Data Expected in Fourth 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 the completion of enrollment
for a Phase 2 independent investigator-sponsored clinical trial of
the combination of trastuzumab (Herceptin®) +/- nelipepimut-S (NPS)
targeting high-risk, high-expression HER2-positive (IHC3+) breast
cancer patients. This trial enrolled 100 patients and top-line data
are expected in the fourth quarter of 2019. SELLAS recently
reported positive data from a separate Phase 2b study of
trastuzumab +/- NPS in low-expression HER2 (IHC 1+/2+) or triple
negative breast cancer patients whose tumors are also identified by
low-to-no expression of hormone receptors.
This trastuzumab + NPS clinical study is a multi-center,
prospective, randomized, single-blinded investigator-sponsored
Phase 2 trial focusing on patients with a diagnosis of
HER2-positive (immunohistochemistry [IHC] 3+ and/or HER2
FISH-amplified) breast cancer who are HLA-A02, A03, A24 or
A26-positive and at high-risk for recurrence after standard therapy
for early-stage disease. Eligible patients were randomized to
receive NPS plus trastuzumab or trastuzumab alone in the adjuvant
setting to prevent or delay disease recurrence. The primary
endpoint of the study is disease-free survival (DFS). Support for
this trial is provided, in part, by the Congressionally Directed
Medical Research Program (CDMRP), funded through the Department of
Defense via a Breast Cancer Research Program Breakthrough Award to
Elizabeth Mittendorf, MD, PhD. The National Breast Cancer
Coalition led the effort to establish the CDMRP to enhance the
funding for breast cancer research and remains integrally involved
in the grant selection process.
“The completion of enrollment of this Phase 2 clinical trial of
NPS marks an important milestone, as it brings us one step closer
to providing this potentially life-saving therapy to high-risk
HER2-positive breast cancer patients facing limited treatment
options,” said Dr. Nicholas J. Sarlis, MD, PhD, Executive Vice
President and Chief Medical Officer of SELLAS. “We are encouraged
for a favorable outcome based on rigorous preclinical work showing
potential synergy between NPS and trastuzumab, and are eager to
gain further insights on the effect of this combination in
HER2-positive early-stage breast cancer in patients with the
highest risk of disease recurrence. This combination has a solid
clinical and immunobiological rationale, as demonstrated by the
recent data from the Phase 2b study of NPS plus trastuzumab in the
maintenance setting in patients with early-stage triple negative
breast cancer. We look forward to reporting data from this second
combination study next year.”
“We are thrilled to complete enrollment in this very important
Phase 2 clinical trial of NPS and trastuzumab as a treatment for
high-risk HER2-positive breast cancer patients. We look forward to
completing the study and to reporting the trial results,” said
Elizabeth A. Mittendorf, MD PhD, Rob and Karen Hale Distinguished
Chair in Surgical Oncology, Director of Research, Breast Surgical
Oncology at Brigham and Women’s Hospital, and Director, Breast
Immuno-Oncology Program Dana-Farber/Brigham and Women’s Cancer
Center and the Principal Investigator of the study. “The addition
of trastuzumab to standard therapy has dramatically improved the
prognosis for patients with early stage, HER2-positive (IHC 3+/HER2
gene FISH-amplified) breast cancer to unprecedented survival
outcomes. Yet, long-term follow-up data indicate that 15-24% of
such patients still develop recurrent disease. Moreover, dual
blockade of HER2 signaling in the adjuvant setting has led to only
small incremental benefits in disease-free survival and the
addition of NPS may prove to be clinically beneficial and enhance
the armamentarium in breast cancer treatments. This unmet
medical need is more prevalent in patients who are unable to
achieve a pathologic complete response after standard neoadjuvant
therapy or those found to have positive lymph nodes above certain
number thresholds at the time of surgery, and then treated with
standard adjuvant therapy.”
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 the National Breast Cancer Coalition
Founded in 1991, the National Breast Cancer Coalition’s (NBCC)
mission is to end breast cancer through the power of action and
advocacy. NBCC is a collaboration of activists, survivors,
researchers, policy makers, grassroots groups, and national
organizations that have come together as disruptive innovators for
social change. NBCC links hundreds of organizations and tens of
thousands of individuals from across the country giving breast
cancer a meaningful voice in Washington, DC, and state capitals, in
laboratories and health care institutions, and in local communities
everywhere. NBCC’s activism has generated more than $3 billion new
dollars for breast cancer research, and such research initiatives
and advocacy are helping bring about novel models of research.
For more information, click on the following
link:http://www.breastcancerdeadline2020.org/about-nbcc/about-nbcc.html
About the Congressionally Directed Medical Research
Programs
The Congressionally Directed Medical Research Programs (CDMRP)
originated in 1992 via a Congressional appropriation to foster
novel approaches to biomedical research in response to the
expressed needs of its stakeholders-the American public, the
military, and Congress.
The CDMRP fills research gaps by funding high impact,
high-risk/high-gain projects that share the common goal of
advancing paradigm shifting research, solutions that will lead to
cures or improvements in patient care, or breakthrough technologies
and resources for clinical benefit. The CDMRP strives to transform
healthcare for Service Members and the American public through
innovative and impactful research.
For more information, please visit:
https://cdmrp.army.mil/aboutus
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 the 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.
For more information on SELLAS, please visit
www.sellaslifesciences.com.
Forward-Looking StatementsThis 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 and the timing of availability of clinical data. 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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