CHICAGO, IL – June 27, 2023 – Xentria Inc., a pioneering clinical-stage biopharmaceutical company dedicated to developing innovative therapies for unmet medical needs, today announced a significant multi-year licensing agreement with Meitheal Pharmaceuticals, Inc. This exclusive partnership focuses on the commercialization of Xentria’s leading drug candidate, XTMAB-16, a novel biologic treatment for pulmonary sarcoidosis, across North America.
Under the terms of this agreement, Meitheal Pharmaceuticals secures exclusive commercialization rights for XTMAB-16 in North America. Xentria Inc. will continue to oversee clinical development, while retaining marketing rights for all other global markets, subject to a right of first offer. This strategic alliance leverages the strengths of both companies to expedite the development and availability of a much-needed therapeutic option for patients suffering from pulmonary sarcoidosis.
The financial structure of the agreement includes an immediate upfront payment of $45 million to Xentria Inc. Further financial milestones include an additional $35 million upon regulatory submission and approval of XTMAB-16. Moreover, Xentria is eligible to receive substantial milestone-based royalties, potentially exceeding $600 million over the duration of the agreement. Upon reaching the $600 million royalty threshold, the intellectual property rights associated with XTMAB-16 will transition to Meitheal’s parent company, Hong-Kong King Friend Industry Co., Ltd.
XTMAB-16, an anti-TNFα monoclonal antibody, is poised to enter Phase 2 clinical trials later this year. These trials will evaluate its efficacy in mitigating the inflammatory response characteristic of pulmonary sarcoidosis. Sarcoidosis is a chronic, inflammatory disorder affecting multiple organs, with the lungs being the most commonly impacted, known as pulmonary sarcoidosis. This condition disproportionately affects women and African Americans.
Kirsten Anderson, COO of Xentria Inc., emphasized the significance of this partnership, stating, “This strategic collaboration underscores Xentria’s commitment to creating comprehensive scientific solutions and advancing challenging drug development through valuable partnerships. By combining the expertise of Xentria and Meitheal, we aim to accelerate the development of XTMAB-16. This therapy holds the promise to become a leading treatment specifically designed for pulmonary sarcoidosis, moving beyond the current standard of care which primarily relies on symptomatic steroid treatments. This partnership also validates the compelling preclinical data and the potential of XTMAB-16 to address the significant treatment gap in pulmonary sarcoidosis as we advance into patient trials.”
Tom Shea, CEO of Meitheal, commented, “Meitheal’s established infrastructure as a fully integrated R&D, manufacturing, and commercial pharmaceutical company makes us an ideal partner to further the advancement of XTMAB-16 for pulmonary sarcoidosis, a condition with a significant unmet treatment need. Meitheal is excited to collaborate with Xentria Inc. to bring XTMAB-16 to patients across North America, and we are committed to establishing a dedicated branded division to support its continued development and commercialization.”
Understanding Sarcoidosis
Sarcoidosis is a chronic, multisystem inflammatory disease of unknown origin. It is characterized by the formation of granulomas, clusters of inflammatory cells, in various organs throughout the body. While sarcoidosis can affect any organ, pulmonary sarcoidosis, affecting the lungs, is the most prevalent, accounting for over 90% of cases. The condition can manifest at any age but is most frequently diagnosed in individuals between 20 and 39 years old.
Untreated pulmonary sarcoidosis can progress into a chronic and debilitating disease. Persistent lung inflammation can lead to scarring (fibrosis), causing irreversible damage to lung tissue, potentially resulting in lung failure and even death. Elevated levels of TNFα, a key cytokine involved in immune responses, are believed to play a crucial role in the formation of harmful granulomas and fibrosis in sarcoidosis patients.
XTMAB-16: A Novel Therapeutic Approach
XTMAB-16, developed by Xentria Inc., is a chimeric human-murine anti-TNFα monoclonal antibody specifically designed as a novel biologic treatment for pulmonary sarcoidosis, with or without extrapulmonary involvement. By targeting and blocking TNFα, XTMAB-16 aims to disrupt the inflammatory pathway and impede granuloma formation. Recognizing its potential, the FDA granted XTMAB-16 Orphan Drug Designation in November 2020. Xentria Inc. successfully completed a Phase 1 clinical trial in healthy volunteers in 2022. Currently, there are no TNFα inhibitors specifically approved for the treatment of sarcoidosis, highlighting the significant unmet need XTMAB-16 aims to address. Extensive preclinical studies have confirmed the physio-chemical and pharmacological properties of XTMAB-16 as a potent TNFα inhibitor, and ongoing clinical studies are further evaluating its therapeutic effects.
About Xentria Inc.
Founded in 2020, Xentria Inc. operates at the forefront of the biopharmaceutical industry, fostering innovative collaborations and partnerships to accelerate the development of challenging and impactful therapeutics. The name Xentria, derived from “centrality,” reflects the company’s core mission: to deliver patient-centric and customized approaches to ambitious drug innovation through meaningful engagement and effective collaborations. Headquartered in Chicago, Xentria Inc. is dedicated to advancing life sciences initiatives on a global scale, while championing diversity, individualism, and sustainability. To discover more about Xentria Inc. and its mission, please visit www.xentria.com.
About Meitheal Pharmaceuticals
Established in Chicago in 2017, Meitheal Pharmaceuticals is committed to the development and commercialization of high-quality generic injectable medications. Since 2022, Meitheal has expanded its focus to include fertility, biologic, and biosimilar products, demonstrating its commitment to addressing a wider range of patient needs. Currently, Meitheal markets 50 FDA-approved products across diverse therapeutic areas, including anti-infectives, oncolytics, intensive care, and fertility. With a robust pipeline, Meitheal has over 20 products in research and development, 21 products slated for launch in 2023, and an additional 20 products under FDA review as of April 2023. Meitheal’s core mission is to ensure easy access to fairly priced medications through efficient manufacturing, reliable supply chains, and rapid responsiveness to customer needs. Recognized as a top workplace in Chicago by Crain’s Best Places to Work, Meitheal embodies its Irish-derived name, representing “Meitheal” (Mee·hall): a principle of collaborative effort towards a common goal for the greater good. For more information about Meitheal Pharmaceuticals, please visit www.meithealpharma.com.
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