CAMBRIDGE, Mass.--(BUSINESS WIRE)--BIND Therapeutics, Inc. (NASDAQ:BIND), a clinical-stage nanomedicine company developing targeted and programmable therapeutics called ACCURINS®, 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 2nd 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 2nd 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® (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®, 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., or Merck (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.
For more information, please visit the Company's web site at www.bindtherapeutics.com.
Forward-Looking Statements Disclaimer
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our interpretation of the data from the iNSITE 1 trial; our expectation that the evolving treatment landscape will benefit from chemotherapy in combination with checkpoint inhibitors; expectations regarding BIND-014’s potential and safety profile; completing enrollment in the squamous cohort of iNSITE 1 in early 2016 and designing additional trials, potentially through a collaboration; expectations regarding the timing of our announcement of data from the second stage of the iNSITE 2 trial; statements regarding our collaborations with Pfizer, AstraZeneca, F. Hoffmann-La Roche Ltd., Merck and Macrophage; and statements regarding upcoming events and presentations.
These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the fact that the Company has incurred significant losses since its inception and expects to incur losses for the foreseeable future; the Company's need for additional funding, which may not be available; raising additional capital may cause dilution to its stockholders, restrict its operations or require it to relinquish rights to its technologies or drug candidates; the Company's limited operating history; the terms of the Company's credit facility place restrictions on its operating and financial flexibility; failure to use and expand its medicinal nanoengineering platform to build a pipeline of drug candidates and develop marketable drugs; the early stage of the Company's development efforts with only BIND-014 in clinical development; failure of the Company or its collaborators to successfully develop and commercialize drug candidates; clinical drug development involves a lengthy and expensive process, with an uncertain outcome; delays or difficulties in the enrollment of patients in clinical trials; serious adverse or unacceptable side effects or limited efficacy observed during the development of the Company's drug candidates; inability to maintain any of the Company's collaborations, or the failure of these collaborations; the Company's reliance on third parties to conduct its clinical trials and manufacture its drug candidates; the Company's inability to obtain required regulatory approvals; any conclusion by the FDA that BIND-014 does not satisfy the requirements for approval under the Section 505(b)(2) regulatory approval pathway; the fact that a fast track or breakthrough therapy designation by the FDA for the Company's drug candidates may not actually lead to a faster development or regulatory review or approval process; the inability to obtain orphan drug exclusivity for drug candidates; failure to obtain marketing approval in international jurisdictions; any post-marketing restrictions or withdrawals from the market; effects of recently enacted and future legislation; failure to comply with environmental, health and safety laws and regulations; failure to achieve market acceptance by physicians, patients, or third-party payors; failure to establish effective sales, marketing and distribution capabilities or enter into agreements with third parties with such capabilities; effects of substantial competition; unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives; product liability lawsuits; failure to retain key executives and attract, retain and motivate qualified personnel; difficulties in managing the Company's growth; risks associated with operating internationally, including the possibility of sanctions with respect to our operations in Russia; the possibility of system failures or security breaches; failure to obtain and maintain patent protection for or otherwise protect our technology and products; effects of patent or other intellectual property lawsuits; the price of our common stock may be volatile and fluctuate substantially; significant costs and required management time as a result of operating as a public company; and any securities class action litigation. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on November 2, 2015, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.