NasVax entered into a joint research and option for license agreement with Novartis Vaccines and Diagnostics to investigate the feasibility of developing improved vaccines using NasVax’ adjuvant technology VaxiSome™. The company also granted Novartis an option to acquire a nonexclusive license to use VaxiSome in vaccines already in Novartis’ pipeline.
Novartis’ option to a nonexclusive license covering the adjuvant technology is exercisable for up to 14 months after the agreement's effective date. It may be extended by Novartis under certain conditions.
If exercised, a license will be granted to Novartis under as yet undecided commercial terms. The deal would include milestone payments and royalties on the sales of vaccines marketed by Novartis that include Vaxisome.
“This is another major step in realizing NasVax's strategy and vision of creating value by introducing its innovative technologies to the market through collaborations with world-leading vaccine manufacturers,” remarks Erez Chimovits, CEO of NasVax. “We look forward to demonstrating VaxiSome's potential for improving the immunogenicity of key vaccines, thus leading to improved products of superior value.”
VaxiSome is based on a synthetic polycationic sphingolipid derived from D-erythro ceramide to which spermine is covalently attached, thereby forming ceramide carbamoyl spermine (CCS). CCS mixed with cholesterol (CCS/C) self-assembles into liposomes known as VaxiSome. Based on its structure and components, CCS is predicted to be biocompatible and biodegradable.
In vitro and in vivo studies suggest that the CCS/C formulation upregulates levels of CD40 and B7 co-stimulatory molecules, which are essential in antigen presentation and T-helper cell activation. As a result, VaxiSome is a potent liposomal adjuvant for stimulating enhanced immune responses via the Th1 and Th2 pathways. Since dual Th1/Th2 activities augment both antibody and cell-mediated responses, VaxiSome should be a useful adjunct to immunotherapeutic applications and to augment the bioactivity of cytokines and other adjuvants.
Preclinical studies have shown that VaxiSome-Influenza is more immunogenic than two commercial adjuvanted influenza vaccines. Preclinical studies with adjuvanted hepatitis B, anthrax, and pandemic flu vaccine antigens have demonstrated increased potency. The adjuvant effect of VaxiSome was apparent in two Phase I/IIa studies of intramuscular commercial influenza vaccine (VaxiSome-Influenza) but was not apparent in a third such study. A Phase II trial of adjuvanted influenza vaccine compared to unadjuvanted vaccine is ongoing in elderly subjects.