- Reinforces Therapeutic Potential of Targeting
Activated Macrophages via the CD206 Receptor-
- Data also suggest a new origin of KS as a
macrophage fusion tumor -
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) and its
subsidiary, Macrophage Therapeutics, Inc., today announced that
imaging results from the Manocept™ clinical trial in Kaposi’s
Sarcoma (KS) and other preclinical studies were presented at the
18th International Workshop on Kaposi's Sarcoma Herpesvirus
(KSHV) and Related Agents in Hollywood, Florida. The clinical
imaging study, using Tc 99m tilmanocept, a Manocept platform
product, in both HIV+ and HIV- patients suggests that KS tumor
lesions, both cutaneous and suspected extra-cutaneous sites, can be
easily visualized and mapped, demonstrating that this technique may
potentially provide a means for routine patient assessment. The
results also show that use of Manocept represents a potential
therapeutic pathway for targeting tumor associated macrophages
(TAMs). Manocept agents are designed to target CD206, which is
highly expressed on TAMs and the KS tumor itself. As a potential
therapeutic, Manocept could be used as a precision vehicle to
deliver payloads to tumor sites throughout the body.
“These pre-clinical and clinical studies support using Kaposi’s
sarcoma as a model tumor system for evaluating therapeutic
approaches for the Manocept platform in other forms of solid
tumors,” commented Michael Tomblyn, M.D., Navidea's Chief Medical
Officer. “They provide evidence that Manocept agents can target
CD206 and are internalized into tumor associated macrophages and
tumor cells. This along with clinical observations that demonstrate
tilmanocept can be used to image KS tumors both externally and
internally indicates excellent potential for immunotherapeutic
utility.”
“Using a targeted imaging agent like tilmanocept in this group
of HHV8+patients represents an elegant approach to potentially
detect internal KS lesions that would previously be difficult or
impossible to non-invasively locate,” commented Toby Maurer, M.D.,
FAAD, Professor of Dermatology at the University of California, San
Francisco (UCSF), and Chief of Dermatology at San Francisco General
Hospital and Trauma Center, who co-led the clinical study at UCSF
with Michael S. McGrath, M.D., PhD. “Further, the specificity and
the ability to quantify tumor burden could enable regular patient
evaluations and monitoring of therapeutic effectiveness addressing
important unmet patient needs.”
Five Human Herpes Virus8 positive (HHV8+) patients (4 HIV+,
1HIV-) were enrolled in the NAV03-12 study. Patients received a
single subcutaneous injection of Technetium Tc 99m tilmanocept in
the region of a cutaneous KS lesion and imaging was performed at 1,
4 and 24-hours post-injection to visualize localization of
tilmanocept. Results represented by whole body Single-Photon
Emission Computed Tomography (SPECT/CT) imaging scans from study
patients were presented. Collectively, the scans show localization
of tilmanocept and detected multiple cutaneous lesions in the
extremities, face and genitalia, as well as extra-cutaneous
localization found in the nasopharynx, lymph nodes and brain.
Results also indicate that KS lesions are anatomically linked in
chains by and within the lymph ducts. The study concludes that both
HIV+ and HIV- patients have pan-tumor expression of CD206, strongly
suggests tilmanocept crosses the blood brain barrier and that a
Manocept-drug conjugate may have the potential as a therapeutic
with high target effect and low off-target concerns.
The data from these studies also suggest a novel theory on the
genesis of KS in which KS arises from an HHV8 infected macrophage
type cell and its interaction with the lymphatic system. This
interaction provides the means for access of the KS through CD206
receptor for diagnosis, evaluation, and potential therapy using the
Manocept platform.
Navidea and Macrophage Therapeutics plan a webcast to provide
investors with a complete look at the data being presented at the
International Workshop on Kaposi's Sarcoma Herpesvirus
(KSHV) and Related Agents conference on July 7, 2015 at 1:00
pm EDT. Webcast details will be available on the Navidea
website.
About the Manocept™ CD206-targeting platform
The 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. This flexible
and versatile platform acts as an engine for purpose-built
molecules that may enhance diagnostic accuracy, clinical
decision-making, targeted treatments and ultimately patient care.
