SELLAS Highlights Clinical Development Progress and Expected 2020 Milestones
January 13 2020 - 8:30AM
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 highlighted its clinical
development progress for galinpepimut-S (GPS) and nelipepimut-S
(NPS) and outlined expected milestones for 2020.
“We made significant clinical and corporate advances in 2019 and
early this month, most notably in our preparations for our Phase 3
registrational study (REGAL study) for GPS in acute myeloid
leukemia in patients who achieved complete remission after
second-line anti-leukemic therapy (CR2) which has now commenced
with patient screening underway,” said Angelos M. Stergiou, MD, ScD
h.c., President and Chief Executive Officer of SELLAS. “We are
excited to continue progressing our GPS program in 2020; in
addition to the REGAL study, we remain focused on advancing GPS in
combination with PD-1 agents, pembrolizumab and nivolumab. We
are also expecting guidance from the U.S. Food and Drug
Administration (FDA) within this quarter regarding our NPS program
in triple negative breast cancer after recent discussions with the
agency. We are indeed excited about the progress we made in 2019
and early 2020 both, clinically as well as on the corporate level,
and look forward to advancing our pipeline of immunotherapies and
creating value for our shareholders.”
Dr. Stergiou will present a corporate overview at the Biotech
Showcase™ on Monday, January 13, 2020 at 9:30 a.m. PT (12:30 p.m.
ET) in San Francisco, CA. A live audio webcast of the presentation
will be available under “Events & Presentations” in the
Investors section of SELLAS’ website at
www.sellaslifesciences.com/investors. A replay of the webcast will
be available for up to 30 days on SELLAS’ website following the
presentation.
2019 and Early 2020 Highlights
Galinpepimut-S (GPS)
- In January 2020, the Company announced that it commenced the
Phase 3 (REGAL) clinical trial of GPS in AML and has begun patient
screening. The Company expects that the first patient will be
treated in February. The pivotal Phase 3 REGAL study is a 1:1
randomized, open-label study comparing GPS monotherapy in the
maintenance setting to investigators’ choice of best available
treatment in 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. The
study is expected to enroll approximately 116 patients across
approximately 50 clinical sites in the United States and Europe.
The primary endpoint is overall survival (OS) from the time of
study entry. The Phase 2 study in AML CR2 patients, which is the
same indication as the Phase 3 REGAL study, showed a 10.9 months
median OS benefit (16.3 months vs. 5.4 months in contemporaneously
treated patients with best standard therapy;
p-value=0.0175).
- In November 2019, SELLAS announced that follow-up data from its
Phase 1 clinical trial of GPS in combination with nivolumab to
treat Wilms Tumor 1 (WT1) positive patients with ovarian cancer in
second- or third-line remission continues to support the
development of GPS in combination with PD-1 inhibitors. Topline
data from this study at 10 months had been presented at the June
2018 meeting of the American Society of Clinical Oncology. The
follow-up data show that three of the 11 patients enrolled in the
study have continued to show no signs of disease progression. The
mean progression free survival (PFS) for these three patients is
35.4 months from the initiation of salvage chemotherapy or mean PFS
of 30.1 months from the first administration of GPS plus nivolumab.
Based on this follow-up information, the estimated two-year PFS
rate for this study is now 27.3% for the intent-to-treat (ITT)
patients (n=11) and approximately 30% for patients who received
greater than two doses of GPS and nivolumab (n=10), as compared to
a historical 3% to 10% PFS rate for patients receiving only salvage
chemotherapy. No new serious adverse events were noted during
the longer follow-up period.
- In November 2019, SELLAS hosted its first R&D KOL Symposium
with internationally renowned experts on immuno-oncology and
myeloid malignancies, including Dr. Hagop M. Kantarjian, MD,
Professor and Chair of the Department of Leukemia at the University
of Texas MD Anderson Cancer Center, and global principal
investigator of the Phase 3 AML REGAL clinical
trial.
