BIND Therapeutics Presents Positive Phase 2 Results Highlighting Potential of BIND-014 as Novel Anti-Cancer Treatment at Q3W Dosing Schedule for Patients with Non-small Cell Lung Cancer at 26th EORTC-NCI-AACR Annual Symposium

BIND Therapeutics Presents Positive Phase 2 Results Highlighting Potential of BIND-014 as Novel Anti-Cancer Treatment at Q3W Dosing Schedule for Patients with Non-small Cell Lung Cancer at 26th EORTC-NCI-AACR Annual Symposium

- Phase 2 study met primary objective of showing anti-tumor activity as measured by overall response rate at Q3W dosing schedule -

- Promising anti-tumor activity and survival in patients with KRAS mutant tumors and squamous histology -

- Clinical program advances with focus on establishing further objective evidence of differentiation in NSCLC and subset populations -

BARCELONA, Spain--(BUSINESS WIRE)-- BIND Therapeutics, Inc. (NASDAQ: BIND), a clinical-stage nanomedicine platform company developing targeted and programmable therapeutics called AccurinsTM, today presented positive results from its ongoing Phase 2 study of BIND-014 in non-small cell lung cancer (NSCLC), demonstrating it has met the primary objective in the once every three weeks (Q3W) arm as measured by overall response rate (ORR). The data demonstrate that BIND-014 is well-tolerated with clinically meaningful anti-tumor activity at a lower dose than conventional docetaxel in patients with advanced or metastatic NSCLC. BIND-014 also demonstrates promising anti-tumor activity in patients with tumors expressing KRAS mutations (mutated Kirsten ras oncogene homolog). KRAS mutations in NSCLC are generally associated with poor response to currently available drug therapy regimens, including docetaxel. An additional signal was observed in patients with squamous cell carcinomas, a major NSCLC subtype poorly served by existing available therapies. These data were presented at the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain.

"We believe the activity and tolerability of BIND-014 demonstrated in this study suggest meaningful differentiation from the historical docetaxel experience, in both the broader NSCLC patient population and in two important groups of patients with high unmet medical need," said Hagop Youssoufian, M.D., M.Sc., Chief Medical Officer, BIND Therapeutics. "Furthermore, as the first product candidate from our Medicinal Nanoengineering® platform to enter the clinic, we believe that the increased efficacy and reduced toxicity at a lower dose compared to historical docetaxel experience suggests that Accurins are successful in targeting the therapeutic payload to the tumor. Based on these positive results, we plan to conduct additional global, multicenter Phase 2 studies to confirm and expand the dataset on BIND-014 and to define an expeditious regulatory path for BIND-014."

The Q3W dosing arm of the open label, multicenter, Phase 2 study enrolled 40 patients with advanced metastatic NSCLC who were treated with 60 mg/m2 of BIND-014 on Day 1 of a 21-day cycle and achieved the following preliminary results:

  • Five patients (13%, N=40) achieved a partial response with a median duration of response of 5.2 months and median progression free survival (PFS) of 2.7 months. There was one unconfirmed partial response that was not included in the analysis per RECIST v1.1.
  • Nine patients were enrolled with a confirmed KRAS mutation and two of those nine experienced an objective response (22%); median PFS in patients with KRAS mutant tumors was 2.7 months.
  • In patients with squamous cell carcinoma (n=9) there were no confirmed objective responses; however, median PFS in patients with squamous cell carcinoma was 2.8 months. Prolonged ( > 4 cycles) disease control was also noted in six of nine (66%) patients with squamous histology.
  • Preliminary median overall survival was 6.2 months for all patients treated, 9.6 months in patients with KRAS mutant tumors and 11.1 months in patients with squamous cell carcinoma.
  • Twenty-one of 40 patients received four or more cycles of therapy, attesting to the tolerability of BIND-014. Consistent with previous results, neutropenia, anemia, neuropathy, and alopecia, commonly observed with docetaxel, were significantly reduced with BIND-014.

"Data from this open label study suggest the potential for BIND-014 superiority over docetaxel in the treatment of NSCLC patients," said Ronald B. Natale, M.D., Medical Director of the Clinical Lung Cancer Program at the Women's Guild Lung Institute and investigator for the Phase 2 trial of BIND-014 in NSCLC. "Furthermore, BIND-014 demonstrated intriguing activity in patients with KRAS mutated lung cancers, a group of patients who have historically been unresponsive to standard treatment with docetaxel. This initial experience with BIND-014 provides a glimpse into a new way to selectively target NSCLC tumors, an area of cancer with high unmet need."

BIND plans to initiate global, multicenter Phase 2 studies of BIND-014 in patients with KRAS mutant NSCLC and in patients with NSCLC of squamous histology who have progressed on prior therapy. These studies aim to assess overall survival and additional endpoints to position BIND-014 for subsequent registration studies.

