SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) (“SELLAS” or the
“Company”), a late-stage clinical biopharmaceutical company focused
on the development of novel cancer immunotherapies for a broad
range of cancer indications, today announced feedback from a Type C
review with the U.S. Food and Drug Administration (FDA) regarding
its clinical development program for nelipepimut-S (NPS) in
patients with triple negative breast cancer (TNBC). Based on
written feedback from the FDA and on the totality of clinical,
safety and translational NPS data presented to date, the Company
has finalized the design and plan for a Phase 3
registration-enabling study of NPS in combination with trastuzumab
for the treatment of patients with TNBC in the adjuvant setting
after standard treatment. If successful, this study may be
considered as the basis for a Biologics License Application (BLA)
submission to the FDA.
“We are indeed pleased with the feedback and
final outcome from our discussions with the Agency, after extended
interaction with them, on the optimal and mutually acceptable
design of a potential registration-enabling Phase 3 clinical trial
for NPS in combination with trastuzumab. Importantly, we
believe we have established an appropriate and expedient pathway to
potentially bring NPS in combination with trastuzumab to patients
in need as quickly as possible,” said Angelos Stergiou, MD, ScD
h.c., President and Chief Executive Officer of SELLAS. “We
believe this regulatory clarity will enhance our business
development efforts to seek out-licensing opportunities to fund and
conduct the future clinical development of NPS in order to maximize
the potential of the program as we continue to focus all of our
resources on the development of our lead asset, galinpepimut-S,
which recently entered a registrational Phase 3 study in acute
myeloid leukemia.”
The planned Phase 3 study will be a 1:1
randomized, blinded two-arm study to evaluate the efficacy and
safety of the NPS vaccine (NPS plus granulocyte macrophage-colony
stimulating factor (GM-CSF)) in combination with trastuzumab vs.
GM-CSF alone as maintenance treatment in the adjuvant setting
following standard-of-care therapy in patients with TNBC, defined
as hormone receptor-negative, HER2 1+/2+ tumors (as assessed by
immunohistochemistry tumors), at high risk of recurrence. The
FDA indicated in its feedback that there is adequate safety
information to support the use of NPS in combination with
trastuzumab.
SELLAS previously reported the final efficacy
and safety results from a Phase 2b study of NPS in combination with
trastuzumab in TNBC patients (n=97). The disease-free survival
(DFS) rate at 24 months was 92.6% for the combination arm vs. 70.2%
for the trastuzumab alone arm, a clinically meaningful and
statistically significant improvement in favor of the combination
therapy (p=0.01). This was associated with a statistically
significant reduction of 71.9% (p=0.01) in the frequency of
clinically detected recurrences also in favor of the combination
arm. Immune response analysis showed that non-recurrent TNBC
patients mounted both vigorous NPS-specific clonal CD8+ cytotoxic
T-lymphocyte expansion and enhanced in vivo post-antigen challenge
cutaneous delayed type hypersensitivity. Most treatment-emergent
adverse events were mild or moderate and consisted of manageable
local injection site reactions, skin induration, pruritus, and
fatigue.
“TNBC is an aggressive type of breast cancer
with limited treatment options and poor prognosis, as it is
associated with high levels of refractoriness and relapse not only
in the metastatic setting, which is true for all types of breast
cancer, but also at an early stage. Indeed, following standard
frontline chemotherapy, TNBC can relapse as early as within 1−3
years, often with a pattern including visceral metastases.
Therefore, optimizing relapse-mitigating approaches in women with
TNBC following initial standard therapy (surgery + radiotherapy +
chemotherapy) with further safe and effective adjuvant therapy is
paramount,” said Elizabeth A. Mittendorf, MD, PhD, Rob and Karen
Hale Distinguished Chair in Surgical Oncology, Director of
Research, Breast Surgical Oncology Brigham and Women’s Hospital,
Director, Breast Immuno-Oncology Program Dana-Farber/Brigham and
Women’s Cancer Center, and the Principal Investigator of this
planned Phase 3 study. “A Phase 3 study investigating the
potential clinical benefit accorded by NPS with trastuzumab, an
easily-administered maintenance therapy with a generally manageable
toxicity profile, has the potential, assuming positive results, to
be practice-changing in the treatment of TNBC, by introducing the
first peptide vaccine-based immunotherapy in the therapeutic
choices for women with this aggressive malignancy.”
About SELLAS Life Sciences Group, Inc.
SELLAS is a late-stage clinical
biopharmaceutical company focused on the development of novel
cancer immunotherapeutics for a broad range of cancer indications.
SELLAS’ lead product candidate, galinpepimut-S (GPS), is licensed
from Memorial Sloan Kettering Cancer Center and targets the Wilms
Tumor 1 (WT1) protein, which is present in an array of tumor types.
GPS has potential as a monotherapy or in combination to address a
broad spectrum of hematologic malignancies and solid tumor
indications. SELLAS’ second product candidate, nelipepimut-S (NPS),
is a HER2-directed cancer immunotherapy with potential for the
treatment of patients with early stage breast cancer with low to
intermediate HER2 expression, otherwise known as HER2 1+ or 2+,
which includes triple negative breast cancer patients, following
standard of care.
For more information on SELLAS, please visit
www.sellaslifesciences.com.
Forward-Looking Statements
This press release contains forward-looking
statements. All statements other than statements of historical
facts are “forward-looking statements” for purposes of the safe
harbor provisions under the Private Securities Litigation Reform
Act of 1995, including those relating to future events. In some
cases, forward-looking statements can be identified by terminology
such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,”
“should,” “project,” “believe,” “estimate,” “predict,” “potential,”
“intend,” or “continue” and other words or terms of similar
meaning. These statements include, without limitation, statements
related to plans for further development of and regulatory plans
for NPS, statements about the use of the Phase 3 study as described
as a potential registration-enabling study, statements regarding
the outcome of discussions with the FDA regarding NPS and
statements about the Company’s strategy and plans for out-licensing
NPS. These forward-looking statements are based on current plans,
objectives, estimates, expectations and intentions, and inherently
involve significant risks and uncertainties. Actual results and the
timing of events could differ materially from those anticipated in
such forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, risks and
uncertainties associated with immune-oncology product development
and clinical success thereof, risks related to the initiation and
the progress of such development programs and clinical trials,
including safety risks, risks related to the availability of data
from these programs, and other risks and uncertainties affecting
SELLAS and its development programs as well as risks relating to
the out-licensing and partnering efforts, as set forth under
the caption “Risk Factors” in SELLAS’ Annual Report on Form 10-K
filed on March 22, 2019 and in its other SEC filings. Other risks
and uncertainties of which SELLAS is not currently aware may also
affect SELLAS’ forward-looking statements and may cause actual
results and the timing of events to differ materially from those
anticipated. The forward-looking statements herein are made only as
of the date hereof. SELLAS undertakes no obligation to update or
supplement any forward-looking statements to reflect actual
results, new information, future events, changes in its
expectations or other circumstances that exist after the date as of
which the forward-looking statements were made.
Investor ContactsWill O’ConnorStern Investor
Relations, Inc.212-362-1200ir@sellaslife.com
Investor RelationsSELLAS Life Sciences Group,
Inc.917-438-4353info@sellaslife.com
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