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Xentria And Meitheal Enter Sarcoidosis Therapy Licensing Deal

Xentria has entered an exclusive multi-year licensing agreement with Meitheal Pharmaceuticals for the marketing of Xentria's new biologic, XTMAB-16, to treat pulmonary sarcoidosis in North America. 

XTMAB-16 is a lead candidate of Xentria and an anti-TNFα monoclonal antibody.

Meitheal will obtain sole rights to market the biologic in North America while Xentria will oversee its clinical development.

Xentria will hold the rights to market the product in all other regions, and will be entitled to $45m in upfront payments and up to $35m on regulatory submission and approval.

The company is also eligible to receive milestone-based royalty payments exceeding $600m for licensing.

The antibody will be tested in Phase II clinical trials in 2023 to analyse its potential to reduce the inflammatory response associated with pulmonary sarcoidosis. 

In 2022, Xentria concluded a Phase I trial of the biologic in healthy subjects.

Xentria COO Kirsten Anderson stated: "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. 

"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."

Chicago Biopharma Spinout Moves To Commercialize Novel Drug

Chicago biopharma startup Xentria is gearing up to commercialize a rare inflammatory cell disease drug in a nearly $700 million licensing deal with Meitheal Pharmaceuticals, a local drugmaker from which Xentria spun out.

The two companies reached an exclusive licensing agreement, announced today, that will manufacture and distribute Xentria's biologic and monoclonal antibody candidate, XTMAB-16. The drug, Xentria's first and only, is designed to treat pulmonary sarcoidosis, a chronic, multisystem inflammatory disorder that commonly affects the lungs and mostly occurs in women and Black people.

As part of the agreement, Meitheal will pay Xentria $45 million in a combination of upfront cash and other payments as the firm hits development milestones. An additional amount up to $35 million will be paid to Xentria if the drug gains approval from the U.S. Food & Drug Administration. And Xentria will also be eligible to collect about $600 million in royalty payments, at which point XTMAB-16's intellectual property will transfer to Meitheal's parent company, Hong-Kong King Friend Industry, a subsidiary of China-based Nanjing King-Friend Biochemical Pharmaceutical.

The drug, given to patients by intravenous infusion, is slated to be tested in Phase 2 human clinical trials later this year. Xentria claims XTMAB-16 is the only drug of its kind to treat pulmonary sarcoidosis.

"XTMAB-16, we believe, will have the ability to get multiple patents and (intellectual property protections) around the project," says Tom Shea, CEO of Meitheal and president of Xentria.

The licensing agreement with Meitheal only applies to distribution in North America, says Xentria Chief Operating Officer Kirsten Anderson, meaning Xentria retains its rights to commercialize XTMAB-16 in other countries with other partners. Anderson says Xentria will begin looking to enter countries in Europe first.

To date, Xentria has been funded by about $38 million from undisclosed investors and employs about 12 people.

Today's deal also represents a transition for Meitheal from a generic drugmaker into one that produces brand-name orphan drugs, an industry term for medications that treat rare diseases.

"This deal, from the Meitheal perspective, is kind of that transition — the inflection point to do something outside of generics," Shea says. "It's a whole new world for us (today)."

Since launching in 2017, Meitheal has primarily focused on the development and distribution of now 50 generic and biologic drugs. With the spinout of Xentria in 2020, the firm put resources into ambitions to develop high-value drugs with patent protection and exclusivity rights.

"Xentria was really formed around this project," Shea explains, adding that Meitheal will soon begin developing biosimilar drugs, too.

Meitheal, recently listed No. 4 on Crain's Fast 50 list, projects generating $270 million in revenue this year, with a net margin of $67.5 million. Meitheal employs nearly 100 employees, Shea says.

Xentria And Meitheal Pharmaceuticals Announce Exclusive Licensing Agreement For XTMAB-16 In North America

CHICAGO--(BUSINESS WIRE)--Jun 27, 2023--

Xentria Inc., a clinical-stage biotherapeutics company focused on developing therapeutics to address unmet clinical needs, and Meitheal Pharmaceuticals, Inc. 1, today announced an exclusive multi-year licensing agreement to commercialize its lead candidate, and novel biologic, XTMAB-16 for pulmonary sarcoidosis in North America.

This press release features multimedia. View the full release here: https://www.Businesswire.Com/news/home/20230627396707/en/

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 and an additional amount of up to $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.

XTMAB-16 - an anti-TNFα monoclonal antibody - will be tested in Phase 2 clinical trials later this year for its ability to reduce an inflammatory response believed to occur in patients living with pulmonary sarcoidosis. Sarcoidosis is a chronic, multisystem inflammatory disorder that more commonly occurs in women and African Americans.

Kirsten Anderson, COO of Xentria said: "This strategic partnership further demonstrates Xentria's ability to build comprehensive scientific solutions to advance challenging drug development through valued partnerships. 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. 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."

"Meitheal has established itself as a fully integrated R&D, manufacturing and commercial pharmaceutical company and this strategic partnership will enable further advancement of XTMAB-16 for pulmonary sarcoidosis where patients face a significant gap in treatment", said Tom Shea, CEO of Meitheal. "Meitheal is thrilled to be collaborating with Xentria, as we seek to bring XTMAB-16 to patients in North American and we look forward to creating a new branded division to further its advancement and potential commercialization."

About Sarcoidosis

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% 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.

About XTMAB-16

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. Through dedicated regulatory work and focus from Xentria's team, 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.

About Xentria

Established in 2020, Xentria works across biopharmaceutics communities creating innovative and authentic collaborations and partnerships that advance challenging drug development. Xentria, derived from "centrality", is dedicated to delivering customized approaches to ambitious drug innovation through meaningful patient engagement and effective partnerships. Headquartered in Chicago, Xentria is taking the lead to support surging life sciences initiatives for global audiences, while nurturing diversity, individualism, and sustainability.

To learn more about Xentria visit www.Xentria.Com.

About Meitheal Pharmaceuticals

Founded in 2017 and based in Chicago, Meitheal Pharmaceuticals is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and biosimilar products. Meitheal currently markets 50 US Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of the end of April 2023, Meitheal, directly or through its partners, has over 20 products in the research and development phase, 21 products planned for launch in 2023, and an additional 20 products under review by the FDA. Meitheal's mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers' needs. Ranked among the top 100 Crain's Best Places to Work in Chicago, Meitheal emulates the traditional Irish guiding principle we are named for — Meitheal (Mee·hall): working together toward a common goal, for the greater good.

Learn more about who we are and what we do at www.Meithealpharma.Com.

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1 Meitheal's parent company, Hong Kong King-Friend Industry Co., Ltd., is also party to the exclusive licensing agreement for payment and potential intellectual property transfer purposes.

View source version on businesswire.Com:https://www.Businesswire.Com/news/home/20230627396707/en/

CONTACT: MEDIA

FTI Consulting

Jacqui Wilmot, Senior Director

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jacqui.Wilmot@fticonsulting.Com

FTI Consulting

Erin Pezza, Director

347.237.2043

erin.Pezza@fticonsulting.Com

KEYWORD: ILLINOIS UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: HEALTH GENERAL HEALTH CLINICAL TRIALS RESEARCH SCIENCE PHARMACEUTICAL BIOTECHNOLOGY

SOURCE: Xentria Inc.

Copyright Business Wire 2023.

PUB: 06/27/2023 06:00 AM/DISC: 06/27/2023 05:59 AM

http://www.Businesswire.Com/news/home/20230627396707/en

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