Spring Bank Submits IND Application for SB 11285, an IV-Administered STING Agonist, for the Treatment of Advanced Solid Tumor...
July 01 2019 - 8:00AM
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 that it has submitted an Investigational
New Drug (IND) application to the U.S. Food and Drug Administration
(FDA) for the company’s intravenously (IV)-administered STimulator
of INterferon Gene (STING) agonist development candidate, SB 11285,
to initiate a Phase 1 trial with the principal goals of evaluating
safety, tolerability and initial anti-tumor activity in patients
with advanced solid tumors. Upon receipt of regulatory clearance,
the company anticipates enrolling patients in this trial with a
plan to report top-line results in mid-2020.
“STING agonists have the potential to become an
important immunotherapeutic approach for the treatment of multiple
cancers. The availability of an intravenously-administered STING
agonist could significantly expand the number of cancers and
patients in which such an immunotherapeutic agent could be
utilized. Importantly, this approach may be able to overcome the
need for intra-tumoral administration observed with the
first-generation STING agonist approaches,” said Jason Luke, M.D.,
Associate Professor of Medicine and Director of the Cancer
Immunotherapies Center at the UPMC Hillman Cancer Center.
Part 1 of the SB 11285 IV 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 SB 11285 in
combination with a checkpoint inhibitor in selected responsive
tumor types based on initial anti-tumor activity. The trial will be
conducted at multiple sites in the United States.
“The filing of the SB 11285 IND application
represents another significant achievement for Spring Bank in 2019.
Based on the progress our company has made with the continued
advancement of our internally developed assets, including our HBV
and immuno-oncology programs, we believe the company’s stock is
currently undervalued and does not adequately reflect the company’s
differentiated approach to the significant unmet needs in HBV and
oncology,” stated Martin Driscoll, President and Chief Executive
Officer of Spring Bank.
Mr. Driscoll continued, “We have the financial
resources to allow us to advance our clinical programs toward
several meaningful value inflection points. Our clinical
development programs have the potential to deliver multiple
catalysts for our company over the next 3-15 months. We believe
that progressing these programs and delivering promising clinical
data is the best way to create long-term value for shareholders,
and we are focused on achieving those objectives.”
About SB 11285Spring Bank
Pharmaceuticals, Inc. is developing its lead STING agonist product
candidate, SB 11285, as a second-generation immunotherapeutic agent
for the treatment of selected cancers. In vitro, in multiple
tumor-derived cell lines, SB 11285 has been observed to cause the
induction of cytokines consistent with engagement of the target. In
vivo, preclinical studies performed to date with SB 11285 have led
to tumor growth inhibition as well as recruitment of key immune
cell types in multiple rodent tumor models when administered
intravenously or intratumorally. These findings indicate that SB
11285 has the potential to be administered clinically by either
route of administration, and that SB 11285 may be used to target a
variety of tumors at various anatomic sites and, if approved, has
the potential to enhance the activity of other therapeutic
modalities.
About Spring Bank
PharmaceuticalsSpring 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 StatementsThis
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 release of
top-line results from the Phase 1 clinical trial and the creation
of additional long-term value for the company’s shareholders. 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: whether the FDA does not allow the IND
for SB 11285; 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; 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 FreveChief Financial Officer(508)
473-5993
McNeil, Gray & RiceKristin NugentSenior
Account Supervisor(617)-367-0100
Source: Spring Bank Pharmaceuticals, Inc.
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