Final data from Phase 2b clinical trial of
nelipepimut-S (NeuVax™) in combination with trastuzumab
(Herceptin®) were previously presented at the European Society for
Medical Oncology (ESMO) 2018 Annual Meeting
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 data from a preplanned
secondary efficacy analysis across human leukocyte antigen (HLA)
allele subgroups from the prospective, randomized, single-blinded,
controlled Phase 2b independent investigator-sponsored clinical
trial of the combination of nelipepimut-S (NeuVax™, NPS) +/-
trastuzumab (Herceptin®) targeting HER2 low-expressing breast
cancer patient cohorts. The data are being presented at the
33rd Annual Meeting of the Society for Immunotherapy of Cancer
(SITC), being held November 7 -11, 2018.
The data presented confirm the therapeutic potential of NPS for
patients with early-stage TNBC in the adjuvant setting across HLA
types A-02, -03, -24 and -26 which cover approximately 80-85% of
the North American/European populations and 86-90% of Asian/Pacific
basin populations. In the subgroup of triple negative breast
cancer (TNBC) patients with the HLA-A24+ allele type, which is
highly prevalent in the Asian population, treated with the
combination of NPS and trastuzumab (n=47), the p-value is 0.003
with a 90.6% relative reduction in risk of relapse or death at 24
months and a hazard ratio of 0.08 in favor of the active
(combination) arm.
“These data not only confirm the clinical effect of the NPS plus
trastuzumab combination in TNBC, which we recently announced at
ESMO with a p-value of 0.013 and a 75% relative reduction in the
risk of relapse or death, but also positions NPS biologically as an
agent that could potentially be used globally, considering the high
prevalence of the HLA-A24 allele in populations across the Pacific
basin and Asia. We are scheduled to meet with the U.S. regulatory
authorities in December 2018 on the most optimal and expeditious
development path for NPS in TNBC, and continue to advance ongoing
interactions with potential partners,” said Dr. Angelos Stergiou,
MD, ScD h.c., President and Chief Executive Officer of SELLAS.
“In this preplanned secondary efficacy analysis, consistent
positive clinical benefit was seen in the TNBC cohort, irrespective
of patients’ HLA allele types in favor of the NPS plus trastuzumab
combination arm. Specifically, the HLA-A24+ TNBC patients had a
significant improvement in disease-free survival both by log-rank
and landmark (24 month) analysis despite the lowest predicted
binding potential between the E75 (NPS) antigen and this HLA-type,”
commented Elizabeth A. Mittendorf, MD, PhD, Rob and Karen Hale
Distinguished Chair in Surgical Oncology, Director of Research,
Breast Surgical Oncology Brigham and Women’s Hospital, Director,
Breast Immuno-Oncology Program Dana-Farber/Brigham and Women’s
Cancer Center, and the Principal Investigator of the Phase 2b
study.
“This suggests that NPS, which is able to bind to the
lower-affinity MHC-I conformations (A24) in addition to the
high-affinity ones, i.e., A02 and A03, may generate an optimally
favorable immunologic response, possibly due to decreased exposure
and tolerance to the E75 epitope. This is important, as other
peptide vaccines can be tolerogenic and lead to progressively
diminishing immunogenicity over time, something we do not expect to
see with NPS,” continued Dr. Mittendorf.
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.
SITC Presentation Information
Date: Friday, November 9th, 2018Time: 12:45 p.m. to 2:15 p.m.
and 6:30 p.m. to 8:30 p.m. ET.Venue: SITC 2018 Annual Meeting,
Walter E. Washington Convention Center, Washington, DCLocation:
Poster Hall EPoster number:
P159 Title:
“Correlation between response and HLA type in a randomized phase
IIb trial of NeuVax + trastuzumab in HER2 low-expressing breast
cancer patients to prevent recurrence.”
About SITC
The Society for Immunotherapy of Cancer (SITC) is the world’s
leading member-driven organization specifically dedicated to
improving cancer patient outcomes by advancing the science and
application of cancer immunotherapy and serves scientists,
clinicians, academicians, patients, patient advocates, government
representatives and industry leaders from around the world.
Currently, SITC has more than 2,000 members who represent 22
medical specialties in 42 countries around the world and brings
together all aspects of the cancer immunology and immunotherapy
community in its annual meeting.
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) and the
European Medicines Agency (EMA) for AML, MPM, and MM; GPS has also
received Fast Track designation for AML, MPM and MM from the FDA.
SELLAS’ second product candidate, nelipepimut-S (NeuVax™, 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 further development of
nelipepimut-S (NeuVaxTM, NPS) for breast cancer, meetings with
regulatory authorities and the outcome of partnering discussions.
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
Group813-864-2571info@sellaslife.com
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