Novavax has completed cGMP scale up of its RSV-F vaccine candidate, with the material being used in preclinical studies, and amended the terms of the H1N1 collaboration with Xcellerex.
Scale up of the vaccine for respiratory syncytial virus (RSV) was achieved using Novavax’s virus-like particle (VLP) manufacturing system, which has risen to prominence following the H1N1 outbreak.
The current good manufacturing practice (cGMP) compliant system promises to cut production times compared to egg-based methods, making it desirable for pandemics, but Novavax is keen to apply the technology to other vaccines.
Included in its pipeline is RSV-F. This has successfully completed a preclinical safety and efficacy study in cotton rats and formal toxicology tests are now underway in rabbits.
Using this data Novavax is preparing an investigational new drug (IND) application. The vaccine consists of a recombinant fusion protein of RSV which is used by the virus to infect cells in the respiratory tract.
Successful development of the vaccine would provide a defence against the virus that causes lower respiratory tract illnesses in infants and children, recurring throughout life, and more severe symptoms in the over-65s, resulting in 900,000 hospitalisations in the US and major European nations.
A formalin-inactivated RSV vaccine was trialled in the 1960s but caused enhancement of the disease. Consequently, RSV vaccines now require a heightened safety evaluation.
Xcellerex deal amended
Novavax has amended its H1N1 deal with Xcellerex. The initial agreement, entered into in October 2009, stated that contract manufacturing organisation (CMO) Xcellerex would use its FlexFactory disposable technology in the production of Novavax’s H1N1 vaccine.
In a filing with the US Securities and Exchange Commission (SEC), Novavax reports that the deal has been amended to extend its right to terminate the deal for various reasons to February 15.
Furthermore, under the terms of the amended deal Novavax will only pay Xcellerex a per dose fee upon the commercial sale of a vaccine using material from the CMO. Xcellerex was paid upon manufacture in the original deal.