- Combining Manocept™ with Rheumco’s Tin-117m
radioisotope to enable earlier disease detection and localized
therapy -
Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB) today announced
that it has formed a joint enterprise with Essex Woodlands-backed
Rheumco, LLC, to develop and commercialize radiolabeled diagnostics
and therapeutics for rheumatologic and arthritic diseases. The
joint enterprise, called R-NAV, LLC, will combine Navidea’s
proprietary Manocept CD206 macrophage targeting platform and
Rheumco’s proprietary Tin-117m radioisotope technology to focus on
leveraging the platforms across several indications with high unmet
medical need:
1)
Detection of rheumatoid arthritis (RA) initially using Tc-99m
tilmanocept, commercially known as Lymphoseek® (technetium Tc-99m
tilmanocept) Injection, 2) Combination of the Manocept platform
with Tin-117m for detection and treatment of RA, 3) Detection and
treatment of human and veterinary osteoarthritis (OA) using the
Tin-117m technology, and 4) Treatment of pediatric hemophilic
arthropathy (PHA); a rare rheumatologic condition.
“We chose to combine our proprietary Tin-117m technology with
Navidea’s Manocept CD206 receptor- targeting technology due to its
unique ability to seek out and attach itself to immune cells
responsible for detrimental inflammation in arthritic conditions,”
said Gilbert Gonzales, M.D., Founder, Rheumco, and R-NAV
Director.
Immanuel Thangaraj, Managing Director and Partner at Essex
Woodlands and R-NAV Director, added, “A broad-based approach using
radiopharmaceuticals would enable earlier detection and therapeutic
intervention before irreversible damage occurs in joints,
distinguish between autoimmune and degenerative diseases, and
potentially improve patient outcomes and quality of care.”
“Through this partnership, we will for the first time explore
the development of our Manocept technology for therapeutic uses,
expanding the commercial potential of the platform beyond the
important role it currently plays in cancer detection,” said
Michael Goldberg, M.D., Navidea Interim Chief Executive Officer.
“We believe R-NAV may help accelerate development of both
diagnostic and therapeutic applications of our Manocept platform in
a cost-effective manner, capitalizing on the proven pathway
established by the FDA approval of Lymphoseek, the first US
FDA-approved product from the Manocept platform. The R-NAV joint
enterprise allows us to leverage our broad Manocept technology
platform for therapeutic and diagnostic applications, including
global license rights to tilmanocept, to multiply the available
funding, create optionality, and efficiently expand our product
pipeline outside of Navidea as we focus our internal resources on
Lymphoseek commercialization and market growth.”
R-NAV will focus on deploying the two technology platforms as an
ideal combination for the development of novel diagnostic and
therapeutic agents for rheumatologic and arthritic conditions. For
a number of years, Essex Woodlands and Rheumco have invested in the
development of their patented, high-specific-activity Tin-117m
technology to optimize its therapeutic potential and safety
profile. Tin-117m possesses unique imaging and therapeutic
properties not found in alternative medical isotopes, including its
ability to locally target disease-causing cells without damaging
adjacent healthy tissue. Navidea’s Manocept technology is able to
quickly seek out and attach to certain immune cells expressing
CD206, called macrophages. Macrophages are an emerging participant
in disease-associated inflammation, which has been found to play a
role in conditions such as RA, cancer, and heart disease.
“We decided to form the joint enterprise with Rheumco and Essex
Woodlands and their financial partners given their successful track
record of investing and building innovative medical technologies
and the resources they will be able to contribute to this venture,”
said Mark Pykett, V.M.D., Ph.D., Head of Navidea’s Manocept
development program and R-NAV Director. “Together, with this proof
statement for our technology platforms, we have the opportunity to
help the millions of patients diagnosed each year with arthritic
conditions as well as the very serious rare disease, pediatric
hemophilic arthropathy, for which there are no effective treatment
options available today.”
R-NAV will be initially funded primarily through a $4 million
investment from Infinity Capital III, of Houston-based McRay Money
Management, and other third-party private investors working closely
with Essex Woodlands, and underpinning the technology contributions
from Rheumco and Navidea. Navidea has committed an additional $1
million to support R-NAV’s development efforts to be paid in equal
installments over three years. In exchange for its cash, in-kind
and technology contributions, Navidea has received both common
units and Preferred Series A units of R-NAV and will initially own
approximately 30% of the combined entity. Joint oversight of R-NAV
is shared between Navidea, Rheumco, Infinity Capital III of
Houston-based McRay Money Management, and the other investors.
