Apr 8 2014
BIND Therapeutics, Inc., a clinical-stage nanomedicine platform company developing targeted and programmable therapeutics called Accurins™, announced today that clinical data on its lead drug candidate, BIND-014, were presented at the American Association of Cancer Research (AACR) meeting.
The clinical data from a completed Phase 1 study demonstrate differentiating attributes of BIND-014 administered with a weekly dosing schedule which may enable increased dose intensity and enhanced therapeutic efficacy of BIND-014. In addition, data supporting the potential utility of PSMA as a target and marker for BIND-014 patient selection were presented.
BIND-014 is a targeted polymeric nanoparticle containing the cytotoxic agent docetaxel. In preclinical cancer models, BIND-014 was shown to increase accumulation of docetaxel at the site of disease which translated to marked improvements in antitumor activity and tolerability. BIND-014 is currently in two Phase 2 studies in non-small cell lung cancer and metastatic castrate resistant prostate cancer.
“These data demonstrated the unique attributes and potential benefits of BIND-014 as a valuable cancer therapy,” said Scott Minick, President and CEO of BIND. “We are highly encouraged that both the once weekly and once every three week dosing schedules of BIND-014 showed favorable safety and promising efficacy results, and we are evaluating both dosing schedules in our ongoing Phase 2 lung study to determine the optimal dose and schedule for BIND-014. In addition, we have generated data supportive of PSMA as a mechanistic target and potential biomarker for clinical patient selection.”
In a poster presentation entitled, “A phase 1 study of BIND-014, a PSMA-targeted nanoparticle containing docetaxel, administered to patients with refractory solid tumors on a weekly schedule,” BIND Therapeutics researchers presented Phase 1 data on safety, pharmacokinetics and preliminary efficacy of BIND-014 administered as a 60-minute infusion, once weekly for three weeks (Q1W), followed by one week of no treatment over a four-week cycle.
- Greater dose intensity by approximately 50% was shown with Q1W dosing of BIND-014 as compared to once every three week dosing of BIND-014 described in a previous study.
- Different tolerability profiles were demonstrated with BIND-014 dosed at Q3W and Q1W. The Q1W schedule demonstrated considerably less neutropenia than Q3W BIND-014, a major dose-limiting toxicity for docetaxel, even at the higher dose intensity.
- Pharmacokinetics of BIND-014 were consistent with prolonged retention of BIND-014 particles in the vascular compartment and controlled release of docetaxel at the tumor.
- Preliminary signals of antitumor activity were observed for BIND-014 administered on the Q1W schedule.
- A Phase 2 clinical study in NSCLC examining both Q3W and Q1W dosing schedules is in progress.
In a poster presentation entitled, “Prostate-specific membrane antigen (PSMA) expression as a potential patient selection marker in patients with refractory solid tumors administered BIND-014, a PSMA-targeted nanoparticle containing docetaxel,” BIND Therapeutics researchers presented data from a retrospective analysis which demonstrated PSMA expression in patients responding to treatment with BIND-014 in the phase 1 clinical study.
- Positive PSMA expression of moderate or high intensity was observed in patients who demonstrated a response to BIND-014 in the Phase 1 study.
- Preferential expression of PSMA was observed on prostate cancer cells and vasculature of non-prostate solid tumors, but not in normal vasculature.
- PSMA expression levels will be evaluated in the tumors of patients enrolled in Phase 2 clinical studies with BIND-014 to investigate the correlation between expression and efficacy as a potential basis for patient selection.
Source: http://www.bindtherapeutics.com/