SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) (“SELLAS” or the
“Company”), a late-stage clinical biopharmaceutical company focused
on the development of novel cancer immunotherapies for a broad
range of cancer indications, today announced preliminary
antigen-specific immune response data from 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 report preliminary results from the National
Cancer Institute-sponsored Phase 2 VADIS trial, showing NPS is
capable of inducing an antigen-specific antitumor immune response
in DCIS patients even after a single vaccination, which is
particularly encouraging,” said Angelos M. Stergiou, MD, ScD h.c.,
President and Chief Executive Officer of SELLAS. “Based on the
immunobiological mechanism of action of NPS, we believe that NPS
could be synergistic with standard therapies or novel
immunotherapeutic approaches in women with DCIS. Moreover, these
data correlate to previous findings of NPS in patients with
invasive (non-DCIS) breast cancer. Given NPS’ low toxicity burden
and high antigen-specific immune response, further clinical study
of NPS as a therapeutic which could address the medical need of
women with DCIS at an early stage of their therapeutic journey is
likely warranted and these data further support our business
development efforts to seek out-licensing opportunities to fund and
conduct the future clinical development of NPS in order to maximize
the potential of the program.”
The study enrolled 13 patients, with nine patients receiving NPS
plus GM-CSF and four patients receiving GM-CSF only. The relative
frequency of NPS-specific CD8 cytotoxic T-lymphocytes as a
percentage (NPS-CLT%) was twice as large in the NPS-treated
patients. The NPS-CLT% was measured in the peripheral blood by a
sensitive and specific assay using dextramer staining followed by
flow cytometry, both at baseline (before vaccination or GM-CSF) and
at 30 (+/-7) days after surgery. The mean difference in NPS-CTL%
increase between the active and control groups was +0.10% vs
+0.05%. The relative magnitude of change in NPS-CTL% mean values in
NPS-treated patients over time was an 11-fold increase, from 0.01%
at baseline to 0.11% after surgery, indicating a continued
antigen-specific T-cell response post-NPS vaccination. NPS was
generally well-tolerated in the study with no drug-related
unexpected serious adverse reactions. The overall adverse event
profile was consistent with previous safety data.
The final data is being further analyzed by the National
Institute of Health, MD Anderson Cancer Center and the study
principal investigator, Dr. Elizabeth Mittendorf, MD, PhD of the
Dana-Farber/Brigham and Women’s Cancer Center, and will be
presented at an upcoming medical conference.
“The preliminary data from the VADIS study showing a doubling of
the difference in increase in antigen-specific CD8 cytotoxic
T-lymphocytes in NPS-treated patients vs. controls, even with a
single NPS inoculation, indicate in vivo immunogenicity of this
cancer vaccine in DCIS. These data, as well as the previously
reported clinical effects of NPS in the adjuvant setting after
frontline therapy for invasive breast cancer, provide support for
the possibility that NPS may be able to decrease the rate of
recurrences in earlier-stage disease, such as DCIS, which I believe
should be studied formally in future clinical studies,” said Dr.
Mittendorf. “While additional analyses of certain histologic and
molecular markers of the patients’ immune responses against the NPS
and other HER2 antigenic epitopes are currently ongoing, these
initial immunobiological results from the VADIS study are
encouraging.”
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.
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 late-stage clinical biopharmaceutical company
focused on the development of 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 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’ second product candidate, NPS,
is a HER2-directed cancer immunotherapy with potential 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, the potential for NPS as a drug
development candidate, and the Company’s plans for seeking
out-licensing opportunities for the further development of NPS.
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 SELLAS’ Annual Report on Form 10-K filed on March 13,
2020 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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