Clinical-stage biopharmaceutical company BIND Biosciences has reported promising preclinical data from the Phase 1 clinical study of BIND-014 in patients with advanced or metastatic cancers.
BIND-014 is a programmable nanomedicine that combines a targeting ligand and a therapeutic nanoparticle to act against prostate specific membrane antigen (PSMA), a cell surface antigen expressed on the surface of cancer cells and on new blood vessels that feed a wide array of solid tumours.
The open label pharmacokinetic and pharmacodynamic dose escalation Phase 1 study was intended to evaluate the safety, tolerability and maximum tolerated dose of BIND-014 and to determine preliminary evidence of antitumour activity.
The preliminary Phase 1 data suggested that BIND-014 demonstrated partial response or stable disease in the pretreated patient population with durable responses of up to six months in some cases.
In addition, BIND-014 showed evidence of antitumour activity in tumours for which conventional docetaxel is known to have minimal activity.
At all dose levels studied, with 75mg/m² reached to date, BIND-014 was generally well-tolerated with no new toxicities observed, the company said.
BIND Biosciences president and chief executive officer Scott MINICK said the encouraging Phase 1 data will support the company to advance BIND-014 into Phase 2 development planned later this year.
"In addition, these data show the emerging potential of BIND-014 to be a significant new cancer therapy for patients by fundamentally changing the pharmacology of docetaxel, allowing it to differentially concentrate in the tumours by up to ten-fold, as shown in our preclinical models, for better clinical efficacy across multiple cancers, including those in which conventional docetaxel has minimal activity," Minick added.
"BIND-014 is the clinical validation of BIND’s Accurin technology platform, and marks an important milestone for the field of nanomedicine, BIND and, most importantly, patients."
In preclinical cancer models, BIND-014 was found to deliver up to ten-fold more docetaxel to tumours than an equivalent dose of conventional docetaxel, thereby improving antitumour activity and tolerability.
The development of BIND-014 was funded in part by the National Cancer Institute and the US National Institutes of Standards and Technology (NIST) under its Advanced Technology Programme (ATP).