SOUTH SAN FRANCISCO, CA, October 30, 2024 – Electra Therapeutics, Inc., a clinical stage biotechnology company developing antibody therapies against novel targets for immunological diseases and cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ELA026 for the treatment of hemophagocytic lymphohistiocytosis (HLH). ELA026, a first-in-class antibody therapy targeting signal regulatory proteins (SIRP), is a novel approach to treat secondary HLH (sHLH), a rare, life-threatening disease for which there is no approved treatment. sHLH can be triggered by cancer, infection, autoimmune disease, or immunotherapy, and is associated with a severe inflammatory response (a cytokine storm) for which patients require immediate intervention.

“The Orphan Drug Designation is an important milestone in ELA026’s clinical development in sHLH,” said Kim‑Hien Dao, DO, PhD, Chief Medical Officer of Electra Therapeutics. “This designation underscores the high unmet medical need in sHLH and supports our continued efforts to evaluate the effectiveness of ELA026 in depleting the pathogenic immune cells responsible for the cytokine storm and addressing the high early mortality observed in this disease.”

The FDA grants ODD status to investigational therapies intended to treat diseases that affect fewer than 200,000 people in the United States. This designation enables certain incentives, including tax credits for qualified clinical trials, prescription drug user-fee exemptions, and potential seven-year marketing exclusivity upon FDA approval.