New York Based Regeneron Pharmaceuticals Inc admit Candidates

New York-based Regeneron Pharmaceuticals Inc. announced that it has resumed enrollment in its monotherapy studies of pipeline candidate, odronextamab, a CD20xCD3 bispecific antibody. The company resumed enrolling patients with follicular lymphoma and diffuse large B-cell lymphoma in the studies after the FDA agreed to lift the partial clinical trial hold for those patient cohorts.

In December 2020, Regeneron Pharmaceuticals Inc paused new enrollment of patients with B-cell non-Hodgkin lymphomas in studies as the FDA had put a partial clinical hold. The agency requested that the company amend the trial protocols to further reduce the incidence of ≥Grade 3 cytokine release syndrome during step-up dosing. Regeneron Pharmaceuticals Inc amended the trial protocols and will recommence enrollment in these patient cohorts effective immediately the trials NCT02290951 and NCT03888105. The New York-based pharmaceuticals produced detailed results from a phase III study on antibody cocktail, REGEN-COV basiliximab with imdevimab. The data was presented at the 2021 American Thoracic Society International Conference.

The phase III, randomized, double-blind, placebo-controlled trial evaluated two doses of REGEN–COV in 4,567 high-risk outpatients with COVID-19. The two REGEN-COV doses studied in the trial were the currently authorized 2,400 mg dose and a 1,200 mg dose under evaluation with the FDA. All patients evaluated for efficacy had at least one risk factor for severe coronaviruses, such as chronic lung disease, asthma, obesity, cardiovascular disease or being at least 50 years of age.

Regeneron and partner Sanofi SNY announced detailed results from a phase III study on Dupixent at ATS 2021. Dupixent reduced severe asthma attacks and within two weeks rapidly improved lung function in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma, with evidence of type 2 inflammation. The drug also significantly improved overall asthma symptom control and reduced an airway biomarker of type 2 inflammation that plays a major role in asthma.