Nordic Nanovector (OSE:NANO) has completed enrollment of the first cohorts of the pre-dosed arms of its non-Hodgkin lymphoma (NHL) trial, keeping it on track to advance into Phase II in the back half of next year.
The two pre-dosing arms are giving NHL patients either rituximab, a CD20 monoclonal antibody sold by Roche ($RHHBY) as Mabthera, or lilotomab before starting them on the experimental treatment being tested. That treatment is Nordic Nanovector’s Betalutin, an anti-CD37 antibody-radionuclide conjugate. By pre-dosing, Nordic Nanovector thinks it can ratchet up Belatin levels without running into the safety issues that blighted an earlier version of the study.
“These arms are designed to investigate if different pre-dosing regimens will allow the use of higher doses of Betalutin to potentially achieve even better efficacy,” Nordic Nanovector CEO Luigi Costa said in a statement.
Once Nordic Nanovector has data from the first three patients in each of the pre-dosing arms, it will decide whether to increase the dose of Betalutin to 17.5 MBq/kg or 20 MBq/kg. The dose-finding trial started out at 10 MBq/kg. Nordic Nanovector has been up to 20 MBq/kg in the past, although some patients who received that dose required platelet transfusions.
That experience also taught Nordic Nanovector that 15 MBq/kg doses can cause transient, reversible thrombocytopenia and neutropenia, a lesson that prompted it to make pre-dosing an integral part of the study.
“The role of pre-dosing is to potentially ensure better control of hematological side effects and more specific tumour targeting with Betalutin,” Costa said.
Data presented earlier this year by Nordic Nanovector at 21st Congress of the European Hematology Association lend credence to this hypothesis. The data, which were taken from the ongoing Phase I/II trial, suggest pre-dosing with lilotomab can boost the proportion of patients who respond to treatment.
Nordic Nanovector is now heading toward the day on which it will learn whether the pre-dosing works as it hopes. Assuming the company can emerge from the dose-finding stage of the trial with a regimen that looks safe and effective, it plans to advance into Phase II in the second half of next year.
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