Navidea also has an option to acquire, at its sole discretion prior
to Phase 3 clinical study, imaging products derived from the
Manocept platform, and therapeutic products combining Manocept
agents from Navidea with the Tin-117m technology for
commercialization.
Detection of RA, a chronic, progressive, systemic autoimmune
disorder, is the nearest-term opportunity being pursued by R-NAV.
Clinicians are often faced with diagnostic confusion early in
disease progression resulting in inaccurate diagnosis when existing
therapies could be most effective. There is currently no approach
to reliably detect, evaluate or therapeutically target the
macrophage inflammatory component of RA, which is a key driver of
RA pathogenesis. Misdiagnosis results in billions of dollars being
spent each year unnecessarily on therapies, which may result in
significant side effects. According to the Centers for Disease
Control (CDC), the overall cost of arthritis and other rheumatic
conditions in the U.S. was approximately $128 billion in 2003. Of
this, $80.8 billion was due to direct costs and $47 billion was due
to indirect costs (lost wages only). The CDC also notes that in
2004 arthritis resulted in 78 million physician visits and 5
million hospitalizations having a principal or secondary diagnosis
of arthritis. Further, current intervention using methotrexate or
biologics is costly, associated with side effects, and in many
cases does not adequately treat the disease or the underlying
inflammatory pathology. A targeted imaging agent such as Manocept
could assist physicians and healthcare providers to better diagnose
patients and allow for earlier and more effective intervention, and
use of a Tin-117m therapeutic could improve and localize
therapeutic intervention for the same patients.
About the Manocept™ Platform
Navidea’s Manocept platform is predicated on the ability to
specifically target the CD206 mannose receptor expressed on
macrophages. Macrophages play important roles in many disease
states and are an emerging target in many disorders where
diagnostic uncertainty exists. This flexible and versatile platform
acts as an engine for purpose-built molecules that may enhance
diagnostic accuracy, clinical decision-making, therapeutic delivery
and ultimately patient care, while offering the potential to
utilize a breadth of radioisotopes and diagnostic imaging
modalities, including SPECT, PET, intra-operative and/or
optical-fluorescence detection. The Company’s FDA-approved
precision diagnostic lymphatic mapping agent, Lymphoseek®
(technetium Tc-99m tilmanocept) Injection, is representative of the
ability to successfully exploit this mechanism to develop powerful,
new diagnostic agents.
About Tin-117m Technology
Tin-117m is a unique radioisotope that has the potential to both
identify and treat multiple disease areas that include rheumatoid
arthritis, vulnerable plaque, cancers, and other medical problems.
Tin-117m has two significant energy emissions, a SPECT gamma photon
similar to Tc-99m enabling imaging, and conversion electrons
ideally suited for therapeutic applications. When linked to a
targeting molecule, the radiopharmaceutical complex selectively
binds to its specific target. This enables both imaging and therapy
to a localized disease area limiting its therapeutic effect to the
desired tissue without damage to adjacent healthy tissue and using
remarkably low doses of radiopharmaceutical.
About Lymphoseek®
Lymphoseek® (technetium Tc 99m tilmanocept) Injection is the
first and only FDA-approved receptor-targeted lymphatic mapping
agent. It is a novel, receptor-targeted, small-molecule
radiopharmaceutical used in the evaluation of lymphatic basins that
may have cancer involvement in patients with breast cancer,
melanoma and head and neck cancer patients with oral cavity
carcinoma. Lymphoseek is designed for the precise identification of
lymph nodes that drain from a primary tumor, which have the highest
probability of harboring cancer. Lymphoseek is approved by the U.S.
Food and Drug Administration (FDA) for use in lymphatic mapping to
assist in the localization of lymph nodes draining a primary tumor
in patients with breast cancer or melanoma and for use in guiding
sentinel lymph node biopsy in head and neck cancer patients with
squamous cell carcinoma of the oral cavity. The Company anticipates
continuing development of Lymphoseek into other solid tumor
areas.
