SELLAS Receives Fast Track Designation from FDA for Galinpepimut-S for the Treatment of Patients with Multiple Myeloma
July 20 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 U.S. Food and Drug
Administration (FDA) has granted Fast Track designation to the
Company’s lead asset, galinpepimut-S (GPS), 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.
The Company reported final clinical and immunological data from
a Phase 2 clinical trial for GPS in the treatment of high-risk
multiple myeloma at the 44th Annual European Society for Blood and
Marrow Transplantation (EBMT) Meeting on March 19, 2018.
The FDA's Fast Track program facilitates the development of
drugs intended to treat serious conditions that have the potential
to address unmet medical needs. A product candidate with Fast
Track status is afforded greater access to the FDA for the purpose
of expediting the product candidate’s development, review and
potential approval. For a product candidate with Fast Track
designation, the FDA may consider sections of its Biologics License
Application (BLA) for review on a rolling basis before the complete
application is submitted if relevant criteria are met.
“The designation of Fast Track for GPS represents important
recognition by the FDA of the potential of this novel
immunotherapeutic to address the significant unmet need in the
treatment of patients with high-risk multiple myeloma in patients
with poor-risk cytogenetics at diagnosis who still harbor minimal
residual disease (MRD) after autologous stem cell transplant,” said
Angelos Stergiou, M.D., Sc.D. h.c., President and Chief Executive
Officer of SELLAS. “We are fully committed to working closely
with the FDA as we continue development of our potential
first-in-class novel WT1-targeting cancer vaccine for select
high-risk MM patients in the post-autotransplant maintenance
setting after standard first-line treatment.”
About the Phase 2 GPS multiple myeloma
study
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 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 the 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: SELLAS is a clinical-stage
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 has Phase 3 clinical
trials planned (pending funding availability) 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 designations for
GPS from the U.S. Food & Drug Administration (FDA) for
AML, MPM, and MM, as well as from the European Medicines
Agency, for AML and MPM; GPS also received Fast Track designation
for AML and MPM 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, including, but not limited to,
statements related to the results of clinical studies and as to
further development of GPS for ovarian cancer as well as for a
broad range of cancer indications, including the timing of clinical
trials. 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. These risks and uncertainties
are described more fully in SELLAS’ Annual Report on Form 10-K and
other filings with the Securities and Exchange Commission.
Other risks and uncertainties of which SELLAS is not currently
aware may also affect SELLAS’ forward-looking statements. 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 Contact: Will O’Connor Stern Investor
Relations, Inc. 212-362-1200 ir@sellaslife.com
David Moser, JD Sellas Life Sciences Group 813-864-2571
info@sellaslife.com
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