TGen-Scottsdale Healthcare clinical trial results for BIND-014 presented at AACR 2013

(Press-News.org) WASHINGTON, D.C. — April 9, 2013 — The nanoparticle drug BIND-014 is effective against multiple solid tumors, according to results generated by the Translational Genomics Research Institute (TGen) and Scottsdale Healthcare, and presented today at the American Association for Cancer Research (AACR) Annual Meeting 2013.

Data for the study was generated at the Virginia G. Piper Cancer Center Clinical Trials, a partnership of TGen and Scottsdale Healthcare.

Dr. Daniel Von Hoff, TGen Physician-In-Chief and Chief Scientific Officer of Scottsdale Healthcare's Clinical Research Institute, will present A Phase 1 Study of BIND-014, a PSMA-targeted Nanoparticle Containing Docetaxel, in Patients with Refractory Solid Tumors during an AACR session at 1 p.m. EDT today at the Washington, D.C., Convention Center, Room 146.

Dr. Von Hoff, the study's Principal Investigator, will present complete Phase 1 clinical data of BIND-014, which is produced by BIND Therapeutics, a clinical-stage biopharmaceutical company developing a new class of highly selective targeted and programmable therapeutics called AccurinsTM. BIND-014 is the company's lead drug candidate.

In 28 patients with advanced or metastatic solid tumors, BIND-014 — with its targeted docetaxel Accurin — was shown to be generally safe and well-tolerated at the established maximum dose of 60 mg/m2. BIND-014 showed encouraging signs of anti-tumor activity, including one complete response, three partial responses and five patients with stable disease lasting at least four, 12-week-plus cycles. In addition, the pharmacokinetic (PK) profile of BIND-014 was substantially different from the published PK of conventional docetaxel.

"This Phase 1 trial has successfully established the safety and tolerability profile and maximum tolerated dose of BIND-014 in patients with advanced or metastatic solid tumor cancers," said Dr. Von Hoff, F.A.C.P., TGen's Distinguished Professor. "There is a critical need for targeted treatment options for patients with difficult-to-treat solid tumors, and we look forward to further evaluating the potential of BIND-014 in patients with specific solid tumor types in the near future."

"In addition to confirming the safety, tolerability and maximum tolerated dose of BIND-014, these data also provide encouraging signs of anti-tumor activity in a variety of solid tumors," said Dr. Gregory Berk, Chief Medical Officer of BIND Therapeutics. "Based on these data, BIND is moving expeditiously to advance BIND-014 into multiple Phase 2 clinical trials in 2013 including non-small cell lung cancer, prostate cancer and bladder cancer."

BIND-014 represents the first targeted and programmable Accurin nanomedicine to reach the clinic from BIND's proprietary drug development platform, which creates targeted therapeutics designed to accumulate at the site of disease for high drug concentration and maximum therapeutic effect. BIND-014 employs a combination of a targeted biodegradable nanoparticle and docetaxel, a well-established chemotherapy agent.

Dr. Von Hoff's presentation of BIND-014 is consistent with previously reported preliminary observations in which safety, tolerability and efficacy in multiple tumor types was demonstrated:

BIND-014 was generally safe and well-tolerated with transient and manageable neutropenia as the dose limiting toxicity. Minimal neuropathy, mucositis, fluid retention, rash, and nail changes were observed.

Established the maximum tolerated dose of 60 mg/m2 when administering BIND-014 on a once every 3 week (Q3W) schedule.

Evidence of anti-tumor activity was shown with BIND-014 at 60mg/m2 in nine out of the 28 patients treated, ranging from one complete response (cervical cancer), three partial responses (non-small cell lung cancer, prostate and ampullary) and five patients with stabilization of disease lasting at least four cycles (> 12 weeks; pancreatic, colorectal, gall bladder, tonsillar and anal cancer).

The PK profile of BIND-014, characterized by prolonged and elevated encapsulated docetaxel levels, was highly differentiated from published PK of conventional docetaxel.

