Colby Pharmaceutical received exclusive worldwide rights to develop and commercialize disease-specific antigen compounds and intra-lymph node delivery technologies from MannKind’s MKC1106 active immunotherapy programs. The goal is to develop therapeutics for melanoma, prostate, hematological disorders, and other human cancers.

Intra-lymph node injections (ILNI) of cancer vaccine antigens reportedly 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, repeat intra-lymph nodal injection for administration of the therapeutic antigens was well-tolerated and generated strong immune responses, clearly meeting the primary endpoints, according to David Zarling, Ph.D., CEO of Colby.

Colby will pay MannKind upfront and milestone payments linked to the development, approval, and commercialization of products, with upfront and potential milestone payments of approximately $140 million total. MannKind will also receive tiered royalties on sales of products.

“MannKind has amassed an extensive and thorough active immunotherapy patent portfolio,” said Dr. Zarling. “We fully appreciate and understand that ILNI generates remarkably superior immune responses that also can be adjuvanted, and our organizations share a passion to advance the current MKC1106 clinical melanoma, prostate, and other programs. We will also evaluate ILNI for potential synergy with our lead adjuvant, JVRS-100, a cationic lipid-based immune activator of both innate and adaptive immunity.”

Regarding MKC1106, scientists at Mannkind explain that they use DNA and peptide reagents to stimulate an immune response that targets tumor-associated antigens which are expressed in a range of tumors. A patient’s immune system is first “primed” by DNA plasmids that are injected directly into accessible, nondiseased, superficial inguinal lymph nodes. These plasmids encode fragments of tumor-associated antigens, encompassing specific epitopes that are presented on the surface of tumor cells.

“Antigen-presenting cells that reside in the lymph nodes take up the plasmids, express the encoded peptides, and display the desired epitopes to specific T cells that are also present in the lymph node. In this manner, the T cells of the immune system effectively become sensitized to the tumor-associated antigens encoded by our plasmids,” said a Mannkind official.

After repeat priming injections, the patient’s lymph nodes are then injected with synthetic analogs of the desired epitopes. These peptides, containing sequence substitutions that enhance their pharmacological properties, are designed to bind with MHC molecules.

“The peptide injection effectively ‘boosts’ the proliferation of specific T cells that target the desired epitopes. This further stimulates their differentiation to ‘killer’ or cytotoxic T cells, with a greater ability to migrate to tumor site and metastatic lesions throughout the body, where they destroy tumor cells,” continued the spokesperson for Mannkind. “By repeating the cycle of plasmid priming and peptide boosting, we can initiate, deploy, and regenerate a potent cell-mediated immune response that targets cancer cells along with (in the case of certain vaccine constructs) the underlying blood supply.”

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