CHICAGO, IL – In a significant move to address unmet needs in pulmonary disease treatment, Xentria Inc., a biopharmaceutical company focused on innovative therapeutics, and Meitheal Pharmaceuticals, Inc., a rapidly growing pharmaceutical company, have announced an exclusive licensing agreement. This strategic partnership centers around the commercialization of Xentria’s lead drug candidate, XTMAB-16, a novel biologic poised to transform the treatment landscape for pulmonary sarcoidosis in North America.
Under the definitive terms of the multi-year agreement, Meitheal Pharmaceuticals secures the exclusive rights to commercialize XTMAB-16 across North America. Xentria will continue to spearhead clinical development, retaining marketing rights for all other global markets, with Meitheal holding a right of first offer for these territories.
The financial structure of this Xentria Meitheal collaboration is substantial, reflecting the potential of XTMAB-16. Xentria will receive an upfront payment of $45 million, followed by an additional $35 million upon regulatory submission and approval milestones. Furthermore, the agreement includes tiered royalties that could exceed $600 million over the lifespan of the partnership. A notable clause in the agreement stipulates that upon reaching $600 million in royalty payments, the intellectual property rights for XTMAB-16 will transition to Meitheal’s parent company, Hong Kong King Friend Industry Co., Ltd.
XTMAB-16, a chimeric human-murine anti-TNFα monoclonal antibody, is on track to commence Phase 2 clinical trials later in 2023. These trials will evaluate its effectiveness in mitigating the inflammatory response characteristic of pulmonary sarcoidosis. Sarcoidosis is a chronic inflammatory disease affecting multiple organs, with a pronounced prevalence among women and individuals of African American descent. The lung is the most commonly affected organ in sarcoidosis, termed pulmonary sarcoidosis.
Kirsten Anderson, COO of Xentria, emphasized the strategic importance of this alliance, stating, “This partnership underscores Xentria’s commitment to developing comprehensive scientific solutions and advancing challenging drug development through strategic collaborations. By combining the strengths of xentria meitheal, we aim to accelerate the development of XTMAB-16. This therapy holds promise as one of the few treatments specifically in development for pulmonary sarcoidosis, offering a potential alternative to the current standard of care, which primarily involves symptomatic steroid treatments. This collaboration validates the compelling preclinical data we have gathered and the potential of XTMAB-16 to address the significant treatment gap in pulmonary sarcoidosis as we move into patient trials.”
Tom Shea, CEO of Meitheal, also commented on the partnership: “Meitheal has rapidly evolved into a fully integrated pharmaceutical company with capabilities spanning R&D, manufacturing, and commercialization. This strategic partnership with Xentria will be instrumental in furthering the advancement of XTMAB-16 for pulmonary sarcoidosis, a condition where patients currently face limited treatment options. Meitheal is excited to collaborate with Xentria and bring XTMAB-16 to patients across North America. We are also planning to establish a new branded division dedicated to the continued development and commercialization of this promising therapeutic.”
Addressing the Unmet Needs in Pulmonary Sarcoidosis Treatment
Sarcoidosis is characterized by the formation of granulomas, clusters of inflammatory cells, in various organs of the body. While sarcoidosis can affect any organ, the lungs are involved in over 90% of cases, leading to pulmonary sarcoidosis. If left untreated, pulmonary sarcoidosis can progress into a chronic and debilitating condition. Persistent lung inflammation can result in irreversible scarring (fibrosis), causing permanent lung damage and potentially leading to respiratory failure and even death. Tumor Necrosis Factor alpha (TNFα), a key cytokine in the inflammatory cascade, is believed to play a significant role in the formation of granulomas and fibrosis in sarcoidosis patients.
XTMAB-16: A Novel Therapeutic Approach
XTMAB-16 represents a novel therapeutic strategy as a chimeric human-murine anti-TNFα monoclonal antibody specifically designed for pulmonary sarcoidosis, with potential applications for extra-pulmonary manifestations as well. By selectively blocking TNFα, XTMAB-16 aims to interrupt the inflammatory pathway that drives granuloma formation in sarcoidosis. Xentria has achieved significant regulatory milestones for XTMAB-16, including Orphan Drug Designation for the New Drug Entity granted in November 2020. A Phase 1 clinical trial in healthy volunteers was successfully completed in 2022, demonstrating the drug’s initial safety profile. Currently, there are no TNFα inhibitors specifically approved for sarcoidosis, highlighting the significant unmet medical need that xentria meitheal are aiming to address. Extensive preclinical studies have validated the physio-chemical properties and pharmacological action of XTMAB-16 as a potent TNFα inhibitor, and clinical studies to further evaluate its therapeutic efficacy are underway.
About Xentria: Pioneering Biopharmaceutical Innovation
Founded in 2020, Xentria is committed to fostering collaborations within the biopharmaceutical sector to accelerate the development of innovative therapies for challenging diseases. The company’s name, derived from “centrality,” reflects its dedication to patient-centric drug development through strategic partnerships. Headquartered in Chicago, Xentria is actively contributing to the growth of the global life sciences industry, emphasizing diversity, innovation, and sustainability. For more information about Xentria, please visit www.xentria.com.
About Meitheal Pharmaceuticals: Expanding Access to Critical Medicines
Established in 2017 and also based in Chicago, Meitheal Pharmaceuticals is dedicated to the development and commercialization of affordable generic injectable medications. Since 2022, Meitheal has broadened its portfolio to include fertility treatments, biologics, and biosimilars. The company currently markets 50 FDA-approved products across a range of therapeutic areas. Meitheal has a robust pipeline with over 20 products in R&D, 21 planned launches in 2023, and 20 more under FDA review. Meitheal’s mission is to ensure consistent supply and rapid response to customer needs, providing accessible and fairly priced medications. The company is recognized as a top workplace in Chicago, embodying the Irish principle of “Meitheal,” emphasizing collaborative teamwork for the common good. To learn more about Meitheal Pharmaceuticals, visit www.meithealpharma.com.
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