Nordic Nanovector Publishes Data from the PARADIGME Phase 2 Clinical Trials with Betalutin® on European Clinical Trials Database

18 Apr 2023 11:15 CEST

Oslo, Norway,18 April 2023

Nordic Nanovector ASA (OSE: NANOV) ("Nordic Nanovector" or the "Company")
announces that full results from its Phase 2 clinical trials of Betalutin®
(177Lu lilotomab satetraxetan) in resistant/refractory (R/R) indolent non
-Hodgkin's lymphoma (NHL) have been published at EudraCT, the European Union
Drug Regulating Authorities Clinical Trials Database (the database for all
interventional clinical trials on medicinal products submitted to the National
Competent Authorities (NCAs) of the European Union). The data from the Phase
1b/2a LYMRIT 37-01 and the Phase 2b PARADIGME studies can be found via this
link:

EU Clinical Trials Register (https://www.clinicaltrialsregister.eu/ctr
-search/trial/2011-000033-36/results)

As previously announced on 5 July 2022, the PARADIGME trial of Betalutin® in 3rd
-line follicular lymphoma patients refractory to rituximab/anti-CD20 (3L R/R FL)
was discontinued following a comprehensive review and independent data
evaluation and a subsequent request for regulatory agency interaction. The data
from the 109 patients enrolled in PARADIGME up until its discontinuation show:

· Overall response rate (ORR) was 38.9% and 32.1%; complete response (CR) rate
was 20.8% and 14.3% in participants receiving doses of 40/15 (Betalutin® dose of
15 MBq/kg after a pre-dose of 40 mg lilotomab) and 100/20 (Betalutin® dose of 20
MBq/kg after a pre-dose of 100 mg lilotomab), respectively.

· Median duration of response (DoR) was approximately 8.5 months for the 40/15
dose and 3.4 months for the 100/20 dose. Median duration of complete response
(DoCR) was 8.5 months for 40/15 and 9.2 months for 100/20. DoR and DoCR are
difficult to interpret due to the small number of responders.

· Over half the participants had progressed 6 months following treatment. The
median progression-free survival (PFS) was 5.9 months versus 5.8 months with
40/15 and 100/20, respectively.

· The majority of treatment emergent adverse events (TEAEs) were due to
cytopenias, most notably decreases in platelets (thrombocytopenia was observed
in 19?[16.8%] and platelet count decreased in 11 [9.7%] participants) and
neutrophils (neutropenia in 18?[15.9%] and decreased neutrophil count in six
[5.3%] participants). Anaemia and fatigue were also reported in >10% of
participants.

As previously communicated in the 5 July 2022 announcement, the former Board of
Directors of Nordic Nanovector took the decision to wind-down PARADIGME in a
structured manner while ensuring that patients received the best possible care
during this period, as the observed profile did not fully meet the objectives
set out for the study. As a result, the former Board was of the opinion that the
demonstrated profile was no longer sufficiently competitive to bring Betalutin®
to the market in 3L R/R FL within a timeframe that made financial and commercial
sense for the Company. The current board and management concurs with the
decision to discontinue PARADIGME and Betalutin® development in the 3L R/R FL
indication.

The Company still believes there could be a market for Betalutin®in light of its
safety profile, promising efficacy in earlier lines of therapy and unique
feature of being delivered as a one-time dose. However, a potential new
development programme would need to be conducted in a different patient
population and line of treatment and would require significant financial
resources.

The Company is exploring all strategic options including potential partnerships
to see if there is a possible way forward for Betalutin®in an alternative
setting.

