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 results from a preplanned
analysis of immunologic responses in the cohort of patients with
triple negative breast cancer (TNBC) from the prospective,
randomized, single-blinded, controlled Phase 2b independent
investigator-sponsored clinical trial of nelipepimut-S (NPS) +/-
trastuzumab (Herceptin®) targeting HER2 low-expressing breast
cancer patients. This analysis was presented on June 2, 2019 at the
55th Annual Meeting of the American Society of Clinical Oncology
(ASCO) in Chicago, IL.
“Effective adjuvant/maintenance therapy strategies are urgently
needed to prevent recurrence or to prolong remission in patients
with TNBC after successful frontline standard therapy for
early-stage disease. In this setting, immune-directed therapy with
NPS, a peptide vaccine targeting HER2, a protein expressed at low
levels in TNBC, along with trastuzumab, led to high rates of
antigen-specific immunization by both ex vivo and in vivo validated
measures, corroborating the immunobiological synergy between these
two agents,” 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
2b study.
“These ex vivo and in vivo results in TNBC patients,
particularly the newly discovered correlation between mounting an
immune response and remaining clinically relapse-free over time,
provide a solid mechanistic rationale for the previously observed
clinically meaningful and statistically significant prolongation in
disease-free survival (DFS), and the significant decrease in the
frequency of relapses identified by standard clinical follow-up, in
favor of NPS plus trastuzumab,” said Angelos M. Stergiou, MD, ScD
h.c., President and Chief Executive Officer of SELLAS.
“As we continue discussions with potential partners and the U.S.
Food and Drug Administration (FDA) on this promising program, we
remain excited with these data demonstrated in the TNBC
population,” added Dr. Stergiou.
The Phase 2b study enrolled patients with HER2-low expressing
breast cancer who remained clinically disease-free after completion
of frontline standard of care therapy. Patients were selected to
harbor node-positive disease and/or TNBC, as well as expressing
human leukocyte antigen (HLA) types indicated for NPS
administration (A2, A3, A24/26; pertinent to approx. 85% of the
global population). Patients were randomized to placebo with
granulocyte-macrophage colony-stimulating factor (GM-CSF) (n=139)
or NPS with GM-CSF (n=136), while they all received trastuzumab
every 3 weeks for one year. The Company previously reported results
of the final analysis of efficacy and safety outcomes in the cohort
of patients whose tumors did not express hormone receptors, TNBC
(n=97). DFS of patients treated with NPS plus trastuzumab
(n=53) was 92.6% compared to 70.2% for those treated with
trastuzumab alone (n=44) and represented a clinically meaningful
and a statistically significant improvement with the combination
therapy, p=0.01. This was associated with a statistically
significant reduction by 71.9% (p=0.01) in the frequency of
clinically detected recurrences in favor of the combination in the
TNBC cohort.
Ninety-one of the 97 TNBC patients in this clinical study were
analyzed for immune responses (IR) at five timepoints, 51 of whom
received the combination therapy. IR were evaluated ex vivo by
clonal expansion of antigen NPS-specific cytotoxic T-lymphocytes
(CTL) by dextramer-staining/flow cytometry at predefined time
points over three years. In vivo IR were assessed by cutaneous
delayed type hypersensitivity (DTH) reactions periodically, by
measuring the diameter of skin induration (in mm) post intradermal
NPS treatment.
NPS plus trastuzumab-treated TNBC patients exhibited increases
in CTL frequencies compared with baseline by 1.1-, 1.73-, and
2.86-fold at 18, 24 and 30 months, respectively. The mean CTL
frequencies in these patients increased from 29±0.1 per 10-4 at
baseline to 112±2.6% at 30 months, a 2.86-fold difference that was
highly clinically indicative (p = 0.058), as compared with patients
receiving trastuzumab only, whereby CTL frequencies were 20±0.1 per
10-4 at baseline compared with 52±1.6 per 10-4 at 30 months, a
1.6-fold non-significant difference (p=0.70). Three patients
in the combination arm recurred (5.9%) as compared with 12 (30%) in
the trastuzumab-alone arm. TNBC patients treated with NPS plus
trastuzumab whose disease recurred did not mount an IR by ex vivo
assessment (absolute CTL frequency change) or by in vivo DTH (no
change in skin induration), while non-recurrent patients mounted
both vigorous NPS-specific clonal CTL expansion and enhanced in
vivo DTH.
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
(pending funding availability) 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 TNBC patients,
following standard of care.
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 NPS for breast cancer and interactions with the FDA.
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, 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 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.
For more information on SELLAS, please visit
www.sellaslifesciences.com.
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.
Investor ContactsWill O’ConnorStern Investor
Relations, Inc.212-362-1200ir@sellaslife.com
David Moser, JDSELLAS Life Sciences
Group813-864-2571info@sellaslife.com
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