– Dosing begins in phase 2 trial in patients with cholangiocarcinoma, cervical cancer, bladder cancer and head and neck cancer; initial clinical data anticipated in first half of 2016 –

CAMBRIDGE, MA, USA I September 9, 2015 I BIND Therapeutics, Inc. (NASDAQ: BIND), a clinical-stage nanomedicine company developing targeted and programmable therapeutics called AccurinsTM, today announced that patient dosing is underway in the iNSITE 2 trial, a global, phase 2, two-stage clinical trial of BIND-014 in patients with four tumor histologies. These diseases (cholangiocarcinoma [bile duct cancer], advanced cervical cancer, advanced bladder cancer, and advanced squamous cancer of the head and neck) each affect fewer than 200,000 patients in the U.S., making investigational drugs for these diseases candidates for orphan drug designation by the U.S. Food and Drug Administration. Stage 1 data readout for the iNSITE 2 trial is expected in the first half of 2016.

“The dosing of the first patient in the iNSITE 2 trial further expands the clinical development opportunities of BIND-014,” said Hagop Youssoufian, M.Sc., M.D., chief medical officer at BIND Therapeutics. “It also represents a new milestone for the first targeted nanoparticle to enter the clinic by utilizing a rigorous biomarker program that can become a useful aid for more reliable patient selection in the future. The orphan tumor types that we have chosen for iNSITE 2 are all cancers with high unmet need and limited treatment options, representing potential opportunities for rapid development. Our choice was also guided by the activity seen with BIND-014 in our phase 1 trial and the historical role of docetaxel in treating these tumors.”

The open-label, phase 2, multi-center two-stage iNSITE 2 clinical trial is designed to determine the activity, safety and tolerability of BIND-014 and will enroll up to 160 patients. In addition, an imaging and biomarker program that can potentially inform the future clinical utility of BIND-014 is also planned. Additional information on this study can be found at: https://www.clinicaltrials.gov.

About BIND Therapeutics
BIND Therapeutics is a clinical-stage nanomedicine 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. BIND has also initiated clinical trials with BIND-014 in cervical, bladder, head and neck and cholangio cancers. In addition, BIND is 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 at or below therapeutic doses.

BIND has announced ongoing collaborations with Pfizer Inc., AstraZeneca AB, F. Hoffmann-La Roche Ltd., Merck & Co., or Merck (known as Merck Sharp & Dohme outside the United States and Canada) and Macrophage Therapeutics (a subsidiary of Navidea Biopharmaceuticals) to develop Accurins based on their proprietary therapeutic payloads and/or targeting ligands. BIND’s collaboration with AstraZeneca has resulted in FDA clearance to begin clinical trials with the Aurora B Kinase inhibitor Accurin AZD2811, which is expected to become the second Accurin candidate to enter clinical development.

SOURCE: BIND Therapeutics