HOPKINTON, Mass., June 06, 2019 — 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 it would present promising results from a healthy volunteer study highlighting the activation of the immune system with inarigivir soproxil 400mg, an orally administered hepato-selective immunomodulator, at The Science of HBV Cure 2019 meeting in Singapore on Saturday, June 8, 2019. The results from this study further demonstrate that inarigivir could become a backbone immune-activator in a combinatorial treatment for chronic hepatitis B virus (HBV) that accelerates and substantially increases functional cure rates for chronic HBV patients.
The results from this study demonstrate that, across all patients, inarigivir rapidly increased activation markers of innate immunity on circulating peripheral monocytes and dendritic cells, which was sustained over a ten-day period of dosing without evidence of tolerance. “Key opinion leaders in the field of hepatitis B treatment believe that re-activation of the chronic HBV patient’s immune system will be required to achieve a significant elevation in HBV functional cure rates,” said Kris Iyer, Ph.D., Spring Bank’s Chief Scientific Officer and Co-Founder. “The results from this study indicate that inarigivir could be a backbone immunomodulator in a combinatorial treatment for chronic HBV without the tolerability issues of interferon therapy as we strive to significantly enhance the functional cure rates for HBV patients.”
Professor Antonio Bertoletti, the Principal Investigator of the study at Duke–NUS Medical School in Singapore, added, “This new immune activation data for inarigivir combined with its effects on HBV DNA, HBV RNA and HBsAg presented in the recently-completed ACHIEVE trial serves as further confirmation of the mechanism of action of inarigivir as a selective immunomodulator for potential HBV cure. In this study, we evaluated immune activation in PBMCs and serum cytokines from healthy volunteers treated with inarigivir 400mg daily. We conducted extensive flow cytometric analysis of selected immune cells using markers for T, NK and myeloid cell activation, and also performed NanoString® RNA analysis of PBMCs. We observed an associated activation of CD8+ T-cells and down-regulation of NK cells resulting in a potentially favorable adaptive immune profile of inarigivir for antiviral response. The results from this study also demonstrated a lack of systemic cytokine activation that is consistent with the selective intra-hepatic targeting of inarigivir, resulting in a favorable tolerability profile.”
Spring Bank will also present further data from the ACHIEVE trial on baseline biomarkers for inarigivir response, including baseline viral burden as determined by HBsAg levels, and the role of serum IP-10 and hepatitis B genotypes, at The Science of HBV Cure 2019 meeting. “The compelling data generated from the responder population in our ACHIEVE trial was instrumental in the design of our recently launched inarigivir CATALYST clinical program that could potentially elevate the clinical responses to inarigivir,” said Dr. Iyer. “We now have a much clearer understanding of the heterogeneity of response to inarigivir with respect to both host and viral factors in HBV patients, and we believe this knowledge will increase the likelihood of success with our inarigivir clinical program.”
Inarigivir Clinical Development Spring Bank has recently launched two global Phase 2 trials (CATALYST 1 and CATALYST 2) examining the administration of inarigivir 400mg as monotherapy and co-administration with a NUC in naïve and virally-suppressed chronic HBV patients. The CATALYST trials include multiple patient cohorts with dosing periods to include 12 weeks, 24 weeks, and 48 weeks. These trials are designed to demonstrate functional cure in chronic HBV patients and Spring Bank could potentially be in a position to reveal functional cure data from one or more of these trials in 2020.
In addition, Gilead Sciences, Inc. is conducting a Phase 2 trial examining the co-administration of inarigivir 50mg and tenofovir alafenamide 25mg (marketed by Gilead as Vemlidy®) and the co-administration of inarigivir 200mg and Vemlidy® in naïve chronic HBV patients, as well as, the administration of inarigivir 100mg in virally-suppressed patients who currently are and continue to be treated with a NUC. Preliminary data from this trial is anticipated to be presented at a scientific conference later this year.
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 inarigivir’s role in the future treatment landscape of HBV, the company’s hopes relating to future clinical responses to inarigivir; the company’s release of future data relating to functional cure of HBV; and presentation of results at future scientific conferences. 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 inarigivir, SB 9225 and SB 11285; any delay of any current or planned clinical trials or the development of Spring Bank’s product candidates; 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 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
LifeSci Advisors, LLC Ashley R. Robinson (617) 535-7742 [email protected]
Source: Spring Bank Pharmaceuticals, Inc.