BIND Therapeutics Presents Data Highlighting Ability Of Accurins To Control Biodistribution And Accumulate In Target Tissue At AACR Annual Meeting 2015

- Studies from proprietary and collaboration programs show potential of Accurins as best-in-class targeted therapeutics -

- Data demonstrate optimized drug properties including improved therapeutic index, elevated accumulation in targeted tissue at tumor sites and sustained release -

CAMBRIDGE, Mass.--(BUSINESS WIRE)--BIND Therapeutics, Inc. (NASDAQ: BIND), a clinical-stage nanomedicine platform company developing targeted and programmable therapeutics called Accurins™, today announced that clinical and preclinical data from its oncology pipeline, including proprietary and collaboration programs, were presented at the American Association of Cancer Research (AACR) Annual Meeting 2015. The presentations include data from the Company’s lead proprietary Accurin drug candidate, BIND-014, and the Accurin drug candidate AZD2811, which is being developed in collaboration with AstraZeneca.

“Accurin-AZD1152 hQPA nanoparticles inhibit growth of diffuse large B-cell lymphomas and small cell lung cancer in preclinical models”

"Collectively, these data demonstrate the unique attributes of Accurins as a new therapeutic modality and their potential to produce therapeutics with a best-in-class profile," said Andrew Hirsch, president and chief executive officer of BIND. "The data describing optimized pharmacological properties across a range of key therapeutic parameters for our proprietary product candidate, BIND-014, and AZD2811, our Aurora B kinase inhibitor program with AstraZeneca, demonstrate the ability of Accurins to control biodistribution and accumulate in target tissue across a broad spectrum of therapeutic payloads.”

Posters presented at AACR:
BIND-014
In a poster presentation entitled, “Pharmacokinetics of BIND-014 (docetaxel nanoparticles for injectable suspension) in preclinical species and patients with advanced solid tumors,” BIND Therapeutics researchers presented clinical and preclinical data demonstrating that the Accurin BIND-014 provided prolonged circulation and controlled release of encapsulated docetaxel when compared to conventional docetaxel consistently across multiple species. The controlled biodistribution and potential for targeted and preferential tumor accumulation may result in increased efficacy and decreased toxicity with BIND-014.

• BIND-014 preclinical and clinical pharmacokinetics (PK) demonstrated monophasic plasma concentration-time profiles well differentiated from solvent-based docetaxel.
• The Accurin BIND-014 displayed higher peak plasma concentration [C_max] and area under the curve [AUC] with reduced clearance [CL] and volume of distribution [V(_d)] for total docetaxel compared to solvent-based docetaxel.
• In all species, the V(_d) of BIND-014 was close to the blood volume. C_max and AUC in human patients with solid tumors demonstrated dose linearity with an R2= 0.98; repeat dosing did not have a significant effect on C_max.
• Evaluation of encapsulated docetaxel plasma concentrations in patients and cynomolgus monkeys demonstrated that most circulating docetaxel was encapsulated in nanoparticles.

AZD2811 (formerly designated AZD1152-hQPA)
In a poster presentation entitled, “Accurin-AZD1152 hQPA nanoparticles inhibit growth of diffuse large B-cell lymphomas and small cell lung cancer in preclinical models,” data were presented demonstrating that the Accurin nanoparticle AZD2811 exhibits promising in vivo and in vitro tumor growth inhibition as monotherapy in diffuse large B-cell lymphomas (DLBCL) and small cell lung cancer (SCLC). Time and duration of exposure is important and these data also indicate that the Accurin nanoparticle AZD2811 has the flexibility to be delivered with different doses/schedules, offering the potential to adapt the therapeutic regimen to different tumors while achieving an improved therapeutic index.

• Models of DLBCL and SCLC show sensitivity to monotherapy Aurora B kinase inhibitors and AZD2811, with increased time of exposure resulting in greater cell death.
• In vivo, Accurin nanoparticle AZD2811 inhibited tumor growth or resulted in tumor regression in multiple DLBCL and SCLC models.
• At 25mg/kg dosed on day 1 and 3, Accurin nanoparticle AZD2811 provided either equivalent or superior activity to AZD1152 delivered at 25mg/kg on days 1, 2, 3 and 4.
• Increased dose intensity resulted in increased anti-tumor effect, while modifying the timing and dose intensity of each dose cycle also influenced the anti-tumor activity.

In a poster entitled, “Imaging Accurin-AZD1152 hQPA nanoparticle accumulation in pre-clinical tumours,” data were presented that show the Accurin nanoparticle AZD2811 accumulates in tumors and achieves prolonged tumor drug exposure. This is the first time distribution of nanoparticles in tumors has been demonstrated.

• Imaging mass spectrometry analysis demonstrated that Accurin nanoparticle AZD2811 accumulates in preclinical tumor models and confirmed that the Accurin accesses the tumor and provides prolonged drug exposure and retention in the target tissue.

• Multiple imaging techniques demonstrated Accurin nanoparticle AZD2811 is still detected at nine days after nanoparticle administration, while no drug was detected 24 hours after the prodrug AZD1152 was administered.

About Accurins™
Accurins are BIND's targeted and programmable therapeutics, which are designed, utilizing BIND's medicinal nanoengineering platform, with specified physical and chemical characteristics to target specific cells or tissues and concentrate a therapeutic payload at the site of disease to enhance efficacy while minimizing adverse effects on healthy tissues. Accurins are polymeric nanoparticles that incorporate a therapeutic payload and are designed to have prolonged circulation within the bloodstream, enable targeting of the diseased tissue or cells, and provide for the controlled and timely release of the therapeutic payload. BIND has demonstrated in preclinical studies that Accurins can improve tumor growth suppression, achieve higher concentrations of the payload in tumors compared to the payload administered in conventional form, and have pharmacokinetics and tolerability differentiated from their therapeutic payloads.

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 (IND) application filing with the U.S. Food and Drug Administration (FDA) 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 MSD outside the United States and Canada), to develop Accurins based on their proprietary therapeutic payloads and targeting ligands.

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 expectations regarding our potential creation of best-in-class therapeutics and benefits of Accurins; the abstracts and data being presented at AACR; BIND-014, including without limitation planned clinical trials of BIND-014 in 2015; Accurins, and developing a pipeline of Accurins; BIND-510, including without limitation our plan to file an IND application with the FDA in 2016; and statements regarding upcoming events and presentations.

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 Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 11, 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.