"After a thorough evaluation of internal and external candidates, the Board is confident that Andrew is the right person to lead the next phase of the Company's growth," said Daniel Lynch, Chairman, BIND Therapeutics Board of Directors. "His vision, operational philosophy and experience are ideally suited for the position. Since stepping in as acting president and CEO in March, we have been very impressed with his ability to quickly develop, and begin implementing, a strategic plan to drive current and future therapeutic opportunities in a direction we believe will most effectively create products that solve serious medical problems and create value for our shareholders."
"I'm excited by the opportunity to continue working with our employees, the senior management team and the Board as we develop therapies with the potential to have a profound impact on the treatment of serious diseases," said Mr. Hirsch. "Our nanomedicine platform, one of the most advanced in the industry, enables independent modulation of targeting, cellular trafficking and drug release. Together, these properties enable us to engineer novel therapeutic approaches that can lead to breakthrough therapies."
BIND's lead compound, BIND-014, is currently in phase 2 clinical trials for KRAS-mutant and squamous histology non-small cell lung cancer. BIND, in collaboration with AstraZeneca, expects to have a second Accurin, AZD2811, in the clinic in the third quarter of 2015. In addition, BIND's pre-clinical programs represent next generation Accurins leveraging novel targeting approaches and payloads appropriate for the multiple therapeutic strategies.
"Our BIND-014 clinical data demonstrates that the technology can alter the biodistribution of a therapeutic agent, leading to an improved therapeutic profile with a validated payload and ligand," continued Mr. Hirsch. "My vision is to move forward using novel targeting ligands and therapeutic payloads to engineer nanomedicines that lead to meaningful improvements in patient care that is currently unachievable by other therapeutic modalities. The research collaboration we announced last week with Macrophage Therapeutics is the first step in implementing that vision."
Mr. Hirsch will deliver a corporate presentation at the JMP Securities Life Sciences Conference 2015 tomorrow at 11:30 a.m. ET at the St. Regis hotel in New York City, where he will provide an update on BIND's pipeline of Accurins and additional details about his vision and the future direction of BIND. A live webcast of the presentation is available on 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 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-014 is currently in development for the treatment of non-small cell lung cancer, or NSCLC, in patients with KRAS mutations or squamous histology. In addition, BIND plans to initiate clinical trials with BIND-014 in cervical, bladder, head and neck and cholangio cancers in 2015. BIND is also 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 (FDA) in 2016. Lastly, BIND is 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 myelotoxicity prior to reaching 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 targeting ligands.
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 beliefs that Accurins have the potential to have a profound impact on the treatment of serious disease; our ability to engineer novel therapeutics approaches that can lead to breakthrough therapies; and the ability to use BIND's technology to improve the therapeutic profile of a therapeutic agent or engineer nanomedicines that lead to meaningful improvements in patient care.
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 May 7, 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.