– Potential for combined Manocept and Accurin
platforms to target the tumor microenvironment –
BIND Therapeutics, Inc. (NASDAQ: BIND), a clinical-stage
nanomedicine company developing targeted and programmable
therapeutics called Accurins™, and Macrophage Therapeutics, a
subsidiary of Navidea Biopharmaceuticals, Inc. (NYSE: NAVB) today
announced they have entered into a research collaboration to
engineer Accurins with the Manocept™ targeting platform that
enables selective, efficient binding to CD206 positive
disease-associated macrophages. Upon achievement of
proof-of-concept, the companies anticipate expanding the
collaboration to develop Manocept-linked Accurins as a novel,
potent approach to impact the tumor microenvironment which, in many
forms of cancer, is a barrier to immune effector cells.
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“This collaboration represents a potentially significant advance
in the evolution of our platform as we develop Accurins with novel
targeting ligands,” said Andrew Hirsch, president and chief
executive officer of BIND Therapeutics. “The modular nature of our
platform offers multiple therapeutic possibilities, and our
collaboration with Macrophage Therapeutics may enable the
development of Accurins that target activated macrophages, which in
cancer, help create an immunosuppressive microenvironment. We
believe the clinically validated Manocept platform, with its unique
ability to seek out activated macrophages, fits into our vision to
engineer Accurins that have a profound impact on the treatment of
diseases, including our current focus in cancer.”
Disease-associated macrophages generally play a pro-tumoral role
and are immunosuppressive, preventing the immune system from
mounting an attack on tumor cells. Based on the expression of CD206
mannose receptors on disease-associated macrophages, BIND and
Macrophage plan to conduct joint research to develop a CD206
targeted Accurin nanoparticle that is capable of concentrating
various therapeutic payloads to the tumor microenvironment.
“We are pleased to work with BIND Therapeutics to explore the
therapeutic potential of our two complementary technology
platforms,” said Michael M. Goldberg, M.D., CEO of Macrophage
Therapeutics and Director of Navidea. “The Manocept platform is the
basis for the FDA-approved CD206 targeted sentinel lymph node
detection agent, Lymphoseek® (technetium Tc 99m tilmanocept)
injection. Coupled with BIND’s specifically engineered Accurins
that concentrate therapeutic payloads to extracellular and
intracellular compartments, with a tunable controlled-release
profile, we are optimistic that we can create a wide range of
therapeutic applications.”
“It is well-established that macrophages play an important role
in many disease states but it has proven difficult to selectively
target and alter macrophages that play a key role in disease
progression,” said Hagop Youssoufian, M.Sc., M.D., chief medical
officer at BIND Therapeutics. “By coupling Accurins with
Macrophage’s well-credentialed CD206 targeting ligand, we may be
able to treat macrophage-mediated diseases through increased
uptake, and concentration, of targeted therapeutic payloads in the
tumor microenvironment. BIND’s Medicinal Nanoengineering® platform
is able to combine multiple molecular components into a targeted,
long-circulating Accurin. An Accurin nanoparticle that binds to
CD206 positive macrophages could be a valuable asset in the
armament against multiple cancers and disease states.”
"The collaboration furthers our vision to develop therapeutic
applications of the Manocept platform through strategic
partnerships,” said Rick Gonzalez, president and CEO of Navidea.
“In collaborating with BIND, we will be able to leverage their
accomplished R&D team who has strong track record for advancing
targeted nanoparticles from concept into the clinic.”
About Accurins
Accurins, a new class of targeted therapeutics developed using
BIND’s Medicinal Nanoengineering® platform, are nanoparticles
engineered to have a profound impact on the treatment of disease.
The elegant and novel design of Accurins allow for prolonged
circulation, controlled and tunable release and selective targeting
of a therapeutic payload to diseased tissue or cells while avoiding
immune surveillance detection and systemic toxicities.
Accurins can be engineered for multiple therapeutic applications
and have the potential to integrate numerous payloads, including
highly potent drugs with mechanism-based toxicities that limit
therapeutic benefit, DNA, RNA, proteins and immunotherapy agents.
