Emergent BioSolutions has been awarded a NIAID contract worth up to $28.7 million to progress clinical development of a third-generation anthrax vaccine candidate that combines its FDA-approved BioThrax® vaccine with the immunostimulatory compound VaxImmune™ (CPG 7909). Emergent says the new contract means total U.S. government funding for development of the vaccine could now reach over $58 million. Phase II trials are anticipated to start in the first quarter of 2012.
The latest four-year contract includes two-year base funding of $9.1 million. Additional milestone-based options would increase the value up to $28.7 million if exercised. The base contract will fund activities relating to manufacture and stability studies of Phase II clinical trials lots, along with process characterization, assay validation, and preparation for Phase II trials. The new award expands the ongoing development program being conducted under a combined Biomedical Advanced Research and Development Authority (BARDA) and NIAID agreement, which was signed in September 2008 and is valued at up to another $29.7 million.
“We believe our vaccine candidate addresses key criteria established by the government for a third-generation anthrax vaccine,” comments Daniel J. Abdun-Nabi, president and CEO at Emergent. “If successfully developed, we believe this product would strengthen the government’s portfolio of biodefense medical countermeasures.”
BioThrax is currently the only FDA-licensed vaccine available for pre-exposure protection against anthrax infection, Emergent points out. In July the firm signed a potentially $107 million BARDA contract to develop and obtain regulatory approval of a large-scale manufacturing process for BioThrax at Building 55, the firm’s vaccine manufacturing facility in Lansing, MI. Back in May Emergent was granted IND clearance to start a Phase I trial with its anthrax monoclonal antibody candidate, which is in development as parenteral post-exposure therapy for individuals who have symptoms of anthrax disease.
The firm is developing a pipeline of prophylactic and therapeutic antibodies and vaccines against anthrax, tuberculosis, typhoid, and influenza. Just last month Emergent and Temasek Life Science Ventures inked a deal to set up a joint venture, Epic Bio, focused on the development and commercialization of a multivalent, cross-protective human vaccine to protect against influenza caused by a broad range of circulating H5 influenza strains.
Separately during August Emergent acquired Trubion Pharmaceuticals for $96.8 million up front, and up to another $38.7 million in success-based milestones. The company maintains this acquisition will diversify its product development pipeline with the addition of Trubion's clinical-stage oncology and autoimmunity candidates. Emergent also gains the acquired firm’s Small Modular Immunopharmaceutic (SMIPTM) and ScorpionTM technology platforms for the development of therapeutics.