Nordic Nanovector Announces Update from Archer-1 Phase 1b Trial of Betalutin® in combination with rituximab in 2L Follicular Lymphoma

Rhea-AI Summary

Nordic Nanovector ASA (OSE: NANOV) reported initial data from the Archer-1 Phase 1b trial, evaluating Betalutin® in conjunction with rituximab for second-line follicular lymphoma. The study showed significant clinical activity, with all seven patients responding—five achieving complete responses and two partial responses—some ongoing for up to two years. The safety profile was favorable, similar to Betalutin® alone, with no dose-limiting toxicities. The trial aims to establish Betalutin® as a viable treatment for patients facing relapsed or refractory disease.

Positive

• 7 out of 7 patients achieved a response in the trial, indicating strong efficacy.
• 5 complete responses and 2 partial responses reported.
• Safety profile of Betalutin® in combination with rituximab is favorable with no dose-limiting toxicities.

Negative

• None.

OSLO, Norway, May 25, 2021 /PRNewswire/ -- Nordic Nanovector ASA (OSE: NANOV) announces initial promising data from the Archer-1 Phase 1b trial investigating Betalutin® (¹⁷⁷Lu 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/m²) 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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SOURCE Nordic Nanovector

FAQ

What are the preliminary results from the Archer-1 Phase 1b trial of Betalutin® and rituximab?

The trial showed that all seven patients achieved a response, with five complete responses and two partial responses.

What is the primary objective of the Archer-1 trial?

The primary objective is to evaluate the safety and tolerability of Betalutin® in combination with rituximab.

When are the top-line results from the PARADIGME trial expected?

Top-line results from the PARADIGME trial are anticipated by the end of 2021.

What is the significance of the Archer-1 trial for Nordic Nanovector?

The trial represents a stepping stone in developing Betalutin® for challenging hematological tumors, contributing to the company's long-term strategy.

What is Betalutin® used for?

Betalutin® is designed to treat non-Hodgkin's lymphoma, specifically targeting CD37.