SELLAS Commences Pivotal Phase 3 REGAL Study of Galinpepimut-S (GPS) in Patients with Acute Myeloid Leukemia (AML)
January 08 2020 - 8:30AM
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 that it has started
patient screening for its pivotal Phase 3 REGAL clinical trial of
its lead clinical candidate, galinpepimut-S (GPS), in patients with
acute myeloid leukemia (AML) who have achieved complete remission
after second-line anti-leukemic therapy (CR2). The study is
expected to enroll approximately 116 patients across approximately
50 clinical sites in the U.S. and Europe. GPS was previously
granted Fast Track designation and orphan drug designation in AML
by the U.S. Food and Drug Administration (FDA) and orphan drug
designation by the European Medicines Agency (EMA).
“The commencement of our Phase 3 clinical trial marks an
important milestone for SELLAS, and reflects our continued
commitment to developing GPS as a potential first-in-class
WT1-targeting cancer vaccine for patients with AML. We are indeed
excited that patient screening is underway for our REGAL study,”
said Angelos Stergiou, MD, ScD h.c., President and Chief Executive
Officer of SELLAS. “In previous Phase 2 studies in patients with
AML, GPS has demonstrated a clinically meaningful and statistically
significant prolonging of survival by delaying or preventing
recurrence in patients in complete remission, who often are at very
high risk of relapse. Of particular note, our Phase 2 AML CR2
study, which is the indication for our Phase 3 study, showed a 10.9
months survival benefit with a p-value of 0.0175. We remain focused
on expeditiously enrolling our Phase 3 study. The results from the
REGAL study, if positive, will be used as the basis for a Biologics
License Application (BLA) submission to the FDA.”
The REGAL study is 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 overall survival (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.
In a previous Phase 2a study in AML patients in the CR2 setting,
GPS demonstrated a clinically meaningful and statistically
significant median OS of 16.3 months in AML CR2 patients vs. 5.4
months in contemporaneously assessed unvaccinated patients (p =
0.0175). Treatment-related adverse events were primarily comprised
of Grade 1 or 2 local injection site reactions and one Grade 3
(transient leukopenia) adverse event. A second previous Phase 2
study of GPS 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%.
About SELLAS Life Sciences Group, Inc.
SELLAS is a late-stage clinical biopharmaceutical company
focused on 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,” 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. 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
SELLAS Life Sciences (NASDAQ:SLS)
Historical Stock Chart
From Mar 2024 to Apr 2024
SELLAS Life Sciences (NASDAQ:SLS)
Historical Stock Chart
From Apr 2023 to Apr 2024