OncoSec Medical Incorporated, a biotechnology company, focuses on designing, developing and commercializing gene therapies, therapeutics and proprietary medical approaches to stimulate and guide an anti-tumor immune response for the treatment of cancer. The company’s portfolio includes biologic immunology therapeutic product candidates intended to treat a range of tumor types. The company’s technology also includes intellectual property relating to its ImmunoPulse delivery technology. ImmunoPulse is an electroporation delivery device that the company uses in combination with its therapeutic product candidates, including DNA plasmids that encode for immunologically active agents, to deliver the therapeutic directly into the tumor and promote an inflammatory response against the cancer. The company’s electroporation devices consist of an electrical pulse generator and disposable applicators, which could be adapted to treat different tumor types. Product Candidates The company’s ImmunoPulse product candidates are based on its proprietary DNA based immunotherapy technology, which is designed to stimulate the human immune system, resulting in systemic anti-tumor immune responses. The company’s major product candidate, ImmunoPulse IL-12, consists of a plasmid construct encoding the proinflammatory cytokine, IL-12, which is delivered into the tumor through in vivo electroporation. ImmunoPulse IL-12 is being studied in various open-label Phase 2 clinical trials. The company is conducting research and development on other DNA-encoded, immunologically-active molecules with an intention to produce additional immunotherapeutic drugs capable of breaking the immune system’s tolerance to cancer. The company could introduce, for example, pro-inflammatory cytokines and chemokines, immune stimulatory receptors, co-stimulatory molecules, adhesion molecules, and T-cell engagement molecules. University of South Florida Licenses In 2012, the company secured a license for specific patented technology from the University of South Florida Research Foundation relating to the delivery of gene-based therapeutics through intratumoral and intramuscular electroporation. This patent directly supports the company’s clinical development focus in solid tumor applications and specifically 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. In June 2015, the company secured a license for a catheter-based electroporation device. This patent supports the company’s development of new electroporation devices with the ability to reach deep visceral tumors that could be reached through the use of standard medical instrumentation (laparoscope, bronchoscope, etc.). Electroporation Delivery The electroporation delivery system consists of an electrical pulse generator and various disposable applicators. Together with the company’s partners and collaborators, it plans to establish electroporation-delivered DNA immunotherapies. The ImmunoPulse approach employs an electroporation system designed to create favorable conditions to deliver plasmid DNA encoding immunotherapeutic cytokines directly into cells of the tumor microenvironment. Clinical Program The company’s major product candidate, ImmunoPulse IL-12, consists of a plasmid construct encoding the proinflammatory cytokine, IL-12, which is delivered into the tumor through in vivo electroporation. As of September 2015, the company completed two Phase 2 studies (OMS-I100 in metastatic melanoma, and OMS-I110 in Merkel Cell Carcinoma) and initiated four additional clinical trials of ImmunoPulse with DNA-encoded IL-12 (OMS-I100 Addendum and CC-15852 in metastatic melanoma, OMS-I130 in head and neck cancer, OMS-I140 in triple-negative breast cancer). The company has a collaboration with the University of California, San Francisco to evaluate the safety and efficacy of combination therapy with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, and ImmunoPulse IL-12 in patients with ‘low TIL’ metastatic melanoma. In 2014, the company announced plans to conduct a Phase 2 trial in head and neck squamous cell carcinoma using its proprietary ImmunoPulse platform. In January 2015, the company announced plans to initiate a pilot study to assess ImmunoPulse IL-12 in patients with triple negative breast cancer (TNBC). By driving cytotoxic immune cells into the tumor, ImmunoPulse IL-12 might be an ideal candidate to combine with checkpoint blockade therapies, which have reported some, but limited activity in TNBC. Strategy The company’s strategy includes expanding the applications of its technologies through strategic collaborations or evaluation of other opportunities, such as in-licensing and strategic acquisitions. Intellectual Property The company owns and has been issued 28 U.S. patents, and has 2 U.S. patent applications pending. The company has filed eight U.S. provisional patent applications and expects to file additional patent applications. The company has a total of 13 issued patents and 6 pending patent applications in other jurisdictions. In addition, the company has licensed intellectual property rights that allow the company to use certain electroporation technology and methods of delivering DNA-based cytokines as an immunotherapy. The bulk of the company’s 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 United States Food and Drug Administration. Research and Development The company recognized $13.1 million in research and development expenses in the year ended July 31, 2015. 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:NASDAQ CM)
9810 Summers Ridge Road
San Diego, CA 92121
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