OncoSec Medical Incorporated operates as a drug-medical device and therapeutic company. The company focuses on designing, developing, and commercializing proprietary medical approaches for the treatment of solid tumors. The OncoSec Medical System (OMS) OMS is a therapeutic approach, which is based on the use of an electroporation delivery device in combination with an approved chemotherapeutic drug and a DNA-based cytokine to treat solid tumors. These two different approaches represent therapeutic modalities, ImmunoPulse and NeoPulse. The company’s ImmunoPulse approach is based on the use of electroporation to improve the local delivery of DNA plasmids, which upon uptake into cells, direct the production of immunostimulatory cytokines to generate a local, regional and systemic immune response for the treatment of various cutaneous cancers. NeoPulse utilizes its electroporation technologies for the local delivery of the chemotherapeutic drug bleomycin to treat solid tumors. OMS consists of an electrical pulse generator console and various disposable applicators specific to the individual tumor size, type and location and is designed to increase the permeability of cancer cell membranes, and as a result, increases the intracellular delivery of selected therapeutic agents. The NeoPulse approach has been developed up to Phase III clinical trials in the United States for the treatment of recurrent head and neck cancer and Phase I/II for the treatment of recurrent breast cancer. NeoPulse has potential application in a range of solid tumors, including basal cell carcinoma, squamous cell carcinoma, melanoma, breast, prostate, and pancreatic cancers. In addition, Phase IV pre-marketing studies to support the commercialization of NeoPulse in Europe have also been performed for the treatment of primary and recurrent head and neck cancers and cutaneous skin cancers. The company is pursuing opportunities primarily focused in Europe, Asia, and North America to partner NeoPulse for further clinical development and commercialization. Two drugs for metastatic melanoma are approved, both on the basis of increased survival. Yervoy, a monoclonal antibody marketed by Bristol-Myers Squibb Co., stops the suppression of T-cells that could seek out and destroy melanoma cells. Zelboraf, a B-Raf inhibitor marketed by Roche and Daiichi Sankyo, interrupts a key process in melanoma growth in patients with a particular melanoma mutation. Both drugs are associated with side effects, and neither is considered a cure for melanoma. In May 2013, two new drugs for metastatic melanoma were approved. Tafinlar and Mekinist are single-agent oral treatments for the treatment of unresectable metastatic melanoma. Like Zelboraf, both of these new agents interrupt a key process in melanoma growth by inhibiting the mitogen activated protein kinase signaling pathway. Also, like Zelboraf, these agents could cause side effects and long-term use might lead to drug resistance by tumor cells. The company’s ImmunoPulse clinical-stage approach consists of directly injecting solid tumors with a DNA plasmid, which upon uptake into cells, direct the production of the encoded immunostimulatory cytokine to generate a loco-regional immune response against the tumor, which might result in a systemic immune response. The company initiated three Phase II clinical trials to assess the cancer-destroying and tissue-sparing properties of the ImmunoPulse technology in patients with melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma during 2012. Its primary ImmunoPulse candidate for these trials is a DNA plasmid coding for IL-12 that is delivered using its OMS electroporation device. Strategy The company’s clinical development strategy includes completing the necessary additional clinical trials in accordance with the Food and Drug Administration (the ‘FDA’) guidelines for cutaneous cancers, including select rare cancers that have limited, adverse or no therapeutic alternatives. Its strategy also includes expanding the applications of its technologies through strategic collaborations or evaluation of other opportunities, such as in-licensing and strategic acquisitions. Research and Development The company incurred $3,159,209 in research and development expenses during the year ended July 31, 2013. Intellectual Property The company owns and has been issued 27 U.S. patents and has 2 U.S. patent applications pending. It has a total of 18 issued patents and patent applications in other jurisdictions. The bulk of its patents, including fundamental patents directed toward its proprietary technology, expire between 2014 and 2027. Government Regulation In the United States, the company’s product candidates are subject to extensive regulation by the FDA. History The company was founded in 2008. It was incorporated under the laws of Nevada in 2008. The company was formerly known as Netventory Solutions Inc. and changed its name to OncoSec Medical Incorporated in 2011.
oncosec medical inc
(ONCS:OTC Markets Group Inc - OTCQB)
9810 Summers Ridge Road
San Diego, CA 92121
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