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Details:

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.


Lead Product(s): Lefitolimod,Fostemsavir,10-1074

Therapeutic Area: Infections and Infectious Diseases Product Name: MGN1703

Highest Development Status: Phase IIProduct Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 21, 2023

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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.


Lead Product(s): Fostemsavir

Therapeutic Area: Infections and Infectious Diseases Product Name: Rukobia

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: GSK

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 29, 2022

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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.


Lead Product(s): Fostemsavir,Undisclosed

Therapeutic Area: Infections and Infectious Diseases Product Name: Rukobia

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 02, 2020

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Celldex utilized their internal capabilities in production cell line development, process development and GMP manufacturing to support clinical development of 3BNC117 and 10-1074.


Lead Product(s): Fostemsavir,10-1074

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase IProduct Type: Large molecule

Partner/Sponsor/Collaborator: Rockefeller University

Deal Size: Undisclosed Upfront Cash: $1.7 million

Deal Type: Collaboration March 03, 2020

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This application seeks approval of fostemsavir, used in combination with other antiretrovirals, for the treatment of adults with multidrug-resistant HIV-1 infection.


Lead Product(s): Fostemsavir

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 10, 2020

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