Xentria and Meitheal Enter Exclusive Licensing Deal for Pulmonary Sarcoidosis Therapy in North America

Rare Daily Staff

Xentria entered into an exclusive multi-year licensing agreement with Meitheal Pharmaceuticals to commercialize its lead candidate and novel biologic, XTMAB-16 for pulmonary sarcoidosis in North America.

Under the terms of the agreement, Meitheal Pharmaceuticals gains exclusive rights to commercialize XTMAB-16 in North America and Xentria remains responsible for clinical development and retains the marketing rights in all other countries subject to a right of first offer.

As part of the agreement, Xentria will receive an up-front payment of $45 million as well as up to another $35 million on regulatory submission and approval of XTMAB-16, along with potential milestone-based royalties for a licensing deal in excess of $600 million over the term of the agreement. Upon achievement of $600 million in royalty payments the intellectual property associated with XTMAB-16 will transfer to Meitheal’s parent company, Hong-Kong King Friend Industry Co., Ltd.

“The collaboration will leverage the strengths of both companies to accelerate the development of XTMAB-16, which could emerge as one of a few therapeutics in development specifically for treating pulmonary sarcoidosis, in contrast to symptomatic steroid treatment as the current standard of care,” said Kirsten Anderson, chief operating officer of Xentria. “The partnership also validates compelling pre-clinical data and the potential of XTMAB-16 to fill the existing treatment gap in pulmonary sarcoidosis as we enter the first trial in patients living with the condition.”

Sarcoidosis is a chronic, multisystem inflammatory disorder of unknown etiology that is characterized by the formation of granulomas — clumps of inflammatory cells — in one or more organs in the body. Sarcoidosis affects people of all ages but is most common among people who are 20 to 39 years of age. While sarcoidosis can occur in any organ, more than 90 percent of patients with sarcoidosis will have the lungs affected, which is called pulmonary sarcoidosis. Left undiagnosed or untreated, the condition of patients with pulmonary sarcoidosis could degenerate into a chronic, progressive disease. Chronic, unresolved lung inflammation may result in scarring (fibrosis) that permanently damages the lung tissue and can lead to lung failure and death. In this complicated cascade of pro-inflammatory cytokines, the enhanced expression of TNFα, a cytokine that plays a significant role in antigen-stimulated, cell-mediated immune responses, may promote the formation of harmful granulomas and fibrosis throughout the body in people with sarcoidosis.

XTMAB-16 is chimeric human-murine anti-TNFα monoclonal antibody being developed as a novel biologic product for the treatment of pulmonary sarcoidosis with or without extra pulmonary involvement. Based on its ability to block TNFα, XTMAB-16 may disrupt an inflammatory pathway and help slow granuloma formation. XTMAB-16 was granted Orphan Drug designation for the New Drug Entity in November 2020. A phase 1 clinical trial in healthy volunteers was completed in 2022. No TNFα inhibitor is currently approved for the treatment of sarcoidosis. Extensive analyses have been conducted to demonstrate the physio-chemical properties and pharmacology of XTMAB-16 as a TNFα inhibitor. The clinical study of this effect remains ongoing.

Photo: Kirsten Anderson, chief operating officer of Xentria