Nordic Nanovector begins dosing in Phase I trial of Betalutin for DLBCL
Norwegian-based Nordic Nanovector has begun dosing patients in a Phase I clinical trial (LYMRIT 37-05) of Betalutin (177Lu-satetraxetan-lilotomab) to treat diffuse large B-cell lymphoma (DLBCL).
Betalutin is a CD37 targeting, antibody-radionuclide conjugate (ARC) being developed to complement the existing treatments for non-hodgkin lymphoma (NHL).
It consists of a tumour-seeking anti-CD37 antibody conjugated to a low intensity radionuclide known as Lutetium 177.
The open-label, single-arm, dose-escalation Phase I trial will evaluate the safety, tolerability, pharmacokinetic profile and preliminary anti-tumour activity of Betalutin.
The firm plans to enrol approximately 24 patients in the US and EU.
Nordic Nanovector chief medical officer Dr Lisa Rojkjaer said: "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 I/II 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."
Nordic Nanovector primarily aims to develop Betalutin alone and in combination with other cancer therapies for the treatment of major types of NHL.
The firm is planning to submit its first regulatory application for relapsed / refractory follicular lymphoma in 2019.
It intends to retain marketing rights and actively participate in the commercialisation of the drug in core markets, as well as explore potential distribution agreements in selected geographies.
Image: Micrograph of a diffuse large B-cell lymphoma. Photo: courtesy of Nephron/Wikipedia.