Pipeline update:

The rest of Nordic Nanovector's pipeline consists of:

1. Humalutin®: a radioimmunotherapy candidate based on a chimeric anti-CD37
antibody and the beta-emitting radionuclide lutetium-177 for NHL. The project
has been on hold since 2016 and all preclinical data have been published in the
following journals:

· The European Journal of Nuclear Medicine and Molecular
Imaging (https://link.springer.com/article/10.1007/s00259-019-04417-1)
· Nature Scientific
Reports (https://www.nordicnanovector.com/sites/default/files/Giesen_89Zr
-PET_imaging_SciRep2022.pdf)
· PLOS
ONE (https://www.nordicnanovector.com/sites/default/files/PLOS%20ONE.0267543%20
-%20April%202022.pdf)

2. Alpha37: an alpha-emitting radioimmunotherapy candidate based on a chimeric
anti-CD37 antibody conjugated to lead-212. The project is a collaboration with
partner OranoMed and has been on hold since 2021. All preclinical data has been
published in:

· PLOS
ONE (https://www.nordicnanovector.com/sites/default/files/Targeted%20alpha%20the
r
apy%20for%20chronic%20lymphocytic%20leukaemia%20and%20non
-Hodgkin%E2%80%99s%20lymphoma%20with%20the%20anti
-CD37%20radioimmunoconjugate%20212Pb-NNV003.pdf)

3. Fully humanized anti-CD37 antibodies with potential in haematological cancers
and autoimmune diseases. Preclinical data were presented in two posters at ASH,
both available on the Nordic Nanovector website:

· ASH posters (https://nordic.prod-mid-euw3.investis.com/node/435)

The project has been on hold in 2023.

4. CD37 DOTA CAR-T cell opportunity in haematological cancers is a research
collaboration with the University of Pennsylvania. Data from preliminary
investigations were inconclusive and the project has been put on hold.

5. Solid tumour radioimmunotherapy: a project directed at radioimmunotherapy for
solid tumours, where target identification has been concluded and several
interesting molecular targets for solid tumour indications have been identified.
Validation of targets and testing of minimal viable products are being
evaluated.

The Board continues to focus on reducing costs where necessary to enable the
Company to minimise cash burn until a strategic partner can be found.

No assurances can be given as to the outcome or timing of the ongoing strategic
review process. The Company will put forward any recommended proposals for
resolution by shareholders in due course.

IR enquiries

Ludvik Sandnes, Interim CEO & CFO
ir@nordicnanovector.com
+4790743017

About Nordic Nanovector

Nordic Nanovector is committed to develop and deliver innovative therapies to
patients to address major unmet medical needs and advance cancer care.

Further information can be found at
www.nordicnanovector.com (https://nam10.safelinks.protection.outlook.com/?url=ht
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4QCaKkOEaehniofM%3D&reserved=0)

Forward-looking statements

This press release contains certain forward-looking statements relating to inter
alia to the business and strategies, financial performance and results of the
Company. Forward-looking statements concern future circumstances and results and
other statements that are not historical facts. These statements are based on
Nordic Nanovector's current expectations and are subject to uncertainty and
changes in circumstances. Any forward-looking statements contained in this
release, including assumptions, opinions and views of Nordic Nanovector or cited
from third party sources, are subject to risks, uncertainties and other factors
that may cause actual results and events to be materially different from those
expected or implied by the forward-looking statements. Nordic Nanovector cannot
provide any assurance that the assumptions underlying such forward-looking
statements are free from errors nor accept any responsibility for the future
accuracy of opinions expressed in this release or the actual occurrence of any
forecasted developments. Nordic Nanovector disclaims any obligation to update or
revise any forward-looking statements, whether as a result of new information,
future events or otherwise.

The terms "anticipates", "assumes", "believes", "can", "could", "estimates",
"expects", "forecasts", "intends", "may", "might", "plans", "should",
"projects", "targets", "will", "would" or, in each case, their negative, or
other variations or comparable terminology are used to identify forward-looking
statements. There are a number of factors that could cause actual results and
developments to differ materially from those expressed or implied in the forward
-looking statements. Factors that could cause these differences include, but are
not limited to, risks associated with implementation of Nordic Nanovector's
strategy, risks and uncertainties associated with the development and/or
approval of Nordic Nanovector's product candidates, ongoing and future clinical
trials and expected trial results technology changes and new products in Nordic
Nanovector's potential market and industry, Nordic Nanovector's freedom to
operate (competitors patents) in respect of the products it develops, 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.

This information is subject to a duty of disclosure pursuant to Sections 4-2 and
5-12 of the Securities Trading Act.

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