On December 12, 2022 Electra Therapeutics, Inc., a clinical stage biotechnology company developing novel antibody therapies that target signal regulatory proteins (SIRP), reported presentations and clinical progress for ELA026, the company’s first-in-class antibody in development for the treatment of secondary hemophagocytic lymphohistiocytosis (sHLH), a life-threatening inflammatory disease. Three poster presentations supporting the company’s clinical development of ELA026 in sHLH are highlighted at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held in New Orleans from December 10-13, 2022 (Press release, Electra Therapeutics, DEC 12, 2022, View Source [SID1234625105]).
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Electra also announced today that a Phase 1b global study of ELA026 in sHLH patients has been initiated and is ongoing (ClinicalTrials.gov identifier: NCT05416307). The Phase 1b study is highlighted as a clinical trial in progress poster at ASH (Free ASH Whitepaper), titled "A Phase 1b study of ELA026 in patients with secondary hemophagocytic lymphohistiocytosis." The Phase 1b study is an open-label, single-arm, multicenter study which will evaluate the safety and efficacy of ELA026, assess biomarkers and identify a dose for Phase 2/3 testing.
"We are excited to advance ELA026 in the clinic as a novel approach targeting SIRP to address the aberrant myeloid and T cell activity that drives the sHLH disease process," said Gary Patou, MD, Chief Medical Officer of Electra. "We have created a robust design for this Phase 1b study with the aim of progressing rapidly toward a Phase 2/3 study so we can accelerate ELA026 as a potential treatment option for sHLH patients in need."
Study Results Presented at ASH (Free ASH Whitepaper) Annual Meeting
Preclinical studies demonstrated ELA026’s proof-of-mechanism of SIRP targeting and depletion of pathological immune cells that drive sHLH. The poster presentation at ASH (Free ASH Whitepaper), titled "Characterization of ELA026, a clinical-stage monoclonal antibody that rapidly and potently depletes myeloid cells and T lymphocytes," describes the pharmacology of ELA026 which binds to and depletes SIRP-expressing cells, and its pharmacokinetic (PK) profile and pharmacodynamic (PD) effects in non-human primates. The preclinical data includes the following highlights:
In in vitro studies, ELA026 was shown to bind to SIRP proteins on the surface of primary human and cynomolgus monkey monocytes and T cells, inducing potent antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).
In vivo administration of ELA026 in cynomolgus monkeys showed a rapid and potent depletion of SIRP-expressing monocytes and lymphocytes, with a well-defined PK/PD relationship. Reversibility of the PD effect was achieved following washout suggesting that ELA026 treatment is not associated with long-term immunosuppression.
Electra also presented results of a sHLH natural history study at the ASH (Free ASH Whitepaper) Annual Meeting in a poster, titled "Identification and characterization of a retrospective cohort of secondary hemophagocytic lymphohistiocytosis (sHLH) patients in the US," showing that sHLH is a complex disease to diagnose and treat. The study has thus far reviewed approximately 1,500 unique patient medical records from a large medical system in the US and supports the need to improve our ability to identify sHLH patients and better understand the potential underestimation of the incidence of sHLH.
"We appreciate the dedication of the Electra team in supporting patients and families impacted by histiocytosis. sHLH is a life-threatening inflammatory disease with no approved treatments and, as a result, many patients suffer the debilitating effects of this condition," said Deanna Fournier, Executive Director, Histiocytosis Association. "We welcome the promising new approach that ELA026 offers, and we join the patient community in supporting the advancement of new treatments for sHLH. Opportunities like these are what continue to give us hope!"
The three posters are available on Electra’s website.
About Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
Secondary hemophagocytic lymphohistiocytosis (sHLH) is a life-threatening hyperinflammatory condition for which there is no approved treatment. sHLH can be triggered by cancer, immunotherapy, infection, or an autoimmune disease. Once triggered, sHLH requires immediate intervention. Without treatment, it can rapidly progress from symptoms such as persistent fever, hepatomegaly and/or splenomegaly, and cytopenias, to multi-organ failure and death.