On November 6, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that ELZONRIS (tagraxofusp; SL-401), a novel targeted therapeutic directed to CD123, will be featured in three presentations, including an oral presentation of ELZONRIS clinical data in myelofibrosis, at the 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, to be held December 7-10, 2019 in Orlando, FL (Press release, Stemline Therapeutics, NOV 6, 2019, View Source [SID1234550550]).
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Details on the ASH (Free ASH Whitepaper) presentations are as follows:
Myelofibrosis – Clinical (monotherapy); oral presentation
Title: Results from a Phase 1/2 Clinical Trial of Tagraxofusp (SL-401) in Patients with Intermediate, or High Risk, Relapsed/Refractory Myelofibrosis
Presenter: Naveen Pemmaraju, MD; MD Anderson Cancer Center
Abstract: 558
Session: 634. Myeloproliferative Syndromes: Clinical: Emerging and Novel Targeted Therapies
Date/Time: Monday, December 9, 2019 8:15 AM ET
Location: Orange County Convention Center, W304EFGH
Multiple Myeloma – Clinical (combination therapy); poster presentation
Title: Results from Phase 1/2 Trial of Tagraxofusp in Combination with Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma
Presenter: Paul G. Richardson, M.D.; Dana-Farber Cancer Institute
Abstract: 3145
Session: 653. Myeloma: Therapy, excluding Transplantation: Poster II
Date/Time: Sunday, December 8, 2019 6:00 PM–8:00 PM ET
Location: Orange County Convention Center, Hall B
Myeloproliferative Neoplasms – Preclinical (combination therapy); poster presentation
Title: Evaluation of Tagraxofusp (SL-401) Alone and in Combination with Ruxolitinib for the Treatment of Myeloproliferative Neoplasms
Presenter: Aishwarya Krishnan, MD; Memorial Sloan Kettering Cancer Center
Abstract: 2967
Session: 635. Myeloproliferative Syndromes: Basic Science: Poster II
Date/Time: Sunday, December 8, 2019 6:00 PM–8:00 PM ET
Location: Orange County Convention Center, Hall B
Ivan Bergstein, M.D., CEO of Stemline Therapeutics, commented, "We are honored that ASH (Free ASH Whitepaper) has selected ELZONRIS data as the subject of three presentations, including an oral presentation of clinical trial data in myelofibrosis (MF). Moreover, given the very encouraging trial results to date that we have witnessed, we are expanding the current cohort to enable additional patient enrollment. Two other presentations, including ELZONRIS clinical combination data in patients with multiple myeloma, and ELZONRIS preclinical combination data in myeloproliferative neoplasms, highlight ELZONRIS’ potential utility across indications. In addition, as we now transition our chronic myelomonocytic leukemia (CMML) program to registration-directed, we remain on track to begin enrollment of the Stage 3a cohort in patients with CMML in the coming months, with the goal of reporting data from this cohort, in both the relapsed/refractory and first-line settings, by 2H20."
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 CD123
CD123 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.