Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) announces the
receipt of an initial notice of award for a Fast- track Small
Business Innovation Research (SBIR) grant providing for up to $1.8
million from the National Institutes of Health’s (NIH) National
Cancer Institute (NCI) to fund evaluation of an investigational
Manocept™-based immunotargeted treatment for Kaposi’s Sarcoma (KS).
The novel Manocept construct is designed to specifically deliver
doxorubicin, a chemotoxin, which can kill KS tumor cells and their
tumor-associated macrophages (TAMs) potentially altering the course
of cancer. KS is a serious and potentially life threatening illness
in persons infected with the human immunodeficiency virus (HIV) and
the third leading cause of death in this population worldwide. The
prognosis for patients with KS is poor with high probabilities for
mortality and greatly diminished quality of life. The development
activities of the Manocept immunotherapeutic platform will be
conducted by Navidea and its subsidiary, Macrophage
Therapeutics.
The funds for this Fast-track grant (National Cancer Institute
of the National Institutes of Health under Award Number
R44CA206788) will be released in three parts, which together have
the potential to provide up to $1.8 million in resources over 2.5
years with the goal of completing an investigational new drug (IND)
submission for a Manocept construct (MT1000 class of compounds)
consisting of tilmanocept linked to doxorubicin for the treatment
of KS. The first part of the grant will provide $232,000 to support
analyses including in vitro and cell culture studies and will be
followed by Part 2 and 3 animal testing studies. If successful, the
information from these studies will be combined with other
information in an IND application that will be submitted to the
U.S. Food and Drug Administration (FDA) requesting permission to
begin testing the compound selected in human KS patients.
“We believe that given the data to date from the Manocept
platform, these studies along with a host of other human tumor
model studies ongoing and planned for animal testing will provide a
powerful gateway to a new class of anti-TAM immunotherapies
directed at solid tumors. A drug that selectively kills cells that
are highly expressing CD206 is expected to have an overwhelming,
immediate, conspicuous and easily measured effect on KS tumors,”
said Frederick Cope, Ph.D., M.S., F.A.C.N., C.N.S., Senior Vice
President and Chief Scientific Officer of Navidea. “This grant will
bring us to submission of an IND and the first time human
evaluation for a Manocept immunotherapeutic. We anticipate if
trials are successful, we can bring an effective and life-sparing
new therapy to KS patients who are in desperate need for such a new
treatment.”
“The Manocept platform may offer a unique approach to the
treatment of Kaposi's sarcoma (KS) and is, we believe, a
translational portal to the therapy of a number of other solid
tumors in which macrophages and tumor-associated macrophages play a
key role in tumorigenesis and metastasis,” said Michael Goldberg,
M.D. Chairman of the Board of Navidea, “We believe that KS serves
as model for a development strategy that can be expanded to other
macrophage-dependent solid tumors as well as a model for
therapeutics targeting viruses that incubate in macrophages. We are
encouraged that our therapeutic program has been recognized by the
NIH so soon after we began our therapeutic development effort. We
plan on submitting additional grant requests as soon as we obtain
results from the multiple ongoing studies in various cancer models,
which should read out shortly.”
About the MT1001 Study Efforts in KS
These IND-enabling studies will be conducted in three parts.
Part 1 studies require in vitro and cell culture experiments
related to safety and efficacy of an intravenous injection of
MT100. In Part 2 and 3, nine preclinical animal studies will build
on the Part 1 results and will further refine safety and efficacy
variables including dosing and drug administration regimens and
evaluating the feasibility of the MT 1000-class of molecules, as a
novel treatment for KS. Following these studies, Navidea expects to
submit an IND application to the FDA seeking permission to begin
Phase 1/2 clinical evaluation of MT1001 in KS patients.
About KS
Kaposi sarcoma (KS) is a serious and potentially life
threatening illness in persons infected with the HIV, the causative
agent of acquired immunodeficiency syndrome (AIDS). Tumor
associated macrophages (TAMs) constitute an important tumor
component for most types of cancer (including KS) that contributes
to tumor growth and protection from immune responses. Navidea,
through its subsidiary Macrophage Therapeutics, is developing a
receptor targeted drug construct that may be able to effectively
treat KS and could contribute to effective immunotherapy for a wide
variety of cancers.
About the Manocept™ CD206-targeting platform
Navidea Biopharmaceuticals is developing Manocept, a new
pharmaceutical platform technology, targeting cells that express
the macrophage mannose receptor (CD206). A wide variety of
immune-targeting applications for this platform technology are
envisioned. 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 an
immunodiagnostic tool, the Manocept technology can utilize a
breadth of imaging modalities, including SPECT, PET,
intra-operative and/or optical-fluorescence detection. By linking 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. MT1000 class of compounds ,
consisting of a Manocept construct linked to doxorubicin, is the
first in a series of drug delivery constructs that will utilize
Navidea’s Manocept CD206 targeted drug delivery platform. Navidea’s
FDA-approved immunodiagnostic 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 immunodiagnostic agents and
immunotherapeutics. The development activities of the Manocept
immunotherapeutic platform will be conducted by Navidea‘s
subsidiary, Macrophage Therapeutics.
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 results
guide therapy decisions and determine 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 600,000 new cases of
breast cancer, 160,000 new cases of melanoma and 100,000 new cases
of head and neck/oral cancer diagnosed 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 immunodiagnostic agents and
immunotherapeutics. 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. The
development activities of the Manocept immunotherapeutic platform
will be conducted by Navidea in conjunction with its subsidiary,
Macrophage Therapeutics. Navidea’s strategy is to deliver superior
growth and shareholder return by bringing to market novel products
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, Inc., a 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.
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, our
ability to repay our debt, the outcome of the CRG litigation,
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.
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Navidea BiopharmaceuticalsInvestors &
MediaSharon Correia, 978-655-2686Senior Director, Corporate
Communications
Navidea Biopharmaceuticals (AMEX:NAVB)
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