ELZONRIS® (TAGRAXOFUSP)

Clinical Trials

ELZONRIS is a novel targeted therapy directed to the IL-3R (CD123). ELZONRIS comprises human IL-3 recombinantly fused to a truncated diphtheria toxin (DT) payload engineered such that IL-3 replaces the native DT receptor-binding domain. The IL-3 domain of ELZONRIS directs the cytotoxic DT payload to cells expressing CD123. Upon internalization, ELZONRIS irreversibly inhibits protein synthesis and induces apoptosis of the target cell. Given this novel mechanism of action, there is a potential to develop ELZONRIS as both a single agent and in combination with other therapies.

ELZONRIS was approved by the Food and Drug Administration (FDA) on December 21, 2018, for the treatment of adult and pediatric patients, 2 years and older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). In January 2021, ELZONRIS was approved by the European Medicines Agency (EMA) as monotherapy for the first-line treatment of adult patients with BPDCN. ELZONRIS is also being evaluated in clinical trials in additional indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and other indications.

For more information on current ELZONRIS clinical trials, click the links below or visit clinicaltrials.gov.

ORSERDU^TM (Elacestrant)

Clinical Trials

ORSERDU is a selective estrogen receptor degrader (SERD) evaluated for potential use as an oral, once daily treatment in patients with estrogen receptor positive (ER+)/HER2- advanced or metastatic breast cancer. In January 2023, ORSERDU was approved by the Food and Drug Administration (FDA) 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.

In studies to date, including the positive results from the EMERALD Phase 3 trial, indicate ORSERDU has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer. Indeed, ORSERDU is the first approved oral SERD, demonstrating positive results in a pivotal, Phase 3 trial as a monotherapy versus standard of care for the treatment of ER+/ HER2- advanced or metastatic breast cancer.

For more information on current ORSERDU clinical trials, click the links below or visit clinicaltrials.gov.

SL-701

Clinical Trials

SL-701 is an immunotherapy designed to activate the immune system to attack tumors. A multicenter clinical trial with SL-701 in combination with an immunostimulant and bevacizumab has completed enrollment of adult patients with glioblastoma multiforme (GBM) in first recurrence.

Discussions around next steps to further unlock potential value from the program are ongoing.

SL-801

Clinical Trials

SL-801 is a novel, oral, small-molecule reversible inhibitor of exportin-1 (XPO1), a key nuclear transport protein. XPO1 is overexpressed by many cancers, leading to mislocalization of key tumor suppressors and growth-regulatory proteins in the cytoplasm.

A Phase 1 trial is ongoing, and currently enrolling patients with advanced solid tumors.