Nordic Nanovector Announces First Patient Dosed in Archer-1 Trial of Betalutin® plus Rituximab in Follicular Lymphom
Oslo, Norway, 2 November 2018
Nordic Nanovector ASA (OSE: NANO) announces that the first patient has been
dosed in the Archer-1 trial investigating Betalutin® (177Lu-satetraxetan
-lilotomab) in combination with rituximab (RTX) in second-line follicular
lymphoma (2L FL).
Rituximab is a CD20-targeting monoclonal antibody that 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 RTX, thus
alternative targets are important. In addition, developing novel “chemo-free”
regimens for patients as an alternative to chemotherapy is desirable.
Archer-1 is a Phase 1b open-label, single-arm, multi-centre dose-escalation
trial to assess the safety and preliminary activity of combining CD37-targeted
Betalutin® with CD20-targeted RTX in 20-25 patients with relapsed/refractory FL
who have received one or more prior therapies. Starting doses of Betalutin® and
lilotomab are 10MBq/kg and 40mg, respectively, with the option for dose
escalation. Following Betalutin® dosing, patients will receive four weekly doses
of RTX (375mg/m2). The primary endpoint is safety, and secondary endpoints
include overall response rate, duration of response, progression free survival
and overall survival.
The rationale for Archer-1 was provided by preclinical data recently published
in the European Journal of Haematology in July 2018 (reference below). These
data demonstrate that treatment with the combination of Betalutin® and RTX
significantly prolonged overall survival in a murine model of NHL compared to
treatment with either agent alone, possibly by reverting downregulation of CD20
and resistance to RTX.
Eduardo Bravo, Nordic Nanovector CEO, commented: “Archer-1 presents an
opportunity to investigate the potential of a novel dual CD37/CD20-targeting
combination approach in 2L FL patients. If the preclinical results translate to
patients, this may indicate a new way to administer biologic therapy in FL.”
Reference
Repetto-Llamazares, A.H.V. et al. Combination of 177Lu-lilotomab with rituximab
significantly improves the therapeutic outcome in preclinical models of non
-Hodgkin’s lymphoma. Eur J Haematol. 2018 https://doi.org/10.1111/ejh.13139
-End-
For further information, please contact:
IR enquiries
Malene Brondberg, VP Investor Relations and Corporate Communications
Cell: +44 7561 431 762
Email: [email protected]
International Media Enquiries
Mark Swallow/David Dible (Citigate Dewe Rogerson)
Tel: +44 207 638 9571
Email: [email protected]
About Betalutin®
Betalutin® is a tumour-seeking anti-CD37 antibody (lilotomab) conjugated to a
low-intensity radionuclide (lutetium-177). It has shown promising efficacy and
safety in the first part of the Phase 1/2 LYMRIT 37-01 clinical study in
relapsed/refractory follicular lymphoma (R/R FL). A global, randomised Phase 2b
trial, PARADIGME, in third line (3L) FL patients who are refractory to anti-CD20
immunotherapy (including rituximab, RTX) is currently on-going. Betalutin® is
also being investigated in the Phase 1b Archer-1 study in combination with RTX
in second-line FL patients, and in the Phase 1 LYMRIT 37-05 study in patients
with R/R diffuse large B-cell lymphoma (DLBCL), the most common form of non
-Hodgkin’s lymphoma (NHL). Betalutin® has been granted Fast Track designation in
the US and Promising Innovative Medicine (PIM) Designation in the UK for the
treatment of patients with R/R FL. Betalutin® also received Orphan Drug
designations for FL in both the USA and Europe in 2014. Betalutin® is selective
for CD37, which is highly expressed on the surface of B-cell non-Hodgkin’s
lymphoma (NHL) cells. When bound to CD37 on tumour cells, Betalutin® is
internalised, causing DNA damage and cell death.
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 20 billion by 2024. Nordic Nanovector intends to retain
marketing rights and to actively participate in the commercialisation of
Betalutin® in core markets. Further information about the Company 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 Securi
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