This clinical study was conducted at the Virginia G. Piper Cancer Center at Scottsdale Healthcare in Scottsdale, Arizona, in collaboration with Phoenix-based TGen, the Scottsdale Healthcare Research Institute, Karmanos Cancer Institute in Detroit, Marin Specialty Care in Greenbrae, Calif., and the Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center.

### About Accurins™ BIND Therapeutics is discovering and developing Accurins, proprietary new best-in-class therapeutics, which have demonstrated superior target selectivity and programmable properties in preclinical studies, offering the potential to improve patient outcomes. Leveraging its proprietary Medicinal Nanoengineering® platform, BIND develops Accurins that are designed to outperform conventional drugs by selectively accumulating in diseased tissues and cells. The objective is to provide higher drug concentrations at the site of action with minimal off-target exposure, and the potential to improve efficacy and safety. In addition to target selectivity, the programmable properties of Accurins allow for fine-tuning the pharmacokinetic and biodistribution of drugs, differentiating characteristics, which have been demonstrated in preclinical studies.

About BIND Therapeutics BIND Therapeutics is a clinical-stage biopharmaceutical company developing a new class of highly selective targeted and programmable therapeutics called AccurinsTM. BIND's Medicinal Nanoengineering® platform enables the design, engineering and manufacturing of Accurins with unprecedented control over drug properties to maximize trafficking to disease sites, with the objective of enhancing efficacy while minimizing toxicities. BIND is developing a pipeline of novel Accurins that hold extraordinary potential to become best-in-class drugs and improve patient outcomes. BIND's lead product candidate, BIND-014, is currently entering Phase 2 clinical testing in cancer patients and is designed to selectively target PSMA, a surface protein upregulated in a broad range of solid tumors. BIND also develops Accurins in collaboration with pharmaceutical and biotechnology partners to enable promising pipeline candidates to achieve their full potential and to utilize selective targeting to transform the performance of important existing drug products. BIND is backed by leading investors, including: Polaris Venture Partners, Flagship Ventures, ARCH Venture Partners, NanoDimension, DHK Investments, EndeavourVision and Rusnano. BIND was founded on proprietary technology from the laboratories of two leaders in the field of nanomedicine, Professors Robert Langer, David H. Koch Institute Professor of the Massachusetts Institute of Technology (MIT) and Omid Farokhzad, Associate Professor of Harvard Medical School. For more information, please visit the company's web site at http://www.bindtherapeutics.com.

Media: Kathryn Morris
The Yates Network
Tel: 845-635-9828
kathryn@theyatesnetwork.com

About the Virginia G. Piper Cancer Center at Scottsdale Healthcare The Virginia G. Piper Cancer Center at Scottsdale Healthcare in Scottsdale, Ariz. offers comprehensive cancer treatment and research through clinical trials, diagnosis, treatment, prevention and support services in collaboration with leading scientific researchers and community oncologists. Scottsdale Healthcare is the nonprofit parent organization of the Virginia G. Piper Cancer Center at Scottsdale Healthcare, Scottsdale Healthcare Research Institute, Scottsdale Healthcare Osborn Medical Center, Scottsdale Healthcare Shea Medical Center and Scottsdale Healthcare Thompson Peak Hospital. For more information, visit http://www.shc.org.

Press Contact: Keith Jones
Public Relations Director
Virginia G. Piper Cancer Center at Scottsdale Healthcare
480-323-1383
kjones@shc.org

About TGen The Translational Genomics Research Institute (TGen) is a Phoenix, Arizona-based non-profit organization dedicated to conducting groundbreaking research with life changing results. Research at TGen is focused on helping patients with diseases such as cancer, neurological disorders and diabetes. TGen is on the cutting edge of translational research where investigators are able to unravel the genetic components of common and complex diseases. Working with collaborators in the scientific and medical communities, TGen believes it can make a substantial contribution to the efficiency and effectiveness of the translational process. For more information, visit: http://www.tgen.org.

Press Contact: Steve Yozwiak
TGen Senior Science Writer END