The Mount Sinai Health System, Emergent BioSolutions (NYSE: EBS),
and ImmunoTek Bio Centers today announced that they will
collaborate to develop, manufacture, and conduct clinical trials to
evaluate Emergent’s COVID-19 hyperimmune globulin product,
COVID-HIG, including a post-exposure prophylaxis (PEP) study on
health care providers at high risk of COVID-19 infection and other
high-risk populations, with $34.6 million in funding from the U.S.
Department of Defense’s (DOD) Joint Program Executive Office for
Chemical, Biological, Radiological, and Nuclear Defense
(JPEO-CBRND).
Located in New York City, one of the early epicenters of the
outbreak, Mount Sinai has experience treating more than 10,000
COVID-19 cases and was among the very first in the United States to
initiate a convalescent plasma program in late March. A leader in
COVID-19 research and clinical care, Mount Sinai developed a
serological assay to detect SARS-CoV-2 antibodies, one of the first
to receive emergency use authorization from the U.S. Food and Drug
Administration (FDA).
“There is emerging evidence that convalescent plasma is an
effective treatment for COVID-19 patients,” said David L. Reich,
MD, President and Chief Operating Officer of The Mount Sinai
Hospital. “Therefore, hyperimmune globulin may become an effective
option in the prevention and treatment of COVID-19 currently, in
the absence of a vaccine, as well as in the future, particularly
for patients who do not develop immunity from a vaccine. It is
imperative that we have more options to prevent this terrible
disease in front-line workers and other high-risk populations and
to potentially decrease the severity of illness in those infected.
We are eager to collaborate with Emergent and ImmunoTek to advance
the science and identify effective therapeutics in the fight
against COVID-19.”
The collaborators will establish plasma collection capabilities
at Mount Sinai through an extension of ImmunoTek’s FDA-approved
establishment license and the transfer of technical know-how to
Mount Sinai. Plasma from recovered donors will support the
development and manufacture of COVID-HIG for evaluation of the
product candidate in clinical trials, and for potential emergency
use or broader patient use as allowed by the FDA.
“Our collaboration with Mount Sinai, ImmunoTek, and the
Department of Defense enhances the response to COVID-19 and
broadens our efforts to have a meaningful impact,” said Dr. Laura
Saward, SVP and Therapeutics Business Unit Head at Emergent
BioSolutions. “The front-line health care workers and others who
protect us are a top priority for reducing the impact of COVID-19.
Emergent is drawing from decades of experience with our human
hyperimmune platform, on which several products have been
FDA-licensed, to develop COVID-HIG. Our mission – to protect and
enhance life – is at the forefront of everything we do.”
Evaluating COVID-HIG in Clinical TrialsMount
Sinai and Emergent will evaluate COVID-HIG in a post-exposure
prophylaxis study in individuals at high risk of exposure to
COVID-19, such as front-line health care workers and military
personnel.
The clinical research program is designed to assess whether
prophylaxis with COVID-HIG could help protect individuals at high
risk of exposure and limit the spread of disease. Under the
agreement with the JPEO-CBRND, Emergent will collaborate to collect
convalescent plasma to manufacture COVID-HIG for use in a clinical
study under a potential Expanded Access Program to support military
personnel.
Establishing Sustainable Plasma Collection
CapabilitiesImmunoTek will provide technical, scientific,
and industry expertise in plasma collection and will extend its FDA
license as an approved source plasma collection establishment to
enable plasma collection onsite at Mount Sinai. ImmunoTek will also
provide staff training and compliance information to assist in
establishing standard operating procedures and plasma criteria.
Mount Sinai intends to collect convalescent plasma from its broad
pool of eligible donors to support Emergent’s manufacture of
COVID-HIG and the evaluation of the product candidate in clinical
trials, and for potential emergency use or broader patient use as
allowed by the FDA.
