Etubics Corporation, a clinical stage bio-pharmaceutical company with a proprietary vaccine platform that results in a long lasting "active" immune response, announced 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 principal 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 3 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.
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 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.
Illustration: Etubics Corporation.
Etubics Corporation News Release (05/06/13)
Abstract (Cancer Immunology, Immunotherapy; (04/2013))