CAMBRIDGE, Mass.--(BUSINESS WIRE)--BIND Therapeutics, Inc. (NASDAQ:BIND), a clinical-stage nanomedicine company developing targeted and programmable therapeutics called ACCURINS(R), today announced that the squamous histology non-small cell lung cancer (NSCLC) cohort of the phase 2 iNSITE 1 trial will advance to the second stage and complete enrollment to 40 patients. The company also announced that the KRAS mutant NSCLC arm will not advance to the second stage. The rationale for these decisions is based on safety and efficacy data from the planned interim analysis of iNSITE 1 as well as updated overall survival (OS) data in the squamous cohort from the previous clinical trial in the broad NSCLC population, the BIND-014-005 trial.
"The activity of BIND-014 as monotherapy in second line NSCLC of squamous histology remains encouraging," said Hagop Youssoufian, M.D., M.Sc., chief medical officer, BIND Therapeutics. "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."
As of October 29, 2015, both the squamous and KRAS cohorts had reached the predefined 20-patient enrollment mark for stage 1, triggering a planned evaluation of the data against pre-specified gating criteria for continuation to stage 2. The major criteria for advancing to the second stage included 6-week disease control rate (6wDCR), tolerability and, in the case of the squamous histology cohort, confirmation of the OS data from the BIND-014-005 trial.
In the squamous histology cohort, data from 20 patients in the intent-to-treat (ITT) population and 11 patients from the Per-Protocol (PP) subset demonstrated an interim 6wDCR of 25 percent (95% CI [confidence interval], 9% to 49%) and 45.5 percent (95% CI, 17% to 77%), respectively. There were no tumor responses by RECIST v1.1.
The final median OS in nine patients with squamous histology from the BIND-014-005 trial was 11.1 months, confirming the interim median OS reported previously, with a 1-year survival rate of 44 percent. These data compare favorably with currently approved treatments. As a reference, in the CheckMate 017 trial in second line NSCLC of squamous histology, a median OS of 9.2 months and 6.0 months and 1-year survival rates of 42 percent and 24 percent were reported for Opdivo(R) (nivolumab) and docetaxel, respectively.
In the KRAS mutant cohort, data from 23 patients in ITT population and 14 patients from the PP subset demonstrated an interim 6wDCR of 17.4 percent (95% CI, 5% to 39%) and 28.6 percent (95% CI, 8% to 58%) respectively, which did not meet pre-specified criteria to move to the second stage of the iNSITE 1 trial. The overall response rate (ORR) by RECIST v1.1 was 4 percent (ITT) and 7 percent (PP). Patients currently enrolled in this cohort will continue to be followed for safety and efficacy.
Safety data in more than 200 patients treated with BIND-014 to date continue to demonstrate meaningful improvements in hematologic and non-hematologic toxicities when compared to historical docetaxel data.
"Based on preliminary data from iNSITE 1 and confirmed median overall survival data from the 005 trial, we 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, 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."
Enrollment is ongoing in the phase 2 iNSITE 2 trial with BIND-014 in patients with advanced cholangiocarcinoma, bladder, cervical and head and neck cancers. Topline data for the second stage of iNSITE 2 are anticipated in the first half of 2016.
ABOUT BIND THERAPEUTICS
BIND Therapeutics is a clinical-stage nanomedicine company developing a pipeline of ACCURINS(R), its novel targeted therapeutics designed to increase the concentration and duration of therapeutic payloads at disease sites while reducing exposure to healthy tissue. BIND is leveraging its Medicinal Nanoengineering platform to develop a pipeline of ACCURINS targeting hematological and solid tumors and has a number of strategic collaborations with biopharmaceutical companies to develop ACCURINS in areas of high unmet need. BIND's lead drug candidate, BIND-014, is a prostate-specific membrane antigen (PSMA) -targeted ACCURIN that contains docetaxel, a clinically-validated and widely-used cancer chemotherapy drug. BIND is currently enrolling patients in a trial with BIND-014 for non-small cell lung cancer, or NSCLC, with squamous histology. In addition, BIND is enrolling patients in a clinical trial with BIND-014 for advanced cervical, bladder, head and neck and cholangio cancers. BIND is advancing BIND-510, its second PSMA-targeted ACCURIN drug candidate containing vincristine, a potent microtubule inhibitor with dose limiting peripheral neuropathy in its conventional form, through important preclinical studies to position it for an Investigational New Drug (IND) application filing with the U.S. Food and Drug Administration. BIND is also developing ACCURINS designed to inhibit PLK1 and KSP, both of which BIND believes are promising anti-mitotic targets that have been limited in the clinic due to systemic toxicity at or below therapeutic doses.
BIND has announced ongoing collaborations with Pfizer Inc., AstraZeneca AB, F. Hoffmann-La Roche Ltd., Merck & Co., Merck & Co. (known as Merck Sharp & Dohme outside the United States and Canada) and Macrophage Therapeutics (a subsidiary of Navidea Biopharmaceuticals) to develop ACCURINS based on their proprietary therapeutic payloads and/or targeting ligands. BIND's collaboration with AstraZeneca has resulted in the Aurora B Kinase inhibitor ACCURIN AZD2811, which became the second ACCURIN candidate to enter clinical development. BIND's collaboration with Pfizer has resulted in the selection of an ACCURIN candidate that is entering IND-enabling studies.