BIND Therapeutics, a clinical-stage nanomedicine platform company, has dosed its first patient in a phase II clinical trial to assess the safety and efficacy of BIND-014, a PSMA-targeted Accurin containing docetaxel, as first-line therapy in patients with chemotherapy naïve metastatic castrate-resistant prostate cancer.
"While treatment options for metastatic castrate-resistant prostate cancer have advanced in recent years, primarily due to an increased understanding of androgen receptor biology, a significant unmet need remains for patients who fail hormonal agents,” said Gregory Berk, MD, chief medical officer of BIND Therapeutics. “We are pleased our phase I trial of BIND-014 established the safety profile and appropriate phase II dose, and we are advancing BIND-014 in clinical development to further evaluate it as a potential treatment option for patients who are in need of more effective therapies."
"Prostate-specific membrane antigen (PSMA) is an attractive target in patients with advanced prostate cancer. By delivering an established cytotoxic to this target, there is the potential to significantly improve the therapeutic index and patient outcomes," commented Howard Scher, MD, the chief of the Genitourinary Oncology Service at Memorial Sloan-Kettering Cancer Centre and professor of Medicine at the Weill Cornell Medical College, and principal investigator of the study.
This 40 patient, open label, single arm multi-centre study is designed to determine the efficacy of BIND-014 as measured by progression-free survival in patients with chemotherapy-naïve metastatic castrate-resistant prostate cancer.
BIND-014 represents the first Accurin nanomedicine to reach the clinic from BIND's Medicinal Nanoengineering platform. BIND-014 targets PSMA, a target expressed on prostate cancer cells and the blood vessels of many types of non-prostate solid tumours, 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.