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 business and
clinical progress in 2020 and expected 2021 milestones.
“2020 was a transformative year for SELLAS as we
commenced the pivotal Phase 3 REGAL study of GPS in patients with
AML who have achieved complete remission after second-line
anti-leukemic therapy (CR2) in the United States and Europe and
also announced important clinical data in the same patient cohort
from our completed Phase 2 study showing a median overall survival
of 21 months vs. 5.4 months in favor of patients who received GPS,
with a p-value of 0.02. We are also intrigued by the recently
announced initial data from two studies of GPS in combination with
checkpoint inhibitors in ovarian and malignant pleural mesothelioma
indications, and we look forward to providing further data from
these studies in the first half of 2021. We were also pleased to
present last month at the 2020 San Antonio Breast Cancer Symposium
positive final data with up to 6 months follow-up from the
randomized Phase 2 trial (the VADIS study) of nelipepimut-S (NPS)
in combination with granulocyte-macrophage colony-stimulating
factor (GM-CSF) in women with ductal carcinoma in-situ of the
breast showing immune stimulation augmented by +1,300% at 6-months
post-NPS treatment and a statistically significant difference of
duration of immune response of NPS vs. control with a p-value of
0.000094,” stated Angelos Stergiou, MD, ScD h.c, President and
Chief Executive Officer of SELLAS.
“Additionally, we began preparations for the
commercialization of GPS, assuming we achieve positive data from
the REGAL study, with a collaboration with 3D Medicines Inc. for
the development and commercialization of GPS in Greater China which
we announced at the end of 2020. This licensing transaction with 3D
Medicines for GPS has been ranked by PharmaCube, a leading Chinese
database, as one of the top ten life sciences licensing
transactions in China in 2020 in terms of the total financial
consideration,” commented Dr. Stergiou.
“Importantly, we strengthened our balance sheet
in 2020 with gross proceeds of approximately $47.9 million from the
sale of securities, exercise of warrants, and the upfront payment
from 3D Medicines and we ended the year with approximately $35.3
million in cash and cash equivalents. The proceeds from these
transactions will significantly support the GPS clinical programs,”
added Dr.
Stergiou.
2020 Clinical Highlights and 2021
Milestones
Galinpepimut-S (GPS)
- In December 2020, the Company
announced initial clinical data for GPS in combination with
checkpoint inhibitors in two solid tumor indications in patients
with advanced solid cancers who had exhausted their standard
therapy options. In the Company’s Phase 1/2 open-label study of GPS
in combination with Merck’s anti-PD-1 therapy pembrolizumab
(Keytruda®) in patients with selected advanced Wilms Tumor 1
positive (WT1+) cancers, the first set of evaluable patients (n =
8) diagnosed with 2nd or 3rd line WT1(+) relapsed or
refractory metastatic ovarian cancer demonstrated a disease control
rate (the sum of overall response rate and rate of stable disease)
of 87.5% with a median follow-up of 9.4 weeks and, at the
first assessment time-point of 6 weeks post-therapy initiation,
100% of the patients were free of disease progression. In the
Company’s Phase 1 investigator-sponsored clinical trial (IST) of
GPS in combination with the checkpoint inhibitor nivolumab
(Opdivo®) in patients with macroscopic measurable deposits of
malignant pleural mesothelioma (MPM) who were either refractory to
or relapsed after frontline tri-modality standard therapy, the
first set of evaluable patients (n = 3) had a median progression
free survival of at least 10 weeks since therapy initiation.
Updated data on both studies are expected in first half of
2021.
- In December 2020, the Company
announced that it had entered into an exclusive license agreement
with 3D Medicines Inc., a China-based biopharmaceutical company
developing next-generation immuno-oncology drugs, for the
development and commercialization of GPS, as well as the Company’s
next generation heptavalent immunotherapeutic GPS+, which is at
preclinical stage, across all therapeutic and diagnostic uses
in the Greater China territory (mainland China, Hong Kong, Macau
and Taiwan). SELLAS retains sole rights to GPS and GPS+ outside of
the Greater China area. Potential payments to SELLAS under the
agreement in licensing fees and milestone payments, not including
potential future royalties, could total $202 million, including an
upfront license fee of $7.5 million paid in December 2020.
- In September 2020, SELLAS announced
that it received approval of its Investigational Medicinal Product
Dossier (IMPD) from the French regulatory authority, Agence
Nationale de Sécurité du Médicament et des Produits de
Santé (ANSM), to advance in France its pivotal Phase 3 REGAL
study of GPS in AML CR2 patients. The Company has subsequently
received IMPD approval from the German health authorities and
expects approvals from additional European health authorities in
early 2021 which will allow SELLAS to expand AML patient enrollment
for the pivotal Phase 3 REGAL study of GPS in Europe.
