Beskrivning
Land | Norge |
---|---|
Lista | OB Match |
Sektor | Hälsovård |
Industri | Läkemedel & Handel |
2020-11-19 07:02:12
Oslo, Norway, 19 November 2020
Nordic Nanovector ASA (OSE: NANO) announces that it enrolled the final two
patients into the second safety cohort of its Phase 1 Archer-1 (LYMRIT 37-07)
trial investigating safety and preliminary efficacy of Betalutin® ([177]Lu
lilotomab satetraxetan) in combination with rituximab in 2[nd]-line follicular
lymphoma (2L FL).
The dosing regimen in this cohort is a single administration of 15 MBq/kg
Betalutin® preceded by 40mg lilotomab, followed by 375 mg/m[2] rituximab once
per week for four weeks.
Data from this cohort is expected in H1'2021 and will be analysed alongside the
data generated from the first cohort of patients receiving 10 MBq/kg
Betalutin®/40mg lilotomab.
As announced in April 2020, Archer-1 is expected to be paused pending this
analysis, which is expected to inform plans for the further development of
Betalutin® development in 2L FL. The Company's primary focus for its resources
is on the timely completion of the pivotal Phase 2b PARADIGME trial of
Betalutin® in 3rd-line FL (3L FL).
Christine Wilkinson Blanc, Chief Medical Officer of Nordic Nanovector, said: "We
are pleased to complete patient enrolment into the second safety cohort of
Archer-1. We look forward to the results from this cohort in H1'2021, which will
add to our understanding of Betalutin® use in FL patients. The data will also
inform our thinking towards further development strategies for Betalutin® in
broader FL populations than that being investigated in our PARADIGME trial in 3L
FL."
About Archer-1
Archer-1 is a Phase 1b open-label, single-arm, multi-centre dose-escalation
trial designed to assess the safety and preliminary activity of combining the
CD37-targeted radioimmunoconjugate Betalutin® with the CD20-targeted
immunotherapy rituximab in patients with relapsed/refractory (2L) FL who have
received one or more prior therapies.
Rituximab was approved for the treatment of non-Hodgkin's lymphoma (NHL),
including FL, more than 20 years ago and is the current standard of care. It is
administered to patients with newly diagnosed or relapsed FL as a single agent
or in combination with chemotherapy. Over time, patients may develop resistance
to rituximab, thus alternative targets and new treatments are important.
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/David Dible (Citigate Dewe Rogerson)
Tel: +44 203 926 8535
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 retains global marketing
rights to Betalutin® and intends to actively participate in the
commercialisation of Betalutin® in the US and other major 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 Sections 4-2 and
5-12 of the Securities Trading Act.