SELLAS Advances Galinpepimut-S (GPS) in Combination with KEYTRUDA® (pembrolizumab) Program with Dosing of First Patient in P...
July 31 2019 - 8:15AM
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 announced the dosing of the first
patient in its Phase 1/2 open-label study of GPS in combination
with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab), in
patients with selected WT1-positive advanced cancers, including
both solid tumors and hematologic malignances.
“This is an important milestone as this study
allows us to potentially enhance our safety and activity profile of
GPS in combination with anti-PD-1 therapies, particularly in
combination with KEYTRUDA® in multiple malignances, following
intriguing initial combination clinical data with OPDIVO®,” said
Angelos M. Stergiou, M.D., ScD h.c., President and Chief Executive
Officer of SELLAS. “We are confident this study will build on our
body of clinical evidence in support of the use of GPS in
combination with PD-1 inhibitors to benefit cancer patients with
limited treatment options. We believe that our innovative WT1
immunotherapeutic, GPS, in combination with anti-PD-1 immunotherapy
agents, may provide therapeutic benefit for patients with WT1
expression. These beliefs are shared by the renowned U.S.
oncologists who are undertaking this work. We look forward to
studying this combination in patients with a wide range of cancers
and expect to provide the first clinical data from this study in
the first quarter of 2020.”
The Company also announced today that Richard
Maziarz, M.D., Medical Director of the Adult Blood and Marrow Stem
Cell Transplant & Cellular Therapy Program at the Knight Cancer
Institute and Professor of Medicine at Oregon Health and Science
University (OHSU) in Portland, OR, and Roisin O'Cearbhaill, M.D.,
Assistant Attending Physician in Gynecologic Medical Oncology
Service at the Memorial Sloan Kettering Cancer Center (MSKCC), are
serving as co-principal investigators for this study.
About the StudyThe Phase 1/2
open-label, multicenter, multi-arm study is being conducted under a
Clinical Trial Collaboration and Supply Agreement (CTSA) with Merck
(known as MSD outside the United States and Canada) to assess the
efficacy and safety of the combination of GPS and KEYTRUDA®.
The primary endpoints of the study include safety
and overall response rate, while secondary endpoints include
progression-free survival, overall survival and immune response
correlates. The study will enroll approximately 90 patients at up
to 20 centers in the United States. The trial is initially
evaluating patients with ovarian cancer (second or third line) and
colorectal cancer (third or fourth line), to be followed by
patients with acute myeloid leukemia (AML) who are unable to attain
deeper morphological response than partial on hypomethylating
agents and who are not eligible for allogeneic hematopoietic stem
cell transplant and patients with triple negative breast cancer
(TNBC) (second line), and small cell lung cancer (second line).
Keytruda® is a registered trademark of Merck Sharp
& Dohme Corp., a subsidiary of Merck & Co., Inc.,
Kenilworth, N.J., USA., and is not a trademark of SELLAS. The
manufacturer of this brand is not affiliated with and does not
endorse SELLAS or its products.
About SELLAS Life Sciences Group,
Inc.
SELLAS is a clinical-stage biopharmaceutical
company focused on 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 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 a Phase 3 clinical trial planned for
GPS in AML and is also studying GPS in combination with
pembrolizumab in multiple indications. SELLAS has received Orphan
Drug designations for GPS from the FDA and the European Medicines
Agency (EMA) for AML, malignant pleural mesothelioma (MPM), and
multiple myeloma (MM); GPS has also received Fast Track designation
for AML, MPM and MM from the FDA. SELLAS’ second product candidate,
nelipepimut-S (NPS), 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+, which includes
TNBC 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 clinical development of GPS
for various indications, including the timing thereof. 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 Company’s 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 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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