Phase 2 Study Met Primary Objective of Showing Anti-Tumor Activity as Measured by Overall Response Rate at Q3W Dosing Schedule

The gist: A drug called BIND-014 has shown some promise for treating advanced or metastatic non-small cell lung cancer (NSCLC). In particular, it has shown promise for treating NSCLC tumors that have mutations in the KRAS gene. BIND-014 is a new form of the chemotherapy drug docetaxel. It is meant to home in on cancer cells to deliver chemotherapy directly. It is being compared to standard docetaxel in volunteer patients in a clinical trial. So far, the results are promising, but more research is needed.

“BIND Therapeutics, Inc. (NASDAQ: BIND), a clinical-stage nanomedicine platform company developing targeted and programmable therapeutics called AccurinsTM, today presented positive results from its ongoing Phase 2 study of BIND-014 in non-small cell lung cancer (NSCLC), demonstrating it has met the primary objective in the once every three weeks (Q3W) arm as measured by overall response rate (ORR). The data demonstrate that BIND-014 is well-tolerated with clinically meaningful anti-tumor activity at a lower dose than conventional docetaxel in patients with advanced or metastatic NSCLC. BIND-014 also demonstrates promising anti-tumor activity in patients with tumors expressing KRAS mutations (mutated Kirsten ras oncogene homolog). KRAS mutations in NSCLC are generally associated with poor response to currently available drug therapy regimens, including docetaxel. An additional signal was observed in patients with squamous cell carcinomas, a major NSCLC subtype poorly served by existing available therapies. These data were presented at the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain.

“ ‘We believe the activity and tolerability of BIND-014 demonstrated in this study suggest meaningful differentiation from the historical docetaxel experience, in both the broader NSCLC patient population and in two important groups of patients with high unmet medical need,’ said Hagop Youssoufian, M.D., M.Sc., Chief Medical Officer, BIND Therapeutics. ‘Furthermore, as the first product candidate from our Medicinal Nanoengineering® platform to enter the clinic, we believe that the increased efficacy and reduced toxicity at a lower dose compared to historical docetaxel experience suggests that Accurins are successful in targeting the therapeutic payload to the tumor. Based on these positive results, we plan to conduct additional global, multicenter Phase 2 studies to confirm and expand the dataset on BIND-014 and to define an expeditious regulatory path for BIND-014.’ ”