This attribute enables Accurins to target multiple diseases,
including cancer, inflammatory, vascular, and infectious
disease.
About Manocept CD206 Targeting Platform for Therapeutics
Development
Manocept™ CD206 Targeting Platform is a proprietary
mannose-containing, receptor-directed technology platform designed
to engineer novel, synthetic receptor targeted imaging agents and
therapeutics for cancer and other diseases. Manocept’s unique
structural and molecular properties enable the design of novel
immuno-constructs that selectively target and bind to CD206
(mannose receptor) and other C-type Lectins found on activated,
disease-associated macrophages and tumor associated macrophages
(TAMs). The Manocept CD206 Targeting Platform provides a novel and
valuable approach to the design of drug molecules targeting CD206
disease-associated macrophages for therapeutic purposes.
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 BIND Therapeutics
BIND Therapeutics is a clinical-stage nanomedicine platform
company developing a pipeline of Accurins™, its novel targeted
therapeutics designed to increase the concentration and duration of
therapeutic payloads at disease sites while reducing exposure to
healthy tissue. BIND is leveraging its Medicinal Nanoengineering®
platform to develop a pipeline of Accurins targeting hematological
and solid tumors and has a number of strategic collaborations with
biopharmaceutical companies to develop Accurins in areas of high
unmet need. BIND's lead drug candidate, BIND-014, is a
prostate-specific membrane antigen (PSMA) -targeted Accurin that
contains docetaxel, a clinically-validated and widely-used cancer
chemotherapy drug. BIND-014 is currently in development for the
treatment of non-small cell lung cancer, or NSCLC, in patients with
KRAS mutations or squamous histology. In addition, BIND plans to
initiate clinical trials with BIND-014 in cervical, bladder, head
and neck and cholangio cancers in 2015. BIND is also advancing
BIND-510, its second PSMA-targeted Accurin drug candidate
containing vincristine, a potent microtubule inhibitor with dose
limiting peripheral neuropathy in its conventional form, through
important preclinical studies to position it for an Investigational
New Drug application filing with the U.S. Food and Drug
Administration in 2016. Lastly, BIND is developing Accurins
designed to inhibit PLK1 and KSP, both of which BIND believes are
promising anti-mitotic targets that have been limited in the clinic
due to myelotoxicity prior to reaching therapeutic doses.
BIND has announced ongoing collaborations with Pfizer Inc.,
AstraZeneca AB, F. Hoffmann-La Roche Ltd. and Merck & Co., or
Merck (known as Merck Sharp & Dohme outside the United States
and Canada), to develop Accurins based on their proprietary
therapeutic payloads and targeting ligands.
For more information, please visit the Company's web site at
www.bindtherapeutics.com.
About Macrophage Therapeutics, Inc.
Macrophage Therapeutics, Inc., 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 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. For more information, please
visit the Company's web site at www.macrophagetherapeutics.com
About Navidea Biopharmaceuticals, Inc.
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.
Forward-Looking Statements Disclaimer
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements contained in this press release that do not
relate to matters of historical fact should be considered
forward-looking statements, including statements regarding
expectations regarding: BIND and Macrophage’s collaboration to
develop Manocept-linked Accurins, or a CD206 targeted Accurin
nanoparticle, including without limitation effects on the tumor
microenvironment, our ability to increase uptake and concentration
of therapeutic payloads, our creation of a wide range of
therapeutic applications, and our creation of a valuable asset; our
platform, including but not limited to its evolution and
therapeutic possibilities; the Manocept platform; Lymphoseek; the
incidence of various types of cancer in the U.S. and Europe;
Macrophage, including without limitation its development of
therapeutics using the Manocept platform and expectations regarding
targeted delivery; Navidea, including without limitation its
development of precision-targeted products and platforms and its
strategy; Accurins, including without limitation developing a
pipeline of Accurins, including in areas of high unmet need, and
Accurins’ impact and potential; BIND-014, including without
limitation the initiation of clinical trials of BIND-014 in 2015
and BIND-014’s potential; BIND-510, including without limitation,
statements regarding our plan for an Investigational New Drug
filing in 2016; and our collaboration agreements with Pfizer, Merck
and AstraZeneca.
