BIND Therapeutics, Inc. (NASDAQ: BIND), a biotechnology company developing targeted and programmable therapeutics called ACCURINS®, today announced preliminary top-line results from the BIND-014 (PSMA-targeted docetaxel nanoparticles) phase 2 iNSITE 1 trial in advanced non-small cell lung cancer (NSCLC) of squamous histology and the iNSITE 2 trial in cervical and head and neck cancers.

In the iNSITE 1 trial, for the primary endpoint, BIND-014 demonstrated a 52.5 percent 6-week disease control rate (6wDCR) for the intent-to-treat population (n=40) and a 70.0 percent 6wDCR in the per protocol population (n=30), which exceeded the protocol defined criteria for success of 65 percent. BIND intends to seek licensing or collaboration opportunities for further development of BIND-014 in NSCLC. In the first stage of the iNSITE 2 trial, for the primary endpoint, BIND-014 demonstrated an objective response rate of 10 percent in the head and neck cancer cohort (n=20); there were no objective responses in the cervical cancer cohort (n=23). Based on these results, BIND has decided to halt further enrollment in the iNSITE 2 trial in advanced cervical and head and neck cancers. Additional details from the iNSITE 1 and iNSITE 2 trials are listed below and the Company expects to present further details at an upcoming medical meeting.

Data from these trials suggest that BIND-014 continues to provide meaningful improvements in safety and tolerability, and at least similar efficacy when administered at a 20 percent lower dose in comparison to historical studies with docetaxel. As a result, the Company believes that these new data further validate the potential of the ACCURINS® platform.

"While the single-arm design of these trials precludes definitive conclusions, we remain especially intrigued by the iNSITE 1 data in squamous histology non-small cell lung cancer patients," said Hagop Youssoufian, M.D., chief medical officer, BIND Therapeutics. "We believe these data provide additional clinical validation that ACCURINS® successfully widen the therapeutic window of conventional docetaxel. Taken together, we believe these data justify further development of BIND-014 in clinical settings where improved safety and tolerability may be valuable to patients."

Following these results and in connection with the previously announced shift in research and development strategy, BIND also announced a restructuring plan designed to streamline operations and reduce the Company's operating expenses. The restructuring will include a workforce reduction of 38 percent, and is expected to be substantially complete by the end of April 2016, after which the Company will have 61 employees. In addition, BIND will evaluate options for the Company's wholly owned subsidiary in Moscow. Collectively, these actions are expected to bring BIND's quarterly cash burn rate to approximately $6 million per quarter by the third quarter of 2016.

"This workforce reduction is a necessary action to bring our operating costs to a more sustainable level, allowing the ongoing development of our pipeline of innovative therapeutic candidates that address challenges small molecule chemistry or antibody engineering have not been able to overcome," said Andrew Hirsch, president and chief executive officer, BIND Therapeutics. "We truly appreciate the efforts of all of the employees affected by this action and thank them for their dedicated service and contributions to the development of our ACCURINS® technology. Furthermore, our decision to continue development of BIND-014 with a collaborator was based on the fact that recent advances in the treatment paradigm for second-line solid tumors have shifted the development, regulatory and reimbursement pathway for BIND-014 such that the capital and resources required to execute on this strategy are more appropriate in collaboration with a larger company."

In addition to the workforce reduction initiatives, the Company is actively working with an investment bank to initiate a review of financial and strategic alternatives with the goal of maximizing stockholder value. Potential alternatives to be explored and evaluated during the review process may include raising additional capital, a strategic collaboration with one or more parties, or the licensing, sale or divestiture of some of the Company's proprietary technologies. Pending a decision to undertake any financial or strategic alternatives, BIND is continuing its development and collaboration activities in accordance with its current innovative medicines strategy while managing its cash position. There is no finite timetable for completion of the financial and strategic review process.

Shift in Research & Development Focus In December 2015, BIND announced the appointment of Jonathan Yingling, Ph.D., to the role of chief scientific officer. BIND believes Dr. Yingling has provided the scientific expertise necessary to accelerate BIND's transformation from a technology platform business focused on improving the therapeutic index of chemotherapeutics to an innovative medicines company focused on leveraging the unique advantages of ACCURINS to maximize clinical benefit for patients. As a result, BIND recently announced a shift in its research and development efforts to focus on developing innovative medicines that incorporate unique combinations of novel tumor-directed targeting ligands and new classes of payloads, including oligonucleotides and molecularly targeted therapies. BIND's innovative medicines strategy aims to create nanoparticles with synergistic properties by leveraging three differentiating attributes of the ACCURINS® technology platform:

  • ACCURINS® can potentially be functionalized with ligands that elicit a biological response and enhance disease tissue accumulation;
  • ACCURINS® are able to incorporate therapeutic payloads with diverse physical and chemical properties, including highly charged APIs; and
  • ACCURINS® can be engineered to optimize the efficacy of the encapsulated drug by controlling its release rate.

