Combination of Betalutin® with Rituximab in Phase 1b clinical trial

Offentlig prosjektsammendrag

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 forecast to be worth nearly USD 20 billion by 2024. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets. This Skattefunn project covers Nordic Nanovector's Archer-1 Phase 1b trial with Betalutin® in combination with rituximab in second-line follicular lymphoma patients. The Archer-1 study builds on preclinical data demonstrating a synergistic anti-tumour effect between Betalutin® and rituximab. Data from these studies were reported at the ASH congress in December 2015 and 2016, and at AACR Malignant Lymphoma congress in 2018. These data showed that treatment with the anti-CD37/ anti-CD20 combination significantly prolonged the survival time of mice compared to those recieving either agent alone. Should this effect be confirmed in Archer-1 and subsequent clinical studies, it would represent a novel dual immunotherapy approach for the treatment of second-line follicular lymphoma and potentially provide access to a market estimated to be worth over USD 1.5 billion. Archer-1 is designed to investigate the safety, tolerability, pharmacokinetic and preliminary efficacy of the Betalutin®/rituximab combination in approximately 20 second-line follicular lymphoma patients, and the study will initially be conducted in Norway. Further countries are expected to be added later. The first patient is expected to be dosed in the second half of 2018.