Nordic Nanovector to discontinue PARADIGM, its Phase 2b trial with Betalutin® in 3L R and R follicular lymphoma
The webcast will take place at 08:30 CEST on Wednesday July 6
Oslo, Norway, July 5, 2022 /PRNewswire/ — Nordic Nanovector ASA (OSE: NANOV) today provides an update on PARADIGM, its phase 2b Betalutin test® (177Lu lilotomab satetraxetan) in 3rd-recurrent follicular lymphoma refractory to anti-CD20 (3L R and R FL). Following a comprehensive review and independent assessment of PARADIGM’s data and a subsequent request for interaction with regulators, the Board of Directors (the Board) has made the difficult decision to discontinue the study. No other patients will be enrolled in PARADIGM.
The PARADIGME trial recruited a total of 109 patients. The Company will now provide a tapering of PARADIGM in a structured way, ensuring that patients receive the best possible care during this time.
While betalutin®, at the chosen dose of 15 MBq/kg after a pre-dose of 40 mg of lilotomab (40/15), continued to show an attractive safety profile and positive signs of efficacy in some patients, the Committee considers that the observed profile do not fully meet the objectives set for the PARADIGME study. Only one in three patients responded to treatment with an average duration of response of around six months. Accordingly, the Board is of the view that the demonstrated profile is no longer sufficiently competitive to bring Betalutin® market in the indication of relapsed and refractory third-line LF, within an economically and commercially logical time frame for the Company.
The Company continues to believe there may be a market for Betalutin® in light of its safety profile, promising efficacy in the first lines of treatment and the unique characteristic of being administered in a single dose. However, a potential new development program would need to be conducted in a different patient population and treatment line. The Company will therefore explore potential partnerships and will also seek guidance from the US Food and Drug Administration (FDA) to discuss whether there might be a way forward for Betalutin.® in an alternative setting.
The Company will now focus its efforts and resources on developing its pipeline of proprietary products targeting CD37 from which Nordic Nanovector believes it can create longer-term shareholder value. 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’s lymphoma (NHL).
· Alpha37, an alpha-emitting radioimmunotherapy candidate based on a chimeric anti-CD37 antibody conjugated to lead-212, being explored with its partner OranoMed for relapsed/refractory chronic lymphocytic leukemia.
· A portfolio of fully humanized anti-CD37 antibodies with potential in hematological cancers and autoimmune diseases.
A CD37 DOTA CAR-T opportunity in hematological cancers, which is the subject of a research collaboration with the University of Pennsylvania.
Following the decision to discontinue PARADIGM, the Board has also decided to implement a restructuring of the Company with immediate effect with the aim of reducing costs where necessary to enable the support of essential activities associated with the development of the pipeline. .
The Company’s cash position at the end of the second quarter of 2022 was approximately NOK 280 million (end Q1 NOK 356.3m). Full second quarter results will now be released on August 31.
President, Jan H. Egberts commented : “The decision to discontinue PARADIGM 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. New data independently reviewed by PARADIGME, in an increasingly competitive market and with slow recruitment, makes PARADIGME’s progress even more difficult. As a result, the Board no longer sees a viable path to commercialization 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 participated in PARADIGM.”
CEO, Erik Skullerud commented : “Our focus will now shift to our pipeline of other assets targeting CD37, which are giving us several shots on goal, including Humalutin®, Alpha37, a portfolio of fully humanized anti-CD37 antibodies and the CD37 CAR-T. We look forward to further communicating our development plans for these assets in the coming months.”
Nordic Nanovector will host a webcast at 08:30 CEST on Wednesday July 6, explaining the strategic decision to discontinue PARADIGM and including a Q&A session. To join the webcast, please register through our website www.nordicnanovector.com.
For more information, please contact:
Malene Brondberg, Chief Financial Officer
Cellular: +44 7561 431 762
E-mail: [email protected]
swallow mark/Frazer Hall (MEDiSTRAVA Consulting)
Tel: +44 203 928 6900
E-mail: [email protected]
About Nordic Nanovector:
Nordic Nanovector is committed to developing and delivering innovative therapies to patients to address major unmet medical needs and advance cancer care. The Company aspires to become a leader in cancer radiotherapy. In addition to betalutin®for which Nordic Nanovector retains worldwide commercialization rights, the Company’s new pipeline includes Humalutin®, a radioimmunotherapy candidate based on a chimeric anti-CD37 antibody and the beta emitter lutetium-177 for NHL; Alpha37, based on a chimeric anti-CD37 antibody and the alpha-emitting radionuclide lead-212, currently being explored with its partner Oranomed for relapsed refractory chronic lymphocytic leukemia; a portfolio of fully humanized anti-CD37 antibodies with potential in hematological cancers and autoimmune diseases; and a CD37 DOTA CAR-T opportunity in hematological 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 uncertainties and changes in circumstances because they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on business, finances and the state and results of operations. The terms “plans”, “assumes”, “believes”, “may”, “could”, “estimates”, “expects”, “plans”, “intends”, “may”, ” could”, “plans”, “should”, “projects”, “targets”, “will”, “would” or, in each case, the negative thereof, or other variations or comparable terminology are used to identify statements prospective. These forward-looking statements are not historical facts. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied by the forward-looking statements. Factors that could cause these differences include, but are not limited to, risks associated with the execution of Nordic Nanovector’s strategy, risks and uncertainties associated with the development and/or approval of product candidates of Nordic Nanovector, ongoing and future clinical trials and expected trial results, the ability to commercialize Betalutin®, technological changes and new products in the potential market and industry of Nordic Nanovector, the freedom to operate of Nordic Nanovector (competing patents) with respect to the products it develops, the ability to develop new products and improve existing products, the impact of competition, changes in general economic conditions and industry, and legislative, regulatory and policy factors. No assurance can be given that these expectations will prove to be 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 disclosure obligation in accordance with Section 5-12 of the Norwegian Securities Act.
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SOURCE Nordic Nanovector