Spring Bank Pharmaceuticals Presents Data on Immunomodulatory Agent SB 9200 at the 2016 European Association for the Study of the Liver Annual Meeting

SB 9200 followed by entecavir resulted in significant declines in viral DNA, RNA and surface antigens in the woodchuck model of HBV; results support advancement of SB 9200 to Phase 2 in HBV

SB 9200 inhibited the replication of HCV genotypes including variants resistant to current direct acting antivirals in patients who were treatment naïve, responders or treatment failures

MILFORD, Mass., April 14, 2016 -- Spring Bank Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, today announced the presentation of scientific data from its hepatitis B virus (HBV) and hepatitis C virus (HCV) research programs at The International Liver Congress™ 2016, 51^st annual meeting of the European Association for the Study of the Liver (EASL), taking place April 13-17 in Barcelona, Spain.

“The preclinical data we presented at EASL this year supports our previous preclinical findings regarding the antiviral activity of SB 9200 against both HBV and HCV through the activation of cellular viral sensors RIG-I and NOD2,” stated Radhakrishnan (Kris) Iyer, Ph.D., Chief Scientific Officer of Spring Bank. “Based on the results of the preclinical trial of SB 9200 for HCV that we presented, we believe that SB 9200 may exhibit potent antiviral activity against HCV, including variants associated with poor response to current direct acting antivirals. In addition, in our sequential dosing study of SB 9200 with entecavir in the woodchuck model of HBV, the sequential dosing resulted in significant suppression of woodchuck hepatitis surface antigen and viral DNA and RNA.”

Spring Bank is presenting the data in support of its ongoing antiviral research programs targeting restoration of the innate immune response through the production of natural immunomodulatory cytokines, including interferon, inside cells through the activation of RIG-I and NOD2 with once daily oral administration of SB 9200. “We believe this data from the woodchuck model supports our Phase 2 HBV program.  We plan to begin enrolling patients in the Phase 2a portion of this program in Canada in May 2016,” said Nezam Afdhal, Chief Medical Officer of Spring Bank.

A summary of the data being presented by Spring Bank at the conference is below:

Poster Presentations

Poster Title: SB 9200, A Novel Agonist of Innate Immunity, Shows Potent Antiviral Activity Against Resistant HCV Strains
Date and Time: Thursday, April 14, 2016, 8:00 a.m. to 6:00 p.m. Central European Time
Abstract Number: 233
Session Title: Viral Hepatitis: Hepatitis C – clinical (new compounds, resistance)
Location: Hall 8.1, Poster Area 2
Summary: New direct-acting antiviral (DAA) agents for chronic HCV infection have substantially increased the rates of sustained virological response (SVR). Relapse after antiviral therapy remains a significant problem, especially in patients with cirrhosis and salvage therapy with new therapeutic agents remains the only viable option. This study evaluated the activity of SB 9200 against HCV positive serum from patients who failed to respond to current treatment regimens and viruses with known variants associated with poor response to current NS5A inhibitors. Patient sera from treatment naïve, responders or treatment failures (with either DAA (Sofosbuvir and Ledipasvir) or pegIFN/RBV +/- DAAs) were tested in a capture-fusion assay. THP-1 cells were exposed to donor serum, fused with Huh7 derivative cells and treated with SB 9200 before qPCR assessment of HCV replication. Dose response curves were used to calculate the IC50 values. Results from this study suggest that activity of SB 9200 is pan-genotypic and not influenced by previous treatment exposure. Ongoing clinical evaluation of SB 9200 in combination with DAAs for patients requiring salvage therapy is warranted.

Poster Title: Antiviral Efficacy and Host Immune Response Induction with SB 9200, an Oral Prodrug of the Dinucleotide SB 9200, in Combination with Entecavir in the Woodchuck Model of Chronic Hepatitis B
Date and Time: Friday, April 15, 2016, 8:00 a.m. to 6:00 p.m. Central European Time
Location: Hall 8.1, Poster Area 2
Abstract Number: 143
Session: Viral Hepatitis: Hepatitis B & D – clinical (therapy, new compounds, resistance)
Summary: SB 9200 is a small orally bioavailable dinucleotide that activates the cellular viral sensors RIG-I and NOD2 causing the induction of IFN signaling cascade for antiviral defense. In this study, SB 9200 was administered orally in combination with entecavir (ETV) to two groups of five woodchucks. Group 1 received ETV for four weeks, followed by SB 9200 for 12 weeks. Group 2 received SB 9200 for 12 weeks followed by ETV for four weeks. Both groups were monitored for eight weeks post-treatment. Results from this study suggest that induction of host immune response by pretreatment with SB 9200 followed by ETV in woodchucks resulted in significant declines in viral DNA, RNA, and antigens that was superior to that seen using the strategy of viral reduction with ETV followed by immune modulation.  Spring Bank believes these data support the planned Phase II clinical trial which will evaluate SB 9200 alone and in combination with a nucleoside in the treatment of chronic HBV.

About Spring Bank Pharmaceuticals

Spring Bank Pharmaceuticals is a clinical-stage biopharmaceutical company engaged in the discovery and development of a novel class of therapeutics using its proprietary small molecule nucleic acid hybrid, or SMNH, chemistry platform. SMNH compounds are small segments of nucleic acids that the company designs to selectively target and modulate the activity of specific proteins implicated in various disease states. The company is developing its most advanced SMNH product candidate, SB 9200, for the treatment of viral diseases. SB 9200 has been designed to selectively activate within infected cells the cellular proteins, retinoic acid-inducible gene 1, or RIG-I, and nucleotide-binding oligomerization domain-containing protein 2, or NOD2, which have been implicated in the body’s immune response to viral infections. Spring Bank believes that SB 9200 may play an important role in antiviral therapy by modulating the body’s immune response through its mechanisms of action to fight viral infections such as HBV.

Note Regarding NIH-Funded Research

Certain studies mentioned in this press release were partly supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number R01AI094469 and NIAID contract laboratories. The content of this press release is solely the responsibility of Spring Bank Pharmaceuticals and does not necessarily represent the official views of the National Institutes of Health.

Contact:

Maeve Conneighton
Argot Partners
(212) 600-1902
[email protected]