Product Pipeline - Stemline Therapeutics

Our Products and Pipeline

Stemline is investing in advanced science and technology to develop a pipeline of new products that make a difference to the lives of patients affected by cancer.

Our pipeline refers to drugs in development, including those in preclinical testing, clinical development, regulatory approval and lifecycle management.

The information in the table reflects Stemline’s development pipeline and is not intended for promotional or marketing purposes. The safety and efficacy of the investigational compounds, or investigational uses of marketed products have not been established and marketing approval has yet to be granted by regulatory authorities.

Compound	Mechanism of Action	Indication	Stage	Additional Detail	External Links
TAGRAXOFUSP	Targeted Biologic (CD123)	BPDCN	Approved (US)	ELZONRIS was approved by the U.S. FDA in 2018 for the treatment of adult and pediatric patients, 2 years or older, with BPDCN.	Important Safety Information
		BPDCN	Approved (EU)	ELZONRIS was approved by the EMA in 2021 as monotherapy for the first-line treatment of adult patients with BPDCN.	Important Safety Information
		AML	Phase 2	TAGRAXOFUSP is being investigated for treatment of Acute Myeloid Leukemia (AML)
		CMML	Phase 2	TAGRAXOFUSP is being investigated for treatment of chronic myelomonocytic leukemia (CMML)
		MF	Phase 2	TAGRAXOFUSP is being investigated for treatment of Myelofibrosis (MF)
ELACESTRANT	SERD (ER)	Breast Cancer	Approved (US)	ORSERDU was approved by the U.S. FDA in 2023 for the treatment of postmenopausal women or adult men, with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.	Review Prescribing Information
		Breast Cancer	Phase 2 - Combination	ELECTRA is a Phase 1b/2 Study of Elacestrant in Combination with Abemaciclib in patients with Brain Metastasis from ER+/HER2- Breast Cancer.
		Breast Cancer	Phase 2 - Combination	ELEVATE is a Phase 1b/2 Umbrella Study to Evaluate Safety and Efficacy of Elacestrant in various combinations in patients with ER+/HER2- metastatic Breast Cancer
		Breast Cancer	Phase 2 - Monotherapy	ELCIN is a Phase 2 trial of Elacestrant in patients with CDK4/6i naïve ER+/HER2- metastatic breast cancer
SL-701	Immunotherapy (IL-13Rα2, EphA2, Survivin)	Glioblastoma	Phase 2	SL-701 is being investigated for the treatment of recurrent glioblastoma multiforme.
MEN1703	SME (PIM/FLT3i)	AML	Phase 2	MEN1703 is being investigated for the treatment for adult patients with relapsed/refractory AML.
MEN1611	SME (PI3Ki)	CRC	Phase 2	MEN1611 is being investigated in patients with PIK3CA mutated, K-RAS, N-RAS and B-RAF wild-type metastatic colorectal cancer (CRC), failing irinotecan, oxaliplatin, 5-FU and anti-EGFR containing regimens.
		Breast Cancer	Phase 1b	MEN1611 is being investigated in patients with PIK3CA-mutated, HER2+ metastatic breast cancer who failed anti-HER2 therapy.
MEN1309	ADC (Anti-CD205)	Solid Tumors	Phase 1b	MEN1309 is being investigated in patients with solid tumors.
FELEZONEXOR	SME (XPO1i)	Solid Tumors	Phase 1b	Felezonexor is being investigated in patients with solid tumors.
SL-901	SME (PI3Ki)	Solid Tumors	Phase 1b	SL-901 is being investigated in patients with solid tumors.

Mission/Beliefs/Values

To build a leading biopharmaceutical company focused on improving the lives of cancer patients by developing and marketing innovative oncology therapeutics that target difficult-to-treat cancers.