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Agreements

Date: 2015-12-01

Type of information: Licensing agreement

Compound: XMetA Program

Company: Xoma (USA - CA) Novo Nordisk (Denmark)

Therapeutic area: Metabolic diseases

Type agreement:

licensing

Action mechanism:

monoclonal antibody. Conventional monoclonal antibodies bind at the ligand-receptor binding site to provide either complete activation or inhibition. However, many receptors also have allosteric sites, binding to which modulates the ligand-receptor interaction. XOMA developed proprietary methods for identifying allosteric modulating monoclonal antibodies using its ModulX™ technology platform and focuses part of its research effort toward the discovery of these types of antibodies. The compounds in the XMet programs, which include the licensed XMetA antibodies and XOMA\'s 129 and 358, are fully human, high-affinity, allosteric monoclonal antibodies that selectively modulate the insulin receptor (INSR).XMetA antibodies bind with high affinity to the INSR and have glucoregulatory activity, as well as reduce hypoglycemia and weight gain in preclinical models of diabetes. The antibodies are partial INSR agonists as they do not upregulate INSR activity to the same extent as insulin. Structurally unrelated to insulin, XMetA antibodies bind the INSR at a different site than insulin and do not significantly interfere with insulin binding.

Disease: diabetes

Details:

* On December 1, 2015, Xoma announced it has exclusively licensed the global development and commercialization rights to its XMetA program of allosteric monoclonal antibodies that up-regulate the insulin receptor to Novo Nordisk. \"Novo Nordisk is recognized globally as the leader in the development of therapies to treat diabetes mellitus. It has the expertise to further develop these first-in-class insulin receptor activators, which were discovered by XOMA\'s scientists,\" said Jim Neal, Senior Vice President and Chief Operating Officer at XOMA. \"Our corporate strategy is to develop novel therapeutics for endocrine diseases, particularly those that are considered rare, and we were able to structure the agreement with Novo Nordisk to retain commercialization rights of the XMetA program for rare indications.\" \"XOMA\'s scientists probed the insulin receptor in order to identify a novel way of treating type 2 diabetes mellitus. Their work resulted in the XMetA program, a series of novel, fully human, high affinity, allosteric monoclonal antibodies that are partial agonists of the insulin receptor. Over the past few years, we have made significant progress in understanding the pharmacology of the compounds in this program,\" stated Paul Rubin, M.D., Senior Vice President, Research and Development and Chief Medical Officer at XOMA. \"In vitro data have shown the lead compound in the XMetA program mimics insulin\'s glucose regulatory functions, but none of its mitogenic actions. Most recently, weekly subcutaneous treatment with the lead molecule in the XMetA program in a clinically relevant animal model of diabetes resulted in robust decreases in hyperglycemia without hypoglycemia and weight gain, along with a significant absolute reduction in HbA1c of 1.2 percent. These findings have been peer-reviewed and were published online in the Journal of Pharmacology and Experimental Therapeutics in November 2015. They provide greater confidence in the development potential of XMetA as a first-in-class pharmacotherapy with broad utility in type 2 diabetes.\"

Financial terms:

Under the terms of the agreement, XOMA retains commercialization rights for rare disease indications. Novo Nordisk has an option to add these additional rights in rare diseases to its license. XOMA will receive $5.0 million in the form of an upfront payment, and the agreement includes up to $290.0 million in additional potential development, regulatory and commercial milestones (excluding potential option payments). In addition, XOMA is eligible to receive tiered royalties on product sales.

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