Globe Newswire 6-Dec-2018 7:00 AM
HOPKINTON, Mass., Dec. 06, 2018 (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, will host a research and development day today in New York to discuss its expanding pipeline of novel small molecule nucleotides that leverage the Company's proprietary development capabilities. The R&D Day will include presentations by Dr. Ira Jacobson, Director of Hepatology at NYU Langone Center, Dr. Adam J. Gehring, Biology Lead at Toronto General Hospital Research Institute (TGHRI), and Dr. Jason Luke, Assistant Professor of Medicine, University of Chicago, specializing in cancer immunotherapy biomarker and drug development for solid tumors. Spring Bank's management team will also provide an overview of the Company's strategic R&D focus and the progress for the development of its pipeline of multiple product candidates.
Presentations will begin at 12:00 pm EST. A live and archived webcast of the event may be accessed on the Events and Presentations page under the Investors section of the Spring Bank website. This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals.
Martin Driscoll, chairman, president and chief executive officer of Spring Bank said, "We are looking forward to providing an update during our R&D Day on the excellent progress we have made in both our hepatitis B virus (HBV) clinical program with inarigivir and our lead second-generation STING agonist compound, SB 11285. We plan to continue in 2019 with the implementation of the broadest clinical program for a new compound under development for the treatment of HBV and the advancement of the first intravenously administered STING agonist into the clinic." Mr. Driscoll continued, "Also, our team will describe during the R&D Day presentations three new programs that have emerged from our discovery efforts, a STING antagonist platform, a program targeting the X protein of HBV, and a novel RIG-I agonist for potential oncology applications."
Key R&D Day Highlights
Inarigivir Clinical Program – the Broadest in Chronic Hepatitis B
Spring Bank is developing inarigivir soproxil as a simple, safe and selective oral immunomodulator. In addition to Spring Bank's current development program that seeks to demonstrate that inarigivir could be a potential backbone of combination therapies for the elevation of HBV functional cure rates, the company will announce at today's R&D Day a novel and expanded development strategy for inarigivir with a focus on the development pathway outlined in the recently-issued FDA Draft Guidance on drug development for HBV. The company's clinical development plan for inarigivir will focus on multiple patient types, starting with the CATALYST 1 trial, a global trial examining the use of inarigivir 400mg and tenofovir alafenamide 25mg (marketed by Gilead Sciences as Vemlidy®) in a total of approximately 70 treatment-naïve HBeAg positive and negative patients, which is expected to initiate in early 2019. Gilead Sciences will be supplying the Vemlidy® for the CATALYST 1 trial. Concurrent with the CATALYST 1 trial, the company plans to initiate the CATALYST 2 trial, a global trial examining the use of inarigivir 400mg following the cessation of treatment with an oral nucleos(t)ide analog or "NUC" (the "Stop and Shock" treatment paradigm) and in combination with the continued dosing of a NUC (the "Suppress and Shock" treatment paradigm). The company's HBV clinical development plan in 2019 will also focus on the efforts required to initiate a planned Phase 3 study of SB 9225, the company's fixed-dose combination of inarigivir and tenofovir disoproxil fumarate 300mg, in 2020.
"Utilizing our knowledge of the safety, efficacy and mechanism of action of inarigivir from the ACHIEVE trial in combination with the recently-issued FDA Draft Guidance on HBV, we believe that we have a pathway for development of inarigivir that could lead to global Phase 3 trials as early as 2020, in both treatment-naïve and NUC-suppressed patients," said Dr. Nezam H. Afdhal, chief medical officer of Spring Bank. Dr. Afdhal continued, "The planned launch of our phase 2 programs in 2019 is designed to effectively inform Spring Bank of the optimal trial design for pivotal Phase 3 studies."
SB 11285 & the Second-Generation STING Agonist Program
Spring Bank is developing multiple second-generation STING agonist compounds that are designed to activate the innate and adaptive immune systems. Spring Bank believes that its STING agonists are best-in-class agents and are differentiated due to their novel chemistry and their potential to be administered intravenously (IV) or intratumorally (IT) for potent and durable anti-tumor activity. Subject to completion of IND-enabling studies, Spring Bank is on track to initiate in 2019 clinical trials examining SB 11285, which could be the first IV-administered STING agonist to enter clinical development.
"We are excited about our second-generation STING agonist compounds that are differentiated by novel chemistry that allow for enhanced cellular uptake, the capability to be administered systemically as well as intratumorally, and the potential to be developed as antibody drug conjugates (ADCs) and as nanoparticle formulations," stated Dr. Radhakrishnan Iyer, co-founder and chief scientific officer of Spring Bank.
New R&D Programs Utilizing Small Molecule Nucleic Acid Platform & Chiral Technology Expertise
Spring Bank also announces today the advancement of three new early research programs utilizing its small molecule nucleic acid chemistry platform combined with the company's proprietary chiral technology expertise. Spring Bank scientists are currently engaged in lead optimization efforts for programs that include a novel platform of STING antagonists, chiral antisense compounds against the HBx gene, and next-generation RIG-I agonists for potential immuno-oncology uses.
Participating Key Opinion Leaders
Dr. Ira Jacobson is the Director of Hepatology at NYU, Langone Medical Center and is a world-renowned clinical investigator in drug development for anti-viral agents in liver diseases. He was instrumental as a lead investigator for over 100 HCV clinical trials including interferon treatment and the new DAA therapies, as well as multiple studies on nucleotide agents for hepatitis B. Dr. Jacobson has published extensively on HCV and HBV, worked on guideline development and is a globally recognized educator in liver diseases.
Dr. Adam Gehring is Biology Lead for the Toronto Centre for Liver Disease at the Toronto General Hospital and an Assistant Professor in the Department of Immunology at the University of Toronto. Dr. Gehring specializes in viral hepatitis and immunology where his lab investigates the pathogenesis of chronic hepatitis B virus infection with the goal of exploiting that knowledge to develop novel immunotherapeutic approaches. Dr. Gehring has pioneered the use of liver fine needle aspirates to evaluate intra-hepatic immune responses to HBV. He received his Ph.D. at Case Western Reserve University in Cleveland, Ohio, and his training included a Postdoctoral Fellowship in the Institute of Hepatology at University College London and a position of Senior Research Fellow, and subsequently Assistant Principal Investigator, at the Singapore Institute for Clinical Sciences.
Dr. Jason Luke is an Assistant Professor at the University of Chicago and a nationally recognized expert in immune-oncology of solid tumors. He has been the lead investigator in multiple clinical trials, including numerous checkpoint antibodies and intra-tumoral STING agonists. Dr. Luke completed his residency at Boston University Medical Center and joint medicine and medical oncology fellowships at Weill Cornell Medical College and Memorial Sloan-Kettering Cancer Center and was a Staff Physician at Dana-Farber Cancer Institute and Brigham and Women's Hospital prior to his appointment at the University of Chicago.
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 selectively activate within infected 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.
Statements in this press release about Spring Bank's future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements about the company's general plans and timing for clinical development of inarigivir and SB 11285, the company's planned clinical trial designs for CATALYST 1 and CATALYST 2, and the anticipated timeline to begin a phase 3 trial for SB 9225.
Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether Spring Bank's product candidates 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 the company's 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, 2017, which was filed with the Securities and Exchange Commission (SEC) on February 20, 2018, Spring Bank's Quarterly Reports on Form 10-Q that have been filed with the SEC, 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 could 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 subsequent to the date hereof.
Spring Bank Pharmaceuticals, Inc.
Chief Financial Officer
LifeSci Advisors, LLC
Ashley R. Robinson
Source: Spring Bank Pharmaceuticals
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