These forward-looking statements are based on management’s
current expectations. These statements are neither promises nor
guarantees, but involve known and unknown risks, uncertainties and
other important factors that may cause our actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements, including, but not limited to, the
following: the fact that the Company has incurred significant
losses since its inception and expects to incur losses for the
foreseeable future; the Company’s need for additional funding,
which may not be available; raising additional capital may cause
dilution to its stockholders, restrict its operations or require it
to relinquish rights to its technologies or drug candidates; the
Company’s limited operating history; the terms of the Company’s
credit facility place restrictions on its operating and financial
flexibility; failure to use and expand its medicinal
nanoengineering platform to build a pipeline of drug candidates and
develop marketable drugs; the early stage of the Company’s
development efforts with only one drug candidate in clinical
development; failure of the Company or its collaborators to
successfully develop and commercialize drug candidates; clinical
drug development involves a lengthy and expensive process, with an
uncertain outcome; delays or difficulties in the enrollment of
patients in clinical trials; serious adverse or unacceptable side
effects or limited efficacy observed during the development of the
Company’s drug candidates; inability to maintain any of the
Company’s collaborations, or the failure of these collaborations;
the Company’s reliance on third parties to conduct its clinical
trials and manufacture its drug candidates; the Company’s inability
to obtain required regulatory approvals; any conclusion by the FDA
that BIND-014 does not satisfy the requirements for approval under
the Section 505(b)(2) regulatory approval pathway; the fact that a
fast track or breakthrough therapy designation by the FDA for the
Company’s drug candidates may not actually lead to a faster
development or regulatory review or approval process; the inability
to obtain orphan drug exclusivity for drug candidates; failure to
obtain marketing approval in international jurisdictions; any
post-marketing restrictions or withdrawals from the market; effects
of recently enacted and future legislation; failure to comply with
environmental, health and safety laws and regulations; failure to
achieve market acceptance by physicians, patients, or third-party
payors; failure to establish effective sales, marketing and
distribution capabilities or enter into agreements with third
parties with such capabilities; effects of substantial competition;
unfavorable pricing regulations, third-party reimbursement
practices or healthcare reform initiatives; product liability
lawsuits; failure to retain key executives and attract, retain and
motivate qualified personnel; difficulties in managing the
Company’s growth; risks associated with operating internationally,
including the possibility of sanctions with respect to our
operations in Russia; the possibility of system failures or
security breaches; failure to obtain and maintain patent protection
for or otherwise protect our technology and products; effects of
patent or other intellectual property lawsuits; the eligibility of
a significant portion of the Company’s total outstanding shares to
be sold into the market, which could cause the market price of its
common stock to drop significantly; increased costs as a result of
operating as a public company; and any securities class action
litigation. These and other important factors discussed under the
caption "Risk Factors" in our Quarterly Report on Form 10-Q filed
with the Securities and Exchange Commission, or SEC, on May 7,
2015, and our other reports filed with the SEC could cause actual
results to differ materially from those indicated by the
forward-looking statements made in this press release. Any such
forward-looking statements represent management's estimates as of
the date of this press release. While we may elect to update such
forward-looking statements at some point in the future, we disclaim
any obligation to do so, even if subsequent events cause our views
to change. These forward-looking statements should not be relied
upon as representing our views as of any date subsequent to the
date of this press release.
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version on businesswire.com: http://www.businesswire.com/news/home/20150611005302/en/
BIND Therapeutics:MediaJeff Boyle,
617-301-8816media@bindtherapeutics.comorInvestorsTom Baker,
617-532-0624investors@bindtherapeutics.comorMacrophage
Therapeutics:James Goldschmidt, Ph.D.,
484-225-0341jgoldschmidt@macrophagetherapeutics.comorNavidea:MediaSharon
Correia, 978-655-2686
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