Xoma: Good News for the Firm We Love and Hate But We Never Divorce

XOMA Announces License Agreement with Novo Nordisk for XMetA Program in Diabetes

Novo Nordisk acquires exclusive global rights to XMetA program, but for diabetes only, while XOMA  retains commercialization rights for rare disease indications

– $5.0 million upfront payment. But the agreement includes up to $290.0 million in additional potential milestone payments

XOMA is entitled to tiered royalties

XOMA (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 A/S.

Under the terms of the agreement:  While XOMA retains commercialization rights for rare disease indications, Novo Nordisk still 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.

Novo Nordisk is indeed, a leader in the development of diabetes mellitus therapies.  It has unique  expertise to further develop the first-in-class insulin receptor activators discovered by XOMA’s scientists.

Jim Neal, Senior Vice President and Chief Operating Officer at Xoma said that as Xoma is interested in developing therapeutics for endocrine diseases, particularly those that are considered rare, the firm structured the agreement with Novo Nordisk in a way that Xoma retains commercialization rights of the XMetA program for rare indications.

The XMetA Program Story

While XOMA’s scientists were probing the insulin receptor in order to identify a novel way of treating type 2 diabetes mellitus, the work resulted in the XMetA program, which is a series of novel, fully human, high affinity, allosteric monoclonal antibodies that are partial agonists of the insulin receptor.

“Over the past few years, Xoma has 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, without 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.”

About the XMetA Program: Conventional monoclonal antibodies bind at the ligand-receptor binding site to provide either complete activation or inhibition. However, many receptors also have sites, termed 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.

Novo Nordisk is a global healthcare firm with more than 90 years of innovation in diabetes care. The firm’s experience and capabilities enabled it to help people defeat hemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 40,300 people in 75 countries and markets its products in more than 180 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit www.novonordisk.com.

Prohost Comments

XOMA is addictive to many, including us, in spite of its failure after failure delivered to its shareholders during the long years of its existence, during which time, the stock had reached $30, then to went down to less than a $1 stock value.

What makes this firm forgivable is its drug design capabilities that led to many drug discoveries that succeeded commercially and medically and became indispensable for the treatment of some difficult-to treat diseases, but unfortunately for other firms. Also its therapeutic groundbreaking monoclonal antibodies, including allosteric antibodies, created not only new opportunities to potentially treat a wide range of human diseases, but created therapeutics that have been approved, also for other firms.

That’s why we look as if married to this firm and now, we continue to try to share with it the fruits of its scientific research that produced six endocrine assets, each of which has the opportunity to address multiple indications.

Xoma’s lead product candidate now is XOMA 358, which is an allosteric monoclonal antibody that reduces insulin receptor activity, which could have a major impact on the treatment of hyperinsulinism.

Recently, Xoma initiated a Phase 2 clinical trial for its drug XOMA 358 in patients withcongenital hyperinsulinism. Additionally, we are still riding together with Xoma, its monoclonal antibody gevokizumab (IL-1 beta modulating antibody) in an ongoing Phase 3 program for patients with pyoderma gangrenosum, which is a rare ulcerative skin condition.

Today’s news about its agreement with Novo Nordisk on its XMetA Program in Diabetes is the third good news we hear from Xoma since its drug gevokizumab had failed treating another condition. The failure does not mean that the monoclonal antibody did not do the job, but that the selection of the disease was not the right decision. Anyway, the disease where the drug has failed to treat was  unrelated to the rare ulcerative skin disease pyoderma gangrenosum. The news brought high volume trading in the stock, adding a gain of few cents in pre market trading then to lose the same and a couple of more cents after the official trading.

Didn’t this opposite moves in the XOMA’s price reflect the description we gave above to investors love-hate relationship with this firm, which continues to manifest while the marriage has never ended with a divorce, or even with a short-term separation in exchange for moments of peace.

We are still in.

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