Stemline Therapeutics Highlights Recent Clinical and Regulatory Developments and Details Upcoming Milestones following its An...
July 08 2019 - 5:50PM
Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage
biopharmaceutical company focused on the development and
commercialization of novel oncology therapeutics, following its
annual shareholder meeting, highlights recent clinical and
regulatory developments, and details other upcoming events.
- ELZONRIS® clinical data were presented at the 2019
American Society of Clinical Oncology (ASCO) annual meeting in
Chicago, Illinois and the 24th Congress of the European Hematology
Association (EHA) in Amsterdam, Netherlands. Presentations
highlighted updated results from ongoing Phase 2 clinical trials in
chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), as
well as final results of the pivotal trial in blastic plasmacytoid
dendritic cell neoplasm (BPDCN). In addition, ELZONRIS preclinical
results in systemic sclerosis, an autoimmune disorder in which
CD123+ plasmacytoid dendritic cells (pDCs) play a role in disease
pathogenesis, were presented at the Annual European Congress of
Rheumatology (EULAR) in Madrid, Spain.
- As previously announced, an additional single-arm cohort of
patients with previously-treated CMML, Stage 3, will be added to
the currently enrolling trial. In the first part of Stage 3 (Stage
3a), enrichment strategies and certain efficacy endpoints
(including spleen size reduction) will be assessed for inclusion in
the confirmatory cohort (Stage 3b), that will aim to provide the
primary evidence of efficacy to support potential registration. We
expect to open enrollment of the new cohort in 4Q19.
- Stemline continues to build out a European commercial
infrastructure in advance of potential approval by the European
Medicines Agency (EMA). A scientific advisory group meeting is
planned for September, and the ELZONRIS marketing authorization
application (MAA) review will proceed on a standard timeline. We
expect an opinion by the Committee for Medicinal Products for Human
Use (CHMP) later this year. If successful, Stemline is targeting a
commercial launch in Europe in 1Q20.
- In an ongoing market expansion effort, corporate and
investigator-sponsored clinical trials with ELZONRIS in additional
indications are ongoing in myelofibrosis (MF) and acute myeloid
leukemia (AML) and others are planned to roll out later this year
and next.
- Stemline continues to advance its clinical-stage assets,
including SL-801 (a reversible inhibitor of XPO1). XPO1 is a
clinically validated target in oncology, and the FDA recently
approved an XPO1 inhibitor in patients with relapsed/refractory
multiple myeloma. Stemline is also developing its preclinical
assets SL-1001 (RET kinase inhibitor) and SL-901 (kinase
inhibitor).
- Stemline will provide further details on commercial and
clinical progress during its second quarter financial results
teleconference in early August. Call-in details will be provided in
advance of the call.
About ELZONRIS®
ELZONRIS® (tagraxofusp-erzs), a CD123-directed cytotoxin, is
approved by the U.S. Food and Drug Administration (FDA) and
commercially available in the U.S. for the treatment of adult and
pediatric patients, two years or older, with blastic plasmacytoid
dendritic cell neoplasm (BPDCN). For full prescribing information
in the U.S., visit www.ELZONRIS.com. In Europe, a marketing
authorization application (MAA) is under review by the European
Medicines Agency (EMA). ELZONRIS is also being evaluated in
additional clinical trials in other indications including chronic
myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute
myeloid leukemia (AML).
About BPDCN BPDCN is an aggressive hematologic
malignancy with historically poor outcomes and an area of unmet
medical need. BPDCN typically presents in the bone marrow and/or
skin and may also involve lymph nodes and viscera. The BPDCN cell
of origin is the plasmacytoid dendritic cell (pDC) precursor. The
diagnosis of BPDCN is based on the immunophenotypic diagnostic
triad of CD123, CD4, and CD56, as well as other markers. For more
information, please visit the BPDCN disease awareness website at
www.bpdcninfo.com.
