Nordic Nanovector announces that the first patient has been dosed in its Phase 1 study evaluating Betalutin (177Lu-satetraxetan-lilotomab), a novel CD37 targeting antibody-radionuclide conjugate, in patients with relapsed diffuse large B-cell lymphoma (DLBCL) – the “LYMRIT 37-05” trial.
“We are excited to begin this study to evaluate Betalutin in patients with relapsed DLBCL who are ineligible for stem cell transplantation. This is an area of significant medical need with no approved treatment options. The encouraging data seen in the Phase 1/2 study in relapsed indolent NHL, presented at ASH in December 2016, provide a strong foundation to advance our development of Betalutin into this second indication,” commented Lisa Rojkjaer, Nordic Nanovector’s CMO.
The open-label, single-arm, dose-escalation study is designed to assess the safety, tolerability, pharmacokinetic profile and preliminary anti-tumour activity of Betalutin. Up to 24 patients are planned to be enrolled in the US and EU. Prof. Timothy Illidge at the Manchester Cancer Research Centre, University of Manchester, is the Principal Investigator for the study.
There are currently very few therapeutic options for patients not eligible for SCT, which make this disease a serious unmet medical need, with a population of over 14 000 patients in the US, EU-5 and Japan. The market for treatment of DLBCL is estimated to be worth more than USD 4.5 billion by 2024.