Human polyclonal immunotherapy platform shows
broad potential to combat infectious disease
SAB Biotherapeutics, Inc. (SAB), a clinical-stage
biopharmaceutical development company, announced its anti-MERS
immunotherapy (SAB-301) appears safe in a Phase I Clinical Trial.
Results of the study, sponsored, funded and conducted by National
Institutes of Health (NIH) were published today in The Lancet
Infectious Diseases.
Presently, there are no approved vaccines or treatments for
Middle East respiratory syndrome (MERS)–a newly discovered,
contagious and sometimes fatal respiratory illness, caused by a
virus known as MERS coronavirus (MERS-CoV). Since the first
confirmed case in Saudi Arabia in 2012, the illness has spread to
27 countries and more than 2,000 people, with a fatality rate
approaching 40%, according to the World Health Organization.
“This is the first study to show the safety of a potential
treatment for MERS,” said John H. Beigel, M.D., a medical affairs
scientist affiliated with Leidos Biomedical Research, supporting
the NIAID Division of Clinical Research, and lead investigator on
the study. “SAB-301–an experimental treatment for MERS developed
from cattle plasma–was safe, well tolerated by healthy volunteers
and had the same half-life as human-derived antibodies.”
Using plasma collected from recovered patients has been a
preferred and effective source of antibodies to combat the
pathogens associated with recent global health concerns involving
influenza, MERS, SARS and Ebola.
“Our novel immunotherapy platform goes back to nature with the
use of human polyclonal antibodies–our own body’s army–to combat
disease,” said Eddie J. Sullivan, PhD, SAB Biotherapeutics
president and CEO. “The use of human convalescent plasma as a
treatment has been proven effective, but short in supply.
Conversely, about 10 of our animals could serve the current MERS
need.”
SAB’s novel DiversitAb™ platform enables the rapid production of
large amounts of targeted human polyclonal antibodies, leveraging
transchromosomic cattle (Tc Bovine™) that have been genetically
designed to produce human antibodies (immunoglobulin G) rather than
bovine in response to an antigen. Animal antibodies have been made
in rabbits, sheep and horses. However, SAB’s platform is the first
to produce fully human antibodies in large animals.
“Our goal is to leverage our immunotherapy platform as a
countermeasure against emerging infectious diseases,” added
Sullivan. “We have the ability to develop antibody treatments
against a variety of infectious diseases in a much faster
timeframe, as few as three months, and in much greater volume than
currently possible.”
To produce SAB-301, Tc Bovine were vaccinated with a MERS
antigen provided by Novavax. Within a brief period of time, they
produced significant amounts of fully human antibodies to combat
the virus. Plasma was collected (in a similar manner as from human
plasma donors), then purified to isolate the antibodies becoming
the therapeutic treatment.
In the study, 28 volunteers were treated with SAB-301 and 10
with a placebo. Six groups of volunteers received different
intravenous doses and were assessed six times over 90 days.
Complaints were common among the treatment and placebo group
including mild headache and cold symptoms.
Funding for the Phase I clinical manufacturing was provided by a
$5.3 million contract from Biomedical Advanced Research and
Development Authority (BARDA), including an allotment for Phase II.
Pre-clinical data from studies conducted by global infectious
disease experts at the Naval Medical Research Center, the
University of Maryland, School of Medicine and NIH paved the way
for the study.
With the trials in healthy candidates complete, Phase II trials
are planned to evaluate the potency and dosing in patients
suffering with MERS in endemic countries.
“We’re also advancing treatments for Ebola, influenza and Zika,”
Sullivan said. “SAB is dedicated to partnering with government and
other organizations to address current and future human health
threats to ultimately save lives.”
About SAB Biotherapeutics, Inc.
SAB Biotherapeutics, Inc. (SAB), headquartered in Sioux Falls,
S.D. is a clinical stage, biopharmaceutical company leading the
science and manufacturing of antibody therapeutics. Utilizing some
of the most advanced antibody science in the world, SAB is
delivering the world’s first large-scale platform to create
immunoglobulins. This natural production platform holds the
potential for treatment of public health problems, rare conditions,
long-term diseases and global pandemic threats.
About the National Institutes of Health (NIH):
NIH, the nation's medical research agency, includes 27
Institutes and Centers and is a component of the U.S. Department of
Health and Human Services. NIH is the primary federal agency
conducting and supporting basic, clinical, and translational
medical research, and is investigating the causes, treatments, and
cures for both common and rare diseases.
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SAB Biotherapeutics, Inc.Melissa Ullerich, +1
605-695-8350mullerich@sabbiotherapeutics.comorNIAID/NIHKen
Pekoc, +1 301-402-1663kpekoc@niaid.nih.gov