Phase 2b study for Betalutin® approval

Offentlig prosjektsammendrag

Nordic Nanovector is a biopharmaceutical company committed to develop and deliver innovative therapies to patients to address major unmet medical needs. The Company aspires to become a leader in the development of CD37-targeted therapies for haematological cancers and immune diseases. Nordic Nanovector's lead clinical-stage candidate is Betalutin®, a novel CD37-targeting antibody-radionuclide-conjugate designed to advance the treatment of non-Hodgkin's Lymphoma (NHL). NHL is an indication with substantial unmet medical need, representing a growing market that is forecast to be worth nearly USD 27 billion by 2029. Nordic Nanovector retains global marketing rights and intends to actively participate in the commercialisation of Betalutin® in core markets. This Skattefunn project is a continuation of a previous project and covers remaining activities of Nordic Nanovector's pivotal PARADIGME Phase 2b trial with Betalutin®. Covered are also remaining manufacturing process related activities required in preparation for a marketing authorization application. PARADIGME is a global randomised Phase 2b clinical trial in third line (3L) follicular lymphoma (FL) patients who are refractory to anti-CD20 immunotherapy, a population with high unmet medical need. Initially two Betalutin® dosing regimens (15 MBq/kg Betalutin® following 40 mg lilotomab pre-dosing; 20 MBq/kg Betalutin® following 100 mg/m2 lilotomab pre-dosing) were compared. Following an interim analysis after recruitment of 50 patients, the 100/20 arm was closed and the 40/15 arm selected for further patient inclusion. PARADIGME aims to enrol 120 patients across 85 sites in 24 countries. The objective of PARADIGME is to determine the best dosing regimen for Betalutin® as a new treatment option for 3L FL patients. The data from this study are expected to support market authorisation applications for Betalutin®. Initial efficacy and safety data read-out for PARADIGME is targeted for the second half of 2022.