Vaxfectin® is a novel proprietary cationic lipid-based formulation that has been shown to effectively enhance both plasmid DNA-based vaccines as well as protein--based vaccines. It is a commixture of a cationic lipid (GAP-DMORIE) and a neutral phospholipid (DPyPE) which, when combined in an aqueous vehicle, self-assemble to form liposomes.
Vaxfectin® was identified through an extensive screening of 100 different lipids, then optimized through an in vitro and in vivo development process, and finally validated through numerous studies using a wide variety of infectious disease models (including anthrax, HIV, influenza, malaria, measles, rabies, and tuberculosis). It has been extensively documented to enhance both antibody and cellular immune responses to vaccines and to provide enhanced protection in disease challenge models. Importantly, Vaxfectin®-adjuvanted vaccines have advanced into several clinical trials and have shown promising safety and immunogenicity profiles.
Amongst the new generation of adjuvants in development, Vaxfectin® is well positioned as it meets the desired requirements for an adjuvant with broad-based applications: it is a synthetic adjuvant with a straightforward scalable synthesis of the two constituting lipids; it formulates reproducibly with different types of vaccines by simple mixing; analytical assays have been developed to ensure lot-to-lot reproducibility; and it is cost-effective.
Vical is developing several products that utilize Vaxfectin® as an adjuvant. These include CyMVectinTM, our prophylactic vaccine against cytomegalovirus infection, and our therapeutic vaccine against herpes simplex type-2 infection. In addition, we are actively seeking partnerships for the licensure of Vaxfectin® with other vaccines.
We entered into a worldwide, nonexclusive license with Bristol-Myers Squibb Company in September 2012 for both Vical's patented platform DNA immunization technology and our Vaxfectin® adjuvant for use in the production of antibodies. Under the agreement, Bristol-Myers Squibb will use our technology to generate antibodies with potential therapeutic uses in humans. We will also provide Vaxfectin® to Bristol-Myers Squibb from time to time.