Aligned with FDA on Phase 3 Registration-Enabling
Trial for Galinpepimut-S (GPS) in Acute Myeloid Leukemia; Trial
Expected to Start in Q2 2019
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 a corporate update on the
Company’s clinical development of galinpepimut-S (GPS) and
nelipepimut-S (NPS), which are both in late-stage development.
“In 2018, SELLAS achieved significant progress towards our
corporate and clinical goals, as we advanced our immunotherapy
pipeline and completed our first year as a public company,” said
Dr. Angelos M. Stergiou, MD, ScD h.c., President and Chief
Executive Officer of SELLAS. “As we look to 2019, we are excited to
initiate our pivotal Phase 3 program for GPS in acute myeloid
leukemia (AML), and are in active discussions with the U.S. Food
and Drug Administration (FDA) regarding the registration-enabling
Phase 3 trial and potential consideration for accelerated approval
and breakthrough designation for NPS to treat triple negative
breast cancer. We also are exploring the potential of GPS in
combination with pembrolizumab in additional tumor types in the
context of a Phase 1/2 basket clinical study and look forward to
continued progress across our broad pipeline in the year
ahead.”
Galinpepimut-S (GPS)
In November 2018, SELLAS aligned with the FDA on the clinical
trial design and biostatistical plan for a Phase 3 registrational
study for GPS in acute myeloid leukemia (AML). The planned Phase 3
registrational study will be a 1:1 randomized, open-label study
comparing GPS in the maintenance setting to investigators’ choice
of best available treatment (BAT) in adult AML patients who have
achieved hematologic complete remission, with or without
thrombocytopenia (CR2/CR2p), after second-line antileukemic therapy
and who are deemed ineligible for or unable to undergo allogeneic
stem-cell transplantation. This study will serve as the basis for a
Biologics License Application (BLA) submission, subject to positive
results, and SELLAS expects to start the Phase 3 trial in the
second quarter of 2019.
The Phase 3 study is expected to enroll approximately 116
patients at approximately 50 clinical sites in the United States
and Europe. The primary endpoint is overall survival (OS) and
secondary endpoints include leukemia-free survival,
antigen-specific T-cell immune response dynamics over time and
rates of achievement of measurable residual disease (MRD)
negativity. The study will have a planned interim safety and
futility analysis after 80 events, expected to occur in the third
quarter of 2020. GPS was previously granted Fast Track and Orphan
Drug designations by the FDA for the treatment of AML.
In December 2018, SELLAS initiated enrollment of the 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).
Nelipepimut-S (NPS)
Based on promising Phase 2b data presented in 2018, SELLAS is
currently in continuing active discussions with the FDA regarding
the optimal development path for NPS in triple negative breast
cancer (TNBC).
In the Phase 2b study of trastuzumab (Herceptin®) +/-
nelipepimut-S (NPS) in HER2 low-expressing breast cancer patient
cohorts, trastuzumab + NPS demonstrated clinically and
statistically significant efficacy in the TNBC cohort, with a
p-value of 0.013 and a 75.2% reduction in risk of relapse or death.
In October 2018, the Data Safety Monitoring Board (DSMB)
unanimously concluded that the final analysis of the Phase 2b study
data with a median follow-up of 26 months confirmed that TNBC
patients should be the key target population for the development of
trastuzumab + NPS in the adjuvant setting in early-stage HER2 1+/2+
breast cancer patients.
A preplanned secondary efficacy analysis across human leukocyte
antigen (HLA) allele subgroups from the Phase 2b study confirmed
the therapeutic potential of NPS in patients with early-stage TNBC
in the adjuvant setting across HLA types A-02, -03, -24 and -26,
which cover approximately 80-85% of the North American/European
populations and 86-90% of Asian/Pacific basin populations.
Additional positive data from the Phase 2b study showed a
clinically meaningful and statistically significant decrease in the
number of clinically detectable relapses in the TNBC cohort with
the combination of trastuzumab + NPS (7.5%) vs. trastuzumab alone
(27.3%) (p=0.004). In addition, four pre-defined subgroups of TNBC
patients in the trastuzumab + NPS arm demonstrated an average
decrease of 84.2% in relative risk of relapse or death at 24 months
(p=0.004-0.014).
In a Type C meeting with the FDA, SELLAS discussed several key
points of the clinical and regulatory strategy for NPS in
combination with trastuzumab for TNBC, including potential for
accelerated approval; a registration-enabling Phase 3 trial design
and biostatistical plan; and the potential for breakthrough
designation. SELLAS expects a further meeting with the FDA in early
2019 regarding the potential for breakthrough designation as well
as an additional meeting in the first quarter of 2019 to reach
agreement for a final development program for NPS in TNBC.
An abstract summarizing the comprehensive set of results from
the final analysis of the NPS + trastuzumab Phase 2b clinical study
has been accepted for an oral presentation at the ASCO-SITC
Clinical Immuno-Oncology Symposium in San Francisco, CA, on March
2, 2019 at 10:15 AM.
NPS was previously granted Fast Track designation by the FDA for
the adjuvant treatment of patients with early stage breast cancer
with low to intermediate HER2 expression following standard of care
upfront therapy (surgery plus chemotherapy +/- radiotherapy).
Expected 2019 Clinical Milestones
- Regulatory and development program with FDA for NPS in TNBC
patients finalized in Q1 2019.
- Phase 3 registration-enabling study of GPS in AML patients
initiated in Q2 2019, with a planned interim analysis expected in
Q3 2020.
- Interim analysis of Phase 1/2 basket study of GPS with
pembrolizumab in multiple tumor types in Q4 2019.
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.
Forward-Looking StatementsThis 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
further development of and regulatory pathway for galinpepimut-S
(GPS) for acute myeloid leukemia and in combination with
immunotherapy in other indications and nelipepimut-S (NPS),
including the timing of clinical results, the potential time to
market for GPS and NPS, the potential results from a clinical trial
and interactions with the U.S. Food and Drug Administration. 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, 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 Exhibit 99.1 in its Current Report on Form 8-K
filed on July 18, 2018 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 Contacts: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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