BIND Therapeutics, Inc., a clinical-stage nanomedicine company developing a targeted and programmable therapeutics called ACCURINS, has announced that the Phase 2 iNSITE1 clinical trial of its lead drug candidate, BIND-014, is ready to move to a second stage and enroll a total of 40 patients with squamous histology non-small cell lung cancer (NSCLC).
The KRAS mutant NSCLC arm of the iNSITE1 trial, however, will not advance. Both decisions, the company said, were based on safety and efficacy data from an interim analysis of iNSITE1, as well as updated overall survival (OS) data from the squamous cohort of a previous clinical trial in NSCLC patients known as BIND-014-005 (11.1 months in nine patients).
“The activity of BIND-014 as monotherapy in 2nd line NSCLC of squamous histology remains encouraging,” said Hagop Youssoufian, MD, MSc, chief medical officer of BIND Therapeutics, said in a press release. “There have been important advances in treatment strategies for NSCLC and we believe the evolving treatment landscape may benefit from chemotherapy in combination with checkpoint inhibitors. The safety profile of BIND-014, along with the potential to target disease sites with greater specificity, supports its development as a cytotoxic partner to checkpoint inhibitors and we will be exploring BIND-014 in this context.”
Both the squamous and KRAS cohorts of iNSITE1’s first phase were evaluated for criteria that included a 6-week disease control rate (6wDCR) and tolerability of the BIND-014 therapy. The squamous histology cohort will also seek to confirm OS data from the previous trial.
First phase results in the squamous histology cohort, comprising 20 patients in the intent-to-treat (ITT) population and 11 patients from the per-protocol (PP) subset, demonstrated an interim 6wDCR of 25% in the ITT group and 45.5% in the subset. In the KRAS mutant cohort, first phase data from 23 ITT patients and 14 PP patients demonstrated an interim 6wDCR of 17.4% and 28.6%, respectively — not meeting the pre-established, second stage criteria.
Safety data in more than 200 patients treated with BIND-014 to date continue to demonstrate improvements in hematologic and non-hematologic toxicities when compared to historical data on docetaxel, the company reports. Docetaxel is a U.S. Food and Drug Administration-approved cancer chemotherapy drug.
ACCURINS is a targeted therapeutics designed to increase the concentration and duration of therapeutic payloads at disease sites while preserving healthy tissue. BIND is developing a pipeline of ACCURINS targeting hematological and solid tumors. BIND-014, its lead candidate, is a prostate-specific membrane antigen-targeted ACCURIN that contains docetaxel.
“[W]e believe that BIND-014 may be ideally suited to broaden the impact of immuno-oncology approaches in the treatment of solid tumors,” said Andrew Hirsch, president and chief executive officer of BIND Therapeutics. “Our next steps are to complete enrollment in the squamous cohort of iNSITE 1 in early 2016 and, in parallel, begin designing a trial in combination with a checkpoint inhibitor that we intend to pursue contingent upon final iNSITE 1 results, potentially through new collaborations with development partners.”
The company is also enrolling patients with advanced cholangiocarcinoma, bladder, cervical, and head and neck cancers for a Phase 2 iNSITE2 trial of BIND-014. Topline results from this trial are expected in the first half of 2016.
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