March 18, 2013
/PRNewswire/ -- Genocea Biosciences Inc., a clinical-stage company pioneering novel T cell vaccines, announced today the publication of new data to support GEN-003, its investigational vaccine for the treatment of HSV-2. The results, which are available today in the print edition of
Journal of Virology
, show that vaccination with GEN-003, along with Matrix-M™ adjuvant, induced antigen- and virus-specific immune responses and improved outcomes in preclinical models of the disease. This is the first HSV-2 therapeutic vaccine to show a significant impact on viral shedding after the completion of the dosing regimen in preclinical models. Genocea has fully enrolled its Phase 1/2a study of GEN-003 and expects to report preliminary data in the second half of 2013.
"These results provide strong support for our ongoing clinical investigation of GEN-003, and provide further validation of our approach for identifying promising, next-generation vaccine candidates capable of preventing and treating a wide variety of complex pathogens," said
, CEO of Genocea.
The antigens were identified using ATLAS™, Genocea's platform for the rapid discovery of antigens that induce T cell immunity. In addition to HSV-2, Genocea is utilizing this technology to develop preventive and therapeutic vaccines for Chlamydia, malaria, and Pneumococcus. The company anticipates beginning clinical trials in late 2013 for GEN-004, a vaccine candidate to prevent infections caused by
GEN-003 is a first-in-class, protein subunit, therapeutic T cell vaccine intended to reduce recurrence and transmission of Herpes Simplex Virus type 2 (HSV-2). GEN-003 includes the antigens ICP4 and gD2, as well as the proprietary adjuvant Matrix-M™, licensed from Isconova AB. The adjuvant is a novel, saponin-derived product that has demonstrated a balanced B and T cell immunostimulatory profile. A Phase 1/2a clinical study is currently underway to determine the safety and tolerability of GEN-003.
Herpes simplex virus type 2 (HSV-2), the most common cause of genital herpes, is a sexually transmitted disease that is estimated to infect more than 500 million people worldwide, and one out of six people aged 15 to 49. In the U.S. alone, an estimated 50-60 million people are affected. HSV-2 infection can cause recurring, painful genital sores, and can be stigmatizing and produce considerable psychological distress in patients. The disease is particularly severe in immunosuppressed patients and poses significant risk to newborns if it is transmitted from mothers during birth. While antiviral drugs are used widely to treat HSV-2, there is neither a cure nor a vaccine for this disease.
About Genocea Biosciences
Genocea Biosciences is harnessing the power of the T cell immunity to develop the next generation of vaccines. T cells are increasingly recognized as a critical element of a protective immune response to a wide range of infectious disease pathogens, but are difficult to target using traditional vaccine discovery methods. Genocea is uniquely able to identify protective T cell antigens from naturally exposed humans using its proprietary technology platform that mimics the human immune response in the laboratory, potentially improving the effectiveness of vaccine candidates and drastically reducing the time needed to create them.
For more information, please visit the company's website at Genocea.com.