SELLAS Reports Encouraging Updated Clinical Data from Ongoing Mesothelioma Study of Galinpepimut-S (GPS) Combined with Opdivo...
June 24 2021 - 8:30AM
SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the
“Company”), a late-stage clinical biopharmaceutical company focused
on developing novel cancer immunotherapies for a broad range of
indications, today announced encouraging updated clinical data from
a Phase 1 investigator-sponsored clinical trial of its lead
clinical candidate, galinpepimut-S (GPS), combined with the
checkpoint inhibitor nivolumab (Opdivo®) in patients with
macroscopic (measurable) deposits of malignant pleural mesothelioma
(MPM).
The study details are as follows:
- Four evaluable male patients, aged approximately 67.3 + 4.1
(standard deviation), received GPS plus nivolumab for at least one
month. Initial tumor stages were II (one patient), IIB (one
patient) and IV (two patients).
- All patients had the MPM epithelioid and/or sarcomatoid
variant, a tumor which is universally expressing Wilms Tumor 1
(WT1), one of the most widely expressed cancer antigens, ranked by
the National Cancer Institute as the top priority among cancer
antigens for immunotherapy.
- Patients have received and progressed with, or are refractory
to, frontline pemetrexed-based chemotherapy.
- Average overall survival (OS) was 35.3 + 24.0 weeks with a
median OS of 35.4 weeks, while average progression-free survival
(PFS) was 8.8 + 4.2 weeks with a median PFS of seven
weeks, both at a median follow-up of 35.4 weeks.
- The safety profile of the GPS-nivolumab combination was similar
to that seen with nivolumab alone, with the addition of only
low-grade, temporary local reactions at the GPS injection site,
consistent with previously performed clinical studies with
GPS.
With approximately 3,300 cases in the United
States each year, accompanied by a rising incidence in developing
countries, MPM is notoriously difficult to treat and can lead to
poor clinical outcomes with respect to both overall
survival and progression-free survival, especially for
those patients with the sarcomatoid variant who show a median
overall survival of approximately 4.0 to 5.0 months. In
relapsed and refractory patients who progressed after the first
line standard of care pemetrexed, a similar patient population to
that in the GPS nivolumab combination trial, the common treatment
regimen is vinorelbine and overall survival in those patients is
reported to be between 4.5 and 6.2 months. In patients treated
with other chemotherapy regimens, such as carboplatin and
irinotecan, median overall survival is reported to be approximately
7.0 months.
“Considering the overall poor prognosis in this
particular clinical setting, these preliminary data suggest that
the combination of GPS with the PD1 inhibitor nivolumab may provide
meaningful clinical benefit to patients with
MPM. Surprisingly, the only sarcomatoid mesothelioma patient
enrolled, who was diagnosed with Stage IV cancer, experienced a
survival of 25 months and is still alive,” said Angelos Stergiou,
M.D., Sc.D. h.c., President and CEO, SELLAS. “Patients treated with
GPS plus nivolumab combination therapy appear to be surviving
significantly longer than expected. We believe that this could
potentially be due to the persistence of a residual cellular
immunity-mediated antitumor effect with this immunotherapy
combination. Studying additional patients along with longer
follow-up of existing patients will hopefully provide further
clarity on these data, which we expect to review over the next six
months as the study progresses.”
SELLAS expects to report additional clinical and
immune response data in Q4 2021, including an assessment of CD8+
and CD4+ T-cell responses to the WT1 peptide pool in the GPS
mixture, as well as epitope spreading (ES) by testing for antibody
presence (IgG’s) directed specifically against the full-length WT1
protein (intra-antigenic ES) and IgG’s presence against other key
oncofetal antigens expressed in MPM (inter-antigenic epitope
spreading).
About SELLAS Life Sciences Group,
Inc.
SELLAS is a late-stage clinical
biopharmaceutical company focused on developing novel cancer
immunotherapeutics for a broad range of indications. SELLAS’ lead
product candidate, GPS, is licensed from Memorial Sloan Kettering
Cancer Center and targets the WT1 protein, which is present in an
array of tumor types. GPS has potential both as a monotherapy and
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 to treat 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 the standard of care.
For more information on SELLAS, please
visit www.sellaslifesciences.com.
Opdivo® is a registered trademark of Bristol Myers
Squibb, and is not a trademark of SELLAS. The manufacturer of this
brand is not affiliated with and does not endorse SELLAS or its
products.
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 clinical development of GPS
for MPM, and the potential for GPS as a drug development candidate.
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 COVID-19 pandemic and its impact
on the Company’s clinical plans, 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 23, 2021 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 Valter Pinto /
Allison Soss KCSA Strategic Communications
Email: SELLAS@kcsa.com Phone: 914.907.2675 / 215.272.2707
Media Contacts Caitlin Kasunich /
Raquel Cona KCSA Strategic Communications Email: SELLAS@kcsa.com
Phone: 212.896.1241 / 212.896.1276
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