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for all responders and 32.0 months for complete responders versus 9.0 months and
20.7 months respectively reported last December at ASH
· Archer-1 - 100% ORR (3/3 complete response (CR)) in the first cohort of
patients in a phase 1b study of Betalutin® + rituximab in relapsed/refractory
follicular lymphoma
Preclinical
· NOK 6 million in Eurostars funding granted for taking the chimeric alpha
-particle emitting anti-CD37 radioimmunoconjugate Alpha37 through the last step
towards clinical testing
· Superior efficacy of Alpha37 with respect to market leading ibrutinib has
been shown in an ibrutinib-resistant mouse model of chronic lymphocytic leukemia
(CLL)
Oslo, Norway, 17 September 2019
Nordic Nanovector ASA (OSE: NANO) will today host an R&D day in Oslo. The
programme will include presentations from three external experts and by Nordic
Nanovector’s senior management team. The full programme of the event is
available at www.nordicnanovector.com under press releases.
The R&D day presentations will cover
· the progress of the company’s research and pre-clinical projects
· the clear medical need in the patient populations suffering from the
diseases targeted by Nordic Nanovector products in development and
· the latest data on some of the clinical trials currently being conducted.
In addition, the company will provide an update on its work and progress on the
CMC (Chemistry, Manufacturing and Control) area, which will be a key part of the
planned regulatory filing for Betalutin® in the first half of 2021.
The pivotal Phase 2b PARADIGME trial of Betalutin® in advanced recurrent
follicular lymphoma (FL) is progressing with 83 sites in 24 countries open for
enrolment as of September 16th, 2019.
“The clinical results obtained so far with Betalutin® demonstrate that the
rationale behind its design for the treatment of non-Hodgkin’s lymphoma was
right”, commented Dr Jostein Dahle, Chief Scientific Officer and Co-founder of
Nordic Nanovector. “Over the last ten years we have continued to advance our
knowledge of the biology of the disease and the peculiarities of our treatment
modality in general and Betalutin® in particular. We are very excited with the
data we continue to generate and the opportunities that this information will
provide to keep the company at the forefront of this race towards finding new
and improved therapies or combinations that will benefit the thousands of
patients still at need”.
Dr J.P. Pouget, PhD, Radiobiology and targeted radiotherapy group Montpellier
Cancer Research Institute (IRCM), French National Institute of Health and
Medical Research (INSERM) will present interesting new pre-clinical results with
Betalutin®, including its increased therapeutic activity when combined with cell
cycle inhibitors.
Dr Jostein Dahle will summarize the focus and most recent advances of Nordic
Nanovector’s research. During his presentation, he will preview data that will
be presented at the EANM (European Association of Nuclear Medicine) Congress in
Barcelona in October that shows the synergistic effect of Humalutin® with the
PARP inhibitor Olaparib in DLBCL (Diffuse Large B Cell Lymphoma) cell lines.
Dr Jostein Dahle will also explain in detail some of the data that the company
has generated with Alpha37 (an anti-CD37 mAb linked to alpha-particle generating
lead 212). This will include demonstration of the superiority of Alpha37 to
ibrutinib in an ibrutinib-resistant mouse model of CLL (chronic lymphocytic
leukaemia). Ibrutinib is today the most widely used product in this indication,
both first line and second line. These data have been selected for the
highlights session of the already mentioned EANM Congress in Barcelona. Alpha37,
which is partnered with OranoMed, has recently been awarded a grant of NOK 6
million by the Eurostar programme.
Prof Pier Luigi Zinzani, Professor of Hematology at Bologna University, will
analyse the therapeutic landscape in recurrent FL and marginal zone lymphoma
(MZL), reviewing the efficacy and safety profile of approved agents and products
in development. Despite the availability of new therapies, the unmet medical
need in recurrent FL and MZL is still high.
Dr Arne Kolstad from the Department of Oncology, Oslo University Hospital, and
the Principal Investigator of the LYMRIT-37-01 trial, will hold a presentation
which provides the latest update from this trial of Betalutin® in patients with
relapsed indolent NHL.
With a median follow-up time for responders of 30 months, this latest update
confirms a median duration of response (mDoR) of 13.6 months for all 45
responders and an even more durable response of 32.0 months for the 22 patients
showing a complete response (compared with 9.0 and 20.7 respectively last
December at ASH).
Dr Arne Kolstad will also present data from the first safety cohort of three
patients of the Phase 1b Archer-1 study of Betalutin® + rituximab (RTX) in
relapsed/refractory follicular lymphoma. This open label, single-arm dose
escalation study in 2L FL expects to recruit a total of 20-25 patients to
evaluate the safety and tolerability of Betalutin® in combination with RTX and
to evaluate the preliminary anti-tumour activity of combination treatment.
In the first safety cohort an overall response rate of 100% was observed with
three complete responders and importantly no dose limiting toxicities. Full data
read out from this study is expected in the second half of 2020.
With Nordic Nanovector’s strategic priorities focused on efforts to maximize the
value of Betalutin® across the major types of NHL (FL and DLBCL) and in earlier
treatment lines in combination with standard treatments, we decided together
with our partner Heidelberg Pharma to discontinue development of NNV014 (anti
-CD37 ADC), an early stage discovery project in leukaemia.
“The data presented during this R&D day highlights our potential to become a
leader in radiopharmaceuticals and our commitment to deliver innovative products
for the patients suffering from these devastating diseases”, commented Eduardo
Bravo, CEO of Nordic Nanovector. “We are very pleased with the latest results
from the LYMRIT-37-01 study and with the early indications from the first safety
cohort in Archer-1. These encouraging data support our decision to broaden the
clinical development of Betalutin® in NHL and to develop the regulatory and
commercial strategy for a commercial launch in the US. We are entering an
exciting phase in the company’s development with key data due to be reported
next year and the prospect of our first regulatory filing for Betalutin® in
third line FL in the first half of 2021.”
For further information, please contact:
IR enquiries
Malene Brondberg, VP Investor Relations and Corporate Communications
Cell: +44 7561 431 762
Email: ir@nordicnanovector.com
International Media Enquiries
Mark Swallow/David Dible (Citigate Dewe Rogerson)
Tel: +44 207 638 9571
Email: nordicnanovector@citigatedewerogerson.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 the development of targeted therapies for
haematological cancers. Nordic Nanovector’s lead clinical-stage candidate is
Betalutin®, a novel CD37-targeting antibody-radionuclide-conjugate designed to
advance the treatment of non-Hodgkin’s lymphoma (NHL). NHL is an indication with
substantial unmet medical need, representing a growing market forecast to be
worth nearly USD 29 billion by 2026. Nordic Nanovector intends to retain
marketing rights and to actively participate in the commercialisation of
Betalutin® in core markets. 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 Securities Trading Act.
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