Nordic Nanovector has announced 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 an anti-CD37 targeting Antibody Radionuclide Conjugate to treat major types of non-hodgkin lymphoma (NHL), including Follicular Lymphoma (FL).
Arm 3 is probing the safety and efficacy of Betalutin in relapsed FL patients who have been pre-dosed with standard anti-CD20 immunotherapy (rituximab) on Day 0, just a few hours before the administration of 15 megabecquerel / kilograms (MBq/kg) of Betalutin.
Arm 4 is analysing the safety and efficacy of Betalutin in relapsed FL patients pre-dosed with high-dose unconjugated 'cold' lilotomab, previously known as HH1, anti-CD37 antibody on Day 0, a few hours before the administration of 15MBq/kg Betalutin.
Nordic Nanovector CEO Luigi Costa said: “We are pleased to have completed the first cohorts of both Arm III and Arm IV 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 decision to raise the dose of Betalutin to 17.5MBq/kg or 20MBq/kg in one or the other arm can be taken based on the analysis of the safety and efficacy data observed in these first three patients of both arms.
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.
The aim of this study is to identify an optimal dose regimen to be taken in the Phase 2 PARADIGME study, expected to commence in the second half of 2017.