Initiation of Phase 1 Clinical Trial in Relapsed
or Refractory MPM Expected in the Second Quarter of 2019
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 agreement with Memorial
Sloan Kettering Cancer Center (MSK) for the conduct of an
investigator-sponsored clinical trial of SELLAS' Wilms tumor-1
(WT1)-targeting peptide immunotherapeutic agent, galinpepimut-S
(GPS), in combination with Bristol-Myers Squibb’s anti-PD-1
therapy, nivolumab, in patients with malignant pleural mesothelioma
(MPM). The Phase 1 open-label clinical study will enroll patients
with MPM who harbor relapsed or refractory disease after having
received frontline standard of care multimodality therapy with
study drug provided by both SELLAS and Bristol-Myers Squibb. The
principal investigator for the study will be Dr. Marjorie G.
Zauderer, MD, Co-Director, Mesothelioma Program, Team Lead,
Thoracic Disease Management Team, and Assistant Attending Physician
in the Division of Thoracic Oncology, Department of Medicine at
MSK.
The purpose of the trial is to determine if the administration
of GPS in combination with nivolumab has the potential to
demonstrate antitumor immune responses and meaningful clinical
activity in the presence of macroscopic disease in MPM patients.
The study will also investigate the tolerability of the
combination, evaluate the immunogenicity of the two agents
administered together, by CD4+ and CD8+ T-lymphocytes (both
peripherally and at the tumor site), and gauge the degree of
clinical benefit by assessment of the overall response rate with
the combination in comparison with that reported with nivolumab
alone in historical comparable patient populations. In a
randomized, controlled, blinded Phase 2 clinical trial in MPM
patients completed in 2017, GPS monotherapy, given as maintenance
after first line tumor-debulking multimodality treatment,
demonstrated meaningful clinical activity with median survival of
22.8 months vs. 18.3 months in the control group (N=41) and with
associated sustained immune responses (both CD4+ and CD8+) against
the WT1 antigen while adverse events were mainly comprised of low
grade reactions at the site of the injection.
"SELLAS is excited to embark upon this trial, as we look to
expand the utility of GPS in combination with PD-1 inhibitors, and
specifically nivolumab. The nivolumab/GPS immunotherapy combination
is well positioned to exploit the unique features of each of these
two agents through potential synergistic immune-based mechanisms of
antitumor action. If positive, this clinical effort will allow us
to consider advancing the clinical development of the combination
of GPS and nivolumab in relapsed or refractory MPM as a potentially
promising approach to treat patients with this recalcitrant
thoracic malignancy," stated Dr. Angelos Stergiou, MD, ScD h.c.,
President and Chief Executive Officer of SELLAS.
“The rationale for this innovative clinical effort is based upon
the presumed immunobiologic and pharmacodynamic synergy between the
two investigational agents. We hypothesize that the negative
influence of tumor microenvironment factors on the immune response
is mitigated by nivolumab, thus providing the opportunity for the
patients' own immune cells to invade and destroy cancerous growth
deposits specifically sensitized against WT1 by GPS. WT1 is both a
densely and frequently expressed tumor-associated antigen in MPM,
and we believe it represents the optimal target for directly
immunizing, vaccine-type therapies such as GPS against this tumor
type,” commented Dr. Nicholas J. Sarlis, MD, PhD, Chief Medical
Officer and Executive Vice President of SELLAS.
Data from a Phase 1 open-label clinical study of patients with
WT1+ ovarian cancer in second or greater remission suggested
clinical activity for the combination of GPS plus nivolumab, with a
progression-free survival (PFS) rate of 70% at one year among
patients who received at least three doses of GPS in combination
with nivolumab (7/10), while historical 1-year PFS rates with best
standard treatment do not exceed 50% in this disease setting.
GPS is also currently being studied in combination with Merck’s
anti-PD-1 therapy, pembrolizumab, in patients with measurable tumor
burden in the context of a Phase 1/2 open-label, non-comparative,
multicenter, multi-arm ‘basket’-type clinical study in five
indications.
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
MSK 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 has a Phase 3 clinical trial planned
(pending funding availability) for GPS in acute myeloid leukemia
(AML) and is also studying GPS in combination with pembrolizumab in
multiple indications. SELLAS has received Orphan Drug designations
for GPS from the U.S. Food and Drug Administration (FDA) and the
European Medicines Agency for AML, 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,
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+, which includes
triple negative breast cancer patients, following standard of
care.
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 results of clinical studies
and as to further development of GPS in various indications. 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 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.
For more information on SELLAS, please visit
www.sellaslifesciences.com.
Investor Contacts
Will 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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