XOMA said today it has exclusively licensed global development and commercialization rights to its XMetA program of allosteric monoclonal antibodies to Novo Nordisk, under a partnership that could generate up to $295 million-plus for XOMA.

The XMetA program consists of novel, fully human, high affinity, allosteric monoclonal antibodies that are partial agonists of the insulin receptor. XOMA identified the antibodies using its ModulX™ technology platform and focuses part of its research effort toward discovering these types of antibodies—which differ from conventional monoclonal antibodies that bind at the ligand-receptor binding site to provide either complete activation or inhibition.

According to XOMA, XMetA antibodies are partial INSR agonists, since 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.

“Over the past few years, we have made significant progress in understanding the pharmacology of the compounds in this program,” Paul Rubin, M.D., XOMA svp, research and development, and CMO, said in a statement.

According to Dr. Rubin, 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, he said, weekly subcutaneous treatment with the lead molecule in the XMetA program in an undisclosed “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%. Those findings were published online in November by the Journal of Pharmacology and Experimental Therapeutics.

The findings “provide greater confidence in the development potential of XMetA as a first-in-class pharmacotherapy with broad utility in type 2 diabetes,” Dr. Rubin added.

Under its collaboration with Novo Nordisk, XOMA retains commercialization rights for rare disease indications—reflecting its corporate strategy of developing novel therapeutics for endocrine diseases, particularly those that are considered rare, XOMA svp and COO Jim Neal added. However, Novo Nordisk has an option to add additional rights in rare diseases to its license.

Novo Nordisk agreed to pay XOMA $5 million upfront, and up to $290 million in additional potential payments tied to achieving development, regulatory, and commercial milestones, excluding potential option payments. XOMA is also eligible to receive tiered royalties on product sales.








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