Electra Therapeutics Presents Late-Breaking Clinical Data at EHA2024 from Ongoing Phase 1b Study of ELA026 in Secondary Hemophagocytic Lymphohistiocytosis (sHLH)
16 Junio 2024 - 2:45AM
Business Wire
ELA026 demonstrated a high overall response
rate (ORR) across a range of sHLH patients and a favorable safety
profile in this life-threatening hyperinflammatory condition
In patients with the poorest prognosis, those
with malignancy-associated HLH, early treatment with ELA026
resulted in 100% ORR and improved survival
Electra Therapeutics, Inc., a clinical stage
biotechnology company developing antibody therapies against novel
targets for immunological diseases and cancer, announced the
presentation of clinical data for ELA026 in secondary
hemophagocytic lymphohistiocytosis (sHLH), a life-threatening
hyperinflammatory condition. The results were presented today as
one of six abstracts selected for oral presentation in a
late-breaking session at the European Hematology Association (EHA)
Congress in Madrid, Spain.
Results were reported for sHLH patients in the ongoing Phase 1b
clinical study, which has enrolled a majority of patients with the
deadliest sHLH subtype, malignancy-associated HLH (mHLH). In
treatment‑naive mHLH patients, ELA026 achieved a 100% overall
response rate (ORR) by week 4 and improved survival at two months
compared to natural history studies. ELA026 also demonstrated a
high response rate across a range of sHLH patients and a favorable
safety profile in this patient population.
ELA026 is a first-in-class monoclonal antibody that targets
signal regulatory protein (SIRP)-α/β1/γ on the cell surface of
myeloid cells and T lymphocytes, the pathological immune cells that
induce hyperinflammation in sHLH. The Phase 1b study is an ongoing
open-label, multi-dose, single-arm, multicenter study designed to
evaluate the safety and efficacy of ELA026, assess biomarkers, and
identify a dose for Phase 2/3 testing (ClinicalTrials.gov
identifier: NCT05416307).
“These data show very promising results for ELA026 as a
potential treatment for sHLH, which is a challenging disease that
is devastating for patients and has no approved treatment options,”
said Swaminathan P. Iyer, MD, Professor in the Department of
Lymphoma/Myeloma at The University of Texas MD Anderson Cancer
Center. “Notably, the analysis reveals improved survival was
achieved with ELA026 in treatment-naïve mHLH patients, suggesting
benefit from early treatment intervention for patients with this
rapidly progressing disease.”
Study Results Presented at EHA 2024 Congress
The oral presentation at EHA2024, entitled “ELA026 Targeting of
SIRP(+) Immune Cells Results in a High Response Rate and Improved
2-Month Survival of Treatment-naïve Malignancy-associated
Hemophagocytic Lymphohistiocytosis in a Phase 1 Study,” was
presented by the lead author, Abhishek Maiti, MD, Assistant
Professor in the Department of Leukemia at The University of Texas
MD Anderson Cancer Center. The data describe analysis of sHLH
patients in three cohorts of the ongoing Phase 1b clinical study,
including the following highlights:
- A majority of enrolled patients had malignancy-associated HLH
(mHLH) which has the poorest prognosis, with a mortality rate of
approximately 50% at two months.1
- ELA026 was observed to have a favorable safety profile, with
manageable adverse events, in this patient population.
- In Cohorts 1 and 2, which have completed enrollment (n=12),
ELA026 achieved an overall response rate (ORR) of 75% by week 4.
Enrollment in Cohort 3 is ongoing (n=5 as of April 17, 2024).
- Across all cohorts, 8 patients had treatment-naïve mHLH; in
this group, ELA026 achieved an ORR of 100% by week 4 and survival
was 88% at two months.
- In the study, pharmacodynamic and biomarker responses
correlated with clinical responses.
- The Phase 1b study has expanded to include up to 20 patients in
Cohort 3 and will continue to evaluate ELA026 in frontline
treatment settings in patients with various subtypes of sHLH.
“We are delighted that the results of the clinical study of
ELA026 in sHLH were recognized and selected as a late-breaking
presentation at EHA. This interim data is extremely encouraging,
particularly with the high response rates and improved survival at
two months achieved in treatment-naïve mHLH patients, and suggests
ELA026’s promise as a first-line treatment. Survival at two months
is a clinically meaningful benefit for this patient population and
demonstrates the ability of ELA026 to rapidly extinguish the
hyperinflammation in sHLH, enabling mHLH patients to pursue
curative therapies for their underlying cancer,” said Kim‑Hien Dao,
DO, PhD, Chief Medical Officer at Electra. “We look forward to
continuing enrollment in this study and advancing the clinical
program to further assess the safety and efficacy of ELA026 in sHLH
patients who currently have no approved therapies.”
About Secondary Hemophagocytic Lymphohistiocytosis
(sHLH)
Secondary hemophagocytic lymphohistiocytosis (sHLH) is a rare,
life-threatening inflammatory disease for which there is no
approved treatment. It can be triggered by cancer
(malignancy-associated HLH, or mHLH), infection, autoimmune
disease, or immunotherapy. sHLH is associated with a systemic
inflammatory response for which patients require immediate
intervention. Without treatment, patients may experience multiple
organ failure and death. sHLH has a high mortality rate during the
first months of diagnosis, with mHLH patients having the poorest
outcomes.
About Electra Therapeutics
Electra Therapeutics is a clinical stage biotechnology company
developing therapies against novel targets for immunological
diseases and cancer. The company’s lead product candidate, ELA026,
is a first-in-class monoclonal antibody that targets SIRP on the
cell surface of myeloid cells and T lymphocytes, and precisely
depletes pathological immune cells. ELA026 is in clinical
development for secondary hemophagocytic lymphohistiocytosis
(sHLH), a rare, life-threatening hyperinflammatory condition for
which there is no approved treatment, as well as additional disease
indications. For more information, please visit
www.electra-therapeutics.com and follow us on LinkedIn.
1 L�fstedt A, et al. Blood. 2024 Jan 18;143(3):233-242.
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