SELLAS To Present Data from Phase 2b Trial of NeuVax + Herceptin® at Upcoming European Society for Medical Oncology (ESMO) 2...
July 23 2018 - 7:40AM
Oral Presentation of NeuVax + Herceptin in the
Adjuvant Treatment of Triple-Negative Breast Cancer
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 that data on the adjuvant
treatment of women with triple-negative breast cancer (TNBC) with
the combination of trastuzumab (Herceptin®) +/-nelipepimut-S
(NeuVax™) will be presented as a Proffered Paper in an oral
presentation at the 2018 Annual Meeting of the European Society for
Medical Oncology October 19-23 in Munich, Germany.
The abstract, “Pre-specified interim analysis of a randomized
phase 2b trial of trastuzumab + nelipepimut-S (NeuVax) vs
trastuzumab for the prevention of recurrence demonstrates benefit
in triple negative (HER2 low-expressing) breast cancer patients,”
describes research undertaken at Cancer Insight, LLC by a team of
clinicians-scientists led by COL (ret) George E. Peoples, MD, FACS,
the principal investigator for the study.
Data will be presented from a prospective, randomized,
single-blinded, controlled Phase 2b independent
investigator-sponsored clinical trial (IST) of Herceptin® +/-
NeuVax in HER 1+/2+ breast cancer patients in the adjuvant setting
to prevent recurrences. As previously announced, a pre-specified
interim analysis of safety and efficacy conducted by the study
independent data safety monitoring board (DSMB), demonstrated a
clinically meaningful and statistically significant difference
between the TNBC cohort of patients and the control arm with a
hazard ratio of 0.26, p-value = 0.023, in favor of the NeuVax +
Herceptin combination compared to Herceptin alone. The analysis
also showed an adverse event profile with no notable differences
between treatment arms and no additional cardiotoxicity in the
NeuVax + Herceptin arm. Based on these positive results, the DSMB
recommended to expeditiously seek regulatory guidance from the U.S.
Food and Drug Administration for further development of the
combination of NeuVax + Herceptin in TNBC, a population with a
large unmet medical need.
Herceptin® is a registered trademark of Genentech, Inc. 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 ESMO
The European Society for Medical Oncology (ESMO) is Europe’s
leading non-profit medical oncology organization. ESMO is a
membership-based society, comprising of 500 expert committee
members and 18,000 oncology professionals. ESMO organizes a large
number of meetings to provide its members and the community with
the resources they need and also plays a major role in public
policy and European affairs. The ESMO 2018 Annual Meeting
represents a multi-professional platform for oncology education and
exchange, and for immense international visibility for scientific
research, and will be held under the tagline “Securing access to
optimal cancer care”.
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, 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 (pending funding availability) 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 designations for
GPS from the U.S. Food & Drug Administration (FDA) for AML,
MPM, and MM, as well as from the European Medicines Agency, for AML
and MPM; GPS also received Fast Track designation for AML and MPM
from the FDA. SELLAS’ second product candidate, NeuVax™
(nelipepimut-S), 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. NeuVax™
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,
including, but not limited to, statements related to the results of
clinical studies and as to further development of GPS for ovarian
cancer as well as for a broad range of cancer indications,
including the timing of clinical trials. 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. These risks and uncertainties are
described more fully in SELLAS’ Annual Report on Form 10-K and
other filings with the Securities and Exchange Commission. Other
risks and uncertainties of which SELLAS is not currently aware may
also affect SELLAS’ forward-looking statements. 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 Contact:
Will O’Connor
Stern Investor Relations, Inc.
212-362-1200
ir@sellaslife.com
David Moser, JD
Sellas Life Sciences Group
813-864-2571
info@sellaslife.com
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