[{"orgOrder":0,"company":"ViiV Healthcare","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ViiV Healthcare submits regulatory application to the European Medicines Agency for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Celldex Therapeutics","sponsor":"Rockefeller University","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"$1.7 million","newsHeadline":"Celldex Therapeutics Announces $1.7 Million Milestone Payment from Rockefeller University ","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"ViiV Healthcare","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ViiV Healthcare Announces US FDA Approval for Rukobia (fostemsavir)","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"ViiV Healthcare","sponsor":"GSK","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ViiV Healthcare Presents Positive Five-year Data at AIDS 2022, Demonstrating the Durability of Fostemsavir in People Living With HIV Who Are Heavily Treatment-experienced","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Gilead Sciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Gilead Presents New Data From HIV Cure Research Program and Collaborations Exploring Novel Investigational Combinations and Strategies","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2023","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"}]
Find Clinical Drug Pipeline Developments & Deals for Fostemsavir
MGN1703 (lefitolimod) is synthetic TLR9 agonist of the double-stem loop immunomodulators or dSLIM family where multiple CG-motifs are embedded into a stable, covalently closed double stem-loop DNA molecule harboring only natural phosphodiester bonds between nucleotides.
Study findings showed that people living with multidrug-resistant HIV-1 treated for approximately five years with Rukobia (fostemsavir)-based regimens experienced durable virologic response and continued clinically meaningful improvement in CD4+ cell count and CD4+/CD8+ ratio.
In a phase III study, a majority (60%) of heavily treatment-experienced adults randomized to receive Rukobia with an optimized background therapy achieved and maintained viral suppression through 96 weeks, addressing a critical unmet need.
Celldex utilized their internal capabilities in production cell line development, process development and GMP manufacturing to support clinical development of 3BNC117 and 10-1074.
This application seeks approval of fostemsavir, used in combination with other antiretrovirals, for the treatment of adults with multidrug-resistant HIV-1 infection.