KBio Announces FDA Clearance of IND Application for EV68-228-N for the Treatment of Acute Flaccid Myelitis and the First Patient Dosed in the Phase 1 Study
28 June 2024 - 3:17PM
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.
KBio Media Contact
Slavena Salve Nissan, M.D.LifeSci
Communicationssnissan@lifescicomms.com