“This unprecedented public health crisis is a critical moment
for Americans to donate plasma,” said Jerome Parnell III, CEO and
President, ImmunoTek Bio Centers. “Specifically, blood plasma
donors from New York impacted by the pandemic could unlock the
potential of a viable hyperimmune globulin product to protect our
health care providers, military, and first responders, and to treat
patients with severe complications from COVID-19. Our unique
collaboration honors our hero donors while highlighting the
importance of expanding plasma collection capabilities across
mainstream communities and diverse municipalities in the fight
against COVID-19 and other rare diseases.”
Emergent will support ImmunoTek and Mount Sinai in other
regulatory and compliance efforts related to plasma collection and
supply, as well as activities leading up to an Investigational New
Drug application submission to the FDA.
Advancing COVID-HIG With U.S. Government
Support In addition to receiving DOD funding to advance a
post-exposure prophylaxis indication for COVID-HIG, Emergent was
awarded $14.5 million in April by the U.S. Department of Health and
Human Services (HHS) to develop COVID-HIG as a potential treatment
for COVID-19. The product candidate will be evaluated in clinical
studies by the National Institute of Allergy and Infectious
Diseases (NIAID), part of the National Institutes of Health (NIH),
as a potential treatment in hospitalized patients and patients at
high risk of progression to severe disease. Emergent will produce
investigational COVID-HIG material from the plasma collected at
Mount Sinai to support the post-exposure prophylaxis and treatment
clinical trials, for which Mount Sinai will serve as a study
site.
"COVID-19 outbreaks in the military cause a significant risk to
readiness and the ability to conduct training and perform our
mission. Military training is often conducted in close contact as a
unit or team, which makes social distancing nearly impossible. Our
goal is to deliver medical solutions to enable military readiness.
Knowing that HIG has been used in other disease outbreaks
successfully as a prophylaxis, we are excited to partner with
Emergent to develop this potential solution for the military and
the nation,” said Army Col. Ryan Eckmeier, the JPEO-CBRND’s Joint
Project Manager for Chemical, Biological, Radiological, and Nuclear
Medical (JPM CBRN Medical).
About Hyperimmune GlobulinHyperimmune globulin,
sometimes referred to as polyclonal antibodies, is a concentrated
antibody product derived from the antibody-rich plasma of people
who were previously infected with and recovered from an illness; in
this case, COVID-19 caused by the virus SARS-CoV-2. In order to
produce plasma-derived therapeutics that can be administered to
patients in need, plasma must be collected from a pool of human
donors and then manufactured, or fractioned, into specialized
therapeutic products. Hyperimmune globulin treatments have been
used successfully to treat other viruses.
About the Mount Sinai Health SystemThe Mount
Sinai Health System is New York City's largest academic medical
system, encompassing eight hospitals, a leading medical school, and
a vast network of ambulatory practices throughout the greater New
York region. Mount Sinai is a national and international source of
unrivaled education, translational research and discovery, and
collaborative clinical leadership ensuring that we deliver the
highest quality care—from prevention to treatment of the most
serious and complex human diseases. The Health System includes more
than 7,200 physicians and features a robust and continually
expanding network of multispecialty services, including more than
400 ambulatory practice locations throughout the five boroughs of
New York City, Westchester, and Long Island. The Mount Sinai
Hospital is ranked No. 14 on U.S. News & World
Report's "Honor Roll" of the Top 20 Best Hospitals in the
country and the Icahn School of Medicine as one of the Top 20 Best
Medical Schools in country. Mount Sinai Health System hospitals are
consistently ranked regionally by specialty and our physicians in
the top 1% of all physicians nationally by U.S. News &
World Report.
For more information,
visit https://www.mountsinai.org or find Mount Sinai
on Facebook, Twitter and YouTube.
About Emergent BioSolutionsEmergent
BioSolutions is a global life sciences company whose mission is to
protect and enhance life. Through our specialty products and
contract development and manufacturing services, we are dedicated
to providing solutions that address public health threats. Through
social responsibility, we aim to build healthier and safer
communities. We aspire to deliver peace of mind to our patients and
customers so they can focus on what’s most important in their
lives. In working together, we envision protecting or enhancing 1
billion lives by 2030. For more information visit
www.emergentbiosolutions.com. Find us on LinkedIn and follow us on
Twitter @emergentbiosolu and Instagram @life_at_emergent.
