BIND Therapeutics and Synergy Pharmaceuticals Announce Collaboration to Develop ACCURINS® with Proprietary Uroguanylin Analogs for Targeting Gastrointestinal Receptors on Tumors

CAMBRIDGE, Mass. & NEW YORK--()--BIND Therapeutics, Inc. (NASDAQ: BIND), a clinical-stage nanomedicine company developing targeted and programmable therapeutics called ACCURINS®, and Synergy Pharmaceuticals Inc. (NASDAQ: SGYP), a biopharmaceutical company pioneering the development of uroguanylin analogs as potential new treatments for functional gastrointestinal (GI) disorders and inflammatory bowel disease (IBD), today announced they have entered into a research collaboration to engineer ACCURINS® incorporating Synergy's proprietary uroguanylin analogs to explore the potential targeting of guanylate cyclase-C (GC-C) receptors expressed on tumors, specifically GI malignancies. Upon achievement of proof-of-concept, the companies anticipate expanding the collaboration to enhance the potential effect of uroguanylin-based ACCURINS® by incorporating therapeutic payloads.

"This collaboration represents another important advance as we develop ACCURINS® with the potential to target a broad range of cells with novel therapeutic payloads," said Jonathan Yingling, Ph.D., chief scientific officer, BIND Therapeutics. "The versatility of our platform is demonstrated by our wide range of collaborations and the ability to leverage our technology platform in a wide variety of applications. We believe the complementary technologies of Synergy and BIND have the potential to generate novel uroguanylin-based therapies that could have a profound impact on the treatment of diseases."

Uroguanylin is a naturally occurring GI peptide and activator of the intestinal GC-C receptor, which is a known target for stimulating a variety of physiological responses. Plecanatide, Synergy's lead uroguanylin analog for functional GI disorders, successfully completed phase 3 clinical trials for chronic idiopathic constipation (CIC) in 2015, and the Company recently filed a new drug application (NDA) for plecanatide to treat CIC. Synergy also recently announced positive data on its second uroguanylin analog, dolcanatide, in a phase 1b proof-of-concept study in ulcerative colitis patients.

"We are pleased to collaborate with BIND Therapeutics on this project, which we believe can broaden the potential therapeutic applications of our proprietary uroguanylin-based platform," said Kunwar Shailubhai, Ph.D., M.B.A., chief scientific officer and executive vice president of Synergy Pharmaceuticals. "BIND's ACCURIN technology has been shown to target diseased tissues with a wide variety of therapeutic payloads. We have separately presented data showing that uroguanylin analogs specifically bind to different types of colorectal polyps and tumor in mice. Together, we believe that we can create uroguanylin-based ACCURINS® that have the potential to provide new treatment options in GI cancer."

This early research collaboration is not expected to have a material financial impact on Synergy Pharmaceuticals or BIND Therapeutics.

About ACCURINS®
ACCURINS®, a new class of targeted therapeutics developed using BIND's Medicinal Nanoengineering® platform, are nanoparticles engineered to have a profound impact on the treatment of disease. The elegant and novel design of ACCURINS® allow for prolonged circulation, controlled and tunable release and selective targeting of a therapeutic payload to diseased tissue or cells while avoiding immune surveillance detection and systemic toxicities.

ACCURINS® can be engineered for multiple therapeutic applications and have the potential to integrate numerous payloads, including highly potent drugs with mechanism-based toxicities that limit therapeutic benefit, DNA, RNA, proteins and immunotherapy agents. This attribute enables ACCURINS® to target multiple diseases, including cancer, inflammatory, vascular, and infectious disease.

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 evaluating BIND-014 in the phase 2 iNSITE 1 trial for non-small cell lung cancer, or NSCLC, with squamous histology. In addition, BIND is enrolling patients in the iNSITE 2 clinical trial with BIND-014 for advanced cancers of the cervix and head and neck. BIND is advancing BIND-510, its second PSMA-targeted ACCURIN drug candidate containing vincristine through important preclinical gating 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), Macrophage Therapeutics (a subsidiary of Navidea Biopharmaceuticals) and Synergy Pharmaceuticals 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.

