Nordic Nanovector ASA, a biotechnology company specialized in developing and commercializing breakthrough hematology and cancer therapeutics, recently announced it will be revising its clinical development strategy on its lead product candidate for non-Hodgkin’s lymphoma (NHL), Betalutin.
Betalutin is a novel formulation of a tumor-seeking anti-CD37 antibody (HH1) conjugated to a low intensity radionuclide (lutetium- 177). An ongoing Phase 1/2 study was able to demonstrate its favorable safety and efficacy profile in patients with complicated NHL treatment needs.
Luigi Costa, CEO of Nordic Nanovector, stated, “We believe that our decision to revise the clinical development plan for Betalutin® makes good strategic sense. In light of newly available data and experts’ advice with regard to pre-dosing, we have concluded that we now have a new opportunity to determine the best regimen to take into the pivotal Phase 2 PARADIGME trial. We are confident that by establishing the most appropriate regimen through an expanded Phase 1/2 study, rather than as part of PARADIGME, we will greatly improve the chances of successfully gaining regulatory approval for Betalutin® with a product profile that would make it a competitive new treatment for follicular lymphoma. I would like to thank all our advisors for their valuable input to this decision.”
According to the company conference call held October 15, 2015, Nordic will be looking in to expand the previous dosing portion of the pivotal study PARADIGME and incorporating it into the ongoing Phase 1/2 (Lymrit 37-01) study. The original plan was to carry out the dosing element in a separate, parallel study to PARADIGME; however, the company believes the new integration will help expedite approval. The PARADIGME study is now being redesigned as a single-arm efficacy and safety study. The revised Phase 1/2 study is expected to come to a conclusion by the end of the first quarter of 2017 and reveal the optimum dosage of Betalutin to be administered during the amended PARADIGME trial, which is projected to launch in the first half of 2017, with the company potentially filing the first regulatory application for the drug by mid-2019. Nordic is confident the amended clinical development plan will be financially sound until the first regulatory submission because of the reduced number of patients required for the PARADIGME trial.