Pre-dosing NHL patients with HH1 anti-CD37 antibody before Betalutin® increases its pharmacokinetic exposure and reduces its haematological toxicity
ePoster to be presented at the 21st Congress of the European Hematology Association (9-12 June)
Oslo, Norway, 10 June 2016
Nordic Nanovector ASA (OSE: NANO) announces that pharmacokinetic analyses of a clinical study in patients with non-Hodgkin lymphoma (NHL) demonstrate that pre-dosing with the anti-CD37 antibody HH1, prior to injection with Betalutin® (177Lu-HH1) significantly increases the pharmacokinetic exposure of NHL tumour cells to Betalutin® (p < 0.001) while protecting against haematological side effects.
The study, part of the ongoing Lymrit 37-01 Phase 1/2 trial of Betalutin® in NHL, evaluated 13 NHL patients who received different doses of Betalutin® either with or without HH1 pre-dosing. The analysis will be presented in an ePoster at the 21st Congress of the European Hematology Association (Copenhagen, Denmark, 9-12 June) by Dr Arne Kolstad, a senior consultant in medical oncology and radiotherapy at Oslo University Hospital, Radiumhospitalet and a member of Nordic Nanovector’s Scientific Advisory Board. The poster is available here EHA 2016 and at www.nordicnanovector.com in the section: Product Info/Scientific Posters.
Jostein Dahle, Nordic Nanovector CSO, commented: “The results presented in this poster continue to support our hypothesis that pre-dosing provides a protective effect on healthy tissues when used prior to Betalutin® treatment.”
The Lymrit 37-01 study is a Phase 1/2 open label, single injection ascending dose study investigating three dose levels of Betalutin® and different pre-dosing regimens in patients with relapsed NHL with the aim of identifying an optimal dose regimen to take into the Phase 2 PARADIGME study, which is expected to start in 2H 2017.
For further information, please contact:
Luigi Costa, Chief Executive Officer
Cell: +41 79 124 8601
Tone Kvåle, Chief Financial Officer
Cell: +47 91 51 95 76
Mark Swallow/David Dible (Citigate Dewe Rogerson)
Tel: +44 207 282 2948/+44 207 282 2949
About Nordic Nanovector
Nordic Nanovector is a biotech company focusing on the development and commercialisation of novel targeted therapeutics in haematology and oncology. The Company’s lead clinical-stage product opportunity is Betalutin®, the first in a new class of Antibody-Radionuclide-Conjugates (ARC) designed to improve upon a 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 worth over USD 12 billion by 2018. Betalutin® comprises a tumour-seeking anti-CD37 antibody (HH1) conjugated to a low intensity radionuclide (lutetium-177). The preliminary data has shown promising efficacy and safety profile in an ongoing Phase1/2 study in a difficult-to-treat NHL patient population. The Company is aiming at developing Betalutin® for the treatment of major types of NHL with first regulator submission anticipated in 1H 2019. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation to Betalutin® in core markets, while exploring potential distribution agreements in selected geographies. The Company is committed to developing its ARC pipeline to treat multiple selected cancer indications.
Further information about the Company can be found at www.nordicnanovector.com
This information is subject to the disclose requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.