Spring Bank Pharma (SBPH) Hitting Clinical Milestones Toward Hepatitis B Cure

Edward Kim  |

The World Health Organization (WHO) recently released its Global Hepatitis Report 2017, revealing that an estimated 325 million people worldwide are living with chronic hepatitis. The vast majority - 257 million - are suffering from hepatitis B virus (HBV). The WHO's report indicates that, while most sufferers live in areas without access to life-saving testing and treatment, 22 million people in the Americas and Europe are estimated to be afflicted. Viral hepatitis led to 1.34 million deaths in 2015, according to the WHO, a death toll on a par with those due to tuberculosis (1.37 million deaths, excluding HIV-associated tuberculosis) and higher than those due to to HIV (1.06 million) or to malaria (440,000).

We've been following a company called Spring Bank Pharmaceuticals (NASDAQ: SBPH) that has been achieving clinical milestones in its development compounds, including its lead candidate, SB 9200 for chronic hepatitis B patients. The company has a proprietary small molecule nucleic acid hybrids (SMNH) chemistry platform that has produced a class of compounds designed to selectively target and modulate the activity of specific proteins implicated in various disease states with the favorable drug-like qualities of traditional small molecules.

Hepatitis B Virus

There are relatively few new therapies in development for the treatment of HBV. The current standard of care requires chronic treatment with antiviral therapies to suppress the HBV virus. These therapies are largely ineffective, however, at significantly reducing and clearing surface antigens and often require lifelong treatment. While there are effective vaccines for the prevention of Hepatitis B infection, there is a need for therapies that improve the clearance of HBsAg and potentially lead to a functional and finite cure. HBsAg is the Hepatitis B surface Antigen that indicates active hepatitis B infection. Clearance of HBsAg would be indicative of a functional cure.

Currently available treatments for HBV include Viread (Gilead Sciences, NASDAQ: GILD) and Barraclude (Bristol-Myers Squibb, NYSE: BMY). These drugs are direct acting antivirals which suppress viral replication and had reported worldwide revenues of approximately $2.5 billion in 2014 primarily for the treatment of HBV. Spring Bank is collaborating with Gilead in the SB 9200 trial, which involves treating patients with Viread after various dosages of SB 9200.

Source: Spring Bank Pharmaceuticals Corporate Presentation, April 2017

The Phase 2a portion of the clinical trial for SB 9200 is a placebo-controlled, sequential-cohort, double-blind trial to evaluate the safety and antiviral effect of increasing doses of SB 9200 (25mg, 50mg, 100mg and 200mg) as a monotherapy for 12 weeks, followed by 300 mg of Gilead's Viread as a monotherapy for an additional 12 weeks. The company completed dosing of SB 9200 last week and anticipates reporting top-line results from the 25mg cohort later this quarter. Full results for all patients treated at various doses are anticipated in the first half of 2018.

Balance of Development Pipeline

Spring Bank is also collaborating in preclinical studies with Arrowhead Pharmaceuticals (NASDAQ: ARWR) and Arbutus Biopharma (NASDAQ: ABUS) to determine other mechanisms of action to treat hepatitis B virus.

Spring Bank also is developing a novel next generation STING (Stimulator of Interferon Genes) agonist for the potential treatment of certain cancers. The company presented preclinical data for SB 11285 at the Keystone Symposia on Cancer Immunology and Immunotherapy in March. Among the key preclinical findings were that SB 11285 showed notable anti-tumor activity in the 4T1 breast cancer syngeneic mouse model and the A20 lymphoma model. In the A20 lymphoma model, when SB 11285 was used in combination with Cytoxan (Bristol-Myers Squibb), additive tumor growth inhibitory and tumor growth delay effects were also seen. Spring Bank hopes to achieve further preclinical proof-of-principle for SB 11285 in relevant oncology models in 2017 and, subject to the results of these preclinical studies, file an IND application for SB 11285 in mid-2018.

We liked the way the company announced its Q1 results last week and the order of priorities in the release. The most important items were those that demonstrated progress in the clinic, followed by the cash position (good through Q3 2018) and operating expenses. Last and least was the company's net loss. By itemizing the list in this order, Spring Bank looked to control the narrative and reinforce to investors that it is focused on clinical progress as it should be. Many public companies at this stage focus unnecessarily on hitting analysts' loss estimates, which are virtually meaningless outside of the context of clinical progress. We'll be keeping a close watch on Spring Bank Pharmaceuticals as they release clinical data over the course of this year.

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Symbol Name Price Change % Volume
GILD Gilead Sciences Inc. 63.33 -0.99 -1.54 4,576,877 Trade
BMY Bristol-Myers Squibb Company 58.79 0.40 0.69 13,396,011 Trade
ARWR Arrowhead Pharmaceuticals Inc. 48.51 3.24 7.15 2,660,279 Trade
ABUS Arbutus Biopharma Corporation 1.52 0.04 2.70 326,198 Trade
SBPH Spring Bank Pharmaceuticals Inc. 2.78 -0.23 -7.64 48,329 Trade



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