SELLAS Receives Orphan Medicinal Product Designation Approval by the Committee for Orphan Medicinal Products of the European ...
September 13 2018 - 8:30AM
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 announced that the Committee for
Orphan Medicinal Products (COMP) of the European Medicines Agency
(EMA) has approved orphan medicinal product designation (OMPD) for
galinpepimut-S (GPS), the Company’s lead product candidate, for the
treatment of multiple myeloma (MM). 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 also
been granted orphan drug designation and fast track designation by
the U.S. Food and Drug Administration (FDA) for the treatment of
MM.
“This OMPD endorsement by the COMP of the EMA for GPS in MM
complements the orphan designation awarded by the US FDA for this
product in the same indication,” said Angelos Stergiou, MD, ScD
h.c., President and Chief Executive Officer of SELLAS. “The results
from our open-label Phase 2 study reinforce the potential of GPS to
serve as a therapy for high-risk MM patients in the
post-autotransplant maintenance setting. The innovative nature and
unique mechanism of action for GPS provide a promising potential
addition to the current arsenal of therapies in this indication. We
continue to work closely with the FDA and EMA, as well as multiple
myeloma KOLs to further advance the clinical development of GPS in
this malignancy and look forward to gaining further insights on the
potential therapeutic role of GPS in high-risk MM patients.”
The EMA orphan medicinal product designation is granted to
medicines being developed for the diagnosis, prevention or
treatment of a life-threatening or chronically debilitating
condition with a prevalence of not more than five in 10,000 people
in the European Union. Orphan designations are granted by
decisions of the European Commission based on opinions from the
Committee for Orphan Medicinal Products within EMA. EMA orphan drug
designation benefits include protocol assistance, access to the EU
centralized authorization procedure, reduced EU regulatory filing
fees and 10 years of market exclusivity across the EU.
About the Phase 2 Trial of GPS in Multiple
Myeloma
The open-label Phase 2 study consisted of 19 patients with
multiple myeloma who had high-risk cytogenetics at initial
diagnosis and remained at least minimal residual disease
(MRD)-positive after a successful autologous stem cell transplant
(“ASCT”). GPS was administered to patients in the study who
achieved a stable disease or better status (per International
Myeloma Working Group criteria) following ASCT. GPS was evaluated
as consolidation therapy (on top of lenalidomide or bortezomib) to
potentially stimulate a highly-specific immune response against WT1
in order to prevent or delay myeloma progression. Median
progression-free survival (PFS) of 23.6 months was reported in this
high-risk disease setting, compared to historically inferior
outcomes while on an immunomodulatory drug (IMID) or proteasome
inhibitor post-ASCT maintenance. Median overall survival has
not been reached to date. GPS stimulated time-dependent and robust
CD4+ T cell or CD8+ T cell immune responses (IRs) specific for all
four WT1 peptides within GPS, two of which are heteroclitic
(mutated, by design). In addition, GPS stimulated similar IRs
against the two counterpart native peptides. The IRs were confirmed
in up to 91% of patients across HLA allele types, with multivalent
IRs emerging in up to 64% of patients. Multifunctional
cross-epitope T cell reactivity was observed in 75% of patients to
antigenic epitopes against which hosts were not specifically
immunized, in a pattern akin to epitope spreading. A link of
clinical activity to antigen-specific immune responses was
suggested.
About Galinpepimut-S (GPS)
GPS is a heteroclitic multivalent, multi-peptide cancer
immunotherapeutic agent composed of four peptides, addressing over
20 epitopes, and derived from the WT1 protein, which has been
ranked by the National Cancer Institute as a top priority among
cancer antigens for immunotherapy. Importantly, because the
WT1 antigen is overexpressed in many malignancies, and is not found
in most normal tissues, GPS has the potential to be a broad
immunotherapy, effective across a multitude of diverse cancer types
and patient populations.
About SELLAS Life Sciences Group, Inc.
SELLAS is a clinical-stage biopharmaceutical company focused on
the development of 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 Phase 3 clinical trials planned for GPS in two indications,
acute myeloid leukemia (AML) and malignant pleural mesothelioma
(MPM) and is also developing GPS as a potential treatment for
multiple myeloma (MM) and ovarian cancer. SELLAS plans to
study GPS in up to four additional indications. SELLAS has
received Orphan Drug (or Medicinal Product) designations for GPS
from both the U.S. Food & Drug Administration (FDA) and the
European Medicines Agency (EMA) for AML, MPM, and MM. GPS also
received Fast Track designation for AML, MPM and MM from the FDA.
SELLAS’ second product candidate, NeuVax™ (nelipepimut-S), 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. NeuVax™ 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+, 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 timing and results of
clinical studies and as to further development of GPS for a broad
range of cancer indications. 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
risks include, without limitation, risks and uncertainties
associated with immune-oncology product development and clinical
success thereof, risks and uncertainties related to the timing of
clinical trials, the uncertainty of regulatory approval, the
uncertainty of partnering its clinical assets, 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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