About CD123CD123 is a cell surface target
expressed on a wide range of myeloid tumors including blastic
plasmacytoid dendritic cell neoplasm (BPDCN), certain
myeloproliferative neoplasms (MPNs) including chronic
myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute
myeloid leukemia (AML) (and potentially enriched in certain AML
subsets), myelodysplastic syndrome (MDS), and chronic myeloid
leukemia (CML). CD123 has also been reported on certain lymphoid
malignancies including multiple myeloma (MM), acute lymphoid
leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL),
and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has
been detected on some solid tumors as well as autoimmune disorders
including cutaneous lupus and scleroderma.
About Stemline Therapeutics Stemline
Therapeutics, Inc. is a commercial-stage biopharmaceutical company
focused on the development and commercialization of novel oncology
therapeutics. ELZONRIS® (tagraxofusp), a targeted therapy
directed to CD123, is FDA-approved and commercially available in
the U.S. for the treatment of adult and pediatric patients, two
years or older, with blastic plasmacytoid dendritic cell neoplasm
(BPDCN). In Europe, a marketing authorization application (MAA) is
under review by the European Medicines Agency (EMA). ELZONRIS is
also being evaluated in clinical trials in additional indications
including chronic myelomonocytic leukemia (CMML), myelofibrosis
(MF) and acute myeloid leukemia (AML). Additional pipeline
candidates include: SL-701 (immunotherapeutic; Phase 2 in
glioblastoma patients completed), SL-801 (XPO1 inhibitor; Phase 1
in advanced solid tumor patients ongoing), SL-901 (novel kinase
inhibitor; prior abbreviated European Phase 1, IND-enabling studies
ongoing), and SL-1001 (novel RET kinase inhibitor, IND-enabling
studies pending). For more information, please visit the company’s
website at www.stemline.com.
Forward-Looking StatementsSome of the
statements included in this press release may be forward-looking
statements that involve a number of risks and uncertainties. For
those statements, we claim the protection of the safe harbor for
forward-looking statements contained in the Private Securities
Litigation Reform Act of 1995. The factors that could cause our
actual results to differ materially include: the success of our
U.S. launch and commercialization; the success of our MAA
submission to the EMA and potential launch in Europe; the success
and timing of our clinical trials and preclinical studies for our
product and product candidates, including ELZONRIS in additional
indications and our other pipeline candidates, including site
initiation, institutional review board approval, scientific review
committee approval, patient accrual, safety, tolerability and
efficacy data observed, and input from regulatory authorities
including the risk that the FDA, EMA, or other ex-U.S. national
drug authority ultimately does not agree with our data, find our
data supportive of approval, or approve any of our product
candidates; the possibility that results of clinical trials are not
predictive of safety and efficacy results of our product candidates
in broader patient populations or of our products if approved; our
plans to develop and commercialize our product candidates,
including, but not limited to delays in arranging satisfactory
manufacturing capabilities and establishing commercial
infrastructure for ELZONRIS; product efficacy or safety concerns
resulting in product recalls or regulatory action; the risk that
estimates regarding the number of patients with the diseases that
our product and product candidates may treat are inaccurate;
inadequate market penetration of our products; our products not
gaining acceptance among patients (and providers or third party
payors) for certain indications (due to cost or otherwise); the
risk that third party payors (including governmental agencies) will
not reimburse for the use of ELZONRIS at acceptable rates or at
all; the company’s ability to produce, maintain or increase sales
of ELZONRIS; the company’s ability to develop and/or commercialize
ELZONRIS; the adequacy of our pharmacovigilance and drug safety
reporting processes; our available cash and investments; our
ability to obtain and maintain intellectual property protection for
our product and product candidates; delays, interruptions, or
failures in the manufacture and supply of our product and product
candidates; the performance of third-party businesses, including,
but not limited to, manufacturers, clinical research organizations,
clinical trial sponsors and clinical trial investigators; and other
risk factors identified from time to time in our reports filed with
the SEC. Any forward-looking statements set forth in this press
release speak only as of the date of this press release. We do not
intend to update any of these forward-looking statements to reflect
events or circumstances that occur after the date hereof.
Contact: Investor RelationsStemline
Therapeutics, Inc.750 Lexington AvenueEleventh FloorNew York, NY
10022Tel: 646-502-2307Email: investorrelations@stemline.com
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