Emerging data on a lead drug candidate within a new class of targeted therapeutics
Data indicative of targeting ability of BIND-014 nanomedicine for high tumour drug concentration
- Date : 10 Apr 2012
- Topic : Anticancer agents & Biologic therapy
Clinical data on a lead drug candidate within a new class of targeted therapeutics that are programmed to concentrate at tumours were presented at the American Association for Cancer Research (AACR) 2012 Annual Meeting (31 March – 4 April, Chicago, USA) by BIND Biosciences, a clinical-stage biopharmaceutical company developing a new class of highly selective targeted therapeutics called AccurinsTM. Presented data are from the ongoing phase I clinical study of BIND-014, targeted docetaxel Accurin, in patients with solid tumours and showed evidence of anti-tumour activity in 6 of 17 patients with advanced or metastatic solid tumour cancers. The preliminary data demonstrated partial response or stable disease in this heavily pretreated patient population with durable responses of up to six months in some cases. In addition, BIND-014 demonstrated evidence of anti-tumour activity in tumours for which conventional docetaxel is known to have minimal activity.
BIND-014 marks an important milestone for the field of nanomedicine
BIND-014 represents the first targeted and programmable Accurin nanomedicine to reach the clinic from BIND's proprietary drug development platform that creates targeted therapeutics designed to accumulate at the site of disease for high drug concentration and maximum therapeutic effect.
BIND-014 is a programmable nanomedicine that combines a targeting ligand and a therapeutic nanoparticle. BIND-014 contains docetaxel, a proven anticancer drug which is approved in major cancer indications including breast, prostate and lung, encapsulated in FDA-approved biocompatible and biodegradable polymers. BIND-014 is targeted to prostate specific membrane antigen, a cell surface antigen abundantly expressed on the surface of cancer cells and on new blood vessels. In preclinical cancer models, BIND-014 was shown to deliver up to ten-fold more docetaxel to tumours than an equivalent dose of conventional docetaxel. The increased accumulation of docetaxel at the site of disease translated to marked improvements in antitumour activity and tolerability. The ongoing phase I study has reached a dose of 75 mg/m2 with dose escalation continuing and BIND-014 continues to be well-tolerated in the study.
Evidence of antitumour activity in cancers in which conventional docetaxel has minimal activity
In a late-breaking poster presentation researchers showed strong translation of pharmacokinetic data from preclinical findings to phase I clinical data with highly differentiated pharmacokinetic profile from conventional docetaxel and strong dose linearity across doses. At all dose levels studied, with 75 mg/m2 reached to date, BIND-014 was generally well-tolerated with no new toxicities observed. This phase I study has an ascending, intravenous dose design and dose escalation continues.
The clinical results are consistent with the preclinical findings that BIND-014 concentrates drug activity in the tumour resulting in improved efficacy. Preliminary evidence of antitumour activity during dose escalation showed antitumour activity in 6 of the 17 patients treated ranging from one durable confirmed partial response (cervical cancer) and five with stabilisation of disease (pancreatic, colorectal, bile duct, tonsillar and anal cancer).
According to the study researchers their ongoing clinical study with BIND-014 lays a strong foundation to advance into phase II development 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 preclinical models, for better clinical efficacy across multiple cancers including those in which conventional docetaxel has minimal activity.
This clinical study is being conducted at the Virginia G. Piper Cancer Center at Scottsdale Healthcare in Scottsdale, Arizona, in collaboration with the Translational Genomics Research Institute and the Scottsdale Healthcare Research Institute, the Karmanos Cancer Institute in Detroit, Michigan, and Marin Specialty Care in Greenbrae, California.
The early development of BIND-014 was funded in part by the USA National Cancer Institute and the USA National Institutes of Standards and Technology under its Advanced Technology Program. BIND is backed by leading investors, Polaris Venture Partners, Flagship Ventures, ARCH Venture Partners, NanoDimension, DHK Investments, EndeavourVision and Rusnano. BIND was founded on proprietary technology from the laboratories of two leaders in the field of nanomedicine, Professors Robert Langer, ScD, David Koch Institute Professor of the Massachusetts Institute of Technology and Dr Omid Farokhzad, Associate Professor of Harvard Medical School.
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