SELLAS Life Sciences Provides Galinpepimut-S and Nelipepimut-S Program Update
February 12 2019 - 8:45AM
Dr. Richard Maziarz and Dr. Roisin O'Cearbhaill
Named Co-Principal Investigators for Galinpepimut-S (GPS) –
Pembrolizumab Phase 1/2 Basket Trial
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 provides an update on its
galinpepimut-S (GPS) and nelipepimut-S (NPS) clinical development
programs.
The Company announces that Richard Maziarz, M.D., Medical
Director of the Adult Blood and Marrow Stem Cell Transplant &
Cellular Therapy Program at the Knight Cancer Institute and
Professor of Medicine at Oregon Health and Science University
(OHSU) in Portland, OR, and Roisin O'Cearbhaill, M.D., Assistant
Attending Physician in Gynecologic Medical Oncology Service at the
Memorial Sloan Kettering Cancer Center (MSKCC), will serve as
co-principal investigators of the Company’s Phase 1/2 open-label,
non-comparative, multicenter, multi-arm study of GPS in combination
with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in
patients with selected WT1-positive advanced cancers, including
both hematologic malignancies and solid tumors. This study, which
is being conducted under a Clinical Trial Collaboration and Supply
Agreement (CTSA) with Merck (known as MSD outside the United States
and Canada), will assess the efficacy and safety of the
combination, with exploratory long-term follow-up for overall
survival and safety. The study will enroll approximately 90
patients at up to 20 centers in the United States. The initial
tumor types to be treated will be acute myelogenous leukemia (AML)
(patients unable to attain deeper morphological response than
partial on hypomethylating agents and who are not eligible for
allogeneic hematopoietic stem cell transplant) and ovarian cancer
(second or third line), to be followed by triple negative breast
cancer (second line), small cell lung cancer (second line), and
colorectal cancer (third or fourth line).
“We are thrilled to announce that Drs. Maziarz and O'Cearbhaill
will serve as co-principal investigators of this important study,”
said Dr. Angelos M. Stergiou, MD, ScD h.c., President and Chief
Executive Officer of SELLAS. “Both Rich and Roisin will be
indispensable in overseeing the scientific rigor of the
investigation, helping to interpret both clinical and correlative
immuno-response data, and guiding us to optimally advance the
development of GPS as a uniquely positioned active immunizer of the
peptide vaccine type for the treatment of recalcitrant malignancies
in the presence of measurable disease.”
Additionally, the Company announces preliminary immune response
data in a subgroup of patients with triple-negative breast cancer
(TNBC) from the prospective, randomized, single-blinded, controlled
Phase 2b independent investigator-sponsored clinical study of the
combination of trastuzumab (Herceptin®) +/- nelipepimut-S (NPS,
NeuVax™) targeting HER2 low-expressing breast cancer patient
cohorts. These data originate from an analysis of the patterns of
induction of antigen (NPS)-specific T-cell responses over time in
patients treated in this study. CD8+ cytotoxic T-lymphocytes
(CTLs) from peripheral blood samples from study patients with TNBC
were measured using specifically designed NPS-specific dextramers
in a flow cytometry-based assay in duplicate. In 64 evaluable TNBC
patients (39 in the NPS plus trastuzumab arm; 25 in the trastuzumab
alone arm) across a median of four time-points (including
baseline), NPS + trastuzumab administration generated up to 3-fold
higher frequencies of NPS-specific CTLs compared to trastuzumab
alone. Moreover, CTL frequencies were much higher among
non-recurrent patients compared with those who recurred (on either
arm). The complete set of data from these correlative analyses will
be presented in an upcoming major scientific meeting.
“These new data provide important insights on the
immunobiological mechanism underlying the statistically significant
and clinically meaningful decrease in detectable tumor relapses and
associated increase in 24-month disease-free survival (DFS) rate
with the combination of NPS plus trastuzumab versus trastuzumab
alone observed within the TNBC cohort of the Phase 2b study we have
previously reported. We are looking forward to completing the
underlying correlative analyses in order to further dissect the
intriguing association between induction of antigen-specific T-cell
immunity and clinical effect post-vaccination, which strongly
suggests a contribution of NPS in the emergence of antitumor
activity in TNBC patients in the adjuvant treatment setting.
We are continuing our discussions with the FDA on the most optimal
development path forward for NPS in TNBC and will provide the
immune response data to the Agency as well,” commented Dr.
Stergiou.
Herceptin® and Keytruda® are registered trademarks of Genentech,
Inc. and Merck Sharp & Dohme Corp., a subsidiary of Merck &
Co., Inc., Kenilworth, N.J., USA., respectively, and are not
trademarks of SELLAS. The manufacturers of these brands are not
affiliated with and do not endorse SELLAS or its products.
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 U.S. Food & Drug Administration (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, 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 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 (TNBC) patients, following standard of care.
For more information on SELLAS, please visit
www.sellaslifesciences.com.
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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