On April 18, 2023 Nordic Nanovector ASA (OSE: NANOV) ("Nordic Nanovector" or the "Company") reported that full results from its Phase 2 clinical trials of Betalutin (177 Lu lilotomab satetraxetan) in resistant/refractory (R/R) indolent non-Hodgkin’s lymphoma (NHL) have been published at EudraCT, the European Union Drug Regulating Authorities Clinical Trials Database (the database for all interventional clinical trials on medicinal products submitted to the National Competent Authorities (NCAs) of the European Union) (Press release, Nordic Nanovector, APR 18, 2023, View Source [SID1234630284]). The data from the Phase 1b/2a LYMRIT 37-01 and the Phase 2b PARADIGME studies can be found via this link:
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EU Clinical Trials Register
As previously announced on 5 July 2022, the PARADIGME trial of Betalutin in 3rd-line follicular lymphoma patients refractory to rituximab/anti-CD20 (3L R/R FL) was discontinued following a comprehensive review and independent data evaluation and a subsequent request for regulatory agency interaction. The data from the 109 patients enrolled in PARADIGME up until its discontinuation show:
Overall response rate (ORR) was 38.9% and 32.1%; complete response (CR) rate was 20.8% and 14.3% in participants receiving doses of 40/15 (Betalutin dose of 15 MBq/kg after a pre-dose of 40 mg lilotomab) and 100/20 (Betalutin dose of 20 MBq/kg after a pre-dose of 100 mg lilotomab), respectively.
Median duration of response (DoR) was approximately 8.5 months for the 40/15 dose and 3.4 months for the 100/20 dose. Median duration of complete response (DoCR) was 8.5 months for 40/15 and 9.2 months for 100/20. DoR and DoCR are difficult to interpret due to the small number of responders.
Over half the participants had progressed 6 months following treatment. The median progression-free survival (PFS) was 5.9 months versus 5.8 months with 40/15 and 100/20, respectively.
The majority of treatment emergent adverse events (TEAEs) were due to cytopenias, most notably decreases in platelets (thrombocytopenia was observed in 19 [16.8%] and platelet count decreased in 11 [9.7%] participants) and neutrophils (neutropenia in 18 [15.9%] and decreased neutrophil count in six [5.3%] participants). Anaemia and fatigue were also reported in >10% of participants.
As previously communicated in the 5 July 2022 announcement, the former Board of Directors of Nordic Nanovector took the decision to wind-down PARADIGME in a structured manner while ensuring that patients received the best possible care during this period, as the observed profile did not fully meet the objectives set out for the study. As a result, the former Board was of the opinion that the demonstrated profile was no longer sufficiently competitive to bring Betalutin to the market in 3L R/R FL within a timeframe that made financial and commercial sense for the Company. The current board and management concurs with the decision to discontinue PARADIGME and Betalutin development in the 3L R/R FL indication.
The Company still believes there could be a market for Betalutin in light of its safety profile, promising efficacy in earlier lines of therapy and unique feature of being delivered as a one-time dose. However, a potential new development programme would need to be conducted in a different patient population and line of treatment and would require significant financial resources.
The Company is exploring all strategic options including potential partnerships to see if there is a possible way forward for Betalutin in an alternative setting.
Pipeline update:
The rest of Nordic Nanovector’s pipeline consists of:
1. Humalutin: a radioimmunotherapy candidate based on a chimeric anti-CD37 antibody and the beta-emitting radionuclide lutetium-177 for NHL. The project has been on hold since 2016 and all preclinical data have been published in the following journals:
· The European Journal of Nuclear Medicine and Molecular Imaging
· Nature Scientific Reports
· PLOS ONE
2. Alpha37: an alpha-emitting radioimmunotherapy candidate based on a chimeric anti-CD37 antibody conjugated to lead-212. The project is a collaboration with partner OranoMed and has been on hold since 2021. All preclinical data has been published in:
PLOS ONE
3. Fully humanized anti-CD37 antibodies with potential in haematological cancers and autoimmune diseases. Preclinical data were presented in two posters at ASH (Free ASH Whitepaper), both available on the Nordic Nanovector website:
ASH posters
The project has been on hold in 2023.
4. CD37 DOTA CAR-T cell opportunity in haematological cancers is a research collaboration with the University of Pennsylvania. Data from preliminary investigations were inconclusive and the project has been put on hold.
5. Solid tumour radioimmunotherapy: a project directed at radioimmunotherapy for solid tumours, where target identification has been concluded and several interesting molecular targets for solid tumour indications have been identified. Validation of targets and testing of minimal viable products are being evaluated.
The Board continues to focus on reducing costs where necessary to enable the Company to minimise cash burn until a strategic partner can be found.
No assurances can be given as to the outcome or timing of the ongoing strategic review process. The Company will put forward any recommended proposals for resolution by shareholders in due course.