OncoGenex Pharmaceuticals, Inc., a biopharmaceutical company, is engaged in the development and commercialization of new therapies that address treatment resistance in cancer patients. Product Candidates The company has three product candidates in its pipeline, such as custirsen, apatorsen, and OGX-225, each of which has a mechanism of action and represents an opportunity for cancer drug development. Of the product candidates in its pipeline, custirsen and apatorsen are clinical-stage assets. The company’s product candidates focus on mechanisms of treatment resistance in cancer patients and are designed to block the production of specific proteins that promote treatment resistance and survival of tumor cells and are over-produced in response to various cancer treatments. Custirsen Custirsen is being evaluated in three phase 3 trials; two in patients with prostate cancer and one in patients with non-small cell lung cancer (NSCLC). Custirsen is designed to inhibit the production of clusterin, a protein that the company promotes survival of cancer cells when overexpressed in various tumors. The company and collaborating investigators have conducted five phase 2 clinical trials to evaluate the ability of custirsen to enhance the effects of therapy in prostate, non-small cell lung and breast cancers. The SYNERGY phase 3 trial is designed to evaluate a survival benefit for custirsen, in combination with first-line docetaxel chemotherapy, in men with metastatic castrate-resistant prostate cancer, or mCRPC. Apatorsen Apatorsen is the company’s product candidate designed to inhibit production of heat shock protein 27, or Hsp27, a cell-survival protein expressed in various types of cancers, including bladder, non-small cell lung, pancreatic, prostate, and breast cancers. Hsp27 expression is stress-induced, including by various anti-cancer therapies. The company and collaborating investigators have conducted, or are in the process of conducting, two phase 1 and seven randomized phase 2 clinical trials that have been designed to evaluate the ability of apatorsen to enhance various treatments in patients with bladder, lung, pancreatic and prostate cancers. In 2013, the company initiated the ‘ORCA’ (On-going Studies Evaluating Treatment Resistance in Cancer) program, which includes clinical trials designed to evaluate whether inhibition of Hsp27 could lead to improved prognosis and treatment outcomes for cancer patients. The company is conducting parallel clinical trials to evaluate apatorsen in various cancer indications and treatment combinations to accelerate the development of apatorsen. OGX-225 OGX-225 is the company’s product candidate designed to inhibit the production of Insulin Growth Factor Binding Proteins -2 and -5 (IGFBP-2 and IGFBP-5), two proteins that affect the growth of cancer cells when overexpressed. Increased IGFBP-2 and IGFBP-5 production are observed in various human cancers, including prostate, breast, colorectal, non-small cell lung, glioblastoma, acute myeloid leukemia, acute lymphoblastic leukemia, neuroblastoma, and melanoma. The company has begun development activities for OGX-225 and toxicology studies are ongoing. Collaboration Agreement The company’s wholly owned subsidiary, OncoGenex Technologies Inc. (OncoGenex Technologies) has a collaboration and license agreement with Teva Pharmaceutical Industries Ltd. (Teva) for the development and global commercialization of custirsen (and related compounds targeting clusterin, excluding apatorsen, and OGX-225). OncoGenex Technologies has an agreement with Isis Pharmaceuticals, Inc. (Isis) to jointly develop and commercialize custirsen. This strategic relationship provided the company with access to Isis’ proprietary position in second-generation antisense chemistry for use in custirsen, and Isis’ expertise in developing antisense therapeutics, including its manufacturing expertise, and allowed the company to develop custirsen. OncoGenex Technologies has a collaboration and license agreement with Isis to jointly identify antisense compounds designed to inhibit the production of proteins encoded by specified gene targets. OncoGenex Technologies is responsible for all product development activities for antisense compounds under this collaboration. This relationship provides OncoGenex Technologies with access to Isis’ proprietary position in second generation antisense chemistry for use in specified products. Strategy Major elements of the company’s strategy include gaining market approval for custirsen by conducting registration trials that demonstrate efficacy and safety, in both prostate and lung cancer, in collaboration with Teva; advancing apatorsen by conducting clinical trials across multiple cancer indications for apatorsen, including bladder, lung, pancreatic and prostate cancers; developing and commercializing new cancer therapies, including OGX-225, to inhibit treatment resistance in cancer patients; and optimizing the development of its product candidates through use of outsourcing and internal expertise. Research and Development Expenditures For the year ended December 31, 2013, the company’s expenditures for research and development activities were $55.3 million. Trademarks The company owns eight trademarks registered in the United States, namely ONCOGENEX, ORCA, Spruce, Rainier, ORCA and design, Pacific and design, Borealis-1 and design, and the helical totem design element that accompanies the clinical trial trademarked identifiers. In Canada, it has OncoGenex registered, and has corresponding Canadian trademark applications pending for the United States registrations. Additional trade-marks in use and still pending registration in both the United States and Canada trademark offices are Borealis-2, Cedar, and the OncoGenex script design.
oncogenex pharmaceutical inc
(OGXI:Consolidated Issue listed on NASDAQ Capital Market)
19820 North Creek Parkway
Bothell, WA 98021
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