KBio Gets FDA Nod for IND of EV68-228-N in Acute Flaccid Myelitis, Starts Phase 1 Trial

KBio, a leading developer of biologics using plant-based production systems, announced that the United States Food and Drug Administration (FDA) has approved the investigational new drug (IND) application for EV68-228-N. This human monoclonal IgG1 targets the capsid of enterovirus D68 (EV-D68) and is designed as an intravenous therapeutic for treating acute flaccid myelitis (AFM). This drug is produced using KBio’s proprietary Rapid Protein Production Platform (RP3), which utilizes Nicotiana benthamiana for biologics manufacturing. The FDA reviewed KBio’s Drug Master File (DMF) as part of this IND submission.

The ongoing Phase 1 trial is a placebo-controlled, double-blinded study that evaluates the safety and pharmacokinetics of single ascending doses of EV68-228-N administered intravenously in healthy adult volunteers. The first patient was dosed at the Vanderbilt University Medical Center (VUMC).

The discovery of EV68-228 can be credited to Dr. Matthew Vogt during his postdoctoral fellowship in the Crowe laboratory at VUMC. The study is being conducted in collaboration with Dr. Vogt and Dr. C. Buddy Creech, the principal investigator and director of the Vanderbilt Vaccine Research Program. KBio and ZabBio transitioned the antibody from research to this first-in-human study by leveraging the RP3 platform, showcasing their regulatory expertise in developing plant-produced biopharmaceuticals.

Patrick Doyle, the chief executive officer at KBio, expressed satisfaction with the FDA’s IND clearance for EV68-228-N in AFM, a rare and severe neurologic condition characterized by muscle weakness and progressive paralysis. AFM cases have been increasing since 2014, and currently, there are no approved disease-specific treatments. Doyle highlighted that using their proprietary plant-based RP3 platform allows for the efficient and cost-effective production of a monoclonal antibody directed against enterovirus, the primary cause of AFM. The platform can produce high-quality biologics within 8-10 weeks, offering a swift manufacturing process. Doyle emphasized the company’s commitment to continued study enrollment and providing hope for AFM patients.

The trial includes 36 healthy volunteers aged 18 to 49. Six participants will receive a placebo, while the remaining 30 will receive either a 3, 10, or 30 mg/kg dose of EV68-228-N intravenously. Researchers will monitor the first two participants in each group receiving the treatment for at least 72 hours before administering it to others. Participants will undergo nine subsequent in-person examinations over the next 120 days as part of the safety evaluation.

The National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH), is sponsoring the trial. It is being conducted in collaboration with multiple academic centers through the NIAID-funded Infectious Diseases Clinical Research Consortium (IDCRC), which includes the Vaccine and Treatment Evaluation Units (VTEU).

Monoclonal antibodies have broad applications across various therapeutic areas, but manufacturing challenges exist. KBio’s eco-friendly production system offers unprecedented speed and scalability, enabling the development of monoclonal antibody therapeutics and vaccines that address a wide range of public health challenges.

KBio is committed to creating a new generation of biologics using its plant-based RP3 platform, which can develop drug candidates much faster and more cost-effectively than traditional methods. The company focuses on discovering and developing monoclonal antibodies targeting validated pathways for immunological diseases. KBio’s platform also excels in addressing public health challenges requiring rapid development and large-scale production of vaccines and other bioactives. Formed in December 2021, KBio operates as a subsidiary of BAT with facilities in the UK and U.S.