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 final follow-up data
for its Phase 1/2 study of GPS in patients with acute myeloid
leukemia (AML) in second complete remission (CR2). The final data
show a median overall survival (OS) of 21.0 months, at a median
follow-up of 30.8 months, in patients receiving GPS therapy
compared to 5.4 months in the AML CR2 patients treated with best
standard care, a statistically significant difference (p-value <
0.02). Final analysis also showed that GPS therapy continued to be
well-tolerated throughout the study.
“We’re extremely pleased with this follow-up data, which show
that GPS may have potential as a longer-term therapy for AML
patients in CR2, an aggressive disease where the majority of
patients typically relapse and have a survival rate of
approximately 5 months with best standard therapy,” said Angelos
Stergiou, MD, ScD h.c., President and Chief Executive Officer of
SELLAS. “The 21-month survival data observed further increases our
confidence in the potential of GPS as a maintenance treatment for
AML patients in CR2, the same patient population as our pivotal
Phase 3 study, known as REGAL.”
“These follow-up data build upon the initially published
clinical results from the Phase 1/2 study of GPS in AML patients in
CR2 and provide further evidence that this novel immunotherapeutic
vaccine approach may improve outcomes for patients in this setting,
who often harbor measurable residual disease and have a poor
prognosis if they are unable to undergo allotransplant,” said
Javier Pinilla-Ibarz, MD, PhD, Director of Immunotherapy for
Malignant Hematology at the H. Lee Moffitt Cancer Center, and
principal investigator of the Phase 1/2 study. “With this
persistently positive efficacy signal, low toxicity burden, and
CD4+ and CD8+ T cell responses, GPS has significant potential to
serve as a maintenance therapy in AML patients in CR2, a patient
population at great risk of leukemic relapse.”
The Company previously reported initial data from the Phase 1/2
study of GPS in AML patients in CR2 at a median follow-up of 19.3
months, showing median OS in GPS-treated patients of 16.3 months
vs. 5.4 months in a patient cohort contemporaneously treated with
best standard therapy (p = 0.0175). The final analysis, at a median
follow-up of 30.8 months, now shows a median OS of 21 months in the
GPS-treated patient cohort.
“Given these results, it is particularly exciting to be involved
in the ongoing pivotal Phase 3 REGAL study of GPS in AML patients
in CR2,” said Hagop M. Kantarjian, MD, Professor and Chair of the
Department of Leukemia at the University of Texas - MD Anderson
Cancer Center, and principal investigator of the Phase 3 REGAL
study. “We are working to rapidly enroll patients who meet
entry criteria for this study and believe these compelling results
will enhance the visibility of this novel therapy and encourage
broader participation in the pivotal Phase 3 trial. I look
forward to initial results from the REGAL study, as I remain
supportive of GPS’s potential promise as an immunotherapeutic agent
in the AML CR2 setting.”
SELLAS is currently enrolling patients in the ongoing Phase 3
REGAL study, a 1:1 randomized, open-label study comparing GPS
monotherapy in the maintenance setting to investigators’ choice
best available treatment in AML patients who have achieved
hematologic complete remission, with or without thrombocytopenia
(CR2/CR2p), after second-line antileukemic therapy and who are
deemed ineligible for or unable to undergo allogeneic stem-cell
transplantation. The primary endpoint is the OS from the time of
study entry. Secondary endpoints include leukemia-free survival,
antigen-specific T-cell immune response dynamics, measurable
residual disease by multigene array, and assessments of AML clonal
evolution and inflammasome molecular signatures in the tumor
microenvironment in bone marrow biopsy samples. SELLAS expects an
interim analysis for safety and futility in the fourth quarter of
2021.
For further information on enrolling in the REGAL study, please
visit:
https://www.clinicaltrials.gov/ct2/show/NCT04229979?term=galinpepimut-S&draw=2&rank=3.
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,
GPS, is licensed from Memorial Sloan Kettering Cancer Center and
targets the 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,” 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 the Company’s plans for further
development of and regulatory plans for GPS, including the timing
of clinical results, and the potential for GPS as a drug
development candidate. 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, the uncertainty of regulatory approval, and other risks
and uncertainties affecting SELLAS and its development programs 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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