-- BIND earns $2.5 million option fee for first compound in global collaboration to pursue development and commercialization of novel Accurins --
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- BIND Therapeutics, Inc. (NASDAQ: BIND), a clinical-stage nanomedicine company developing targeted and programmable therapeutics called AccurinsTM, today announced that Pfizer Inc. exercised its option to obtain an exclusive license to develop and commercialize an Accurin drug candidate for the treatment of solid tumors under the companies' global collaboration agreement. The actively targeted Accurin is designed to impart cellular targeting capability and was engineered by BIND using one of Pfizer's proprietary kinase inhibitors and one of BIND's proprietary ligands. As a result of the option exercise, BIND will receive a $2.5 million option exercise fee from Pfizer. In parallel with exercising its first option, Pfizer informed BIND that it will not exercise its option for the second compound in the collaboration.
"Pfizer's decision to obtain an exclusive license to our actively targeted Accurin further validates what we believe is the unique ability of our platform to optimize the therapeutic potential of potent pathway inhibitors," said Andrew Hirsch, president and chief executive officer at BIND Therapeutics. "This milestone with Pfizer is an important step toward our goal of advancing this innovative Accurin drug candidate into clinical testing. Working closely with Pfizer has allowed us to identify the Accurin candidate with the greatest potential in the collaboration. We now have the potential to have at least four Accurins in clinical development over the next two years, both through collaborations and with internal product candidates. With our belief in the ability of Accurins to deliver the right concentration of the right drug to the right place for the right amount of time, combined with Pfizer's experience and expertise, we are pleased to move to the next stage in this collaboration."
"Our experiments to date have resulted in data that we believe justify advancing this candidate to the next stage of research," said Robert Abraham, Ph.D., senior vice president, Oncology-Rinat Research & Development Group, Pfizer. "BIND's Accurin technology may help us to achieve an optimal efficacy-safety ratio for this investigational drug. We look forward to further exploring this potential in our ongoing collaboration with BIND."
Under terms of the original collaboration agreement, which was established in April 2013, Pfizer was granted options to obtain exclusive licenses to pursue development and commercialization of two Accurins that incorporate specified Pfizer small molecular targeted therapies. For the Accurin that has been selected, both companies will work together on preclinical research; Pfizer will have responsibility for development and commercialization, and BIND will conduct chemistry, manufacturing and control activities.
In addition to the $2.5 million option exercise fee, BIND received an upfront payment of $4.0 million in 2013 and achieved a $1.0 million preclinical development milestone for the selected Accurin in December 2014. BIND has the potential to receive additional milestone payments for the selected Accurin of up to $86.0 million in aggregate upon the achievement of additional specified development and regulatory events under the Pfizer collaboration agreement. BIND may also receive additional milestone payments for the selected Accurin of up to $110 million in aggregate for specified commercial events as well as royalties in the low single to high single digit percentages on potential future sales of the selected Accurin, if any.
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 KRAS mutations or squamous histology. In addition, BIND is enrolling patients in a clinical trial with BIND-014 for 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 application filing with the U.S. Food and Drug Administration in 2016. 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 myelotoxicity 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 FDA clearance to begin clinical trials with the Aurora B Kinase inhibitor Accurin AZD2811, which we expect to be the second Accurin candidate to enter clinical development.
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 the option exercise being an important step toward clinical testing; Accurins, including without limitation our ability to have at least four Accurins in clinical development over the next two years, their therapeutic potential, and developing a pipeline of Accurins; potential milestone payments and royalties under the collaboration agreement with Pfizer; BIND-510, including without limitation, statements regarding our plan for an Investigational New Drug filing in 2016; and our collaboration agreements with Pfizer, Merck, AstraZeneca, F. Hoffmann-La Roche Ltd., 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 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 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 August 5, 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.