SELLAS Announces Completion of Enrollment in Randomized Phase 2 VADIS Trial of Nelipepimut-S (NPS) in Women with Ductal Carci...
August 05 2019 - 8:30AM
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 completion of enrollment in
a Phase 2 randomized investigator-sponsored trial (IST) of
nelipepimut-S (NPS) in combination with granulocyte-macrophage
colony-stimulating factor (GM-CSF) in women with ductal carcinoma
in situ (DCIS) of the breast who are HLA-A2+ or A3+ positive,
express HER2 at IHC 1+, 2+, or 3+ levels, and are pre- or
post-menopausal.
“We are pleased to announce completion of enrollment in the
Phase 2 VADIS trial, an important milestone for our NPS clinical
program. The premise of the VADIS study is quite innovative, as it
will provide valuable data and give us the opportunity to gauge in
a controlled, randomized setting whether NPS can effectively induce
an antitumor immune response in DCIS patients. We believe NPS could
serve as an earlier stage treatment for women with breast cancer
and hope to gain through this study further insights on the
immunobiological mechanism underlying the clinical activity of NPS.
The VADIS results could inform us as to potential synergies between
NPS and standard therapies in women with DCIS. We are excited to
move NPS another step closer to our goal of improving the
therapeutic options for breast cancer patients by potentially
serving as an early stage treatment for patients with DCIS. We look
forward to seeing the initial data by the end of 2019,” said
Angelos M. Stergiou, MD, ScD h.c., President and Chief Executive
Officer of SELLAS.
“We are delighted to have completed enrollment in the VADIS
study, which will test for an array of sophisticated histologic,
immunodynamic and molecular markers of immune responses following
treatment with NPS, including induction of HER2-specific cytotoxic
T lymphocyte (CTL) and epitope spreading, the latter being the
herald of clinical efficacy for a successful peptide vaccine,” said
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 2 VADIS trial.
“VADIS is poised to inform us on the design of future treatment
strategies for DCIS, which remains an unmet medical need, including
combinations of NPS with standard therapies in a broad population,”
concluded Dr. Mittendorf.
About the Phase 2 VADIS Trial
This Phase 2 randomized trial is sponsored and operationalized
by the National Cancer Institute (NCI) to study NPS’ potential
clinical effects in earlier-stage disease. Patients are randomized
to receive, prior to surgery, either GM-CSF followed by NPS two
weeks later or GM-CSF alone. The primary endpoint of the trial is
the difference in the frequency of newly induced NPS-cytotoxic T
lymphocytes (CTL; CD8+ T-cell) in peripheral blood between the two
arms of the study, using a dextramer assay. Secondary endpoints to
be compared between the two arms include the nature and incidence
of adverse events and in vivo immune response to NPS, in addition
to other select histologic and molecular biomarkers. Initial data
from this trial are expected by the end of 2019.
About DCIS
DCIS is defined by the NCI as a noninvasive condition in which
abnormal cells are found in the lining of a breast duct and have
not spread outside the duct to other tissues in the breast. DCIS is
the most common type of breast neoplasm with malignant potential.
In some cases, DCIS may become invasive cancer and spread to other
tissues and, currently, it is not possible to know which lesions
could become invasive. Current treatment options for DCIS include
breast-conserving surgery and radiation therapy with or without
tamoxifen, breast-conserving surgery without radiation therapy, or
total mastectomy with or without tamoxifen. Tamoxifen is given in
cases with hormone receptor positivity only. No targeted or immune
therapies have shown any definitive clinical activity in DCIS to
date. The current standard treatment aims at forestalling the
progression of DCIS to invasive cancer. In approximately 15-25% of
cases progression does occur. DCIS is diagnosed in more than 60,000
women each year in the United States, comprising 1 in 5 newly
diagnosed cases of breast cancer.
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 a Phase 3 clinical trial planned for
GPS in Acute Myeloid Leukemia (AML) and is also studying GPS in
combination with pembrolizumab in multiple indications. SELLAS has
received Orphan Drug designations for GPS from the FDA and the
European Medicines Agency (EMA) for AML, malignant pleural
mesothelioma (MPM), and multiple myeloma (MM); GPS has also
received Fast Track designation for AML, MPM and MM from the FDA.
SELLAS’ second product candidate, 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 triple negative breast cancer 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 clinical development of NPS for breast cancer,
including DCIS, including the timing thereof. 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 the Company’s 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.
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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