SELLAS Receives IMPD Approval from the French Regulatory Authority for its Pivotal Phase 3 REGAL Study of Galinpepimut-S in P...
September 09 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 announced that it has 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 galinpepimut-S
(GPS) in patients with Acute Myeloid Leukemia (AML) who have
achieved complete remission after second-line anti-leukemic therapy
(CR2).
“This clearance marks an important milestone for
SELLAS, as the IMPD allows us to expand AML patient enrollment for
our pivotal Phase 3 REGAL study of GPS in France,” commented
Angelos M. Stergiou, MD, ScD h.c., President and Chief Executive
Officer of SELLAS. “Obtaining IMPD clearance is a stringent
process, and includes submission of information related to the
quality, manufacture and controls of GPS as well as data from
non-clinical and clinical studies. We look forward to
advancing our REGAL study in France and, upon the receipt of
requisite approvals, other countries in Europe, particularly given
the previously obtained orphan drug designation for GPS in AML by
the European Medicines Agency. “ In February 2020,
SELLAS announced positive follow-up data from its Phase 2 study of
GPS in CR2 AML 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 compared to 5.4 months in patients
treated with best standard care (p-value < 0.02). GPS therapy
continued to be well tolerated throughout the study.
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, nelipepimut-S, 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.
About the REGAL Study
The REGAL study is a 1:1 randomized, open-label
study comparing GPS monotherapy in the maintenance setting to
investigators’ choice 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 primary endpoint is overall survival
from the time of study entry. Secondary endpoints include
leukemia-free survival, antigen-specific T-cell immune response
dynamics, measurable residual disease by multigene array, and
assessments of AML clonal evolution and inflammasome molecular
signatures in the tumor microenvironment in bone marrow biopsy
samples. The Company anticipates interim analysis for safety and
futility in the fourth quarter of 2021.
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 including the timing of
clinical results and additional regulatory filings, 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 and business strategy, 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 Contacts Adam Holdsworth PCG Advisory
646-862-4607 adamh@pcgadvisory.com
Investor Relations SELLAS Life Sciences Group, Inc. 917-438-4353
info@sellaslife.com
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