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SEATTLE (May 6, 2013) – Etubics Corporation, a clinical stage bio-pharmaceutical company with a proprietary vaccine platform that results in a long lasting "active" immune response, announced today results from a first-in-man, Phase I/II clinical trial for its immunotherapy product candidate targeting carcinoembryonic antigen (CEA)-expressing cancers, such as colorectal cancer. The immunotherapy drug, called ETBX-011, induced an immune response in advanced colorectal cancer patients and gave encouraging overall survival results.
ETBX-011 utilizes the Etubics Platform, an Ad5-based delivery vector with novel deletions in the E1 and E2B regions. In the phase I/II study, 61% of patients treated with ETBX-011 induced a significant CEA-specific cell mediated immunity (CMI) to the cancer in the setting of both naturally acquired and immunization-induced Ad5-specific immunity. This was boosted over the course of three treatments.
Frank R. Jones, Ph.D., founder, Chairman and Chief Executive Officer of Etubics stated, "The ability to boost CMI in both Ad5 naive and Ad5 immune patients shows that ETBX-011 can break tolerance against CEA in these patients. This is very exciting to us, as we feel this is a key element in creating a successful immunotherapy for colorectal cancer."
Minimal toxicity was seen and 48% of patients were still surviving at 12 months, regardless of pre-existing Ad5 neutralizing antibody levels. The treatment is delivered by a subcutaneous injection.
Etubics Phase I/II clinical trial was held at Duke University Medical Center and Medical Oncology Associates, in Spokane, Wash. The primary objective was to determine the safety of ETBX-011 in patients with advanced or metastatic CEA-expressing cancers. The secondary objectives were to evaluate CEA-specific immune response due to immunizations and obtain preliminary data on overall survival.
Michael Morse, M.D. gastrointestinal oncologist at Duke University Medical Center and Principle Investigator of the trial noted, “This early study indicated the immunization strategy was well-tolerated, easily administered, and — though a secondary endpoint — was associated with encouraging survival among those patients refractory to standard chemotherapy and biologic therapy.”
"This early trial has indicated that ETBX-011 immunotherapy may avoid immunological clearance by patients and induce a potent response against colorectal cancer," said H. Kim Lyerly, M.D., of Duke University Medical Center. "I'm hopeful these results will be confirmed in subsequent trials involving greater numbers of patients."
Patients had previously failed life extending therapies, had a survival expectancy of at least three months and had not been treated with any active immunotherapy prior to entering the trial. Prior to initiation of ETBX-011, patients were taken off all other anti-cancer treatment for at least 30 days.
Etubics will be entering a randomized Phase IIb clinical trial with ETBX-011 in 2013.
More information on Etubics Phase I/II clinical trial with its colorectal cancer immunotherapy can be found in the Cancer Immunology, Immunotherapy paper entitled "Novel Adenoviral Vector Induces T Cell Responses Despite Anti-Adenoviral Neutralizing Antibodies in Colorectal Cancer Patients." To view the publication online, visit http://www.ncbi.nlm.nih.gov/pubmed/23624851.
Etubics is developing next generation vaccine and immunotherapy product candidates, utilizing a patented advanced generation adenovirus delivery platform and a validated manufacturing human cell line, collectively the Etubics Platform. The Etubics Platform delivers a long lasting "active" immune response against diseases and induces Cell Mediated Immunity (CMI). The Company believes that its Platform enables the rapid expansion of its pipeline of immunotherapeutic drugs for a wide variety of cancers and vaccines for difficult o treat infectious diseases.
Research reported in this press release has been funded primarily through grants and contracts from the National Institute of Health (NIH) to the Company (National Institute of Health, National Cancer Institute Grant # 1R43CA134063 and 2R44CA134063 and contract # HHSN261200900059C). The NIH has also awarded Etubics a $1.5 million contract to manufacture ETBX-011 for this clinical trial (National Institute of Health, National Cancer Institute Contract # HHSN261201100097C). In addition the NIH has awarded earlier grants to Etubics for its breast cancer and HPV induced cancer pre-clinical programs. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Etubics Corporation, based in Seattle, Wash., is a clinical stage bio-pharmaceutical company, which has developed a proprietary platform technology consisting of a next generation Ad5 vector vaccine platform and a manufacturing E.C7 human cell line, collectively the Etubics Platform. Clinical work to date shows that the Etubics Platform overcomes problems associated with existing adenovirus vectors. The Etubics Platform can be used to efficiently and rapidly develop immunotherapeutic drugs and preventive vaccines for a wide range of infectious diseases and cancers. www.etubics.com
Statements herein relating to future financial, business performance, conditions or strategies and other financial and business matters, including expectations regarding future revenues and operating expenses, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Etubics is a private company. Etubics cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by Etubics to secure and maintain relationships with collaborators; risks relating to the early state of Etubics’s product candidates under development; uncertainties relating to clinical trials; risks relating to the commercialization, if any, of Etubics proposed candidates; dependence on the efforts of third parties; dependence on intellectual property; and risks that it may lack the financial resources and access to capital to fund its operations. Further information on the factors and risks that could affect Etubics business, financial conditions and results of operations, are contained in Etubics’s documents on file at the Company. These forward-looking statements speak only as of the date of this press release and Etubics assumes no duty to update forward-looking statements.
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