April 7, 2014

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 vasculature.
  • 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 patient selection.

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.

Media:
The Yates Network
Gina Nugent, 617-460-3579
gina@theyatesnetwork.com
or
Investors:
Stern Investor Relations
Paul Cox, 212-362-1200
BIND@sternir.com

Source: BIND Therapeutics, Inc.

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