Date: 2016-04-06
Type of information: Results
phase: 2
Announcement: results
Company: Bind Therapeutics (USA - MA)
Product: BIND-014 (docetaxel encapsulated in a polymeric nanoparticle)
Action
mechanism: taxane derivative. BIND-014 is a targeted biodegradable polymeric nanoparticle containing the cytotoxic agent docetaxel. BIND-014 is targeted to prostate-specific membrane antigen (PSMA), a cell surface antigen abundantly expressed on the surface of cancer cells and on new blood vessels that feed a wide array of solid tumors. In preclinical cancer models, BIND-014 was shown to deliver up to 20 times more docetaxel to tumors than an equivalent dose of Taxotere. The increased accumulation of docetaxel at the site of disease translated to marked improvements in antitumor activity and tolerability.The development of BIND-014 was funded in part by the National Cancer Institute and the U.S. National Institutes of Standards and Technology (NIST) under its Advanced Technology Program (ATP).
Disease: urothelial carcinoma, cholangiocarcinoma, cervical cancer, squamous cell carcinoma of head and neck
Therapeutic area: Cancer - Oncology
Country: Russian Federation, USA
Trial
details: The open-label, phase 2, multi-center two-stage iNSITE 2 clinical trial is designed to determine the activity, safety and tolerability of BIND-014 and will enroll up to 160 patients. In addition, an imaging and biomarker program that can potentially inform the future clinical utility of BIND-014 is also planned. (NCT02479178)
Latest
news: * On April 6, 2016, Bind Therapeutics announced preliminary top-line results from the BIND-014 (PSMA-targeted docetaxel nanoparticles) phase 2 iNSITE 2 trial in cervical and head and neck cancers. In the first stage of the iNSITE 2 trial, for the primary endpoint, BIND-014 demonstrated an objective response rate of 10 percent in the head and neck cancer cohort (n=20); there were no objective responses in the cervical cancer cohort (n=23). Based on these results, Bind has decided to halt further enrollment in the iNSITE 2 trial in advanced cervical and head and neck cancers. Additional details from the iNSITE 2 trial will be presentend at an upcoming medical meeting. Data from these trials suggest that BIND-014 continues to provide meaningful improvements in safety and tolerability, and at least similar efficacy when administered at a 20 percent lower dose in comparison to historical studies with docetaxel. As a result, the Company believes that these new data further validate the potential of the ACCURINS® platform. iNSITE 2 in advanced cervical and head and neck cancers: * On September 9, 2015, Bind Therapeutics announced that patient dosing is underway in the iNSITE 2 trial, a global, phase 2, two-stage clinical trial of BIND-014 in patients with four tumor histologies. These diseases (cholangiocarcinoma [bile duct cancer], advanced cervical cancer, advanced bladder cancer, and advanced squamous cancer of the head and neck) each affect fewer than 200,000 patients in the U.S., making investigational drugs for these diseases candidates for orphan drug designation by the FDA. Stage 1 data readout for the iNSITE 2 trial is expected in the first half of 2016.
The primary endpoint of the two-stage iNSITE 2 trial was ORR with a target of at least one response in the first 20 patients for advancement from stage 1 to stage 2. In the head and neck cancer cohort (20 evaluable patients), the ORR was 10 percent; there were no responses in the cervical cancer cohort (23 evaluable patients). Based on these results, the Company has decided to halt further enrollment in the iNSITE 2 trial in advanced cervical and head and neck cancers. Safety data in more than 300 patients treated with BIND-014 to date continue to demonstrate meaningful improvements in hematologic and non-hematologic toxicities when compared to historical docetaxel data.