About Synergy Pharmaceuticals Inc.
Synergy Pharmaceuticals (NASDAQ: SGYP) is a biopharmaceutical company focused on the development and commercialization of novel GI therapies. Synergy's proprietary GI platform is based on uroguanylin and includes two lead product candidates - plecanatide and dolcanatide. Plecanatide is Synergy's first uroguanylin analog currently being developed for two functional GI disorders, CIC and irritable bowel syndrome with constipation (IBS-C). Plecanatide is a 16-amino acid peptide that is structurally identical to uroguanylin with the exception of a single amino acid change. Taken as a tablet once-a-day, plecanatide is designed to mimic the function of uroguanylin by working locally in the upper GI tract to activate and regulate fluid movement required for healthy bowel function. In 2015, Synergy announced positive phase 3 data in two CIC clinical trials and on January 29, 2016 the company filed a NDA with plecanatide for CIC. Synergy is continuing to progress two phase 3 clinical trials with plecanatide for IBS-C. The company expects top-line results from the first phase 3 IBS-C trial in 1H 2016 and results from the second phase 3 IBS-C trial are expected in 2H 2016. Synergy intends to file its second NDA with plecanatide for IBS-C by year-end 2016. Dolcanatide is Synergy's second uroguanylin analog currently being explored for ulcerative colitis. Dolcanatide is designed to be an analog of uroguanylin with enhanced resistance to standard digestive breakdown by proteases in the intestine. In January 2016, Synergy announced positive phase 1b data with dolcanatide in patients with mild-to-moderate ulcerative colitis and the company is presently evaluating plans for further clinical development in IBD. For more information, please visit www.synergypharma.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 expectations regarding: BIND and Synergy's collaboration , including without limitation expanding the collaboration by incorporating therapeutic payloads, and generating novel uroguanylin-based therapies that could have a profound impact on the treatment of diseases; providing new treatment options in GI cancer; the financial impact of the collaboration on BIND and Synergy; BIND's platform, including but not limited to its therapeutic possibilities; Accurins, including without limitation BIND developing a pipeline of Accurins, including in areas of high unmet need, and Accurins' impact and potential; BIND-510, including without limitation, statements regarding BIND's plan for an Investigational New Drug filing in 2016; BIND's collaborations with Pfizer, AstraZeneca, F. Hoffmann-La Roche Ltd., Merck and Macrophage; and the timing of Synergy's announcement of clinical trial results.

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 BIND's and Synergy's 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 BIND has incurred significant losses since its inception and expects to incur losses for the foreseeable future; BIND'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; BIND's limited operating history; the terms of BIND'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 BIND's development efforts with only BIND-014 and ACCURIN AZD2811 in clinical development; failure of BIND 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 BIND's drug candidates; inability to maintain any of BIND's collaborations, or the failure of these collaborations; BIND's reliance on third parties to conduct its clinical trials and manufacture its drug candidates; BIND'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 BIND'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 BIND's growth; risks associated with operating internationally, including the possibility of sanctions with respect to BIND's operations in Russia; the possibility of system failures or security breaches; failure to obtain and maintain patent protection for or otherwise protect BIND's technology and products; effects of patent or other intellectual property lawsuits; the price of BIND's 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 BIND's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on November 2, 2015, with respect to BIND, and Synergy's Annual Report on Form 10-K filed with the SEC on March 16, 2015, with respect to Synergy, and BIND's and Synergy's 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 the companies' views to change. These forward-looking statements should not be relied upon as representing the companies' views as of any date subsequent to the date of this press release.

Contacts

BIND Therapeutics:
Media
Jeff Boyle, 617-301-8816
[email protected]
or
Investors
Tom Baker, 617-532-0624
[email protected]
or
Synergy Pharmaceuticals:
Gem Gokmen Hopkins, 212-584-7610
VP, Corporate Communications and Investor Relations
[email protected]

 

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