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Nordic Nanovector: Safety Review Committee for Nordic Nanovector's Lymrit 37-01 trial recommends dose escalation to 20 MBq/kg with Betalutin®

Date: 04.11.2016        Press Release no: 54/2016

Oslo, Norway, 4 November 2016

Nordic Nanovector ASA (OSE: NANO) announces that the independent
Safety Review Committee (SRC) for the ongoing Lymrit 37-01 clinical
trial of Betalutin® in relapsed/refractory NHL, has recommended
escalating the dose of Betalutin® in Arm 4 from 15 MBq/kg to 20
MBq/kg following pre-dosing with 100 mg/m2 lilotomab. Recruitment of
3 patients into Arm 4 to receive this new higher dosing regimen is
now underway. The SRC also concluded that Arm 3 should be

The decision follows a review by the SRC of the available safety and
dosimetry data from the first cohorts of 3 patients each enrolled in
Arms 3 and 4 to determine which arm should continue, if dose
escalation is warranted and to what extent. Patients in Arm 3 were
pre-dosed with standard rituximab immunotherapy prior to receiving 15
MBq/kg Betalutin®; patients in Arm 4 received 100 mg/m2 lilotomab
prior to 15 MBq/kg Betalutin®.

The SRC recommendation for advancing Arm 4 was based on safety data
demonstrating that pre-dosing with 100 mg/m2 lilotomab prior to
Betalutin® reduces bone marrow toxicity as a result of lower absorbed
radiation dose to this tissue. In addition, available dosimetry data
from Arm 4 showed that higher pre-dosing does not prevent
therapeutically relevant amounts of Betalutin® being taken up into
the tumours.

Update on dose escalation in Arm 1/Phase 2

The SRC has also agreed that the company can change the treatment
regimen used in Arm 1/Phase 2 to match that used in Arm 4. The dose
of Betalutin® specified in Phase 2 will be increased from 15 MBq/kg
to 20 MBq/kg pending review of the safety data from the first 3
patients treated in Arm 4 with 20 MBq/kg.

Escalation to the new higher dosing regimen in Arm 1/Phase 2 will also
require the approval of a protocol amendment by the European
regulators. The planned amendment will allow for additional patients
to be enrolled into Arm 1/Phase 2, which is expected to contribute to
building a more robust safety database, particularly with data from
patients receiving the new higher dosing regimen.

Luigi Costa, Nordic Nanovector CEO, commented: "This is an important
milestone in the development of Betalutin® in FL. We are delighted
with outcome of the SRC review that provides us with the opportunity
to test a higher dose of Betalutin®. We believe that the new dosing
regimen will deliver an even higher efficacy than that so far
observed and favourable safety, based on the evidence to date. We are
confident that we will meet our goal of having a clear view on the
optimum dosing regimen to use in the pivotal PARADIGME trial by the
end of the first quarter 2017 as planned."

About Lymrit 37-01

The LYMRIT 37-01 study is an ongoing Phase 1/2 open label, single
injection ascending dose study investigating in 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 a pivotal Phase 2 PARADIGME trial.

Updated results from the Lymrit 37-01 trial including those in Arms 3
and 4, will be presented at the 58th Annual American Society of
Hematology (ASH) meeting on 3 December 2016.

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

Media enquiries:
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

This information is subject to the disclose requirements pursuant to
section 5-12 of the Norwegian Securities Trading Act.


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