Stemline Therapeutics Recaps Felezonexor (SL-801) Clinical Data Presentation From ESMO 2019 Congress
October 01 2019 - 7:30AM
Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage
biopharmaceutical company focused on the development and
commercialization of novel oncology therapeutics, presented updated
clinical data on the felezonexor (SL-801) Phase 1 trial in patients
with advanced solid tumors at the European Society of Medical
Oncology (ESMO) 2019 Annual Congress in Barcelona, Spain. The
presentation is now available on the Stemline website,
www.stemline.com, under the Scientific Presentations tab.
Felezonexor is a novel, oral, small molecule that reversibly
inhibits Exportin-1 (XPO1), a nuclear export protein, overexpressed
in a variety of solid and hematologic malignancies. XPO1 is a
mediator of nuclear-cytoplasmic transport of nuclear proteins and
has been associated with aggressive tumor behavior and poor
prognosis. XPO1 is a clinically validated target in oncology, and
the FDA recently approved an XPO1 inhibitor drug, in combination
with other agents, for the treatment of certain oncology patients
(with relapsed/refractory multiple myeloma). Felezonexor has
demonstrated potent in vitro and in vivo preclinical activity.
Interim results from the ongoing Phase 1 clinical trial reported at
ESMO are summarized below.
Key Felezonexor Highlights from Ongoing Phase 1 Trial in
Patients with Advanced Solid Tumors
- Partial response (PR) achieved with single agent felezonexor in
a 4th line patient with KRAS-positive, microsatellite stable (MSS)
colorectal cancer (18+ weeks, ongoing)- PR (RECIST 1.1 criteria)
reported after 2 cycles of felezonexor (70mg then 65mg due to
elevated creatinine), with the patient demonstrating serial
reductions in the two target lesions (liver and spleen)- Treatment
with felezonexor ongoing (cycle 6); Next staging pending
- Stable disease (SD) achieved in 12 patients, with 11/12 of
these patients 3rd line or greater
- Five patients had SD for 4 and 11 months, including 1 patient
with basal cell carcinoma with SD for ~11 months- 20% disease
shrinkage noted in one patient with heavily pre-treated
neuroendocrine tumor
- Pharmacokinetic (PK) analyses suggest dose-dependent increases
in exposure
- Dosing regimen previously adjusted (Schedule B) to improve
tolerability while maintaining dose intensity; 1 patient in
Schedule B (n=7) experienced grade 3 weakness, the 75mg cohort has
been expanded and enrollment continues
- Ideal therapeutic dose and regimen not yet determined, and dose
escalation ongoing
- Further updates expected as Phase 1 trial continues to
enroll
Ivan Bergstein, M.D., CEO of Stemline, commented, “We are very
encouraged to witness evidence of clinical activity in a patient
with a heavily pretreated and highly mutated solid tumor with poor
prognostic features with single agent felezonexor in a regimen and
dose that has potentially not yet been fully optimized. We continue
to enroll patients with the goal of refining the ideal dose and
schedule to take forward into a focused and abbreviated Phase 2
program, and plan to provide periodic updates as the Phase 1
progresses.”
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 and 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: felezonexor (SL-801) (XPO1 inhibitor; Phase 1
in advanced solid tumor patients ongoing), SL-1001 (novel RET
kinase inhibitor, IND-enabling studies ongoing), SL-701
(immunotherapeutic; Phase 2 in glioblastoma patients completed),
and SL-901 (novel kinase inhibitor; prior abbreviated European
Phase 1, IND-enabling studies ongoing). 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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