- In the spring of 2020, the Company
established an Independent Data Monitoring Committee (DMC) of
leading clinical and biostatistics experts to review and evaluate
patient safety and efficacy data for the Phase 3 REGAL trial
and also appointed a Steering Committee of leading AML experts for
the study. The DMC is responsible for reviewing and evaluating
patient safety and efficacy data and will review study data at
regular intervals in order to ensure the safety of all patients
enrolled in the study. The Steering Committee will provide
scientific oversight and guidance of the practical aspects of the
study and will make recommendations regarding the monitoring of the
study in consultation with the DMC.
- In February 2020, the Company
announced positive final follow-up data from its Phase 2 clinical
trial of GPS in AML CR2 patients. The final data showed a median
overall survival (OS) of 21.0 months, at a median follow-up of 30.8
months, in patients receiving GPS therapy compared to 5.4 months in
the AML CR2 patients treated with best standard care, a
statistically significant difference (p-value < 0.02). Final
analysis showed that GPS therapy continued to be well-tolerated
throughout the study. The Company previously reported initial data
from this Phase 1/2 study at a median follow-up of 19.3 months,
showing median OS in GPS-treated patients of 16.3 months vs. 5.4
months in a patient cohort contemporaneously treated with best
standard therapy (p = 0.0175).
Nelipepimut-S (NPS)
- In December 2020, the Company
announced positive final data with up to 6 months follow-up from
the randomized Phase 2 trial (the VADIS study) 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. This IST randomized
patients to receive, prior to surgery, either GM-CSF followed by
NPS two weeks later or GM-CSF alone. Preliminary data previously
reported showed that treatment with even a single dose of NPS was
capable of newly inducing NPS-specific cytotoxic T-lymphocytes
(CTLs) in peripheral blood in DCIS patients. The updated data,
based on a 6-month follow-up, demonstrate that CD8+ T-cell
responses persist long-term post-NPS treatment, with treated
patients retaining and modestly enhancing their antigen-specific
immune response. When compared to baseline (BL), i.e., prior to
investigational agent administration, the relative frequency of
NPS-specific CD8 CTLs as a percentage (NPS-CLT%) in peripheral
blood at the 1-month and 6-month post-operative time-points
increased in the NPS+GM-CSF group (n=9) by 11- and 14-fold:
0.01+0.02% [BL] vs. 0.11+0.12% [1-mo] and 0.14+0.12% [6-mo],
respectively, while in the GM-CSF alone group (n=4) the
NPS-CLT% in peripheral blood increased by only 2.25- and 3.75-fold:
0.04+0.07% [BL] vs. 0.09+0.15% [1-mo] and 0.15+0.03% [6-mo],
respectively. For the NPS+GM-CSF group, the differences in absolute
NPS-CTL% mean values between baseline and 1- or 6-months
post-vaccination were statistically significant, with p-values of
0.039 and 0.0125, respectively. The relative change in NPS-CTL%
mean values at 6 months post-vaccination was +1,300+450% for the
NPS+GM-CSF group vs. 250+150% in the GM-CSF alone group, which was
highly statistically significant in favor of the NPS+GM-CSF group:
p=0.000094. These data were presented at the San Antonio Breast
Cancer Symposium on December 11, 2020.
Financial Summary
The Company’s preliminary and unaudited cash and
cash equivalents as of December 31, 2020 was approximately $35.3
million. The estimated cash and cash equivalents as of December 31,
2020 are preliminary and may change, are based on information
available to management as of the date of this press release, and
are subject to completion by management of the financial statements
as of and for the year ended December 31, 2020. There can be no
assurance that the cash and cash equivalents as of December 31,
2020 will not differ from these estimates. Complete annual results
will be included in the Company’s Annual Report on Form 10-K for
the year ended December 31, 2020.
About SELLAS Life Sciences Group,
Inc.
SELLAS is a late-stage clinical
biopharmaceutical company focused on the development of novel
cancer immunotherapeutics for a broad range of cancer 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 as a
monotherapy or in combination to address a broad spectrum of
hematologic malignancies and solid tumor indications. SELLAS’
second product candidate, 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.
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. 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 various cancer indications, including AML, ovarian cancer and
MPM, the potential for regulatory approval and commercialization of
GPS, statements related to the clinical development of NPS for
breast cancer, including DCIS. 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
13, 2020 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 ContactsAdam
HoldsworthPCG Advisory917-497-9287adamh@pcgadvisory.com
Investor RelationsSELLAS Life
Sciences Group, Inc.917-438-4353info@sellaslife.com
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