Regeneron Pharmaceuticals ((REGN)) announced an update on their ongoing clinical study.
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Regeneron Pharmaceuticals recently updated its clinical study investigating the safety and tolerability of odronextamab, officially titled ‘An Open-Label, Multi-Center Phase 1 Study to Investigate the Safety and Tolerability of REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients With CD20+ B-Cell Malignancies Previously Treated With CD20-Directed Antibody Therapy (ELM-1)’. The study aims to assess the potential of odronextamab in treating CD20+ B-cell malignancies, such as Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia, which are significant due to their prevalence and treatment challenges.
The intervention being tested is odronextamab, a bispecific monoclonal antibody designed to target CD20 and CD3 proteins. It is administered in multiple dose levels either intravenously or subcutaneously, aiming to improve treatment outcomes for patients with B-cell malignancies.
This Phase 1 study is non-randomized with a parallel intervention model and no masking, focusing on treatment as its primary purpose. It includes two parts: Part A involves intravenous administration with dose escalation and expansion phases, while Part B involves subcutaneous administration with similar phases.
The study began on November 7, 2014, and was last updated on October 9, 2025. The primary completion and estimated completion dates are not specified, indicating the study’s ongoing nature and continuous data collection.
The completion of this study could significantly impact Regeneron Pharmaceuticals’ stock performance and investor sentiment, as successful results may enhance the company’s position in the oncology market. This is particularly relevant given the competitive landscape of cancer therapeutics, where advancements in treatment options are highly valued.
The study is ongoing, and further details can be accessed on the ClinicalTrials portal.