- In July 2019, SELLAS announced the dosing of the first patient
in its Phase 1/2 open-label study of GPS in combination with
Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab), in patients
with selected WT1-positive advanced cancers, including both solid
tumors and hematologic malignancies. The two initial indications
being studied in this basket study, with approximately 30 patients
in total in these indications, are ovarian cancer (second or third
line) and colorectal cancer (third or fourth line). The Phase 1/2
open-label, multicenter, multi-arm study is being conducted under a
Clinical Trial Collaboration and Supply Agreement with Merck (known
as MSD outside the United States and Canada) to assess the efficacy
and safety of the combination of GPS and KEYTRUDA®. The primary
endpoints of the study include safety and overall response rate,
while secondary endpoints include progression-free survival,
overall survival and immune response correlates. The study is
expected to enroll approximately 90 patients across all arms at up
to 20 centers in the U.S. SELLAS expects an interim analysis from
this study in the second half of 2020.
- In April 2019, SELLAS announced an agreement with Memorial
Sloan Kettering Cancer Center (MSK) for the conduct of an
investigator-sponsored clinical trial (IST) of GPS in combination
with Bristol-Myers Squibb’s anti-PD-1 therapy, nivolumab, in
patients with malignant pleural mesothelioma (MPM). The Phase 1
open-label clinical study will enroll patients with MPM who harbor
relapsed or refractory disease after having received frontline
standard of care multimodality therapy. SELLAS has been informed by
MSK that it expects the first patient to be dosed in this study in
January 2020.
Nelipepimut-S (NPS)
- Based on promising Phase 2b data presented in 2018, SELLAS is
in continued active discussions with the FDA regarding the optimal
development path for NPS in triple negative breast cancer (TNBC).
The Company provided supplemental information to the FDA in
September 2019 and, after recent discussions with the agency,
expects feedback from the FDA within the first quarter of 2020.
- In 2019, SELLAS presented immune response data from the TNBC
cohort of the Phase 2b study at the 55th Annual Meeting of the
American Society of Clinical Oncology (ASCO) and presented final
results from an efficacy and safety data analysis of the Phase 2b
study at the 2019 ASCO-SITC Clinical Immuno-Oncology
Symposium.
- In August 2019, SELLAS announced the completion of enrollment
in a Phase 2 randomized IST of 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. Initial data from this trial are expected
in the first quarter of 2020.
Expected 2020 Clinical Milestones
- First patient dosed in the Phase 3 registration-enabling study
of GPS in AML patients in February 2020.
- First patient dosed in the Phase 1 open-label study of GPS with
nivolumab in MPM patients in January 2020.
- Interim analysis of the Phase 1/2 basket study of GPS with
pembrolizumab in multiple tumor types in the second half of
2020.
- Guidance from the FDA on the regulatory and development pathway
for NPS in TNBC patients in the first quarter of 2020.
- Initial data from Phase 2 trial of NPS in DCIS in the first
quarter of 2020.
Corporate
- On January 9, 2020, the Company announced that it had entered
into a securities purchase agreement with institutional investors
to purchase approximately $6.5 million of its common shares (or
pre-funded warrants to purchase common shares in lieu
thereof) in a registered direct offering priced at-the-market
under Nasdaq rules and warrants to purchase common shares in a
concurrent private placement. The combined purchase price for one
common share (or pre-funded warrants to purchase common shares in
lieu thereof) and a warrant to purchase 0.5 common shares is
$3.9825.
- In June 2019, SELLAS announced the closing of an underwritten
public offering of (i) 527,344 shares of common stock together with
common stock warrants to purchase 527,344 shares of common stock
and (ii) 1,472,656 pre-funded warrants, with each pre-funded
warrant exercisable for one share of common stock, together with
common warrants to purchase 1,472,656 shares of common stock, for
net proceeds of approximately $13.4 million.
Keytruda® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J.,
USA., and is not a trademark of SELLAS. The manufacturer of this
brand is not affiliated with and does not endorse SELLAS or its
products.
About SELLAS Life Sciences Group, Inc.
SELLAS is a late-stage clinical 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’ second product candidate,
nelipepimut-S (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 Company’s plans for further
development of and regulatory plans for GPS and NPS, including the
timing of clinical results, and the timing of the closing of its
registered direct offering. 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 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.
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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