CAMBRIDGE, Mass.--(BUSINESS WIRE)--BIND Therapeutics, a clinical-stage nanomedicine platform company developing targeted and programmable therapeutics called AccurinsTM, announced today that it has dosed the first patient in a Phase 2 clinical trial to assess the safety and efficacy of BIND-014, a PSMA-targeted Accurin containing docetaxel, as second-line therapy in patients with non-small cell lung cancer.
“There are limited options for patients with advanced non-small cell lung cancer in the second-line setting. We are pleased our Phase 1 trial of BIND-014 established the safety profile and appropriate Phase 2 dose for this drug candidate, and we are advancing BIND-014 into Phase 2 development to further evaluate its clinical activity as a potential treatment option for patients who are in need of more effective therapies,” said Gregory Berk, MD, Chief Medical Officer of BIND Therapeutics.
This 40 patient, open label, single arm, multi-center study is designed to determine the efficacy of BIND-014 as measured by objective response rate in patients with Stage III/IV non-small cell lung cancer who have failed one prior platinum-containing chemotherapy regimen for advanced or metastatic disease. For more specific information on the trial, including patient eligibility and clinical trial endpoints, please visit www.clinicaltrials.gov (NCT01792479).
BIND-014 represents the first Accurin nanomedicine to reach the clinic from BIND’s Medicinal Nanoengineering® platform. BIND-014 targets prostate-specific membrane antigen (PSMA), a target expressed on prostate cancer cells and the blood vessels of many types of non-prostate solid tumors, and contains docetaxel, a clinically-validated and widely used chemotherapy drug. Docetaxel is currently FDA-approved for the treatment of breast cancer, non-small cell lung cancer, metastatic castrate-resistant prostate cancer, head and neck cancer, and gastric cancer.
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 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. To date in 2013, 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.