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New plan designed to enhance the chances of Betalutin®, gaining
regulatory approval with a competitive product profile
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Current cash resources expected to be sufficient until first
submission, anticipated 1H 2019
Nordic Nanovector ASA (OSE:NANO), a company focusing on the development
and commercialisation of novel targeted therapeutics in haematology and
oncology, announces that it has taken the decision to revise its
clinical development plan for Betalutin®, its lead product candidate in
development for the treatment of major types of non-Hodgkin’s lymphoma
(NHL), including Follicular Lymphoma.
A conference call to discuss the revised development plan will take
place today at 9.30 a.m. CET / 8.30 a.m. BST – details below.
Luigi Costa, CEO of Nordic Nanovector, said: “We believe that our
decision to revise the clinical development plan for Betalutin® makes
good strategic sense. In light of newly available data and experts’
advice with regard to pre-dosing, we have concluded that we now have a
new opportunity to determine the best regimen to take into the pivotal
Phase 2 PARADIGME trial. We are confident that by establishing the most
appropriate regimen through an expanded Phase 1/2 study, rather than as
part of PARADIGME, we will greatly improve the chances of successfully
gaining regulatory approval for Betalutin® with a product profile that
would make it a competitive new treatment for follicular lymphoma. I
would like to thank all our advisors for their valuable input to this
decision.”
The revised clinical development plan sees the previous dose-finding
element of the pivotal PARADIGME trial being expanded and integrated
into the Phase 1/2 (Lymrit 37-01) trial that is currently underway.
Previously, the dose-finding element was to be conducted in parallel as
a ‘run-in’ phase to PARADIGME to potentially accelerate the time to
approval. PARADIGME is now being planned as a single arm efficacy and
safety trial.
The revised Phase 1/2 trial is projected to read out around the end of
Q1 2017 and will allow the selection of the optimal dosing regimen to be
used for the amended PARADIGME trial, which is now expected to start in
1H 2017. As a result, the first regulatory submission for Betalutin® is
expected in the 1H 2019.
Based on the current plan, the Company expects that cash resources will
be sufficient to reach the first regulatory submission despite the
extended timelines. This is due to the overall reduction in patient
numbers required for the PARADIGME study in the revised plan.
Conference call details
A conference call to discuss the revised development plan will take
place today at 9.30 a.m. CET / 8.30 a.m. BST.
Please make sure to dial in 5-10 minutes prior to scheduled conference
call start time using the number and confirmation code below:
Local - Norway +47 2350 0486
Local - UK +44 (0)20 3427 1912
Local
– USA and International ++1 646 254 3366
Confirmation Code: 4608153
The presentation for the conference call will be publicly available at www.nordicnanovector.com
in the section; Investor relations/Reports and
Presentation/Presentation/2015.
For further information, please contact:
Luigi Costa, Chief Executive Officer
Cell: +41 79 124 8601
Tone Kvåle, Chief Financial Officer
tkvale@nordicnanovector.com
Tel:
+47 22 18 33 01
Cell: +47 91 51 95 76
International Media Enquiries
Mark Swallow/David Dible (Citigate
Dewe Rogerson)
mark.swallow@citigatedr.co.uk
/ david.dible@citigatedr.co.uk
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). It has shown
promising efficacy and a favourable 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
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