2014年11月20日讯 /生物谷BIOON/ --对于今年的Bind Therapeutics公司来说，太需要一场胜利来提振公司士气。今年早些时候，安进公司结束了与Bind Therapeutics公司的合作关系，这也意味着双方价值1亿8千万美元的癌症联合疗法合作正式划上句号。最近，Bind Therapeutics公司又公布了其纳米疗法BIND-014治疗非细小型细胞肺癌的二期临床研究数据。
BIND-014是Bind Therapeutics公司开发的利用公司独有Accurin纳米靶向技术输送多烯紫杉醇的纳米药物。这一技术能够靶向肿瘤细胞，从而指引抗肿瘤药物特异性杀死肿瘤细胞，避免波及肿瘤组织周围的正常细胞。在最近刚刚结束的二期临床研究中，每三周接受一次BIND-014治疗的患者组达到了实验的预期终点。其中有40名非细小细胞肺癌患者的肿瘤出现体积减小的表现，总反应率达到13%。其中有9名患者是KRAS基因突变型患者。据此，研究人员又设计了新的临床二期研究以探究这一药物是否对于这一基因突变型癌症患者有特殊疗效。然而，在每周接受BIND-014治疗的患者中并为出现显着差异。这一截然不同的结果显然也出乎Bind Therapeutics公司的意料，虽然公司没有公布此次二期临床研究的具体数据，但是公司表示目前将暂停对每周一次治疗组的进一步研究。公司的股价也受此消息影响而下降。
近年来，Bind Therapeutics公司一直专注于其纳米颗粒疗法Accurin的研发。不少医药巨头如默沙东、阿斯利康等都对这一技术表现出兴趣。
详细英文报道：
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 cancershrink, 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.