BIND Announces Preliminary Results From BIND-014; To Cut 38% Of Jobs

(RTTNews) - BIND Therapeutics Inc. (BIND) announced preliminary results from the BIND-014 (PSMA-targeted docetaxel nanoparticles) phase 2 iNSITE 1 trial in advanced non-small cell lung cancer or NSCLC of squamous histology and the iNSITE 2 trial in cervical and head and neck cancers. BIND has decided to halt further enrollment in the iNSITE 2 trial in advanced cervical and head and neck cancers.

BIND also announced a restructuring plan, which will include a workforce reduction of 38 percent, and it is expected to be substantially complete by the end of April 2016, after which the Company will have 61 employees. In addition, BIND will evaluate options for the Company's wholly owned subsidiary in Moscow. Collectively, these actions are expected to bring BIND's quarterly cash burn rate to approximately $6 million per quarter by the third quarter of 2016.

In addition to the workforce reduction initiatives, the Company is actively working with an investment bank to initiate a review of financial and strategic alternatives with the goal of maximizing stockholder value. Potential alternatives to be explored and evaluated during the review process may include raising additional capital, a strategic collaboration with one or more parties, or the licensing, sale or divestiture of some of the Company's proprietary technologies.

BIND said it is continuing its development and collaboration activities in accordance with its current innovative medicines strategy while managing its cash position. There is no finite timetable for completion of the financial and strategic review process.

In the iNSITE 1 trial, for the primary endpoint, BIND-014 demonstrated a 52.5 percent 6-week disease control rate (6wDCR) for the intent-to-treat population (n=40) and a 70.0 percent 6wDCR in the per protocol population (n=30), which exceeded the protocol defined criteria for success of 65 percent. BIND intends to seek licensing or collaboration opportunities for further development of BIND-014 in NSCLC. 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 1 and iNSITE 2 trials are listed below and the Company expects to present further details 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.

The Company currently has one kinase inhibitor Accurin, AZD2811, in phase 1 clinical trials in collaboration with AstraZeneca. A second kinase inhibitor Accurin is currently in IND (investigational new drug) -enabling activities through a collaboration with Pfizer. Following optimization of lead product candidates and completion of preclinical studies, BIND anticipates initiation of clinical testing for one or more proprietary innovative product candidates as early as 2018.