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Nordic Nanovector ASA (OSE: NANOV) today provides an update on PARADIGME, its
Phase 2b trial of Betalutin[® ]([177]Lu lilotomab satetraxetan) in 3[rd]-line
relapsed and anti-CD20 refractory follicular lymphoma (3L R and R FL). Following
a comprehensive review and independent data evaluation of PARADIGME and a
subsequent request for regulatory agency interaction, the Board of Directors
(Board) has taken the difficult decision to discontinue the study. No further
patients will be enrolled into PARADIGME.
The PARADIGME trial enrolled a total of 109 patients. The Company will now
ensure a wind-down of PARADIGME in a structured manner ensuring patients receive
the best possible care during this period.
While Betalutin[®], at the selected dose of 15 MBq/kg after a pre-dose of 40 mg
lilotomab (40/15), has continued to display an attractive safety profile and
positive signs of efficacy in some patients, the Board considers that the
observed profile does not fully meet the objectives set out for the PARADIGME
study. Only one out of three patients responded to the treatment with the
average duration of the response of approximately six months. As a result, the
Board is of the opinion that the demonstrated profile is no longer sufficiently
competitive to bring Betalutin[®] to the market in the third line relapsed and
refractory FL indication, within a timeframe that makes financial and commercial
sense for the Company.
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. The Company will therefore explore potential
partnerships and will also seek advice from the US Food and Drug Administration
(FDA) to discuss if there could be a possible way forward for Betalutin[®] in an
alternative setting.
The Company will now focus its efforts and resources on developing its pipeline
of proprietary CD37-targeting products from which Nordic Nanovector believes it
can create value for shareholders over the longer term. These pipeline
opportunities include:
· Humalutin[®], a radioimmunotherapy candidate based on a chimeric anti-CD37
antibody and the beta-emitting radionuclide lutetium-177 for non-Hodgkin
lymphoma (NHL).
· Alpha37, an alpha-emitting radioimmunotherapy candidate based on a chimeric
anti-CD37 antibody conjugated to lead-212, currently being explored with partner
OranoMed for relapsed/refractory chronic lymphocytic leukaemia.
· A portfolio of fully humanized anti-CD37 antibodies with potential in
haematological cancers and autoimmune diseases.
· A CD37 DOTA CAR-T cell opportunity in haematological cancers, which is the
subject of a research collaboration with the University of Pennsylvania.
Following the decision to discontinue PARADIGME, the Board has also decided to
implement a restructuring of the Company with immediate effect with the purpose
of reducing costs where necessary to enable support of essential activities
associated with development of the pipeline.
The Company’s cash position at the end of Q2 2022 was approximately NOK 280m
(end of Q1 NOK 356.3m). Full Q2 results will now be reported on 31 August.
Chairman, Jan H. Egberts commented: "The decision to discontinue PARADIGME is
extremely disappointing not only for the Nordic Nanovector team, but also for
patients, healthcare providers and our shareholders as there continues to be an
unmet medical need in frail and elderly patients with Follicular Lymphoma. The
new independently reviewed data from PARADIGME, in an increasingly competitive
market and with the slow speed of recruitment makes progressing PARADIGME
further very difficult. Consequently, the Board no longer sees a viable path to
commercialisation in the current indication that would make sense for the
Company and its shareholders. We are extremely grateful to all the clinical
investigators and patients who have participated in PARADIGME.
CEO, Erik Skullerud commented: Our focus will now shift to our pipeline of other
CD37-targeting assets, which give us multiple shots on goal, including
Humalutin[®], Alpha37, a portfolio of fully humanized anti-CD37 antibodies and
the CD37 CAR-T. We look forward to communicating our development plans for these
assets in more detail in the coming months."
Nordic Nanovector will host a webcast at 08.30 CEST on Wednesday 6 July,
elaborating on the strategic decision to stop PARADIGME and including a Q&A
session. To join the webcast please sign up via our website
www.nordicnanovector.com.
For further information, please contact:
IR enquiries
Malene Brondberg, CFO
Cell: +44 7561 431 762
Email: ir@nordicnanovector.com
Media Enquiries
Mark Swallow/Frazer Hall (MEDiSTRAVA Consulting)
Tel: +44 203 928 6900
Email: nordicnanovector@medistrava.com
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. The
Company aspires to become a leader in radionuclide therapy of cancer. In
addition to Betalutin[®],[ ]for which Nordic Nanovector retains global marketing
rights, the Company’s novel pipeline includes Humalutin[®], a radioimmunotherapy
candidate based on a chimeric anti-CD37 antibody and the beta emitter lutetium
-177 for NHL; Alpha37, a based on a chimeric anti-CD37 antibody and the alpha
emitting radionuclide lead-212, currently being explored with partner Oranomed
for relapsed refractory chronic lymphocytic leukaemia; a portfolio of fully
humanized anti-CD37 antibodies with potential in haematological cancers and
autoimmune diseases; and a CD37 DOTA CAR-T cell opportunity in haematological
cancers, which is the subject of a research collaboration with the University of
Pennsylvania.
Further information can be found at www.nordicnanovector.com.
Forward-looking statements
This press release contains certain forward-looking statements. These statements
are based on management’s current expectations and are subject to uncertainty
and changes in circumstances, 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”, “targets”, “will”, “would” or, in each case, their
negative, or other variations or comparable terminology are used to identify
forward-looking statements. These forward-looking statements are not historic
facts. 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, the ability to commercialise Betalutin®,
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. 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 Norwegian Securities Trading Act.
Kilde
ikke helt sammenlignbart, men man trekker noe ut, gjennomfører chemoterapi og leverer det tilbake i blodbanen. Noe skjer, helt åpenbart, men hva? Og er det lignende mekanismer ved annen sykdom man kan få? 
