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.
OncoSec will be presenting subset data from the Phase II melanoma study at the EADO conference on November 14 – 17 in Barcelona, Spain.
More news to come soon.
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.
CE Certification Enables Commercialization of OncoSec Medical System (OMS) Electroporation Device in European Economic Area
SAN DIEGO – October 17, 2012 – OncoSec Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse drug-based chemotherapy to treat solid tumor cancers, announced it has 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.”
Company to Present at SITC 2012 and 6th World Meeting of Interdisciplinary Melanoma/Skin Cancer Centres/8th EADO Congress
SAN DIEGO – October 09, 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 the company will be presenting data at two upcoming medical conferences.
Dr. Shailender Bhatia, assistant professor at the University of Washington School of Medicine, will be presenting preliminary clinical data from OncoSec’s ongoing Phase II Merkel cell carcinoma trial at the 27th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2012), October 26-28, 2012, at the Bethesda North Marriott Hotel & Conference Center in North Bethesda, Maryland.
The company will also be presenting preliminary clinical data from its ongoing Phase II metastatic melanoma trial to the 6th World Meeting of Interdisciplinary Melanoma/Skin Cancer Centres/8th EADO Congress, November 14-17, 2012, at the Hotel Fira Palace in Barcelona, Spain.
Preliminary analyses of both the Merkel cell carcinoma and metastatic melanoma trials will be based on a subset of enrolled subjects, and will evaluate clinical response to at least one cycle of ImmunoPulse treatment.
At the Melanoma/EADO meeting on November 15 at 5:30 PM local Barcelona time, Adil I. Daud, M.D., co-director of melanoma clinical research at the University of California San Francisco’s Helen Diller Family Comprehensive Cancer Center and lead investigator for OncoSec’s metastatic melanoma trial, along with Axel Hauschild, M.D., professor of dermatology at the University of Kiel, will co-chair an OncoSec-sponsored symposium titled “Electrogenetherapy: Intralesional Immunotherapy Approach for Skin Cancers Using Electroporation.”
The company will provide a complete summary of the data presented at both conferences in upcoming press releases.
About SITC 2012
The SITC Annual Meeting & Associated Programs serve as the premier destination for scientific exchange, education and networking in the cancer immunotherapy community. Basic researchers, clinicians, students, postdoctoral fellows and allied health professionals dedicated to improving cancer patient outcomes come together to experience cutting edge research, education and training that serves as the catalyst to advance the field.
About the 6th World Meeting of Interdisciplinary Melanoma/Skin Cancer Centres/8th EADO Congress
The World Meeting of Interdisciplinary Melanoma/Skin Cancer Centers is an opportunity for clinicians and researchers who are part of multidisciplinary melanoma centers can interact, learn from one another, establish collaborations and set an agenda for the further evolution of multidisciplinary melanoma care and research. The meeting has been combined with the EADO congress whose focus is on melanoma, cutaneous lymphoma and epithelial skin cancers and is specifically designed to attract young investigators and skin cancer-treating physicians in the field.
About OncoSec Medical Inc.
OncoSec Medical Incorporated is a biopharmaceutical company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumor cancers. ImmunoPulse and NeoPulse therapies address an unmet medical need and represent a potential solution, for less invasive and less expensive therapies that are able to minimize detrimental effects resulting from currently available cancer treatments such as surgery, systemic chemotherapy or immunotherapy and other treatment alternatives. OncoSec’s core technology is based upon its proprietary use of an electroporation platform to dramatically enhance the delivery and uptake of a locally delivered DNA-based immunocytokine (ImmunoPulse) or chemotherapeutic agent (NeoPulse). Treatment of various solid cancers using these powerful and targeted anti-cancer agents has demonstrated selective destruction of cancerous cells while sparing healthy normal tissues during early and late stage clinical trials. OncoSec’s clinical programs include three Phase II clinical trials for ImmunoPulse targeting lethal skin cancers.
This press release contains forward looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward looking statements.” Forward looking statements are based on management’s current preliminary expectations and are subject to risks and uncertainties which may cause our results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include our ability to raise additional funding, our ability to acquire, develop or commercialize new products, uncertainties inherent in pre-clinical studies and clinical trials, unexpected new data, safety and technical issues, competition and market conditions. These and additional risks and uncertainties are more fully described in OncoSec’s filings with the Securities and Exchange Commission. Undue reliance should not be placed on forward looking statements which speak only as of the date they are made. OncoSec disclaims any obligation to update any forward looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
SAN DIEGO, CA, October 2, 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 today that the company will be presenting at the 3rd Annual Cancer Immunotherapy: A Long-Awaited Reality conference taking place from 8:00 a.m. to 6:30 p.m. EDT on October 4, 2012, at the New York Academy of Medicine in New York.
Punit Dhillon, President and CEO, will provide an overview of ImmunoPulse, a treatment that uses OncoSec’s patented electroporation platform to dramatically enhance the delivery and uptake of a locally delivered DNA-based immunocytokine.
The presentation is expected to begin at 9:15AM ET.
A live and archived webcast of the company’s presentation at the conference hosted by MD Becker Partners LLC will be available at www.regonline.com/mdb2012.
About the 3rd Annual Cancer Immunotherapy: A Long-Awaited Reality Conference
“Cancer Immunotherapy: A Long Awaited Reality” is a unique, single-day conference event that unites founding visionary researchers, clinicians, business leaders, key investors, and other stakeholders to engage in discussions, exchange information, highlight opportunities, and showcase leading companies in the field of cancer immunotherapy.
University of Washington To Become Fourth Enrolling Center in Trial
SAN DIEGO, CA, September 25, 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 that it has established the University of Washington (UW) as the fourth enrolling site for its Phase II metastatic melanoma clinical trial (OMS-I100). Investigational Review Board (IRB) approval has been received by UW, and investigators are actively recruiting for this clinical trial.
“UW now joins the University of California, San Francisco, John Wayne Cancer Institute and Lakeland Cancer Center as our fourth site for the melanoma study,” said Punit Dhillon, President and CEO of OncoSec. “We have enjoyed working with UW and Dr. Shailender Bhatia for the Merkel cell carcinoma program, and look forward to having them join the melanoma trial as well.”
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.
Dr. Shailender Bhatia, principal investigator at UW, commented “We have had experience with this treatment in the Phase II Merkel cell carcinoma study, so we are glad to have the opportunity to now offer this treatment as an experimental therapy to the patients who are suffering from melanoma.”
ImmunoPulse utilizes OncoSec’s proprietary technology to deliver a DNA-based cytokine coded for the immune stimulating agent interleukin-12, or DNA IL-12. The OncoSec Medical System (OMS) applies short electric impulses to the tumor, causing pores to open in the membrane of cancer cells that significantly increases DNA IL-12 uptake into these cells. Phase I data using ImmunoPulse to treat malignant melanoma demonstrated that this therapy was safe and well tolerated. In addition, 53% of patients with distant metastatic lesions demonstrated an objective response, with 15% of these patients having a complete response to the treatment.
For more information about this trial visit: http://clinicaltrials.gov/ct2/show/NCT01502293.
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 which 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, there remains few treatment options for patients with late stage metastatic disease that can extend survival for the broad population.