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Archer-1 Phase 1b trial investigating Betalutin® ([177]Lu lilotomab
satetraxetan) in combination with rituximab (RTX) in second-line follicular
lymphoma (2L FL).
The preliminary results show clinical activity with seven out of seven patients
achieving a response, including 5 complete responses and 2 partial responses.
All responses are currently ongoing, 5 of them 2 years after Betalutin®
administration.
Across this patient group, Betalutin® with RTX showed a very good safety
profile, comparable to that of single agent Betalutin®, with no dose limiting
toxicities observed.
Archer-1 is a Phase 1b open-label, single-arm, multi-centre dose-escalation
trial to assess the safety and preliminary activity of CD37-targeted Betalutin®
in combination with CD20-targeted RTX in patients with relapsed/refractory FL
who have received one or more prior therapies.
The starting doses of Betalutin® and lilotomab were 10MBq/kg and 40mg,
respectively, which was escalated to Betalutin® 15MBq/kg and lilotomab 40mg in
the second cohort. Following Betalutin® dosing, patients received four weekly
doses of RTX (375mg/m[2]) on days 7, 14, 21 and 28. Patients who did not
progress (including CR, PR, SD) were scheduled to receive RTX maintenance for 2
years.
The primary objective of the study was to evaluate the safety and tolerability
of Betalutin® in combination with RTX, the secondary objective to evaluate the
preliminary anti-tumour activity of combination treatment.
The rationale for Archer-1 was provided by earlier preclinical data showing
Betalutin® can up-regulate CD20 expression in different rituximab-sensitive NHL
cell lines and act synergistically with rituximab in a rituximab-sensitive NHL
animal model and, more recently, that Betalutin® has the potential to counteract
resistance to rituximab in non-Hodgkin’s lymphoma models.
Peter Braun, Nordic Nanovector CEO, commented: "We are encouraged by the results
in this small Phase I study in second line FL patients. Both the overall safety
of this combination and the preliminary signs of efficacy are promising. We look
at this study as an additional building block in our overall strategy to develop
Betalutin® for difficult to treat hematological tumors. Our near-term focus
remains very much on completing PARADIGME in 3L FL and delivering top line 3
-month data by the end of 2021.
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 26 billion by 2028. 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.
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