive interim data from its ongoing Phase 2 trial of OMS-I100 in the treatment of metastatic melanoma. The results were presented by principal investigator Adil Daud, MD, at the Advances in Cancer Immunotherapy meeting at the University of California San Francisco.

Data from the multicenter, open-label, single-arm study confirm the safety of OncoSec’s lead product candidate, ImmunoPulse, which leverages the company’s OMS electroporation technology to deliver the anti-tumor agent pIL-12 directly into the tumor. In Phase 1 and Phase 2 studies, a total of 47 melanoma patients have been treated to date without a single drug-related, serious adverse event.

Patients treated in OMS-I100 also demonstrated positive response rates based on RECIST criteria, the gold standard measure of solid-tumor response to treatment. Interim efficacy analysis of 21 evaluable patients on Day 180 indicated that 38.1% (8/21) achieved an objective overall response, defined as >30% reduction in summed size of lesions. At the time of this interim analysis, six patients (28.6%) had demonstrated a partial response, and two patients (9.5%) had achieved a complete response, lasting at least 6 months. An additional 9.5% (2/21) of patients exhibited clinically beneficial disease stabilization for at least 3 months.

These data strengthen and expand upon previously reported Phase 1 results, which indicated a complete response in 16% of patients (3/19) and disease stabilization in 38% (7/19). These data were published in Journal of Clinical Oncology in 2008.

Importantly, 61.1% of patients (11/18) with evaluable lesions exhibited systemic antitumor immune responses, as evidenced by objective regression (>30% reduction in size) in at least one untreated lesion.

“The response rate of untreated tumors suggests an induction of systemic antitumor response, without systemic toxicity,” commented Dr. Daud. “We will continue to assess the responses of our remaining patients and look forward to sharing our findings.”

Robert H. Pierce, MD, OncoSec’s chief medical officer, added, “Systemic response is significant for two main reasons. First, it suggests that unlike most locally administered melanoma treatments, ImmunoPulse may induce antitumor response throughout the entire body, which would have clear benefits in the treatment of metastatic disease. Secondly, the favorable safety profile of ImmunoPulse indicates its potential to deliver systemic benefit, without the toxicities associated with many other systemic treatments. We are therefore highly encouraged by this finding, combined with the safety and primary efficacy data, and look forward to continuing our investigation of OMS-I100 in the treatment of metastatic melanoma.”

About Melanoma

Melanoma is the most serious form of skin cancer. If it is recognized and treated early, it is almost always curable. If it is not, the cancer can advance and spread to other parts of the body, where it becomes hard to treat and can be fatal. While it is not the most common of the skin cancers, it causes the most deaths. The American Cancer Society estimates that at present, about 123,000 new cases of melanoma in the U.S. are diagnosed in a year, resulting in approximately 10,000 deaths. Melanoma originates in melanocytes, the cells that produce the pigment melanin that colors our skin, hair, and eyes. The majority of melanomas are black or brown, but often they can also be skin-colored, pink, red, purple, blue or white. Currently, few treatment options remain for patients with late-stage metastatic disease that can extend survival for the broad population.

 

 

 45 percent of Treated Lesions Demonstrated a Durable Response Of At Least 6 Months

 

SAN DIEGO – March 25, 2013  — OncoSec Medical Inc. (OTCQB: ONCS) – a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors – announced positive, durable response results in an update on interim data from its Phase II metastatic melanoma trial. The data was presented at the HemOnc Today Melanoma and Cutaneous Malignancies Conference on March 22, in New York City.

In this analysis, all melanoma lesions that demonstrated at least a partial or complete response (PR or CR) to treatment with ImmunoPulse were followed, to determine durable response. Sixty-eight percent and fourty-five percent of treated lesions demonstrated a durable response at three and six months, respectively.

Punit Dhillon, President and CEO said, “We are encouraged by this updated data from the interim analysis, especially in light of recent announcements related to durability of response for other intralesional therapies. This data not only shows that ImmunoPulse can effectively eliminate the targeted tumors but also that our treatment can have a lasting effect on those tumors.”

