Important Regulatory Milestone Provides Runway to Move XTMAB-16 into the Clinical Phase
CHICAGO, IL, USA I March 03, 2021 I Xentria Inc., a biopharmaceutical company focused on developing novel biologics and biosimilars to address unmet clinical needs, today announced that it submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) on February 26, 2021. The IND application supports a proposed indication for its intravenous TNF-alpha (TNF-α) inhibitor, XTMAB-16, for treatment of sarcoidosis, a potentially life-threatening inflammatory disease. TNF-α is a proinflammatory cytokine that has been implicated in the pathogenesis of sarcoidosis and associated granuloma formation. The Company previously received Orphan Drug Designation (ODD) in November 2020 from the FDA for XTMAB-16.
“With no TNF-α inhibitor currently approved for the treatment of sarcoidosis, this IND application brings us a step closer to a new treatment option for underserved sarcoidosis patients,” said Thomas Shea, President of Xentria. “We are excited about advancing XTMAB-16 into the clinical phase as we believe that this novel biologic product will be key in the treatment of this rare disease. We anticipate beginning our Phase 1 trial as soon as possible after FDA review.”
The IND application includes data, reports and overview summaries of numerous studies that characterize the monoclonal antibody binding, cross-reactivity, the pharmacology, pharmacokinetics, and toxicology of XTMAB-16 both in vitro and in vivo, including representative disease models. Additionally, the application describes the manufacture of the drug substance and drug product to be used in human clinical trials. The main purpose of the IND is to share with the FDA the extensive non-clinical data supporting an acceptable safety profile when XTMAB-16 is first administered to humans (Phase 1 First-in Human). The FDA will review this application and determine the acceptability of the data before Xentria begins this first clinical trial, which could be as early as Q2 2021. It is possible that the FDA will require additional information.
Founded in April 2020, Xentria is an innovative biopharmaceutical company with the primary focus of building an expansive product pipeline of cost-effective and efficacious biologics and biosimilars to treat rare diseases, immunologic, metabolic diseases, musculoskeletal disorders, and certain types of cancer.
About Sarcoidosis
Sarcoidosis is a chronic, multisystem inflammatory disorder of unknown etiology that is characterized by the presence of noncaseating epithelioid granulomas, accompanied by infiltration of mononuclear cells and destruction of microarchitecture. The disease can affect the skin, eyes, heart, and central nervous system, and >90% of cases involve the lungs. Symptoms range from asymptomatic to severe—including respiratory insufficiency, blindness, neurological disease, and cardiac death. While medications for systemic organ involvement often control this disease, some patients fail to respond to initial treatments and require additional targeted therapy, resulting in significant costs and treatment burdens. This disease presents a significant unmet medical need and a very important area of research and development for Xentria.
About XTMAB-16
XTMAB-16 is a chimeric human-murine IgG1κ anti-TNFα monoclonal antibody with a molecular weight of ~149 kDa being developed as a novel biologic product for the treatment of patients with sarcoidosis with or without extrapulmonary involvement. No TNF-α 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 TNF-α inhibitor.
About Xentria
Xentria, whose name stems from the word “centrality” was founded in 2020 and is an innovative biopharmaceutics company whose primary focus is to build an expansive product pipeline of cost-effective and efficacious biologics and biosimilars to address critical unmet need for patients suffering from rare diseases, immunologic, metabolic, and musculoskeletal disorders, as well as oncology. Headquartered in Chicago, with partners in Israel and China, the company is dedicated to research and development, clinical science, manufacturing, and commercialization and driven to treat the clinical and social burdens of diseases while fostering sustainable growth.
To learn more about Xentria visit www.xentria.com
SOURCE: Xentria
Post Views: 226
Important Regulatory Milestone Provides Runway to Move XTMAB-16 into the Clinical Phase
CHICAGO, IL, USA I March 03, 2021 I Xentria Inc., a biopharmaceutical company focused on developing novel biologics and biosimilars to address unmet clinical needs, today announced that it submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) on February 26, 2021. The IND application supports a proposed indication for its intravenous TNF-alpha (TNF-α) inhibitor, XTMAB-16, for treatment of sarcoidosis, a potentially life-threatening inflammatory disease. TNF-α is a proinflammatory cytokine that has been implicated in the pathogenesis of sarcoidosis and associated granuloma formation. The Company previously received Orphan Drug Designation (ODD) in November 2020 from the FDA for XTMAB-16.
“With no TNF-α inhibitor currently approved for the treatment of sarcoidosis, this IND application brings us a step closer to a new treatment option for underserved sarcoidosis patients,” said Thomas Shea, President of Xentria. “We are excited about advancing XTMAB-16 into the clinical phase as we believe that this novel biologic product will be key in the treatment of this rare disease. We anticipate beginning our Phase 1 trial as soon as possible after FDA review.”
The IND application includes data, reports and overview summaries of numerous studies that characterize the monoclonal antibody binding, cross-reactivity, the pharmacology, pharmacokinetics, and toxicology of XTMAB-16 both in vitro and in vivo, including representative disease models. Additionally, the application describes the manufacture of the drug substance and drug product to be used in human clinical trials. The main purpose of the IND is to share with the FDA the extensive non-clinical data supporting an acceptable safety profile when XTMAB-16 is first administered to humans (Phase 1 First-in Human). The FDA will review this application and determine the acceptability of the data before Xentria begins this first clinical trial, which could be as early as Q2 2021. It is possible that the FDA will require additional information.
Founded in April 2020, Xentria is an innovative biopharmaceutical company with the primary focus of building an expansive product pipeline of cost-effective and efficacious biologics and biosimilars to treat rare diseases, immunologic, metabolic diseases, musculoskeletal disorders, and certain types of cancer.
About Sarcoidosis
Sarcoidosis is a chronic, multisystem inflammatory disorder of unknown etiology that is characterized by the presence of noncaseating epithelioid granulomas, accompanied by infiltration of mononuclear cells and destruction of microarchitecture. The disease can affect the skin, eyes, heart, and central nervous system, and >90% of cases involve the lungs. Symptoms range from asymptomatic to severe—including respiratory insufficiency, blindness, neurological disease, and cardiac death. While medications for systemic organ involvement often control this disease, some patients fail to respond to initial treatments and require additional targeted therapy, resulting in significant costs and treatment burdens. This disease presents a significant unmet medical need and a very important area of research and development for Xentria.
About XTMAB-16
XTMAB-16 is a chimeric human-murine IgG1κ anti-TNFα monoclonal antibody with a molecular weight of ~149 kDa being developed as a novel biologic product for the treatment of patients with sarcoidosis with or without extrapulmonary involvement. No TNF-α 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 TNF-α inhibitor.
About Xentria
Xentria, whose name stems from the word “centrality” was founded in 2020 and is an innovative biopharmaceutics company whose primary focus is to build an expansive product pipeline of cost-effective and efficacious biologics and biosimilars to address critical unmet need for patients suffering from rare diseases, immunologic, metabolic, and musculoskeletal disorders, as well as oncology. Headquartered in Chicago, with partners in Israel and China, the company is dedicated to research and development, clinical science, manufacturing, and commercialization and driven to treat the clinical and social burdens of diseases while fostering sustainable growth.
To learn more about Xentria visit www.xentria.com
SOURCE: Xentria
Post Views: 226
