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Spring Bank Submits IND Application for SB 11285, an IV-Administered STING Agonist, for the Treatment of Advanced Solid Tumors

HOPKINTON, Mass., July 01, 2019 (GLOBE NEWSWIRE) -- Spring Bank Pharmaceuticals, Inc. (Nasdaq: SBPH), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, inflammatory diseases and certain cancers, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the company’s intravenously (IV)-administered STimulator of INterferon Gene (STING) agonist development candidate, SB 11285, to initiate a Phase 1 trial with the principal goals of evaluating safety, tolerability and initial anti-tumor activity in patients with advanced solid tumors. Upon receipt of regulatory clearance, the company anticipates enrolling patients in this trial with a plan to report top-line results in mid-2020.

“STING agonists have the potential to become an important immunotherapeutic approach for the treatment of multiple cancers. The availability of an intravenously-administered STING agonist could significantly expand the number of cancers and patients in which such an immunotherapeutic agent could be utilized. Importantly, this approach may be able to overcome the need for intra-tumoral administration observed with the first-generation STING agonist approaches,” said Jason Luke, M.D., Associate Professor of Medicine and Director of the Cancer Immunotherapies Center at the UPMC Hillman Cancer Center.

Part 1 of the SB 11285 IV Phase 1 trial is a dose-escalation study with monotherapy followed by combination with a checkpoint inhibitor and is designed to determine a recommended phase 2 dose. Part 2 of the trial will explore SB 11285 in combination with a checkpoint inhibitor in selected responsive tumor types based on initial anti-tumor activity. The trial will be conducted at multiple sites in the United States.

“The filing of the SB 11285 IND application represents another significant achievement for Spring Bank in 2019. Based on the progress our company has made with the continued advancement of our internally developed assets, including our HBV and immuno-oncology programs, we believe the company’s stock is currently undervalued and does not adequately reflect the company’s differentiated approach to the significant unmet needs in HBV and oncology,” stated Martin Driscoll, President and Chief Executive Officer of Spring Bank.

Mr. Driscoll continued, “We have the financial resources to allow us to advance our clinical programs toward several meaningful value inflection points. Our clinical development programs have the potential to deliver multiple catalysts for our company over the next 3-15 months. We believe that progressing these programs and delivering promising clinical data is the best way to create long-term value for shareholders, and we are focused on achieving those objectives.”

About SB 11285
Spring Bank Pharmaceuticals, Inc. is developing its lead STING agonist product candidate, SB 11285, as a second-generation immunotherapeutic agent for the treatment of selected cancers. In vitro, in multiple tumor-derived cell lines, SB 11285 has been observed to cause the induction of cytokines consistent with engagement of the target. In vivo, preclinical studies performed to date with SB 11285 have led to tumor growth inhibition as well as recruitment of key immune cell types in multiple rodent tumor models when administered intravenously or intratumorally. These findings indicate that SB 11285 has the potential to be administered clinically by either route of administration, and that SB 11285 may be used to target a variety of tumors at various anatomic sites and, if approved, has the potential to enhance the activity of other therapeutic modalities.

About Spring Bank Pharmaceuticals
Spring Bank Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company engaged in the discovery and development of a novel class of therapeutics using its proprietary small molecule nucleotide platform. The company designs its compounds to selectively target and modulate the activity of specific proteins implicated in various disease states. The company’s lead product candidate, inarigivir, is being developed for the treatment of chronic hepatitis B virus (HBV). Inarigivir is designed to activate within hepatic cells retinoic acid-inducible gene 1 (RIG-I), which has been shown to inhibit HBV viral replication and induce the intracellular interferon signaling pathways for antiviral defense. The company is also developing its lead STING agonist product candidate, SB 11285, an immunotherapeutic agent for the treatment of selected cancers. For more information, please visit www.springbankpharm.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, as amended, about Spring Bank’s future expectations, plans and prospects. These statements include, but are not limited to, statements about the company’s expectations for the release of top-line results from the Phase 1 clinical trial and the creation of additional long-term value for the company’s shareholders. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “will,” “would,” “could,” “potential,” “possible,” “hope,” “likelihood” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to: whether the FDA does not allow the IND for SB 11285; Spring Bank’s ability to successfully demonstrate the safety and efficacy of its product candidates, including SB 11285; any delay of any current or planned clinical trials or the development of SB 11285; whether SB 11285 will advance through the clinical trial process on a timely basis, or at all; whether Spring Bank’s cash resources will be sufficient to fund its continuing operations for the periods and/or trials anticipated; whether the results of such trials will warrant submission for approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether Spring Bank’s product candidates will receive approval from regulatory agencies on a timely basis or at all; whether, if product candidates obtain approval, they will be successfully distributed and marketed; and other factors discussed in the “Risk Factors” section of Spring Bank’s Annual Report on Form 10-K for the year ended December 31, 2018, which was filed with the Securities and Exchange Commission (SEC) on March 11, 2019 and in other filings Spring Bank makes with the SEC from time to time.

In addition, the forward-looking statements included in this press release represent Spring Bank’s views as of the date hereof. Spring Bank anticipates that subsequent events and developments will cause Spring Bank’s views to change. However, while Spring Bank may elect to update these forward-looking statements at some point in the future, Spring Bank specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Spring Bank’s views as of any date after the date hereof.

Spring Bank Pharmaceuticals, Inc.
Jonathan Freve
Chief Financial Officer
(508) 473-5993

McNeil, Gray & Rice
Kristin Nugent
Senior Account Supervisor

Source: Spring Bank Pharmaceuticals, Inc.

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Source: Spring Bank Pharmaceuticals, Inc.