Vaxonco initiates Phase I clinical trial of novel DNA-based polyepitope vaccine against malaria

Sep 23 2010

Vaxonco Inc., a Korean company specializing in peptide-based vaccines and Ichor Medical Systems (Ichor), whose advanced TriGrid™ Delivery System (TriGrid™) is being tested worldwide for its ability to enhance delivery of DNA drugs and vaccines, announced today the initiation of a Phase I clinical trial to evaluate a novel DNA-based polyepitope vaccine against malaria. The study is supported by the United States National Institutes of Health and Vaxonco, Inc.'s subsidiary Epimmune, Inc and EP1300 will be delivered using Ichor's TriGrid™. The study will be conducted as a randomized, prospective, placebo-controlled, dose-escalating trial at the Emory Vaccine and Treatment Evaluation Unit in Atlanta, Georgia, and will be supported by the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health.

“We are delighted to be working with Vaxonco and NIAID to test this exciting epitope-based approach to treat this major disease. We anticipate the resulting human data will continue to position the TriGrid™ as a universal vaccine delivery platform for a multitude of infectious diseases”

The objectives of the study are to evaluate the safety, reactogenicity, tolerability, and immunogenicity of the DNA vaccine candidate when delivered in healthy adult volunteers using the TriGrid. Study participants will include 39 healthy adults aged 18-40 years who have no previous history of malaria exposure or infection.

"Epitope-based vaccines represent a very logical approach to treating a heterogeneous general population because they allow one to overcome restrictions associated with population heterogeneity in immune responses, thereby achieving a broader range of coverage. We are excited to be entering into the clinic with Ichor's technology to address the major challenge of efficiently delivering DNA vaccines into cells," stated Michelle Kim, Vice President from Vaxonco, Inc.

"We are delighted to be working with Vaxonco and NIAID to test this exciting epitope-based approach to treat this major disease. We anticipate the resulting human data will continue to position the TriGrid™ as a universal vaccine delivery platform for a multitude of infectious diseases," said Robert Bernard, CEO from Ichor Medical Systems.

The proposed clinical trial will be the first to evaluate a DNA-based, polyepitope vaccine against P. falciparum malaria. Malaria is a mosquito-borne disease caused by protozoan parasites of the genus Plasmodium (P.falciparum). The World Heath Organization estimates that there are more than 250 million clinical cases of malaria per year, accounting for over 800,000 deaths. The majority of deaths occur among children under five years of age in Africa, especially in those areas with poor access to healthcare services.