BIND Therapeutics, a clinical-stage nanomedicine platform company developing targeted and programmable therapeutics called Accurins, has dosed the first patient in a phase II 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 I trial of BIND-014 established the safety profile and appropriate phase II dose for this drug candidate, and we are advancing BIND-014 into phase II 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.
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.