ELA822

Electra Therapeutics, a clinical-stage biotechnology company focused on novel targets in immunology and oncology, has announced that ELA026, its lead candidate for secondary haemophagocytic lymphohistiocytosis (sHLH), has received Breakthrough Therapy designation (BTD) from the US Food and Drug Administration (FDA) and Priority Medicines (PRIME) designation from the European Medicines Agency (EMA). The company has also successfully completed a $183m Series C funding round to support ongoing and planned clinical trials of ELA026. Both BTD and PRIME designations are awarded to therapies addressing unmet medical needs or demonstrating substantial improvement over existing treatments. They provide enhanced engagement with regulatory authorities and streamlined review pathways. The designations follow data from a phase 1b trial assessing the safety and efficacy of ELA026, a first-in-class monoclonal antibody targeting regulatory proteins on immune cells, in patients with sHLH. In patients with malignancy-associated HLH (mHLH) – a subgroup with particularly poor prognosis – frontline treatment with ELA026 was associated with significant improvements in overall survival and response rates, and hospital discharge outcomes. “Receiving FDA BTD and EMA PRIME designations reinforces ELA026’s potential to deliver meaningful benefit for patients with sHLH, a disease with limited treatment options and a devastating prognosis,” said Kim-Hien Dao, Chief Medical Officer of Electra Therapeutics. “These recognitions reflect the compelling phase 1b results demonstrating substantial improvement over available therapies. We are working closely with regulatory agencies and leveraging these designations to accelerate development and bring ELA026 to patients as quickly as possible.” The phase 2/3 study is currently enrolling patients across the US and Europe and has initiated dosing. Electra is also evaluating ELA026 for haematologic cancers and advancing a second signal regulatory protein (SIRP) programme, ELA822, into clinical development. Funding for a pivotal phase 2/3 study was raised through the Series C round. “We are pleased to have the support of a distinguished group of investors who share our vision to deliver life-changing treatments for patients with underserved diseases,” said Kathy Dong, President and CEO of Electra Therapeutics. “With strong momentum, we are driving the pivotal study of ELA026 in sHLH forward and accelerating our second SIRP-targeted programme into the clinic.”