PharmAthene has agreed to develop and commercialize a recombinant Protective Antigen (rPA) anthrax vaccine candidate using Immunovaccine's DepoVax™ vaccine platform.

The deal could generate more than $50 million in annual payments, milestone payments, and royalties for Immunovaccine, which announced the exclusive worldwide license agreement with PharmAthene today.

PharmAthene has agreed to work exclusively with Immunovaccine to develop an adjuvanted non-alum based rPA vaccine. In return, Immunovaccine has granted PharmAthene exclusive worldwide rights to use DepoVax.

The platform is designed to provide controlled and prolonged exposure of antigens plus adjuvant to the immune system, resulting in a strong, specific, and sustained immune response with the potential for single-dose effectiveness. According to Immunovaccine, DepoVax can be used with a broad range of target antigens for preventative or therapeutic applications. The technology is designed to be commercially scalable, with the potential for years of shelf life stability.

“This type of strategic partnership will allow us to capitalize on the broad potential of the DepoVax platform in infectious disease while advancing core opportunities for DepoVax™ in immuno-oncology,” Immunovaccine CEO Marc Mansour said in a statement. “This collaboration with PharmAthene has the potential for efficient and rapid development of a best-in-class anthrax vaccine.”

Under the licensing deal, PharmAthene agreed to pay Immunovaccine annual payments of $200,000, up to $8 million tied to achieving development, U.S. and international regulatory milestones, and initial product sales, as well as up to $42 million tied to achieving sales targets—a total of up to $50 million if all milestones are achieved.

Immunovaccine will also receive a royalty on net sales, and will not be responsible for product development costs, the company said.

The agreement comes a few months after Mansour told investors in the company’s first quarter “Management’s Report on Financial Position and Operating Results” that Immunovaccine was “actively seeking commercial partnerships with the owner of an anthrax antigen” to advance the program, following positive preclinical results.

In January, Immunovaccine said a study led by the NIH demonstrated that three different rPA vaccines formulated with DepoVax protected animals against a lethal anthrax challenge after a single vaccination.

PharmAthene’s rPA is the active component antigen of the company’s clinical-stage SparVax® anthrax vaccine. The second rPA anthrax vaccine is being developed to protect against inhalation anthrax, and contains a single, highly purified protein or “protective antigen” produced using a standard production strain of E.coli.

According to PharmAthene, SparVax has been shown to stimulate protection against anthrax by eliciting a specific immune response to one of the primary proteins excreted by the Bacillus anthracis organism. SparVax has been studied in one Phase I and two Phase II clinical trials completed to date, and involving more than 700 healthy human subjects.

PharmAthene’s rPA platform has been developed with funding from the U.S. and U.K. governments.

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