Press Releases 01.07.2016
BIND Therapeutics Presents Complete Data on Clinical Activity of BIND-014 in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) at the 2016 Genitourinary Cancers Symposium
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- BIND Therapeutics, Inc. (NASDAQ: BIND), a clinical-stage nanomedicine company developing targeted and programmable therapeutics called ACCURINS®, today announced the presentation of complete data from its phase 2 clinical trial of BIND-014, a PSMA-targeted ACCURIN containing docetaxel, in patients with chemotherapy-naive metastatic castration-resistant prostate cancer (mCRPC) who either were or were not exposed to anti-androgens (abiraterone acetate and/or enzalutamide). BIND-014 was clinically active and well-tolerated and the study met its primary endpoint with 71 percent of patients achieving rPFS of at least 6 months. The complete data are being presented on January 7, 2016 during a poster session at the 2016 Genitourinary Cancers Symposium held in San Francisco.
"We are encouraged by the safety and activity profile of BIND-014 in this phase 2 trial, which support its potential to be a nanomedicine alternative superior to conventional docetaxel," said Hagop Youssoufian, M.D., M.Sc., chief medical officer, BIND Therapeutics. "Although these data are encouraging, recent advances with anti-androgen therapy limit our ability to compare BIND-014 data to historical benchmarks. At this time, we are not planning further development of BIND-014 in mCRPC given the evolving treatment landscape. We anticipate additional BIND-014 data from both the iNSITE 1 trial in squamous histology non-small cell lung cancer and the iNSITE 2 trial in multiple tumor types during the first quarter of 2016, which we expect to determine our next steps in the clinical development of BIND-014."
In addition to the primary endpoint, data presented from the trial included measurements of safety and tolerability, objective response rates (ORR), prostate-specific antigen (PSA) response, changes in circulating tumor cells (CTC) and overall survival (OS). Key results include:
BIND-014 administered at 60 mg/m² on day 1 of a 21-day cycle was clinically active and well-tolerated when administered to patients (n=42) with chemotherapy-naive mCRPC, including the 74% of patients with prior exposure to abiraterone acetate and/or enzalutamide.
Median rPFS of 9.9 months (95% CI, 7.1 - 12.6) was achieved (n=42 with 8 censored).
A confirmed ORR of 21% was observed in patients with measurable disease (n=19).
A 50% reduction in PSA was observed in 30% of PSA evaluable patients (n=40).
CTC conversion from ≥ 5 cells/7.5 mL blood at baseline to < 5 cells/7.5 mL blood was observed in 50% of patients.
Median OS was 13.4 months (95% CI, 9.9 - 18.6 months [n=42 with 10 censored]).
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 cancers of the cervix, bladder, head and neck or biliary tree (cholangiocarcinoma). 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 potentially 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 their 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 BIND-014's potential to be a nanomedicine alternative superior to conventional docetaxel; our plan to no longer develop BIND-014 in mCRPC; expectations regarding the timing of our announcement of data from the iNSITE 1 trial in squamous histology NSCLC and the iNSITE 2 trial in multiple tumor types; expectations regarding BIND-510, including without limitation the filing of an IND application with the U.S. Food and Drug Administration; and expectations regarding our collaborations with Pfizer, AstraZeneca, F. Hoffmann-La Roche Ltd., Merck and Macrophage.
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 and ACCURIN AZD2811 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.