Nordic Nanovector ASA has announced 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.
Commenting on the start of the trial, Dr. Lisa Rojkjaer, Nordic Nanovector's CMO, 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 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".
DLBCL is an aggressive form of non-Hodgkin's Lymphoma (NHL) that accounts for up to 43% of all NHL cases, making it the most common form of the disease. After first line combination treatment with rituximab-chemotherapy (R-CHOP) approximately 40% of DLBCL patients relapse and only 30-40% of relapsed patients respond with subsequent high-dose chemotherapy followed by stem cell transplant (SCT). 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.
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.
Nordic Nanovector is committed to develop and deliver innovative therapies to patients to address major unmet medical needs and advance cancer care. The company aspires to become a leader in the development of targeted therapies for haematological cancers.
Nordic Nanovector's lead clinical-stage candidate is Betalutin, a novel CD37-targeting Antibody-Radionuclide-Conjugates (ARC) designed to improve upon and complement current options for the treatment of non-Hodgkin Lymphoma (NHL). NHL is an indication with substantial unmet medical need and orphan drug opportunities, representing a growing market forecast to be worth nearly USD 20 billion by 2024.