Bind Therapeutics ($BIND) believes its lead nanoparticle treatment can make a difference for a subgroup of lung cancer patients, pointing to some positive results from an otherwise mixed mid-stage trial as it prepares for further study.
The drug, BIND-014, pairs the well-understood anticancer agent docetaxel with Bind's proprietary Accurin technology, a nano-engineered targeting mechanism that binds to tumor cells and delivers a toxic payload with limited damage to nearby healthy tissue. The idea is to boost efficacy and reduce dosage by getting more concentrated drug content to the locus of a patient's cancer.
In one arm of an open-label Phase II study, the drug met its primary goal of tumor shrinkage in 40 patients with non-small cell lung cancer (NSCLC) who received BIND-014 every three weeks, charting a 13% response rate. In the other arm of the study, in which 22 patients got the drug every week, the company failed to confirm any response. Bind didn't disclose detailed results from that arm but said in a statement it's holding off on any plans for a weekly BIND-014 dosing schedule.
The glass was looking more half-empty, though, than half-full to investors this morning. Bind's shares dropped 15% in morning trading.
Digging into subpopulation results in the every-three-weeks arm, Bind points out that two of the 9 patients in the study with KRAS gene mutations saw their cancer shrink, which CEO Scott Minick touts as a promising result for a patient population long plagued by poor response rates to standard docetaxel. And the 9 patients with squamous cell carcinoma, a tough-to-treat NSCLC subtype, charted a median progression-free survival of 11.1 months, a result Minick said far outpaces past studies using docetaxel alone.
With those subtype results in mind, Bind has outlined two more Phase II studies, one enrolling 40 subjects with KRAS-mutated NSCLC and another targeting squamous patients. Each will assess a primary endpoint of overall survival, and Bind expects to report out data throughout the next year. If successful, the trials will set the table for further registration studies designed to support an FDA submission, the company said.
Bind is touting the Phase II efficacy signal as further affirmation of the Accurin platform, whose promise has lured the likes of Merck ($MRK), AstraZeneca ($AZN), Pfizer ($PFE) and Roche ($RHHBY) to partner up with the company in hopes that its nano-targeting system can help deliver their cytotoxic candidates.
"What's hard in oncology is you're trying to kill tumor cells that are virtually identical to the tissues around them, so there's a lot of collateral damage," Minick said. "... Overall, this validates the central premise of the platform, which is trafficking more therapeutic payload to the site of disease with less exposure to healthy tissues. This shows great promise that our platform has the ability to do that in a clinical setting."
Bind, co-founded by MIT's Robert Langer, is moving on from a setback with one of its early collaborators, in which Amgen ($AMGN) walked away from a $180 million deal to pair one of the biotech's Accurins with an undisclosed cancer therapy. The news marred Bind's shares over the summer, but the company believes it's back on the up and up, this month pairing up with Merck on an Accurin-powered take on the chemotherapy vincristine and recruiting Hagop Youssoufian, a veteran of Eli Lilly ($LLY) and Sanofi ($SNY), to serve as its chief medical officer.
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