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Nordic Nanovector: Nordic Nanovector announces first patient enrolled in the last cohort (Arm 4) of expanded Phase 1/2 study of Betalutin® in NHL patients

Date: 18.05.2016        Press Release no: 25/2016

Oslo, Norway, 18 May 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 patient has been enrolled into the
second of the two new arms, and the last cohort, of its expanded
Lymrit 37-01 clinical study with Betalutin®.

Betalutin® is a novel anti-CD37 targeting Antibody Radionuclide
Conjugate in development for the treatment of major types of
non-Hodgkin's lymphoma (NHL), including Follicular Lymphoma (FL).

The final cohort (Arm 4) is designed to investigate the safety and
efficacy of Betalutin® in up to 12 patients with relapsed FL
pre-dosed with high-dose unconjugated "cold" HH1 anti-CD37 antibody
on Day 0, a few hours prior to the injection of Betalutin®.

Luigi Costa, Nordic Nanovector CEO, commented: "We are pleased to
initiate the last arm in the Lymrit 37-01 study. The data so far
shown for Betalutin® with low-dose HH1 pre-dosing (AACR April 2016)
are highly encouraging for this group of patients. Arms 3 and 4 in
the study are designed to investigate if different pre-dosing
regimens will allow the use of higher doses of Betalutin® to
potentially achieve an even stronger product profile with an even
higher efficacy. We believe that this can be achieved using a regimen
that ensures better control of haematological side effects and more
specific tumour targeting with Betalutin®. With this last Arm
Betalutin's clinical development plan for FL is in full execution
mode according to our planned timelines."

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.

Data and analysis recently published at the American Association of
Cancer Research annual meeting (16-20 April) confirmed that
Betalutin® was generally well tolerated and showed a 63.2% Overall
Response Rate (ORR) and a 31.6% Complete Response (CR) in evaluable
patients. Clinical responses observed were sustained, with Duration
of Response exceeding 12 months in most responders in the 15 MBq/kg
group who have been followed up for at least 12 months.

Patient recruitment into the Phase 2 part of Arm 1 (15Mbq/kg plus
50mg/ml "cold" HH1 anti-CD37 antibody) is progressing as planned with
dose-escalation expected to begin in 2H 2016.

A decision to increase the dose of Betalutin to 17.5 MBq/kg in Arm 1
can be made based on the evaluation of the safety and efficacy data
observed in the 15 patients treated with 15 MBq/kg. A decision to
increase the dose of Betalutin to 17.5 MBq/kg or 20 MBq/kg in one or
the other of Arms 3 and 4 can be made based on the evaluation of the
safety and efficacy data observed in the first three patients of both

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 (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

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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