BIND Therapeutics Presents Clinical Data Highlighting Unique Attributes of Lead Cancer Drug Candidate, BIND-014, at AACR 2014 Annual Meeting
Results Demonstrated Increased Dose Intensity of Weekly Dosing vs.
Every Three Week Dosing Schedule of BIND-014 and Utility of PSMA as a
Biomarker for Patient Selection
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
BIND Therapeutics, Inc. (NASDAQ: BIND), a clinical-stage nanomedicine
platform company developing targeted and programmable therapeutics
called Accurins™, announced today that clinical data on its lead drug
candidate, BIND-014, were presented at the American Association of
Cancer Research (AACR) meeting. The clinical data from a completed Phase
1 study demonstrate differentiating attributes of BIND-014 administered
with a weekly dosing schedule which may enable increased dose intensity
and enhanced therapeutic efficacy of BIND-014. In addition, data
supporting the potential utility of PSMA as a target and marker for
BIND-014 patient selection were presented.
BIND-014 is a targeted polymeric nanoparticle containing the cytotoxic
agent docetaxel. In preclinical cancer models, BIND-014 was shown to
increase accumulation of docetaxel at the site of disease which
translated to marked improvements in antitumor activity and
tolerability. BIND-014 is currently in two Phase 2 studies in non-small
cell lung cancer and metastatic castrate resistant prostate cancer.
"These data demonstrated the unique attributes and potential benefits of
BIND-014 as a valuable cancer therapy," said Scott Minick, President and
CEO of BIND. "We are highly encouraged that both the once weekly and
once every three week dosing schedules of BIND-014 showed favorable
safety and promising efficacy results, and we are evaluating both dosing
schedules in our ongoing Phase 2 lung study to determine the optimal
dose and schedule for BIND-014. In addition, we have generated data
supportive of PSMA as a mechanistic target and potential biomarker for
clinical patient selection."
In a poster presentation entitled, "A phase 1 study of BIND-014, a
PSMA-targeted nanoparticle containing docetaxel, administered to
patients with refractory solid tumors on a weekly schedule," BIND
Therapeutics researchers presented Phase 1 data on safety,
pharmacokinetics and preliminary efficacy of BIND-014 administered as a
60-minute infusion, once weekly for three weeks (Q1W), followed by one
week of no treatment over a four-week cycle.
Greater dose intensity by approximately 50% was shown with Q1W dosing
of BIND-014 as compared to once every three week dosing of BIND-014
described in a previous study.
Different tolerability profiles were demonstrated with BIND-014 dosed
at Q3W and Q1W. The Q1W schedule demonstrated considerably less
neutropenia than Q3W BIND-014, a major dose-limiting toxicity for
docetaxel, even at the higher dose intensity.
Pharmacokinetics of BIND-014 were consistent with prolonged retention
of BIND-014 particles in the vascular compartment and controlled
release of docetaxel at the tumor.
Preliminary signals of antitumor activity were observed for BIND-014
administered on the Q1W schedule.
A Phase 2 clinical study in NSCLC examining both Q3W and Q1W dosing
schedules is in progress.
In a poster presentation entitled, "Prostate-specific membrane antigen
(PSMA) expression as a potential patient selection marker in patients
with refractory solid tumors administered BIND-014, a PSMA-targeted
nanoparticle containing docetaxel," BIND Therapeutics researchers
presented data from a retrospective analysis which demonstrated PSMA
expression in patients responding to treatment with BIND-014 in the
phase 1 clinical study.
Positive PSMA expression of moderate or high intensity was observed in
patients who demonstrated a response to BIND-014 in the Phase 1 study.
Preferential expression of PSMA was observed on prostate cancer cells
and vasculature of non-prostate solid tumors, but not in normal
PSMA expression levels will be evaluated in the tumors of patients
enrolled in Phase 2 clinical studies with BIND-014 to investigate the
correlation between expression and efficacy as a potential basis for
About BIND Therapeutics
BIND Therapeutics is a clinical-stage nanomedicine platform company
developing Accurins, its novel targeted therapeutics. BIND intends to
leverage its Medicinal Nanoengineering® platform to develop a
pipeline of Accurins, initially in oncology, as well as Accurins in
collaboration with biopharmaceutical companies. BIND's lead drug
candidate, BIND-014, is an Accurin that targets PSMA and contains
docetaxel, a clinically-validated and widely used cancer chemotherapy
drug. BIND-014 is currently in Phase 2 clinical trials for non-small
cell lung cancer and metastatic castrate-resistant prostate cancer.
BIND has announced collaborations with Amgen Inc., Pfizer Inc. and
AstraZeneca AB to develop Accurins based on therapeutic payloads from
their product pipelines. BIND's platform originated from the pioneering
nanotechnology research at the Massachusetts Institute of Technology and
Brigham and Women's Hospital/Harvard Medical School of BIND's scientific
founders and directors Dr. Robert Langer and Dr. Omid Farokhzad. For
more information, please visit the company's web site at www.bindtherapeutics.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 the Company's expectations regarding the
efficacy and safety of BIND-014.
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: failure to use and expand
the Company's medicinal nanoengineering platform to build a pipeline of
drug candidates and develop marketable drugs; 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; effects of recently enacted and future
legislation; failure to retain key executives and attract, retain and
motivate qualified personnel; and risks associated with operating
internationally, including the possibility of sanctions with respect to
our operations in Russia. These and other important factors discussed
under the caption "Risk Factors" in our Annual Report on Form 10-K filed
with the Securities and Exchange Commission, or SEC, on March 25, 2014,
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.
The Yates Network
Gina Nugent, 617-460-3579
Paul Cox, 212-362-1200
Source: BIND Therapeutics, Inc.
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