Adil Daud, MD – the study’s principal investigator at the University of California San Francisco – said, “This data demonstrates that the lesions we have selected for treatment are responding well to the therapy and that the ImmunoPulse can trigger a lasting immune response, against the treated lesion. It is now important for us to see if this local immune reaction can result in a more widespread response against untreated lesions.”

These interim results reinforce previously announced Phase I data demonstrating that ImmunoPulse therapy is safe and well tolerated, as well as producing robust objective response rates, in patients with metastatic melanoma. OncoSec expects to complete enrollment of approximately 25 patients in total, in Q2 2013, with final analysis anticipated in Q4 2013.

About the Phase II ImmunoPulse Study

A total of up to 25 patients with stage III or IV cutaneous and in-transit metastatic melanoma will be enrolled in this Phase II, single-arm, open-label and multi-center study. The trial is designed to assess local and distant objective response, following treatment of cutaneous melanoma lesions with DNA IL-12 and electroporation, with a primary endpoint of 24 weeks. One treatment cycle will consist of three treatments applied to up to four lesions on days 1, 5 and 8, with a maximum dose of 1.5 mg DNA IL-12 per treatment cycle. At 12 months, patients will be moved to the follow-up phase of the study and will be followed for up to five years, for safety.

About Melanoma

Melanoma is the most serious form of skin cancer. If it is recognized and treated early, it is almost always curable but, if it is not, the cancer can advance and spread to other parts of the body where it becomes hard to treat and can be fatal. While it is not the most common of the skin cancers, it causes the most deaths. The American Cancer Society estimates that, at present, about 123,000 new cases of melanoma in the US are diagnosed in a year; resulting in approximately 10,000 deaths. Melanoma originates in melanocytes: the cells that produce the pigment melanin that colors our skin, hair, and eyes. The majority of melanomas are black or brown but can also often be skin-colored, pink, red, purple, blue or white. Currently, there remain few treatment options for patients with late-stage metastatic disease that can extend survival for the broad population.

 

Exclusive License Extends Patent Protection for ImmunoPulse Technology

SAN DIEGO – September 11, 2012 – OncoSec Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage ImmunoPulse and NeoPulse therapies to treat solid tumor cancers, announced it has secured an exclusive license for specific patented technology from the University of South Florida Research Foundation (USFRF) relating to the delivery of gene-based therapeutics via intratumoral and intramuscular electroporation. This patent is directly related to the ongoing Phase II trials for metastatic melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma using the company’s ImmunoPulse therapy, and extends patent protection for the ImmunoPulse technology to the year 2024. Financial terms of this agreement were not disclosed.

OncoSec’s proprietary gene and drug delivery platform, the OncoSec Medical System (OMS) electroporation device, is currently being used to develop the company’s ImmunoPulse and NeoPulse therapies. This platform encompasses patents, technology and other intellectual property for intratumoral methods for delivering drugs and gene-based treatments in humans.

ImmunoPulse involves the application of a brief electric field to the surface of the skin. This temporarily opens pores in the cell membrane, allowing anti-cancer agent DNA IL-12, to be absorbed more efficiently. DNA IL-12, which normally has difficulty penetrating the tumor cell membrane to get inside these cells, has been shown to significantly stimulate the immune system’s T-cells to fight the cancer. The new license from USFRF complements OncoSec’s seminal patents, particularly for the protection of the methods involved in the ImmunoPulse treatment, and specifically for the use of DNA IL-12.

“Our licensing agreement with the USFRF significantly strengthens OncoSec’s intellectual property rights in the area of gene and drug delivery via in vivo electroporation,” said Punit Dhillon, OncoSec’s President and CEO. “We anticipate that the further development of this technology will enhance the ability of ImmunoPulse to address the serious unmet need among patients with skin cancer. OncoSec’s patent portfolio places us in a preeminent position within the field of electroporation-based delivery of gene-based treatments for cancer.”

“OncoSec is the ideal choice to further develop this technology that I and my colleagues pioneered while working at the University of South Florida, and I am pleased they have secured this license,” said Richard Heller, Ph.D., author of the patented technology. “The technology involves short-pulsed electric fields that can deliver plasmid DNA to stimulate the immune system. As a result, it is a natural fit with OncoSec’s ongoing program to develop its ImmunoPulse therapy.”

 

 


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