Recently, a researcher on our Linkedin DNA Vaccines group asked if any DNA vaccines have been licensed for use in humans. The short answer is no. Most DNA vaccine clinical programs are still in phase I and phase II. Currently, the only phase III trial being conducted is by San Diego-based Vical. Their cancer immunotherapy vaccine Allovectin®, is an immunotherapeutic vaccine for metastatic melanoma.
More progress has been made for veterinary applications, however. In July of 2005 Kansas-based Fort Dodge Animal Health, received approval to sell their DNA vaccine Innovator® to protect horses from West Nile disease. Also in 2005, Vical announced the approval from the Canadian Food Inspection Agency to sell its DNA vaccine APEX-IHN, which protects farm-raised salmon against the infectious haematopoietic necrosis virus. And in 2010, Merial announced the USDA’s approval of its new DNA vaccine ONCEPT™, for treating canine oral melanoma. This vaccine is being used in dogs after the onset of the disease to impede disease progress and to extend life. According to Dr. David Kaslow, Vice President and Head, Vaccines Integration and Pipeline Management at Merck Research Laboratories, the DNA vaccines approved for use in animals “represent solid progress” in the path towards human approval. Though we have yet to see any DNA vaccines gain approval for humans, Dr. Kaslow also believes that “over the next three to six years we’ll see substantial clinical trial data roll out to see where we stand – whether we’ve made the jump from fish and horses into humans.”
Similar to DNA vaccines, plasmid-based gene therapies are also making progress through the pipeline. The first gene therapy product to be approved for use in animals was VGXI’s LifeTide™, a growth hormone releasing hormone (GHRH) for use in swine. In 2008, the product was approved by the AVPMA for veterinary use in Australia.
On the human side, Richmond, CA-based Sangamo Biosciences is gearing up for its phase III trial for a diabetic neuropathy gene therapy called SB-509 which is designed to restore and regenerate nerves (neuroregenerative) and promote the growth of blood vessels (angiogenic).