Company Granted FDA Investigational New Drug Status for CEA Expressing Cancers
SEATTLE (July 28, 2010) – Etubics Corporation, a development stage biopharmaceutical company developing “next generation” vector vaccines, has entered into Phase I trials at Duke University with its ETBX-011, a therapeutic vaccine candidate that is intended to treat Carcinoembryonic Antigen (CEA)-expressing cancers such as colorectal cancer. Etubics dosed its first patient yesterday, Tuesday, July 27, 2010. Etubics was recently granted clearance by the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to begin studying ETBX-011 in humans.
Michael Morse, M.D. gastrointestinal oncologist at Duke Comprehensive Cancer Center noted, “Etubics’ novel vector vaccine approach activates cell mediated immunity and antibodies against cancers that express CEA. We look forward to studying this vaccine candidate in patients with cancers that express CEA.”
Etubics ETBX-011 utilizes a novel adenovirus serotype 5 (Ad5) vector platform technology, called Ad5 [E1, E2b-]-CEA. CEA represents an attractive target antigen for immunotherapy since it is over-expressed in nearly all colorectal cancers and pancreatic cancers, 70% of non-small cell lung cancers and approximately 50% of breast cancers. When tested against a conventional Ad5 platform, Etubics’ vaccine induced a significantly greater T-cell immune response in mice. Ad5 vectors have been used extensively in clinical studies but have been presented with the challenge of the patient’s own immunity against the vaccine itself. Pre-clinical data suggests that ETBX-011 may break through this barrier to induce an immune response.
Etubics Phase I CEA trial will be held at Duke University Medical Center and led by Dr. Morse. The dose-escalation study is designed to further understand the safety profile of the vaccine at three different doses, as well as to gather preliminary efficacy data. Trial patients will be vaccinated under the skin in their leg once every three weeks. After receiving three injections, patients will be monitored every three months for the first year of the study. Up to 30 patients will take part in the study.
Kim Lyerly, M.D., Director of Duke Comprehensive Cancer Center noted, “We have been researching immunotherapy for cancer patients for many years, and Etubics’ drug platform may provide us with another option for delivering tumor associated antigens for immunotherapy of our cancer patients in the future. We look forward to better understanding the potential for this candidate as a result of this preliminary study.”
Colorectal cancer, which expresses CEA, is the third leading cause of cancer-related deaths in the United States when men and women are considered separately, and the second leading cause when both sexes are combined. According to The American Cancer Society there were 106,100 new cases of colon cancer (52,010 in men and 54,090 in women) and 40,870 new cases of rectal cancer (23,580 in men and 17,290 in women) in the United States in 2009.
Frank Jones, Ph.D., founder, Chairman and Chief Executive Officer of Etubics stated, “This FDA clearance of the IND for Etubics’ next generation vectored vaccine candidate for CEA expressing cancers marks an important step for Etubics. We look forward to the day that Etubics therapeutic vaccine is widely available to treat these cancers and remain committed to bringing this new drug through the FDA licensing process.”
Etubics Phase I CEA trial has been funded entirely through grants from the National Cancer Institute (NCI). The NCI also awarded earlier grants to Etubics for its CEA pre-clinical work. For more information on this trial, please visit ClinicalTrials.gov. More information regarding Etubics vaccine can be found in a recently published Cancer Immunol Immunother paper entitled “Anti-tumor immunotherapy despite immunity to adenovirus using a novel adenoviral vector Ad5 [E2-, E2b-]-CEA.”
Etubics is developing the next generation in vaccines, utilizing a patented advanced generation adenovirus vector delivery platform and a validated manufacturing human cell line, called E.C7. Etubics intends to develop vector vaccines for a variety of indications utilizing its platform technology, which has attributes that allow for broad transgene expression.
Etubics Corporation, based in Seattle, Wash., is a next generation clinical stage bio-pharmaceutical company, which has developed a proprietary platform technology consisting of a next generation Adenovirus 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 Company’s Platform can be used to efficiently and rapidly develop immunotherapeutic drugs and preventive vaccines for a wide range of infectious diseases and cancers .
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 and regulatory requirements and actions; risks relating to the commercialization, if any, of Etubics proposed product candidates; competitive risks to marketed products; 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’s offices, 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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