Accurate diagnostic evaluation of cancer is critical, as it
guides therapy decisions and determines patient prognosis and risk
of recurrence. According to publicly available information,
approximately 235,000 new cases of breast cancer, 76,000 new cases
of melanoma and 45,000 new cases of head and neck/oral cancer are
expected to be diagnosed in the United States in 2014, and
approximately 367,000 new cases of breast cancer, 83,000 new cases
of melanoma and 55,000 new cases of head and neck/oral cancer
diagnosed in Europe annually.
Lymphoseek Indication and Important Safety
Information
Lymphoseek (technetium Tc 99m tilmanocept) Injection is
indicated, using a hand-held gamma counter, for:
- Lymphatic mapping to assist in the
localization of lymph nodes draining a primary tumor site in
patients with breast cancer or melanoma;
- Guiding sentinel lymph node biopsy, in
patients with clinically node negative squamous cell carcinoma
(SCC) of the oral cavity.
Important Safety Information
In clinical trials with Lymphoseek, no serious hypersensitivity
reactions were reported, however Lymphoseek may pose a risk of such
reactions due to its chemical similarity to dextran. Serious
hypersensitivity reactions have been associated with dextran and
modified forms of dextran (such as iron dextran drugs).
Prior to the administration of Lymphoseek, patients should be
asked about previous hypersensitivity reactions to drugs, in
particular dextran and modified forms of dextran. Resuscitation
equipment and trained personnel should be available at the time of
Lymphoseek administration, and patients observed for signs or
symptoms of hypersensitivity following injection.
Any radiation-emitting product may increase the risk for cancer.
Adhere to dose recommendations and ensure safe handling to minimize
the risk for excessive radiation exposure to patients or health
care workers. In clinical trials, no patients experienced serious
adverse reactions and the most common adverse reactions were
injection site irritation and/or pain (<1%).
Full Lymphoseek Prescribing Information Can Be Found at:
WWW.LYMPHOSEEK.COM
About Navidea Biopharmaceuticals Inc.
Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB) is a
biopharmaceutical company focused on the development and
commercialization of precision diagnostics and radiopharmaceutical
agents. Navidea is developing multiple precision diagnostic
products and platforms, including NAV4694, NAV5001, Manocept™ and
NAV1800 (RIGScan™), to help identify the sites and pathways of
undetected disease and enable better diagnostic accuracy, clinical
decision-making and, ultimately, patient care. Lymphoseek®
(technetium Tc-99m tilmanocept) Injection, Navidea’s first
commercial product from the Manocept platform, was approved by the
FDA in March 2013. For more information, please visit
www.navidea.com.
About Rheumco, LLC.
Rheumco, LLC is a privately held early-stage pharmaceutical
development company focused on rheumatological applications using
Tin-117m. Tin-117m is a theranostic isotope that can be used for
medical imaging and therapeutic applications.
The Private Securities Litigation Reform Act of 1995 (the Act)
provides a safe harbor for forward-looking statements made by or on
behalf of the Company. Statements in this news release, which
relate to other than strictly historical facts, such as statements
about the Company’s plans and strategies, expectations for future
financial performance, new and existing products and technologies,
anticipated clinical and regulatory pathways, and markets for the
Company’s products are forward-looking statements within the
meaning of the Act. The words “believe,” “expect,” “anticipate,”
“estimate,” “project,” and similar expressions identify
forward-looking statements that speak only as of the date hereof.
Investors are cautioned that such statements involve risks and
uncertainties that could cause actual results to differ materially
from historical or anticipated results due to many factors
including, but not limited to, the Company’s continuing operating
losses, uncertainty of market acceptance of its products, reliance
on third party manufacturers, accumulated deficit, future capital
needs, uncertainty of capital funding, dependence on limited
product line and distribution channels, competition, limited
marketing and manufacturing experience, risks of development of new
products, regulatory risks and other risks detailed in the
Company’s most recent Annual Report on Form 10-K and other
Securities and Exchange Commission filings. The Company undertakes
no obligation to publicly update or revise any forward-looking
statements.
Navidea BiopharmaceuticalsBrent Larson, 614-822-2330Executive VP
& CFOorSharon Correia, 978-655-2686Associate Director,
Corporate Communications
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