Updated results to be reported at the American Association of Cancer
Research Annual Meeting 2016
Nordic Nanovector ASA (OSE: NANO), a biotechnology company focusing on
the development of novel targeted therapeutics in haematology and
oncology, announces updated results of its ongoing Phase 1/2 study with
Betalutin® in relapsed non-Hodgkin lymphoma (NHL) patients. Betalutin®
was generally well tolerated and showed a 63.2% Overall Response Rate
(ORR) including 31.6% Complete Response (CR) among 21 patients with
previously treated CD37+ NHL patients. This data include two additional
patients whose efficacy data has become available following submission
of the abstract.
Data and analysis will be presented on Tuesday 19 April in a poster at
the American Association for Cancer Research (AACR) annual meeting
(16-20 April 2016, New Orleans, LA, USA) by Dr. Jostein Dahle, Nordic
Nanovector’s Chief Scientific Officer. A conference call to discuss the
results will be held on Monday 18 April at 8:30am CEST. Please see
conference call details below.
The data being presented in the poster at AACR are from the ongoing
Phase 1/2 single dose, open label, dose-finding study investigating
three dose levels of Betalutin® in 21 patients with relapsed CD37+ NHL,
19 with Follicular Lymphoma and two with Mantle Cell Lymphoma,
previously treated with one to eight treatment regimens. One patient
recruited into the study had transformed disease and was excluded from
the response rate calculation.
The updated data in the poster confirm the favourable safety profile of
Betalutin® and its promising efficacy as a single agent in patients who
have failed many prior regimens, characterised by a sustained duration
of response.
Key conclusions from the update include:
• Betalutin® is well tolerated, with a predictable and manageable safety
profile: most adverse events are haematological in nature, and all have
been transient and reversible
• Betalutin® delivers a highly favourable response rate (best response)
in this heavily pre-treated patient population (Overall Response Rate
63.2% and Complete Response 31.6%)
• The median Duration of Response (DoR) has not yet been reached.
Clinical responses observed are sustained, with DoR exceeding 12 months
in most responders
Luigi Costa, Nordic Nanovector’s Chief Executive Officer, commented:
“These new data continue to confirm Betalutin’s efficacy potential and
favourable safety profile. In addition, Duration of Response (DOR) in
patients who responded to treatment with Betalutin® has further improved
confirming the product’s potential to become a significant treatment of
NHL. These encouraging results support the continued clinical
development of Betalutin®. We are pleased with the progress that we are
making in executing our revised Phase 1/2 study and look forward to
confirming the optimal dosing regimen for the pivotal Phase 2 study,
PARADIGME, expected in Q1 2017.”
The poster will be presented between 8.00am -12.00pm Central Daylight
Time (CDT)/3:00pm – 7:00pm CEST on 19 April and will be available at: http://www.nordicnanovector.com/product-info/scientific-posters
at the same time.
The abstract (No. LB-252) was published today online at AACR
abstract.
Conference call details
A conference call to discuss the results will take place on Monday 18
April at 8.30am CEST.
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 21 00 26 10
Local - UK +44 (0) 203 043 2002
Local – USA and International +1 719 457 1036
Conference ID: 5241435
The presentation for the conference call will be publicly available at www.nordicnanovector.com
in the section; Investor relations/Reports and
Presentation/Presentation/2016.
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 www.nordicnanovector.com
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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