US drugmaker MannKind Corp (Nasdaq: MNKD) has licensed agreement exclusive worldwide rights to privately-held Colby Pharmaceutical to develop and commercialize disease-specific antigen compounds and intra-lymph node delivery technologies from MannKind’s novel MKC1106 active immunotherapy programs, which are currently being developed for the treatment of melanoma, prostate, hematological disorders and other human cancers.
Under the terms of the accord, Colby will pay MannKind upfront and milestone payments linked to the development, approval and commercialization of products, with upfront and potential milestone payments of about $140 million total. MannKind will also receive tiered royalties on sales of products.
Intra-lymph node injections (ILNI, vaccine inoculation directly into the normal lymph node with ultrasound image guided standard syringes) of cancer vaccine antigens have been reproducibly shown to generate much more potent therapeutic T-cell responses, when compared to cancer vaccine antigen immunizations using traditional intra-muscular or sub-cutaneous injections of the same cancer vaccine antigens in animals. In a Phase I human melanoma study of MKC1106-MT, the most advanced ILNI regimen from this program, repeat intra-lymph nodal injection for administration of the therapeutic antigens was well-tolerated and generated strong immune responses, clearly meeting the primary endpoints.
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