Stemline Therapeutics Announces Presentation of ELZONRIS™ (tagraxofusp; SL-401) Preclinical Data in Systemic Sclerosis, an Autoimmune Disorder, at EULAR Congress
The poster, entitled “SL-401, a Novel Targeted Therapy Directed to the Interleukin-3 Receptor (CD123), Kills Plasmacytoid Dendritic Cells (pDCs) from Systemic Sclerosis Patients”, was presented today. Preclinical data demonstrated the activity of ELZONRIS against potentially pathogenic plasmacytoid dendritic cells (pDCs), suggesting a novel approach for the treatment of systemic sclerosis and certain other autoimmune disorders.
Notably, the CD123+ pDC is the cell of origin of the malignancy blastic plasmacytoid dendritic cell neoplasm (BPDCN) an indication for which ELZONRIS™ (tagraxofusp; SL-401), a novel targeted therapy directed to CD123, has been granted breakthrough therapy designation (BTD). ELZONRIS has successfully completed a pivotal trial in BPDCN, and a rolling Biologics License Application (BLA) submission is underway.
Presentation Highlights and Conclusions
- Plasmacytoid dendritic cells (pDCs), from which the malignancy BPDCN is derived, are immune cells that express CD123, secrete IFN-α, and play a role in inflammation and pathogenesis observed in certain autoimmune diseases including systemic sclerosis (SSc)
- SL-401 is cytotoxic against CD123+ pDCs
- Concurrent with pDC depletion, a reduction in secreted IFNα and IL-6 was observed in cell culture supernatant
- Depletion of pDCs or attenuation of pDC function may represent a novel mechanism of action for the treatment of patients with SSc
- As such, these data present a potentially novel approach of targeting pDCs and inflammation in the treatment of SSc and warrant further investigation
A copy of the full presentation will be available on Stemline’s website (www.stemline.com) under the Scientific Presentations tab.
About ELZONRIS™ (tagraxofusp; SL-401)
ELZONRIS™ (tagraxofusp; SL-401) is a novel targeted therapy directed to CD123, a cell surface receptor expressed on a range of malignancies. ELZONRIS has successfully completed a pivotal trial in blastic plasmacytoid dendritic cell neoplasm (BPDCN), an indication for which it was granted Breakthrough Therapy Designation (BTD). A rolling Biologics License Application (BLA) submission is underway. ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).
Please visit the BPDCN disease awareness website: www.bpdcninfo.com.
Some 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 and timing of our BLA submission to the
Source: Stemline Therapeutics, Inc.