GeoVax and Vivalis signed a potentially €4 million biomanufacturing agreement for the production of GMP-grade materials for the latter’s MVA-based vaccines. The firms have been working together since 2008, with financial support from the French innovation agency OSEO, to generate a process for manufacturing the MVA component of GeoVax’ HIV/AIDS vaccines in Vivalis’ duck embryonic stem-cell-derived EB66® cell line. The new supply agreement covers the production of master and working cell banks of the EB66 cells as the first step leading to production of clinical trial materials in Vivalis’ own GMP facility.
The MVA vaccine products are in development both for the prevention of HIV infection and also as a component of a therapeutic product for already infected individuals, GeoVax explains. Phase IIa studies with the preventative MVA vaccine are ongoing through the U.S. government-sponsored HIV Vaccine Trials Network (HVTN), and Phase I therapeutic evaluation was initiated in 2010. “Currently, our MVA vaccine is grown in cells derived from embryonated chicken eggs,” says Robert McNally, Ph.D., GeoVax’ president and CEO. “The EB66 cell line is a much more practical and cost effective method to manufacture commercial-scale recombinant MVAs.”
Vivalis says the deal with GeoVax is the third manufacturing agreement signed this year, and also follows on from five new EB66 cell line agreements and three supply agreements signed in 2011. Earlier this month Vivalis and DELTA-VIR announced that the two companies inked a commercial agreement for the manufacture GMP-grade material of Newcastle disease virus (NDV) in the SEB66® cell line. Vivalis says the deal is first step of a broader collaboration between the companies to develop an EB66-based production process of purified NDV virus and to manufacture clinical grade NDV to be used in conjunction with a cell-based antitumor vaccine for therapeutic treatment of different human neoplasms.
The EB66 cell line is already being used to produce two vaccines that are undergoing clinical trials in the U.S. and Japan. In addition to its utility in viral vaccine manufacture, Vivalis is also exploiting the cell line for the production of recombinant proteins including antibodies.