Based on the promising results of the Q3W arm presented today and the more patient-friendly once every three week dosing schedule, combined with the absence of a confirmed partial response in the first 22 patients enrolled on the Q1W schedule, the company will not continue enrollment on the weekly dosing schedule.

Data from the Phase 2 study will be included in a presentation by BIND CEO Scott Minick at the Stifel Nicolaus Weisel Healthcare Conference in New York at 8:35 a.m. EST today. Interested parties may access a live webcast of the presentation by visiting the BIND Therapeutics website at www.bindtherapeutics.com. The webcast will be archived on the BIND Therapeutics website following the event for one week.

About BIND-014

BIND-014, a targeted polymeric nanoparticle, represents the first Accurin nanomedicine from BIND's Medicinal Nanoengineering® platform to reach the clinic. BIND-014 targets prostate-specific membrane antigen (PSMA), a target expressed on prostate cancer cells and the blood vessels of many types of non-prostate solid tumors, and contains docetaxel, a clinically-validated and widely used anti-cancer agent. In preclinical cancer models, BIND-014 was shown to increase accumulation of docetaxel at the site of disease which translated to marked improvements in antitumor activity and tolerability. In clinical studies conducted to date, BIND-014 was shown to be generally well-tolerated and displayed anti-tumor activity at low doses and in tumors where conventional docetaxel has minimal activity.

About the study

Data are being presented on 40 patients who have completed treatment, and who are being followed for overall survival, in the Q3W dosing arm (60 mg/m2 on Day 1 of a 21-day cycle) of the Phase 2 study of BIND-014 in advanced NSCLC. The primary study objective for the ongoing open-label, multicenter study are to determine the efficacy of BIND-014 (docetaxel nanoparticles for injectable suspension) when administered at 60 mg/m2s on day one of a 21 day cycle as measured by investigator assessed objective response rate (ORR) in patients with stage III/IV non-small cell lung cancer who have failed one prior platinum containing chemotherapy regimen for advanced or metastatic disease. Secondary objectives are to assess the safety and tolerability of BIND-014 and to assess the overall survival (OS), duration of response (DOR) and progression free survival (PFS) of patients administered BIND-014.

  • Abstract number 41 (poster board no. 35): "Clinical activity of BIND-014 (docetaxel nanoparticles for injectable suspension) as second-line therapy in patients (pts) with Stage III/IV non-small cell lung cancer"
  • Poster session on Wednesday, 18.00-19.30 CET

About Accurins™

Accurins are BIND's targeted and programmable therapeutics, which are designed, utilizing BIND's medicinal nanoengineering platform, with specified physical and chemical characteristics to target specific cells or tissues and concentrate a therapeutic payload at the site of disease to enhance efficacy while minimizing adverse effects on healthy tissues. Accurins are polymeric nanoparticles that incorporate a therapeutic payload and are designed to have prolonged circulation within the bloodstream, enable targeting of the diseased tissue or cells, and provide for the controlled and timely release of the therapeutic payload. BIND has demonstrated in preclinical studies that Accurins can improve tumor growth suppression, achieve higher concentrations of the payload in tumors compared to the payload administered in conventional form, and have pharmacokinetics and tolerability differentiated from their therapeutic payloads.

About BIND Therapeutics

BIND Therapeutics is a clinical-stage nanomedicine platform company developing Accurins, its novel targeted therapeutics. BIND is leveraging its Medicinal Nanoengineering® platform to develop an internal pipeline of Accurins, initially in oncology, as well as Accurins in collaboration with biopharmaceutical companies. BIND has announced ongoing collaborations with Pfizer Inc., AstraZeneca AB, F. Hoffmann-La Roche Ltd. and Merck to develop Accurins based on their proprietary therapeutic payloads and targeting ligands. BIND's platform originated from the pioneering nanotechnology research at the Massachusetts Institute of Technology and Brigham and Women's Hospital/Harvard Medical School of BIND's scientific founders Dr. Robert Langer and Dr. Omid Farokhzad. 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 statements regarding our beliefs regarding the efficacy and tolerability of BIND-014 as compared to docetaxel and the ability of Accurins to traffic therapeutic payload to tumors; expectations regarding the meaning of study and clinical trial results; expectations regarding future studies and clinical trials; expectations regarding a regulatory path for BIND-014; Accurins, and developing a pipeline of Accurins; and 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 or require it to relinquish rights to its technologies or drug candidates; the Company's limited operating history; 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 one drug candidate 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 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 our growth; risks associated with operating internationally, including the possibility of sanctions with respect to our operations in Russia; failure to obtain and maintain patent protection for or otherwise protect our technology and products; effects of patent or other intellectual property lawsuits; the eligibility of a significant portion of the Company's total outstanding shares to be sold into the market, which could cause the market price of its common stock to drop significantly; increased costs 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 6, 2014, 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.

Media:
The Yates Network
Gina Nugent, 617-460-3579
[email protected]
OR
Investors:
Stern Investor Relations
Paul Cox, 212-362-1200
[email protected]

Source: BIND Therapeutics, Inc.

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