Actuate’s Elraglusib Enters 20-Patient Cohort in BEACON2 Phase 1/2 Trial
ACTU•Elraglusib will enter a 20-patient dose-confirmation cohort in the BEACON2 European Phase 1/2 trial combining the GSK-3β inhibitor with dinutuximab beta plus chemotherapy in relapsed/refractory pediatric neuroblastoma. The program follows a complete response in a refractory neuroblastoma patient and FDA Rare Pediatric Disease designation, underpinning clinical and regulatory momentum.
1. BEACON2 Trial Inclusion
Elraglusib has been selected for the BEACON2 multi-arm, multi-stage Phase 1/2 platform trial in high-risk relapsed and refractory neuroblastoma, with an initial dose-confirmation cohort of up to 20 patients. The regimen combines elraglusib with dinutuximab beta and chemotherapy to determine safety, the maximum tolerated dose, recommended Phase 2 dose and pharmacokinetic profile before potentially advancing to a randomized cohort of approximately 75 patients with an interim efficacy analysis.
2. Preclinical and Early Clinical Evidence
Preclinical studies demonstrated that elraglusib enhanced chemotherapy and immunotherapy efficacy in Th-MYCN mouse models, with 60% of treated animals tumor-free at one year versus 0% in controls (P<0.0001), and increased CD4+, CD8+ and NK cell tumor infiltration. In an ongoing Phase 1/2 study, a heavily pretreated high-risk neuroblastoma patient achieved complete bone marrow response within nine treatment cycles, supporting further investigation.
3. Regulatory Designation and Outlook
Elraglusib holds FDA Rare Pediatric Disease designation for neuroblastoma, reflecting its potential to address a significant unmet need. Success in BEACON2 could de-risk the program, generate pivotal clinical data across up to 60 sites in 16 countries and position Actuate for partnership or accelerated development in pediatric oncology.
