Nordic Nanovector to Discontinue PARADIGME, its Phase 2b Trial with Betalutin[®] in 3L R and R Follicular Lymphoma
Oslo, Norway, 5 July 2022
Nordic Nanovector ASA (OSE: NANOV) today provides an update on PARADIGME, its Phase 2b trial of Betalutin® (177Lu lilotomab satetraxetan) in 3rd-line relapsed and anti-CD20 refractory follicular lymphoma (3L R and R FL). Following a comprehensive review and independent data evaluation of PARADIGME and a subsequent request for regulatory agency interaction, the Board of Directors (Board) has taken the difficult decision to discontinue the study. No further patients will be enrolled into PARADIGME.
The PARADIGME trial enrolled a total of 109 patients. The Company will now ensure a wind-down of PARADIGME in a structured manner ensuring patients receive the best possible care during this period.
While Betalutin®, at the selected dose of 15 MBq/kg after a pre-dose of 40 mg lilotomab (40/15), has continued to display an attractive safety profile and positive signs of efficacy in some patients, the Board considers that the observed profile does not fully meet the objectives set out for the PARADIGME study. Only one out of three patients responded to the treatment with the average duration of the response of approximately six months. As a result, the Board is of the opinion that the demonstrated profile is no longer sufficiently competitive to bring Betalutin® to the market in the third line relapsed and refractory FL indication, within a timeframe that makes financial and commercial sense for the Company.
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. The Company will therefore explore potential partnerships and will also seek advice from the US Food and Drug Administration (FDA) to discuss if there could be a possible way forward for Betalutin® in an alternative setting.
The Company will now focus its efforts and resources on developing its pipeline of proprietary CD37-targeting products from which Nordic Nanovector believes it can create value for shareholders over the longer term. These pipeline opportunities include:
- Humalutin®, a radioimmunotherapy candidate based on a chimeric anti-CD37 antibody and the beta-emitting radionuclide lutetium-177 for non-Hodgkin lymphoma (NHL).
- Alpha37, an alpha-emitting radioimmunotherapy candidate based on a chimeric anti-CD37 antibody conjugated to lead-212, currently being explored with partner OranoMed for relapsed/refractory chronic lymphocytic leukaemia.
- A portfolio of fully humanized anti-CD37 antibodies with potential in haematological cancers and autoimmune diseases.
- A CD37 DOTA CAR-T cell opportunity in haematological cancers, which is the subject of a research collaboration with the University of Pennsylvania.
Following the decision to discontinue PARADIGME, the Board has also decided to implement a restructuring of the Company with immediate effect with the purpose of reducing costs where necessary to enable support of essential activities associated with development of the pipeline.
The Company’s cash position at the end of Q2 2022 was approximately NOK 280m (end of Q1 NOK 356.3m). Full Q2 results will now be reported on 31 August.
Chairman, Jan H. Egberts commented: “The decision to discontinue PARADIGME is extremely disappointing not only for the Nordic Nanovector team, but also for patients, healthcare providers and our shareholders as there continues to be an unmet medical need in frail and elderly patients with Follicular Lymphoma. The new independently reviewed data from PARADIGME, in an increasingly competitive market and with the slow speed of recruitment makes progressing PARADIGME further very difficult. Consequently, the Board no longer sees a viable path to commercialisation in the current indication that would make sense for the Company and its shareholders. We are extremely grateful to all the clinical investigators and patients who have participated in PARADIGME.
CEO, Erik Skullerud commented: Our focus will now shift to our pipeline of other CD37-targeting assets, which give us multiple shots on goal, including Humalutin®, Alpha37, a portfolio of fully humanized anti-CD37 antibodies and the CD37 CAR-T. We look forward to communicating our development plans for these assets in more detail in the coming months.”
Nordic Nanovector will host a webcast at 08.30 CEST on Wednesday 6 July, elaborating on the strategic decision to stop PARADIGME and including a Q&A session. To join the webcast please sign up via our website www.nordicnanovector.com.
For further information, please contact:
Malene Brondberg, CFO
Cell: +44 7561 431 762
Mark Swallow/Frazer Hall (MEDiSTRAVA Consulting)
Tel: +44 203 928 6900
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 radionuclide therapy of cancer. In addition to Betalutin®,for which Nordic Nanovector retains global marketing rights, the Company’s novel pipeline includes Humalutin®, a radioimmunotherapy candidate based on a chimeric anti-CD37 antibody and the beta emitter lutetium-177 for NHL; Alpha37, a based on a chimeric anti-CD37 antibody and the alpha emitting radionuclide lead-212, currently being explored with partner Oranomed for relapsed refractory chronic lymphocytic leukaemia; a portfolio of fully humanized anti-CD37 antibodies with potential in haematological cancers and autoimmune diseases; and a CD37 DOTA CAR-T cell opportunity in haematological cancers, which is the subject of a research collaboration with the University of Pennsylvania.
Further information can be found at www.nordicnanovector.com.
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 Norwegian Securities Trading Act.
Source: Nordic Nanovector