ModeX Therapeutics Inc., an OPKO Health, Inc. company (NASDAQ:
OPK), has been awarded a contract from the Biomedical Advanced
Research and Development Authority (BARDA), part of the
Administration for Strategic Preparedness and Response at the
U.S. Department of Health and Human Services (HHS), to advance a
platform and specific candidates designed to address a range of
public health threats in viral infectious diseases.
The awarded funding will enable research, development and
clinical evaluation of potent multispecific antibodies, based on
ModeX proprietary MSTAR technology. MSTAR is a flexible
plug-and-play platform able to incorporate four to six independent
antibody binding sites into a single molecule, dramatically
expanding their therapeutic potential while enabling rapid
responses to emerging infections and their viral variants,
including COVID-19, influenza, and other pathogens.
The SARS-CoV-2 program is supported by HHS’ Project NextGen,
which is dedicated to advancing a pipeline of innovative vaccines
and therapeutics against COVID-19. The BARDA contract includes an
initial $59 million for the development, manufacturing, and
execution of a Phase 1 clinical trial for a next-generation MSTAR
multispecific antibody with broad neutralizing activity against
known variants of SARS-CoV-2. Such antibodies have the potential
for both treatment and prevention of COVID-19.
This initiative builds on a collaboration between ModeX and the
Vaccine Research Center of the National Institutes of Health (NIH)
for the discovery and characterization of novel therapeutic
antibodies against SARS-CoV-2. Additional funding of up to $109
million may be available from BARDA upon achieving particular
milestones to develop multispecific antibodies targeting other
viral pathogens such as influenza. As part of the research program,
gene-based delivery methods for the multispecific antibodies will
be developed using mRNA or DNA vectors to leverage the body’s
natural protein production processes.
“We are excited to partner with BARDA to advance the potential
of our MSTAR multispecific antibody platform as a versatile
solution to major viral threats,” said Drs. Gary Nabel and Elias
Zerhouni, Co-Founders of ModeX and, respectively, President, Chief
Executive Officer of ModeX and President of OPKO. “This support
allows ModeX to evaluate promising candidates in clinical trials to
treat or prevent SARS-CoV-2 infection and explore the utility of
the platform against diverse viruses. We eagerly anticipate working
closely with BARDA to explore and further advance this innovative
platform.”
“This BARDA award represents the second major collaboration this
year built on the strength of ModeX’s research and development
programs,” added Dr. Phillip Frost, Chief Executive Officer of
OPKO. “In March 2023, ModeX entered into an exclusive worldwide
license and collaboration agreement with Merck to develop MDX2201,
its nanoparticle vaccine candidate for Epstein-Barr virus. With
BARDA’s support, ModeX is poised to advance another exciting new
technology with high potential to benefit patients.”
This project has been funded in whole or in part with federal
funds from the Department of Health and Human Services;
Administration for Strategic Preparedness and Response; Biomedical
Advanced Research and Development Authority, under contract number
75A50123C00056.
About ModeX TherapeuticsModeX Therapeutics is a
clinical-stage biopharmaceutical company developing innovative
multispecific biologics for cancer and infectious disease. Its
platforms unite the power of multiple biologics in a single
molecule to create multispecific antibodies and vaccines with
unprecedented versatility and potency in fighting complex disease.
The ModeX pipeline includes candidates against both solid and
hematologic tumors, as well as several of the world’s most pressing
viral threats. Its founding team includes globally recognized
medical innovators with proven track records of delivering
breakthroughs for patients. ModeX is an OPKO Health company based
in Natick, Massachusetts. For more information, please
visit www.modextx.com.
About OPKO Health, Inc.OPKO is a multinational
biopharmaceutical and diagnostics company that seeks to establish
industry-leading positions in large, rapidly growing markets by
leveraging its discovery, development, and commercialization
expertise and novel and proprietary technologies. For more
information, visit www.opko.com.
Cautionary Statement Regarding Forward-Looking
StatementsThis press release contains "forward-looking
statements," as that term is defined under the Private Securities
Litigation Reform Act of 1995 (PSLRA), which statements may be
identified by words such as "expects," "plans," "projects," "will,"
"may," "anticipates," "believes," "should," "intends," "estimates,"
and other words of similar meaning, including statements. These
statements concern, and these risks and uncertainties include,
among others, product candidates being developed by ModeX and/or
its collaborators or licensees and research and clinical programs
now underway or planned, including without limitation ModeX’s MSTAR
technology, and its next-generation MSTAR multispecific antibody
therapy intending to target known variants of SARS-CoV-2, as
discussed in this press release, whether additional funding of up
to $109 million will be granted to ModeX even if it were to achieve
the specified milestones, the extent to which the results from the
research and development programs conducted by ModeX and/or its
collaborators may lead to advancement of product candidates to
clinical trials, therapeutic applications, or regulatory approval;
the likelihood, timing, and scope of possible regulatory approval
and commercial launch of ModeX’s product candidates; uncertainty of
the utilization, market acceptance, and commercial success of
ModeX’s product candidates and the impact of studies (whether
conducted by ModeX or others) on any of the foregoing or any
potential regulatory approval of ModeX’s product candidates; safety
issues resulting from the administration of ModeX’s product
candidates in patients, including serious complications or side
effects in connection with the use of ModeX’s product candidates in
clinical trials; determinations by regulatory and administrative
governmental authorities which may delay or restrict ModeX’s
ability to continue to develop or commercialize its product
candidates; competing drugs and product candidates that may be
superior to, or more cost effective than, ModeX’s product
candidates; unanticipated expenses; the costs of developing
products; the potential for any license or collaboration,
(including ModeX’s agreement with Merck) to be cancelled or
terminated; the impact of public health outbreaks, epidemics, or
pandemics (such as the COVID-19 pandemic) on ModeX’s business; and
risks associated with intellectual property of other parties and
pending or future litigation relating thereto, as well as other
non-historical statements, including statements about our
expectations, products, beliefs or intentions regarding ModeX,
projected future clinical developments, the potential for ModeX
products and pipeline and any other statements regarding OPKO’s and
ModeX’s future expectations, beliefs, plans, product candidates,
objectives, financial conditions, assumptions or future events or
performance. Many factors could cause our actual activities or
results to differ materially from the activities and results
anticipated in forward-looking statements. These factors include
those described in our Annual Reports on Form 10-K filed and to be
filed with the Securities and Exchange Commission and under the
heading “Risk Factors” in our other filings with the Securities and
Exchange Commission. In addition, forward-looking statements may
also be adversely affected by general market factors, competitive
product development, product availability, federal and state
regulations and legislation, the regulatory process for new
products and indications, manufacturing issues that may arise,
patent positions and litigation, among other factors. The
forward-looking statements contained in this press release speak
only as of the date the statements were made, and we do not
undertake any obligation to update forward-looking statements. We
intend that all forward-looking statements be subject to the
safe-harbor provisions of the PSLRA.
Contacts:
Investors:LHA Investor RelationsYvonne Briggs,
310-691-7100ybriggs@lhai.com
or
Bruce Voss, 310-691-7100bvoss@lhai.com
Media:ModeX Media RelationsTyler Reilly,
617-640-3595media@modextx.comtyler@tenbridgecommunications.com
Opko Health (NASDAQ:OPK)
Historical Stock Chart
From Apr 2024 to May 2024
Opko Health (NASDAQ:OPK)
Historical Stock Chart
From May 2023 to May 2024