"We've made significant advances in the ACCURINS® technology since BIND-014 was developed in 2009 and we are leveraging those advances to accelerate our new innovative medicines pipeline," said Jonathan Yingling, Ph.D., chief scientific officer at BIND. "In addition to ongoing collaborations that have resulted in molecularly targeted kinase inhibitor ACCURINS®, one of which is in phase 1 trials, several new product concepts are being pursued internally. We believe our ACCURINS® technology has the potential to create a pipeline of products that elicit tumor cell death, modulate the tumor microenvironment, or both, as a means to maximize clinical benefit for patients."

The Company currently has one kinase inhibitor Accurin, AZD2811, in phase 1 clinical trials in collaboration with AstraZeneca. A second kinase inhibitor Accurin is currently in IND (investigational new drug) -enabling activities through a collaboration with Pfizer. Following optimization of lead product candidates and completion of preclinical studies, BIND anticipates initiation of clinical testing for one or more proprietary innovative product candidates as early as 2018.

iNSITE 1 in squamous histology NSCLC The Company's decision to pursue additional development of BIND-014 through a collaboration or licensing opportunity follows an analysis of 40 patients in the intent-to-treat (ITT) population and 30 patients in the per-protocol (PP) population with squamous histology NSCLC.

           
        ITT [n=40]       PP[n=30]
6-week Disease Control Rate(6wDCR)       52.5%

[36.1-68.5]
      70.0%

[50.6-85.3]
6wDCR ± 7 days*       70.0%

[53.5-83.4]
      86.7%

[69.3-96.2]
Overall Response Rate (ORR)       10.0%

(1 confirmed, 3 unconfirmed)
      13.3%

(1 confirmed, 3 unconfirmed)
 

*Per the study protocol, scans were performed every 6 weeks after Cycle 1 Day 1 and had a ± 7 day allowance. The primary endpoint was strictly defined as disease control rate of 6 weeks or greater which had the effect of excluding patients whose data was gathered within the 7 day allowance of the 6 week timepoint. As a result, patients whose first post-treatment scan occurred between week 5 and week 6 were excluded from the primary analysis. Including these patients in a sensitivity analysis results in an 86.7 percent response rate in the PP population. While the study protocol does not permit the inclusion of these patients in the primary endpoint, the Company believes these data are meaningful.

iNSITE 2 in advanced cervical and head and neck cancers The primary endpoint of the two-stage iNSITE 2 trial was ORR with a target of at least one response in the first 20 patients for advancement from stage 1 to stage 2. In the head and neck cancer cohort (20 evaluable patients), the ORR was 10 percent; there were no responses in the cervical cancer cohort (23 evaluable patients). Based on these results, the Company has decided to halt further enrollment in the iNSITE 2 trial in advanced cervical and head and neck cancers.

Safety data in more than 300 patients treated with BIND-014 to date continue to demonstrate meaningful improvements in hematologic and non-hematologic toxicities when compared to historical docetaxel data.

About BIND TherapeuticsBIND Therapeutics is a biotechnology company developing novel targeted therapeutics, primarily for the treatment of cancer. BIND'S product candidates are based on proprietary polymeric nanoparticles called ACCURINS®, which are engineered to target specific cells and tissues in the body at sites of disease. BIND is developing ACCURINS® with three different therapeutic objectives, both through internal research programs and with collaborators: Innovative medicines; enabling potent pathway inhibitors; and differentiated efficacy with approved drugs. BIND's internal discovery efforts are focused on designing oligonucleotide and immune-oncology-based ACCURINS®.

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), Macrophage Therapeutics (a subsidiary of Navidea Biopharmaceuticals), Synergy Pharmaceuticals and PeptiDream 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 DisclaimerThis 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 pursuing strategic initiatives to maximize stockholder value; our intent to seek licensing or collaboration opportunities for further development of BIND-014 in NSCLC; our beliefs regarding the meaning of results from the iNSITE 1 and iNSITE 2 trials, including that the data validate the ACCURINS® platform; expectations regarding our restructuring plan, including the timing of completion of our workforce reduction and effect on our quarterly cash burn rate; potential of ACCURINS® technology; Dr. Yingling's expected impact on the transformation of our business; the timing of initiation of clinical testing for our proprietary innovative product candidates; upcoming presentations; and our collaboration agreements with Pfizer, Merck, AstraZeneca, F. Hoffmann-La Roche Ltd., Macrophage, Synergy and PeptiDream.

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, in order to continue as a going concern; effects of adverse capital market conditions on the Company's liquidity; any default on the Company's credit facility, which could impact its ability to continue as a going concern; adverse effects on the Company's business due to the report of its independent registered public accounting firm on its financial statements for the year ended December 31, 2015, which contains an explanatory paragraph regarding the Company's ability to continue as a going concern; 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; limitations on the Company's ability to utilize net operating loss carryforwards and certain other tax attributes; failure to use and expand its MEDICINAL ENGINEERING® 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; inability to enter into a collaboration for BIND-014; 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; 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 15, 2016, 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.

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