Nordic Nanovector announces that the first cohorts of both Arm 3 and 4 of the expanded Lymrit 37-01 clinical study with Betalutin have been completed.
Betalutin is a novel anti-CD37 targeting Antibody Radionuclide Conjugate in development for the treatment of major types of non-Hodgkin lymphoma (NHL), including Follicular Lymphoma (FL).
Arm 3 is investigating the safety and efficacy of Betalutin in relapsed FL patients pre-dosed with standard anti-CD20 immunotherapy (rituximab) on Day 0, a few hours prior to the administration of 15 MBq/kg Betalutin. Arm 4 is investigating the safety and efficacy of Betalutin in relapsed FL patients pre-dosed with high-dose unconjugated “cold”lilotomab (previously referred to as HH1) anti-CD37 antibody on Day 0, a few hours prior to the administration of 15 MBq/kg Betalutin.
Luigi Costa, Nordic Nanovector CEO, commented: “We are pleased to have completed the first cohorts of both Arm 3 and Arm 4 of the expanded Lymrit 37-01 study. These arms are designed to investigate if different pre-dosing regimens will allow the use of higher doses of Betalutin® to potentially achieve even better efficacy and an even more compelling product profile. The role of pre-dosing is to potentially ensure better control of haematological side effects and more specific tumour targeting with Betalutin®.”
A potential decision to increase the dose of Betalutin to 17.5 MBq/kg or 20 MBq/kg in one or the other arm can be made based on the evaluation of the safety and efficacy data observed in these first 3 patients of both arm.
The Lymrit 37-01 study is a Phase 1/2 open label, single injection ascending dose study investigating three dose levels of Betalutin and different pre-dosing regimens in patients with relapsed NHL with the aim of identifying an optimal dose regimen to take into the Phase 2 PARADIGME study, which is expected to start in 2H 2017.