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 the formation of the
Steering Committee for its Phase 3 REGAL clinical trial of
galinpepimut-S (GPS) in patients with acute myeloid leukemia (AML)
who have achieved complete remission after second-line
anti-leukemic therapy (CR2).
“We continue to make important progress toward
ensuring that our Phase 3 AML trial is a well-executed pivotal
study and are working diligently toward its timely execution
despite the COVID-19 pandemic," said Dr. Angelos Stergiou, MD, ScD
h.c., SELLAS’ President & Chief Executive Officer. "We are
pleased that our internal clinical leadership team, which includes
individuals with extensive late-stage hematology-oncology
development experience, is now supplemented by a Steering Committee
with deep and extraordinary international hematology
experience.”
The Steering Committee will provide scientific
oversight and guidance of the practical aspects of the ongoing
REGAL study. The Steering Committee will also review the results of
the trial as they become available, analyze current clinical
practices to identify AML patients most likely to benefit from
entry to the study, design and implement the most efficient
continued approaches to conducting the study and make
recommendations regarding the monitoring of the clinical study in
consultation with the independent data monitoring committee.
Dr. M. Yair Levy, MD, Director of Hematologic
Malignancies at the Baylor University Medical Center commented,
“Over the past several years, new treatment modalities have
improved response rates in AML in the second line (salvage)
setting, resulting in an increasing number of patients achieving
complete remission (CR2). However, patients who successfully enter
CR2 represent a clinical population for which there is an enduring
unmet medical need, with a median overall survival of around five
months. Currently, REGAL is the only Phase 3 study aiming at
remission prolongation through maintenance post-CR2 therapy – other
than allogeneic stem cell transplantation - that is actively
enrolling patients in this setting.”
"The REGAL trial is a rigorously designed study
which will provide pivotal data assessing the potential
contribution of maintenance therapy with galinpepimut-S, an
innovatively engineered and promising WT1-targeting
immunotherapeutic, in candidate AML patients in CR2. I look forward
to reviewing the clinical and safety data as they become available
and to serving as a member of its Steering Committee,” concluded
Dr. Levy.
The Steering Committee currently consists of
three members:
- Dr. Hagop Kantarjian, MD, Professor and Chair of the Department
of Leukemia at The University of Texas MD Anderson Cancer Center,
and Principal Investigator at MD Anderson for the multi-center
Phase 3 REGAL study and Chair of the REGAL Steering
Committee*
- Dr. Javier Pinilla-Ibarz, MD, PhD, Director of Immunotherapy
for Malignant Hematology at the H. Lee Moffitt Cancer Center and
member of the SELLAS Scientific Advisory Board
- Dr. Moshe Yair Levy, MD, Director of Hematologic Malignancies
at the Texas Oncology - Baylor Charles A. Sammons Cancer
Center
The Company previously reported initial data
from the Phase 2a study of galinpepimut-S in AML patients in CR2 at
a median follow-up of 19.3 months, showing median overall survival
(OS) in vaccine-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, showed a median OS of 21 months in the GPS-treated patient
cohort. A second previous Phase 2 study of galinpepimut-S in AML
patients who achieved first complete remission (CR1) also met its
primary endpoint with an OS rate at 3 years from first vaccination
of 47%.
The REGAL study is an ongoing 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 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. The Company anticipates 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.
*Dr. Kantarjian’s role on the steering committee
is under review by MD Anderson’s Conflict of Interest Committee to
ensure compliance with institutional policy.
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 clinical
development of 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 the COVID-19 pandemic and its impact
on the Company’s clinical plans and business strategy,
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 13, 2020 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 Contacts Adam
Holdsworth PCG Advisory 646-862-4607 adamh@pcgadvisory.com
Investor Relations SELLAS Life Sciences Group,
Inc. 917-438-4353 info@sellaslife.com
Source: SELLAS Life Sciences Group
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