As a diagnostic tool, the Manocept technology has the potential to
utilize a breadth of imaging modalities, including SPECT, PET,
intra-operative and/or optical-fluorescence detection. By adding a
therapeutic agent on the Manocept molecular backbone, there is the
potential to develop novel, targeted immunotherapies specifically
designed to selectively deliver an agent that can kill or alter
disease-associated macrophages. Navidea’s FDA-approved precision
diagnostic imaging agent, Lymphoseek® (technetium 99m tilmanocept)
injection, is representative of the platform’s ability to
successfully exploit this mechanism and offer the potential for
development of new CD206-targeted diagnostic agents and
therapeutics.
About Kaposi’s Sarcoma
Kaposi sarcoma (KS) is a cancer that develops from the cells
that line lymph nodes or blood vessels. It usually appears as
tumors on the skin or on mucosal surfaces such as inside the mouth,
but tumors can also develop in other parts of the body, such as in
the lymph nodes (bean-sized collections of immune cells throughout
the body), the lungs, or digestive tract. The abnormal cells of KS
form purple, red, or brown blotches or tumors on the skin. These
affected areas are called lesions. The skin lesions of KS most
often appear on the extremities, trunk and face. AIDS-related KS is
the most common type of KS in the United States which develops in
people who are infected with HIV, the virus that causes AIDS. KS
can also develop in people whose immune systems have been
suppressed after an organ transplant and is called
transplant-related KS.1
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. 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 solid tumor cancers where lymphatic mapping is a
component of surgical management and for guiding sentinel lymph
node biopsy in patients with clinically node negative breast
cancer, melanoma or squamous cell carcinoma of the oral cavity.
Lymphoseek has also received European approval in imaging and
intraoperative detection of sentinel lymph nodes in patients with
melanoma, breast cancer or localized squamous cell carcinoma of the
oral cavity.
Accurate diagnostic evaluation of cancer is critical, as it
guides therapy decisions and determines patient prognosis and risk
of recurrence. Overall in the U.S., solid tumor cancers may
represent up to 1.2 million cases per year. The sentinel node label
in the U.S. and Europe may address 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 in the U.S., 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 is a radioactive diagnostic agent indicated with or
without scintigraphic imaging for:
- Lymphatic mapping using a handheld
gamma counter to locate lymph nodes draining a primary tumor site
in patients with solid tumors for which this procedure is a
component of intraoperative management.
- Guiding sentinel lymph node biopsy
using a handheld gamma counter in patients with clinically node
negative squamous cell carcinoma of the oral cavity, breast cancer
or melanoma.
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
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a
biopharmaceutical company focused on the development and
commercialization of precision diagnostics, therapeutics and
radiopharmaceutical agents. Navidea is developing multiple
precision-targeted products and platforms including Manocept™ and
NAV4694 to help identify the sites and pathways of undetected
disease and enable better diagnostic accuracy, clinical
decision-making, targeted treatment 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 and in Europe in November 2014. Navidea’s
strategy is to deliver superior growth and shareholder return by
bringing to market novel radiopharmaceutical agents and
therapeutics, and advancing the Company’s pipeline through global
partnering and commercialization efforts. For more information,
please visit www.navidea.com.
About Macrophage Therapeutics
Macrophage Therapeutics, a newly created subsidiary of Navidea
Biopharmaceuticals, Inc. (NAVB), is developing therapeutics using
the patented Manocept immunotherapy platform licensed from Navidea
to target over-active macrophages implicated in cancer,
cardiovascular, central nervous system, autoimmune, antiviral, and
skin diseases. Manocept specifically targets CD206, or the mannose
receptor prevalent on over-active macrophages. The technology
enables highly specific targeted delivery of active (either
existing or yet to be developed) agents that can modulate the
activity of over-active macrophages that have been implicated in
many diseases. Targeted delivery should significantly enhance a
given compound’s efficacy and safety.
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Company’s most recent Annual Report on Form 10-K and other
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1 American Cancer Society web accessed 22May2015.
http://www.cancer.org/cancer/kaposisarcoma/detailedguide/kaposi-sarcoma-what-is-kaposi-sarcoma
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Navidea BiopharmaceuticalsInvestorsTom Baker,
617-532-0624tbaker@navidea.comorMediaSharon Correia, 978-655-2686Associate
Director, Corporate Communications
Navidea Biopharmaceuticals (AMEX:NAVB)
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