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

HOPKINTON, Mass., July 29, 2019 (GLOBE NEWSWIRE) -- Spring Bank Pharmaceuticals, Inc. SBPH, a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, inflammatory diseases and certain cancers, announced that its Investigational New Drug (IND) application for a Phase 1 trial of SB 11285, the company's intravenously (IV)-administered STING (STimulator of INterferon Gene) agonist development candidate, is now effective following clearance by the FDA. The Phase 1 trial aims to evaluate safety, tolerability and initial anti-tumor activity of IV SB 11285 in patients with advanced solid tumors.

"The FDA's acceptance of our IV SB 11285 IND will allow us to soon begin the clinical development program for our novel second-generation intravenously-administered STING agonist product candidate," said Atif Abbas, M.D., Vice President & Head of Oncology/Immunology Development at Spring Bank. "An intravenously-administered STING agonist may have the ability to treat a broad range of cancers. We look forward to working with our Phase 1 trial investigators to explore the effects of a new novel intravenously-administered immunotherapeutic treatment regimen in patients."

SB 11285 is a second-generation STING agonist immunotherapeutic agent being investigated for the treatment of selected cancers such as certain breast cancers, certain lung cancers, colo-rectal cancers and melanoma. In vitro and in vivo preclinical findings indicate that SB 11285, if approved, may be used to target a variety of tumors at various anatomic sites and has the potential to enhance the activity of other therapeutic modalities such as immune checkpoint inhibitors. Preclinical studies also indicated that SB 11285 could be administered clinically either intratumorally or intravenously.

Part 1 of the IV SB 11285 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 IV SB 11285 antitumor activity in combination with a checkpoint inhibitor in selected tumor types. The trial will be conducted at multiple sites in the United States. The company intends to enroll patients in this trial expeditiously with a plan to report top-line results in mid-2020.

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 timing of enrollment for initiation of the Phase 1 clinical trial and the release of top-line results from the Phase 1 clinical trial. 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: 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; the analysis of top-line results or other data derived from our pre-clinical studies or trials; 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.

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

McNeil, Gray & Rice
Kristin Nugent
Senior Account Supervisor
(617)-367-0100

Source: Spring Bank Pharmaceuticals, Inc.