Novavax, Inc., together with its wholly-owned Swedish subsidiary, Novavax AB, operates as a clinical-stage vaccine company that focuses on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants. Using proprietary recombinant nanoparticle vaccine platform technology, the company produces vaccine candidates to respond to both known and emerging disease threats. The company’s vaccine candidates are genetically engineered three-dimensional nanostructures that incorporate recombinant proteins critical to disease pathogenesis. The company’s product pipeline targets various infectious diseases with vaccine candidates in clinical development for respiratory syncytial virus (RSV), seasonal influenza, pandemic influenza, and Ebola virus (EBOV). The company has additional preclinical stage programs for various infectious diseases. The company is also developing proprietary technology for the production of immune stimulating saponin-based adjuvants, through Novavax AB. The company’s major adjuvant, Matrix-M, has been tested in a Phase 1/2 clinical trial for its pandemic influenza H7N9 vaccine candidate and in a Phase 1 clinical trial for the company’s EBOV vaccine candidate. Genocea Biosciences, Inc. has licensed rights to the company’s Matrix technology and is conducting Phase 2 clinical trials with its herpes simplex 2 vaccine candidate using Matrix-M. Clinical Product Pipeline The company’s clinical product pipeline includes vaccine candidates engineered to elicit differentiated immune responses with potential to provide increased protection. The company’s nanoparticle technology platform targets antigens with conserved epitopes essential for viral function. Its vaccine technology could be applied to various human infectious diseases. RSV The company is developing its RSV fusion (F) protein nanoparticle vaccine candidate (RSV F Vaccine) for three susceptible target populations, such as older adults (60 years of age and older), infants via maternal immunization, and children 6 months to 5 years of age (pediatrics). RSV Older Adults Program: In August 2015, the company announced positive top-line data from a Phase 2 clinical trial of its RSV F Vaccine in 1,600 older adults. The company initiated a pivotal Phase 3 clinical trial, known as Resolve, of its RSV F Vaccine in older adults in November 2015. In December 2015, the company completed enrollment of 11,850 older adult subjects at 60 sites in the U.S. The company expects to provide top-line data from this clinical trial in the third quarter of 2016. In October 2015, the company completed enrollment of 1,330 older adults in its Phase 2 rollover clinical trial of its RSV F Vaccine in the older adults who had participated in the recently concluded prior Phase 2 clinical trial. This trial is designed to evaluate safety and immunogenicity in response to immunization with the RSV F Vaccine during a second RSV season, and the company expects to provide top-line data from this trial in the second half of 2016. RSV Infants via Maternal Immunization Program: In September 2015, the company announced positive top-line data from a Phase 2 clinical trial of its RSV F Vaccine in 50 healthy pregnant women and their infants. The company announced the initiation of a global pivotal Phase 3 clinical trial, known as Prepare, of the RSV F Vaccine in 5,000 to 8,255 healthy pregnant women in December 2015. In 2014, the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (FDA) granted Fast Track designation to the company’s RSV F Vaccine for protection of infants via maternal immunization. RSV Pediatric Program: In September 2015, the company announced positive top-line data from a Phase 1 clinical trial of its RSV F Vaccine in healthy children between two and six years of age. This clinical trial evaluated the safety and immunogenicity of the company’s RSV F Vaccine, with one or two doses, with or without aluminum phosphate adjuvant. The company is assessing the data from this clinical trial and evaluating the next steps in the development of the company’s RSV F Vaccine for pediatrics. Influenza
novavax inc (NVAX:NASDAQ GS)
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