• The United States Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for EV68-228-N, a human monoclonal IgG1 against the capsid of enterovirus D68 (EV-D68) designed as an intravenous therapeutic for the treatment of acute flaccid myelitis (AFM)
• The Phase 1 study is ongoing, and the first patient has been dosed at the Vanderbilt University Medical Center (VUMC)
LONDON, UK I June 28, 2024 I KBio, one of the leading developers of new biological treatments derived from a plant-based production system, today announced that the United States Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for EV68-228-N, a human monoclonal IgG1 against the capsid of enterovirus D68 (EV-D68) designed as an intravenous therapeutic for the treatment of acute flaccid myelitis (AFM). EV68-228-N is being manufactured by KBio using its proprietary Rapid Protein Production Platform (RP3), which allows for the production of biologics using Nicotiana benthamiana. KBio’s Drug Master File (DMF) was reviewed by the FDA as part of this IND submission.
The Phase 1 placebo-controlled double-blinded study is evaluating the safety and pharmacokinetics of single ascending doses of EV68-228-N following intravenous administration in healthy adult volunteers. The first patient has been dosed at the Vanderbilt University Medical Center (VUMC).
Dr. Matthew Vogt discovered EV68-228 as a postdoctoral fellow in the Crowe laboratory at the Vanderbilt University Medical Center. In partnership with Dr. Vogt and Dr. C. Buddy Creech, the study’s principal investigator and director of the Vanderbilt Vaccine Research Program, KBio and ZabBio successfully transitioned the antibody from research and discovery into this first-in-human study by leveraging the RP3 platform and the combined decades of regulatory expertise in developing plant-produced biopharmaceuticals at KBio and ZabBio.
“We’re pleased that the FDA has granted IND clearance for EV68-228-N in AFM, which is a rare and serious neurologic condition that can cause symptoms such as muscle weakness and progressive paralysis. AFM cases have been rising since 2014, and there are no approved disease-specific treatments,” said Patrick Doyle, chief executive officer at KBio. “Using our proprietary plant-based RP3 platform, we’re able to manufacture a monoclonal antibody that is directed against enterovirus, the most common cause of AFM. This novel platform was developed to produce high-quality biologics in an unprecedented 8-10 weeks, which allows for cost-effective and efficient production. We’re looking forward to continued enrollment in the study and providing a sense of renewed hope for these patients.”
The trial will include 36 healthy volunteers ages 18 to 49. Six will receive a placebo (control group) and 30 (in groups of 10) will receive either a 3, 10 or 30 mg/kg dose of EV68-228-N intravenously. As part of the safety evaluation, scientists will monitor the first two participants in each group receiving the experimental treatment for at least 72 hours before others receive the infusion. Researchers will then monitor and evaluate participants during nine subsequent in-person examinations during the next 120 days.
The trial is being sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH). It is being conducted in collaboration with multiple academic centers through the NIAID-funded Infectious Diseases Clinical Research Consortium (IDCRC), which encompasses the Institute’s long-standing Vaccine and Treatment Evaluation Units (VTEU).
Monoclonal antibodies have expansive applications across diverse therapeutic areas. However, limitations exist in manufacturing these potentially life-saving medicines. Leveraging an eco-friendly production system that offers unprecedented speed and scalability, KBio develops monoclonal antibody therapeutics and vaccines with the potential to address a broad range of indications and public health challenges.
About KBio
KBio aims to create a new generation of biologics using its plant-based platform, Rapid Protein Production Platform (RP3), which has demonstrated the ability to create drug candidates at a fraction of the time and cost of conventional platforms. The Company is focused on discovering and developing monoclonal antibodies targeting validated pathways for immunological diseases and due to the speed and accuracy of its antibody production system, is positioned well to develop fast follower therapies against validated drug targets. KBio’s plant-based platform also has unique capabilities for addressing public health challenges where rapid development and large-scale production of vaccines and other bioactives are critical. Through a third-party partner, the Company is working with several health organizations that are funding its public health-specific pipeline.
Formed in December 2021, KBio is a subsidiary of BAT with operations in the UK and U.S. For more information, please visit www.kbio.com.
About Infectious Disease Clinical Research Consortium (IDCRC)
The IDCRC, consisting of the Vaccine Treatment and Evaluation Units (VTEUs) and the IDCRC Leadership Group (UM1AI148684), was formed in 2019 to support the planning and implementation of infectious diseases clinical research that efficiently addresses the scientific priorities of NIAID. The consortium includes infectious diseases leaders and clinical researchers from Emory University, University of Maryland School of Medicine, Baylor College of Medicine, Cincinnati Children’s Medical Center and University of Cincinnati, FHI360, Fred Hutchinson Cancer Research Center, Johns Hopkins University, Kaiser Permanente Washington Health Research Institute, New York University, Saint Louis University, Vanderbilt University Medical Center, University of Alabama at Birmingham, University of Rochester, University of Washington, and NIAID. View other IDCRC studies.
