Oslo, Norway, 18 August 2016
Nordic Nanovector ASA (OSE: NANO), a biotechnology company focusing on the
development of novel targeted therapeutics in haematology and oncology,
announces that the first cohorts of both Arm 3 and 4 of the expanded Lymrit 37
-01 clinical study with Betalutin® have been completed. Betalutin® is a novel
anti-CD37 targeting Antibody Radionuclide Conjugate in development for the
treatment of major types of non-Hodgkin lymphoma (NHL), including Follicular
Lymphoma (FL).
Arm 3 is investigating the safety and efficacy of Betalutin® in relapsed FL
patients pre-dosed with standard anti-CD20 immunotherapy (rituximab) on Day 0, a
few hours prior to the administration of 15 MBq/kg Betalutin®. Arm 4 is
investigating the safety and efficacy of Betalutin® in relapsed FL patients pre
-dosed with high-dose unconjugated “cold” lilotomab (previously referred to as
HH1) anti-CD37 antibody on Day 0, a few hours prior to the administration of 15
MBq/kg Betalutin®.
Luigi Costa, Nordic Nanovector CEO, commented: “We are pleased to have completed
the first cohorts of both Arm 3 and Arm 4 of the expanded Lymrit 37-01 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 and an even more compelling product profile. The role of pre-dosing is
to potentially ensure better control of haematological side effects and more
specific tumour targeting with Betalutin®.”
A potential decision to increase the dose of Betalutin® to 17.5 MBq/kg or 20
MBq/kg in one or the other arm can be made based on the evaluation of the safety
and efficacy data observed in these first 3 patients of both arm.
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:
IR enquiries:
Luigi Costa, Chief Executive Officer
Cell: +41 79 124 8601
Tone Kvåle, Chief Financial Officer
Cell: +47 91 51 95 76
Email: ir@nordicnanovector.com
Media enquiries:
Mark Swallow/David Dible (Citigate Dewe Rogerson)
Tel: +44 207 282 2948/+44 207 282 2949
Email: nordicnanovector@citigatedr.co.uk
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
Forward-looking statements
This announcement may contain certain forward-looking statements and forecasts
based on uncertainty, since they relate to events and depend on circumstances
that will occur in the future and which, by their nature, will have an impact on
Nordic Nanovector’s business, financial condition and results of operations. The
terms “anticipates”, “assumes”, “believes”, “can”, “could”, “estimates”,
“expects”, “forecasts”, “intends”, “may”, “might”, “plans”, “should”,
“projects”, “will”, “would” or, in each case, their negative, or other
variations or comparable terminology are used to identify forward-looking
statement. There are a number of factors that could cause actual results and
developments to differ materially from those expressed or implied in a forward
-looking statement or affect the extent to which a particular projection is
realised. Factors that could cause these differences include, but are not
limited to, implementation of Nordic Nanovector’s strategy and its ability to
further grow, risks associated with the development and/or approval of Nordic
Nanovector’s products candidates, ongoing clinical trials and expected trial
results, the ability to commercialise Betalutin®, technology changes and new
products in Nordic Nanovector’s potential market and industry, the ability to
develop new products and enhance existing products, the impact of competition,
changes in general economy and industry conditions and legislative, regulatory
and political factors. No assurance can be given that such expectations will
prove to have been correct. Nordic Nanovector disclaims any obligation to update
or revise any forward-looking statements, whether as a result of new
information, future events or otherwise.
This information is subject to a duty of disclosure pursuant to Section 5-12 of
the Securities Trading Act.
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