About ImmunoTek Bio Centers LLCImmunoTek Bio
Centers is an emerging bio-tech company committed to the safe
collection and procurement of human blood plasma from the public.
The management team has extensive experience in the blood, plasma,
and biopharma industries. Through contracts and strategic
agreements with pharmaceutical companies, IMMUNOTEK is fully
capable of constructing, opening, FDA/EU licensing, and managing
multiple plasma collection sites and plasma supply contracts in
order to meet on going demand in the plasma proteins therapeutics
market. Growth of current therapeutic drugs and vaccines as well as
additional new therapeutic indications expected to put considerable
strain on global blood plasma supply. IMMUNOTEK currently owns and
operates plasma collection centers in the USA and has over 40
collection centers in development through 2020. For more
information, please visit www.immunotek.com.
About the JPEO-CBRNDThe Joint Program Executive
Office for Chemical, Biological, Radiological and Nuclear Defense
(JPEO-CBRND) protects the Joint Force by providing medical
countermeasures and defense equipment against chemical, biological,
radiological and nuclear threats. As an effective DoD acquisition
program, the JPEO-CBRND’s vision is a resilient Joint Force enabled
to fight and win unencumbered by a CBRN environment; championed by
innovative, agile, results-oriented acquisition professionals. Its
Joint Project Manager for Chemical, Biological, Radiological, and
Nuclear Medical (JPM CBRN Medical) facilitates the advanced
development and acquisition of medical solutions to combat CBRN and
emerging threats. JPM CBRN Medical works with JPEO-CBRND’s Joint
Project Lead for Chemical, Biological, Radiological and Nuclear
Defense - Enabling Biotechnologies to provide new and improved
medical countermeasures to enable a single treatment for many
threats, rapid medical countermeasure responses, genomic sequencing
and the capability to diagnose CBRN threats before the onset of
symptoms. To learn more about JPEO-CBRND’s COVID-19 response, visit
https://www.jpeocbrnd.osd.mil/coronavirus.
Emergent BioSolutions Safe Harbor StatementThis
press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
Any statements, other than statements of historical fact, including
statements regarding our ability to collect convalescent plasma,
develop COVID-HIG for prophylaxis or treatment, obtain FDA approval
or authorization for emergency or broader patient use are
forward-looking statements. These forward-looking statements are
based on our current intentions, beliefs and expectations regarding
future events. We cannot guarantee that any forward-looking
statement will be accurate. Investors should realize that if
underlying assumptions prove inaccurate or unknown risks or
uncertainties materialize, actual results could differ materially
from our expectations. Investors are, therefore, cautioned not to
place undue reliance on any forward-looking statement. Any
forward-looking statement speaks only as of the date of this press
release, and, except as required by law, we do not undertake to
update any forward-looking statement to reflect new information,
events or circumstances.
There are a number of important factors that could cause the
company's actual results to differ materially from those indicated
by such forward-looking statements, including the success of the
collaboration and planned development programs; the timing of and
our ability to obtain and maintain regulatory authorizations or
approvals; and our commercialization, marketing and manufacturing
capabilities. The foregoing sets forth many, but not all, of the
factors that could cause actual results to differ from our
expectations in any forward-looking statement. Investors should
consider this cautionary statement, as well as the risk factors
identified in our periodic reports filed with the SEC, when
evaluating our forward-looking statements.
Contacts:
Mount Sinai Health SystemElizabeth
DowlingDirector, Media
Relations347-541-0212elizabeth.dowling@mountsinai.org
Emergent
BioSolutionsMedia:Miko B. NeriSenior
Director, Corporate Communications240-631-3392nerim@ebsi.com
Investor:Robert G. BurrowsVice President,
Investor Relations240-631-3280burrowsr@ebsi.com
ImmunoTek Bio CentersPam Farris Executive
Administrative Assistant
337-500-1294pfarris@immunotek.com
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