SOURCE: KBio
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• The United States Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for EV68-228-N, a human monoclonal IgG1 against the capsid of enterovirus D68 (EV-D68) designed as an intravenous therapeutic for the treatment of acute flaccid myelitis (AFM)
• The Phase 1 study is ongoing, and the first patient has been dosed at the Vanderbilt University Medical Center (VUMC)
LONDON, UK I June 28, 2024 I KBio, one of the leading developers of new biological treatments derived from a plant-based production system, today announced that the United States Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for EV68-228-N, a human monoclonal IgG1 against the capsid of enterovirus D68 (EV-D68) designed as an intravenous therapeutic for the treatment of acute flaccid myelitis (AFM). EV68-228-N is being manufactured by KBio using its proprietary Rapid Protein Production Platform (RP3), which allows for the production of biologics using Nicotiana benthamiana. KBio’s Drug Master File (DMF) was reviewed by the FDA as part of this IND submission.
The Phase 1 placebo-controlled double-blinded study is evaluating the safety and pharmacokinetics of single ascending doses of EV68-228-N following intravenous administration in healthy adult volunteers. The first patient has been dosed at the Vanderbilt University Medical Center (VUMC).
Dr. Matthew Vogt discovered EV68-228 as a postdoctoral fellow in the Crowe laboratory at the Vanderbilt University Medical Center. In partnership with Dr. Vogt and Dr. C. Buddy Creech, the study’s principal investigator and director of the Vanderbilt Vaccine Research Program, KBio and ZabBio successfully transitioned the antibody from research and discovery into this first-in-human study by leveraging the RP3 platform and the combined decades of regulatory expertise in developing plant-produced biopharmaceuticals at KBio and ZabBio.
“We’re pleased that the FDA has granted IND clearance for EV68-228-N in AFM, which is a rare and serious neurologic condition that can cause symptoms such as muscle weakness and progressive paralysis. AFM cases have been rising since 2014, and there are no approved disease-specific treatments,” said Patrick Doyle, chief executive officer at KBio. “Using our proprietary plant-based RP3 platform, we’re able to manufacture a monoclonal antibody that is directed against enterovirus, the most common cause of AFM. This novel platform was developed to produce high-quality biologics in an unprecedented 8-10 weeks, which allows for cost-effective and efficient production. We’re looking forward to continued enrollment in the study and providing a sense of renewed hope for these patients.”
The trial will include 36 healthy volunteers ages 18 to 49. Six will receive a placebo (control group) and 30 (in groups of 10) will receive either a 3, 10 or 30 mg/kg dose of EV68-228-N intravenously. As part of the safety evaluation, scientists will monitor the first two participants in each group receiving the experimental treatment for at least 72 hours before others receive the infusion. Researchers will then monitor and evaluate participants during nine subsequent in-person examinations during the next 120 days.
The trial is being sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH). It is being conducted in collaboration with multiple academic centers through the NIAID-funded Infectious Diseases Clinical Research Consortium (IDCRC), which encompasses the Institute’s long-standing Vaccine and Treatment Evaluation Units (VTEU).
Monoclonal antibodies have expansive applications across diverse therapeutic areas. However, limitations exist in manufacturing these potentially life-saving medicines. Leveraging an eco-friendly production system that offers unprecedented speed and scalability, KBio develops monoclonal antibody therapeutics and vaccines with the potential to address a broad range of indications and public health challenges.
About KBio
KBio aims to create a new generation of biologics using its plant-based platform, Rapid Protein Production Platform (RP3), which has demonstrated the ability to create drug candidates at a fraction of the time and cost of conventional platforms. The Company is focused on discovering and developing monoclonal antibodies targeting validated pathways for immunological diseases and due to the speed and accuracy of its antibody production system, is positioned well to develop fast follower therapies against validated drug targets. KBio’s plant-based platform also has unique capabilities for addressing public health challenges where rapid development and large-scale production of vaccines and other bioactives are critical. Through a third-party partner, the Company is working with several health organizations that are funding its public health-specific pipeline.
Formed in December 2021, KBio is a subsidiary of BAT with operations in the UK and U.S. For more information, please visit www.kbio.com.
About Infectious Disease Clinical Research Consortium (IDCRC)
The IDCRC, consisting of the Vaccine Treatment and Evaluation Units (VTEUs) and the IDCRC Leadership Group (UM1AI148684), was formed in 2019 to support the planning and implementation of infectious diseases clinical research that efficiently addresses the scientific priorities of NIAID. The consortium includes infectious diseases leaders and clinical researchers from Emory University, University of Maryland School of Medicine, Baylor College of Medicine, Cincinnati Children’s Medical Center and University of Cincinnati, FHI360, Fred Hutchinson Cancer Research Center, Johns Hopkins University, Kaiser Permanente Washington Health Research Institute, New York University, Saint Louis University, Vanderbilt University Medical Center, University of Alabama at Birmingham, University of Rochester, University of Washington, and NIAID. View other IDCRC studies.
SOURCE: KBio
Post Views: 2,056
