SELLAS Announces Enrollment of First Patient in Phase 1 Trial of Galinpepimut-S (GPS) in Combination with Nivolumab (Opdivo®...
February 11 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 the enrollment of the
first patient in an investigator-sponsored clinical trial of its
Wilms tumor-1 (WT1)-targeting peptide immunotherapeutic agent, GPS,
in combination with Bristol-Myers Squibb’s anti-PD-1 therapy,
nivolumab (Opdivo®), in patients with MPM.
The Phase 1 open-label clinical study is being conducted by
Memorial Sloan Kettering Cancer Center (MSK) and is enrolling
patients with MPM who harbor relapsed or refractory disease after
having received frontline, standard-of-care multimodality therapy.
The principal investigator for the study is Marjorie G. Zauderer,
MD, Co-Director, Mesothelioma Program and Associate Attending
Physician in the Thoracic Oncology Service, Department of Medicine
at MSK.
“We are pleased to be collaborating with Memorial Sloan
Kettering on this Phase 1 trial and excited to have expanded the
clinical evaluation of GPS in combination with nivolumab to
patients with advanced MPM,” said Angelos Stergiou, MD, ScD h.c.,
President and Chief Executive Officer of SELLAS. “There are few
effective therapies for mesothelioma, a disease which is
characterized by high expression of the WT1 antigen, and we believe
that the combination of GPS and nivolumab could be promising for
patients with MPM, due to the combination’s potential synergistic
immune-based mechanisms for anti-tumor activity. We look forward to
gaining further insights on the safety and clinical outcomes of
this combination in MPM.”
The trial is investigating the potential of GPS in combination
with nivolumab to demonstrate anti-tumor immune responses and
meaningful clinical activity in the presence of macroscopic disease
in MPM patients and gauging 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.
“There is significant preclinical and translational science
evidence that PD-1 inhibitors may enhance the anti-cancer activity
of cancer vaccines, with immuno-biologic and pharmacodynamic
synergy from the combination of two such agents,” said Dr.
Zauderer. “By mitigating the negative effects of tumor
microenvironment factors on immune response, PD-1 inhibitors, such
as nivolumab, potentially allow for a patient’s immune cells to
destroy cancerous growths that may be sensitized by GPS against
WT1. I believe that WT1 serves as an ideal target for directly
immunizing therapies in MPM, and I look forward to evaluating the
combination of GPS and nivolumab in the clinic.”
In a previous randomized, controlled, blinded Phase 2 clinical
trial in MPM patients, 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 with the most common adverse events mild (grade 1 and 2)
and self-limited injection site reactions.
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 MSKCC 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.
MSK has institutional financial interests related to SELLAS in
the form of intellectual property rights in galinpepimut-S (GPS)
and associated interests by virtue of the licensing agreement
between MSK and SELLAS.
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. 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, 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 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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