SELLAS Life Sciences Presents Interim Phase 1 Clinical Data of Galinpepimut-S (GPS) in Combination with Nivolumab to Treat Wi...
June 04 2018 - 8:45AM
1-year progression-free survival (PFS) rate of
70% with induction of serum levels of WT1 Antigen-Specific
Immunoglobulin G (IgG) in 86% of patients treated with GPS in
combination with programmed cell death protein-1 (PD-1)
inhibition
SELLAS Life Sciences Group, Inc. (NASDAQ:SLS) (“SELLAS” or “the
Company”) today announces interim Phase 1 data of GPS in
combination with nivolumab in patients with WT1+ ovarian cancer in
second or third remission after salvage chemotherapy at the 2018
American Society of Clinical Oncology (ASCO) Annual Meeting. The
presentation, “A phase I study of concomitant galinpepimut-S (GPS)
in combination with nivolumab (nivo) in patients (pts) with WT1+
ovarian cancer (OC) in second or third remission,” is being
delivered by Roisin E. O’Cearbhaill, M.D., Gynecologic Medical
Oncology Service, Memorial Sloan Kettering Cancer Center, during
the “Gynecologic Cancer” session from 1:15 to 4:45 p.m. CT. The
primary endpoint of the study is safety and assessment of toxicity,
and treatment is continued until disease progression or toxicity.
The secondary endpoint is immune response, and the exploratory
endpoints include landmark 1-year PFS rate compared to historical
controls and correlative analyses between clinical and immune
responses.
Exploratory efficacy interim data from this open-label Phase 1
investigator-sponsored trial showed that GPS, when combined with a
PD-1 inhibitor, demonstrated PFS of 64% at one year in an intent to
treat (ITT) group of 11 evaluable patients with WT1+ ovarian cancer
in second or greater remission. Among patients who received at
least three doses of GPS in combination with nivolumab, PFS at one
year was 70% (7/10). The historical rates with best standard
treatment do not exceed 50% in this disease setting. The most
common adverse events were Grade 1 or 2, including fatigue and
injection site reactions. Dose limiting toxicity was observed in
one patient, following the second dose of the combination. No
additional adverse event burden was observed for the combination as
compared to nivolumab monotherapy. WT1 is a tumor antigen that is
expressed in about half of ovarian cancers. The combination
induced a high frequency of T- and B-cell immune responses.
Based on these safety, clinical activity and immunogenicity
data, SELLAS expects to initiate a Phase 1/2 clinical study of GPS
in combination with the PD-1 inhibitor pembrolizumab in a variety
of tumor types, including WT1+ ovarian cancer in the third quarter
of 2018.
“Patients with advanced relapsed ovarian cancer, in which WT1 is
highly expressed, have few treatment options with limited
efficacy,” said Angelos Stergiou, MD, ScD h.c., President &
Chief Executive Officer of SELLAS. “The interim data being
presented today further support the therapeutic potential of GPS in
high-risk cancer populations, including ovarian cancer. In this
Phase 1 trial, the combination of GPS and nivolumab showed
promising clinical and immune response activity with no additional
adverse event burden as compared to nivolumab monotherapy,
warranting further evaluation. These data bolster our commitment to
developing GPS, alone and in combination, across a wide range of
cancers, and we look forward to initiating our Phase 1/2 basket
trial investigating the combination of GPS with pembrolizumab in
five WT1+ tumor types, including ovarian, small cell lung,
colorectal and triple negative breast cancer and acute myeloid
leukemia.”
Of the 11 patients evaluated:
- 7 patients were in second remission and 4 patients were in
third remission
- 10 patients received six total doses of GPS (800 mcg) over 12
weeks in combination with seven infusions of I.V. nivolumab (3
mg/kg) over 14 weeks
- all underwent toxicity assessments with each dose of GPS, and
three weeks after the completion of therapy at Week 15.
Non-progressors at Week 15 were permitted to receive four
additional GPS doses, administered every eight weeks.
With regard to clinical and immune responses:
- in 11 evaluable patients, the landmark 1-year PFS rate was 64%
in the ITT group and 70% in the ten patients who received at least
three doses of GPS + nivolumab. Historical rates do not exceed 50%
in this disease setting
- serum levels of antigen-specific IgG, against both individual
WT1 peptides within GPS and the full-length WT1 protein, were
induced in 86% of patients
- achievement of high titers of WT1-specific IgG post-GPS results
from Immunoglobulin (Ig) M to IgG class switching, the latter being
a surrogate marker of induction of activated T-helper (Th) cells
after vaccination
- antigen-specific T-cell responses to individual WT1 peptides
were observed between Weeks 6-15, primarily CD4 T-cells and, to a
smaller extent, CD8 T-cells
“Effective consolidation or maintenance strategies are needed to
prevent further recurrence or to prolong remission in patients with
ovarian cancer after successful salvage from a previous relapse. In
this setting, immune-directed therapy with a combination of blocker
nivolumab and GPS, a multivalent, heteroclitic peptide vaccine
targeting WT1, an antigen expressed in about half of ovarian
cancers, led to high rates of antigen-specific immunization. We
anticipate that this enhanced immunogenicity will translate into a
reduction in relapses in larger studies,” mentioned Dr.
O’Cearbhaill. She added “these encouraging interim data suggest
that the combination of GPS plus PD-1 inhibitors deserves further
study in WT1+ ovarian cancer.”
About Galinpepimut-S (GPS): GPS is a
heteroclitic multivalent, multi-peptide cancer immunotherapeutic
agent composed of four peptides, addressing over 20 epitopes, and
derived from the WT1 protein, which has been ranked by the National
Cancer Institute as a top priority among cancer antigens for
immunotherapy. Importantly, because the WT1 antigen is
overexpressed in many malignancies, and is not found in most normal
tissues, GPS has the potential to be a broad immunotherapy,
effective across a multitude of diverse cancer types and patient
populations.
About SELLAS: 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) for AML, MPM, and MM, as well as from the
European Medicines Agency, for AML and MPM; GPS also received Fast
Track designation for AML and MPM from the FDA. SELLAS’ second
product candidate, NeuVax™ (nelipepimut-S), 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. NeuVax™ 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+, following standard of care.
For more information on SELLAS, please visit
www.sellaslifesciences.com.
Forward-Looking StatementsThis press release
contains forward-looking statements, including, but not limited to,
statements related to the results of clinical studies and as to
further development of GPS for ovarian cancer as well as for a
broad range of cancer indications, including the timing of clinical
trials. 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. These risks and uncertainties
are described more fully in SELLAS’ Annual Report on Form 10-K and
other filings with the Securities and Exchange Commission. Other
risks and uncertainties of which SELLAS is not currently aware may
also affect SELLAS’ forward-looking statements. 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 Contact: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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