Updated results from Phase 1/2 trial of Betalutin® in non-Hodgkin lymphoma to be presented at ASH annual meeting in December
Oslo, Norway, 3 November 2016
Nordic Nanovector ASA (OSE: NANO) announces that updated results and analysis from its ongoing Phase 1/2 clinical trial of Betalutin® (177Lu-satetraxetan-lilotomab) in subjects with relapsed/refractory non-Hodgkin lymphoma (NHL) will be presented in a poster at the 58th Annual American Society of Hematology (ASH) meeting (3-6 December 2016 in San Diego, CA, USA).
The Lymrit 37-01 study is an ongoing 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 pivotal Phase 2.
The poster will provide an update of safety and efficacy results (including duration of response) in the Lymrit 37-01 trial to those previously presented in April at the American Association of Cancer Research (AACR) annual meeting (21 patients) and to those noted in the abstract published by ASH today (abstract 1780), which includes data as of 8 August 2016 (date of submission of the abstract to ASH), based on 24 evaluable NHL patients from 36 patients enrolled at the time. See details on abstract 1780 below.
The poster will include the first available safety and efficacy results from patients enrolled into Arms 3 and 4 of the trial who received two different pre-dosing regimens prior to Betalutin® injection.
The ASH annual meeting is the premier event for scientific exchange in the field of hematology, attracting more than 20,000 attendees from all over the world. Typically, more than 5,000 scientific abstracts are submitted each year, and more than 3,000 abstracts are accepted for oral and poster presentations through an extensive peer review process.
Abstract title: 177lu-Satetraxetan-Lilotomab in the Treatment of Patients with Indolent Non-Hodgkin B-Cell Lymphoma (NHL), Phase 1/2 Safety and Efficacy Data from Four Different Pre-Dosing Regimens
Authors: Kolstad, A et al.
Session Name: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster I
Date/Time: Saturday, 3 December 2016, 5:30 PM – 7:30 PM (Pacific Std Time)
Location: San Diego Convention Center, Hall GH
Link to abstract: https://ash.confex.com/ash/2016/webprogram/Paper97356.html
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 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 worth over $12 billion by 2018.
Betalutin® comprises a tumour-seeking anti-CD37 antibody, lilotomab (previously referred to as HH1), conjugated to a low intensity radionuclide (lutetium-177). The preliminary data has shown promising efficacy and safety profile in an ongoing Phase 1/2 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 regulatory submission anticipated in 1H 2019.
Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of 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.
Source: Nordic Nanovector