Data Safety Monitoring Board met on October
15, 2018 for final analysis
SELLAS Life Sciences Group Inc., (Nasdaq: SLS) (SELLAS or the
Company), a clinical-stage biopharmaceutical company focused on
novel cancer immunotherapies for a broad range of cancer
indications, today announced that the independent Data Safety
Monitoring Board (DSMB) unanimously concluded that the final data
from the Phase 2b study of trastuzumab (TZ, Herceptin®) +/-
nelipepimut-S (NPS, NeuVax™) in HER2 1+/2+ breast cancer patients
confirms the previously announced findings from the interim
analysis of this study. The DSMB concluded that there was an
incremental improvement in the outcomes and statistics with a
longer median follow-up (more than 7 months; 26.1 months at final
vs. 18.8 months at interim analysis). The final analysis showed no
new safety signals and continued to show no difference in
cardiotoxicity between TZ + NPS compared to TZ alone. Finally, the
DSMB confirmed that the final analysis continues to identify
patients with triple negative breast cancer (TNBC) as the key
target patient population for development of the NPS + TZ
combination in the adjuvant setting in early-stage HER2 1+/2+
breast cancer patients.
On March 28, 2018, based on a pre-specified interim analysis and
the positive TNBC results, the DSMB had recommended to
expeditiously seek regulatory guidance by the U.S. Food and Drug
Administration (FDA) for further development of the combination of
NPS + TZ in TNBC, a population with large unmet medical
need.
SELLAS will host a conference call at 8:00 a.m. ET on October
22, 2018, following the oral presentation at the ESMO 2018 Annual
Meeting of the interim and updated final clinical data from its
Phase 2b trial of the combination of trastuzumab (Herceptin®) +/-
nelipepimut-S (NPS, NeuVax™) targeting HER2 low-expressing breast
cancer patient cohorts. Management and invited Key Opinion
Leaders, Dr. Elizabeth Mittendorf, MD, PhD and Dr. George Peoples,
MD, FACS, will participate in the conference call.
Conference Call Details for Monday, October 22, 2018 at
8:00 a.m. ET:
To participate in the conference call, please dial (866)
416-7995 (domestic) or +1 (409) 217-8225 (international) and refer
to conference ID 5571389. A live webcast of the call can be
accessed under "Events & Presentations" in the Investors
section of the Company's website at www.sellaslifesciences.com.
An archived webcast recording will be available on the SELLAS
website beginning approximately two hours after the call.
Details for the ESMO presentation are as
follows:Title: 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 Date and Time: 22 October, 2018; 11:54 am
Central European Time (5:54 am ET)Location: Hall
A2 - Room 18; Messe Munich Congress Venue, Munich, Germany
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 both the U.S. Food & Drug Administration (FDA) and
European Medicines Agency (EMA) for AML, MPM, and MM; 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. 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 nelipepimut-S (NeuVax™) for breast
cancer. 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 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 Contact:Will O’ConnorStern Investor
Relations, Inc.212-362-1200ir@sellaslife.com
David Moser, JDSELLAS Life Sciences Group,
Inc.813-864-2571info@sellaslife.com
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