SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) (“SELLAS” or the
“Company”), a clinical-stage biopharmaceutical company focused on
the development of novel cancer immunotherapies for a broad range
of cancer indications, today provided an update on its late-stage
clinical development program for the Company’s proprietary
galinpepimut-S (GPS) in patients with acute myeloid leukemia
(AML).
Following a clinical and regulatory strategy
defining Type C dialogue with the U.S. Food and Drug Administration
(FDA), the Company plans to proceed with a clinical study design
and biostatistical plan to support a Phase 3 registrational study
for maintenance therapy for AML patients who have achieved complete
remission after second line (salvage) antileukemic therapy, or CR2.
This study will be used as the basis for a Biologics License
Application (BLA) submission, subject to results that are both
statistically significant and reflective of an effect of sufficient
magnitude to be clinically meaningful.
“Following discussion with the FDA, we are
embarking upon a revised Phase 3 study for GPS in the monotherapy
maintenance setting for AML patients who have achieved CR2.
The new design is expected to streamline sample size, time to
accrual completion, primary endpoint readout and potential time to
market, as well as costs. We believe this new study design
provides SELLAS with a quicker path to approval, provided the study
is positive,” said Dr. Angelos M. Stergiou, MD, ScD h.c., President
and Chief Executive Officer of SELLAS. “In addition to a
statistical analysis plan which we believe accords a viable pathway
for meeting the primary endpoint, we have built in an adaptive
design, thus further enhancing the probability of a positive
study.”
GPS was previously given fast track and orphan
drug designations in AML by the FDA.
The planned Phase 3 registrational study will be
a 1:1 randomized, open-label study comparing GPS monotherapy
in the maintenance setting to investigators’ choice best available
treatment (BAT) 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 study is expected to enroll approximately
116 patients at around 50 clinical sites in the United States and
Europe. It is powered at 90% to show a statistically
significant difference in the primary endpoint of overall survival
(OS) from the time of study entry. Secondary endpoints to be
measured 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 study will have a planned interim
analysis for safety and futility after 80 events.
This streamlined CR2 study design, as compared
to the previously planned study in AML patients who achieved
complete remission following first-line antileukemic therapy (CR1),
substantially reduces the study size (116 patients in CR2 vs. 390
patients in CR1) and time until topline data (up to 2.5 years in
CR2 vs. 4.5 years in CR1) which will result in corresponding
significant cost savings. A Phase 2a study of GPS in the AML
CR2 setting conducted at the Moffitt Cancer Center previously
demonstrated a clinically meaningful and statistically significant
three-fold OS prolongation in patients receiving GPS when compared
to a comparable group of contemporaneously assessed
unvaccinated patients with a median OS of 16.3 months vs 5.4 months
and a p-value of 0.0175, respectively, with
treatment-related adverse events primarily comprised of grade 1 or
2 local injection site reactions and only one grade 3
(transient leukopenia) adverse event. A prior Phase 2 study
of GPS in AML patients who achieved CR1 also met its primary
endpoint with an OS rate at 3 years from first vaccination of
47%.
“We are excited to begin this late-stage Phase 3
program with GPS in AML. Earlier studies have positioned this
agent to be a potentially effective approach in prolonging survival
by delaying or preventing recurrence in patients in complete
remission, most of whom harbor measurable residual disease and have
a poor prognosis if they are unable to undergo allotransplant. We
are hopeful that this new immunotherapeutic vaccine approach will
improve outcomes in this patient population, which is at a very
high risk of leukemic relapse,” 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 upcoming Phase 3 AML clinical development
program.
About SELLAS Life Sciences Group,
Inc.
SELLAS is a clinical-stage 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 has Phase 3 clinical trials planned for
GPS in two indications, acute myeloid leukemia (AML) and malignant
pleural mesothelioma (MPM) and is also developing GPS as a
potential treatment for multiple myeloma (MM) and ovarian
cancer. SELLAS plans to study GPS in up to four additional
indications. SELLAS has received Orphan Drug (or Medicinal
Product) designations for GPS from both the U.S. Food & Drug
Administration (FDA) and the European Medicines Agency (EMA) for
AML, MPM, and MM. GPS also received Fast Track designation for AML,
MPM and MM from the FDA. SELLAS’ second product candidate,
nelipepimut-S (NPS, NeuVax™), is a HER2-directed cancer
immunotherapy being investigated for the prevention of the
recurrence of breast cancer after standard of care treatment in the
adjuvant setting. NPS has received Fast Track status designation by
FDA for the treatment of patients with early stage breast cancer
with low to intermediate HER2 expression, otherwise known as HER2
1+ or 2+, 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 further development of
galinpepimut-S (GPS) for acute myeloid leukemia, including the
timing of clinical results, the cost of clinical trials, the
accrual of patients in a clinical trial, the potential time to
market for GPS and the potential results from a clinical trial.
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, the uncertainty of finding potential partners for product
candidate development, and other risks and uncertainties affecting
SELLAS and its development programs as set forth under the caption
“Risk Factors” in Exhibit 99.1 in its Current Report on Form 8-K
filed on July 18, 2018 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:Will
O’ConnorStern Investor Relations,
Inc.212-362-1200ir@sellaslife.com
David Moser, JDSELLAS Life Sciences Group,
Inc.813-864-2571info@sellaslife.com
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