SELLAS Life Sciences Receives FDA Orphan Drug Designation for Galinpepimut-S (GPS) for Treatment of Multiple Myeloma (MM)
May 09 2018 - 4:30PM
SELLAS Life Sciences Group Inc. (Nasdaq:SLS) (“SELLAS”), a
clinical-stage biopharmaceutical company focused on novel cancer
immunotherapies for a broad range of cancer indications, today
announced that the U.S. Food and Drug Administration (FDA) has
granted orphan drug designation to its novel drug candidate,
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.
“We are delighted to receive this orphan drug designation as it
underscores the great need for innovative, effective treatments for
this rare cancer, and recognizes the potential benefits that GPS
may provide for patients with MM,” said Angelos Stergiou, MD, ScD
h.c., President & Chief Executive Officer of SELLAS. “Receiving
orphan drug designation for the treatment of MM is a significant
regulatory milestone in the development of GPS. We have
reported median progression-free survival (PFS) of 23.6 months in
the high-risk MM disease setting, compared to historically inferior
outcomes in such a patient cohort of around 12 months, and GPS
stimulated time-dependent and robust CD4+ T cell or CD8+ T cell
immune responses as well as multifunctional cross-epitope T cell
reactivity.”
GPS has also received orphan drug designation for the treatment
of acute myeloid leukemia (AML) and malignant plural mesothelioma
(MPM). SELLAS has Phase 3 clinical trials planned for GPS in both
AML and MPM and is developing GPS as a potential treatment for a
broad range of other cancer indications, including multiple
myeloma.
The FDA's Office of Orphan Drug Products grants
orphan status to support development of medicines for safe and
effective treatment, diagnosis or prevention of rare diseases or
disorders that affect fewer than 200,000 people in the United
States. Orphan drug designation may provide certain benefits,
including a seven-year period of market exclusivity if the drug is
approved, tax credits for qualified clinical trials and an
exemption from FDA application fees.
About SELLAS Life Sciences Group
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 for GPS in two indications, acute myeloid leukemia (AML)
and malignant plural mesothelioma (MPM) and is also developing GPS
as a potential treatment for multiple myeloma and ovarian cancer.
SELLAS has received Orphan Drug designations from the U.S. Food
& Drug Administration (FDA), as well as the European Medicines
Agency, for GPS in AML, MPM and MM; GPS also received Fast Track
designation for AML and MPM from the FDA. SELLAS’ second product
candidate, NeuVax™ (nelipepimut-S), is a first-in-class,
HER2-directed cancer immunotherapy being investigated for the
prevention of the recurrence of breast cancer after standard of
care treatment in the adjuvant setting.
For more information on SELLAS, please visit
www.sellaslifesciences.com.
Investor Contact:Will O’ConnorStern Investor
Relations, Inc.212-362-1200ir@sellaslife.com
David Moser, JDSELLAS Life Sciences Group,
Inc.813-864-2571info@sellaslife.com
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