Nordic Nanovector Provides Update on PARADIGME, its Phase 2b Pivotal Trial with Betalutin® in R/R Follicular Lymphoma
Oslo, Norway, 3 August 2021
Nordic Nanovector ASA (OSE: NANOV) provides an update on the timeline for PARADIGME, its ongoing pivotal Phase 2b trial of Betalutin® (177Lu lilotomab satetraxetan) in 3rd-line relapsed rituximab/anti-CD20 refractory follicular lymphoma (3L R/R FL). The Company, having reviewed the recent rate of patient recruitment in discussion with its clinical advisors and in light of the continuing impact from the COVID pandemic, now anticipates the preliminary three-month data readout from PARADIGME during the first half of 2022.
The Company will host a live webcast and Q&A on Thursday, 5 August 2021, at 08.30 CEST. A link to the webcast will be available in the afternoon on Wednesday, 4 August on www.nordicnanovector.com.
The Company reports that 92 patients have been enrolled into PARADIGME as of 3 August, compared with 83 patients enrolled as of 25 May 2021 and 73 as of 17 February 2021.
While the changes to the PARADIGME protocol and initiatives implemented to improve execution of the trial have positively impacted recruitment, the ongoing COVID pandemic situation, exacerbated by the spread of the more infectious SARS-CoV-2 delta variant, continues to affect the Company’s ability to screen, enrol and treat new patients. This is because the physical condition of the patient population targeted for this study means they are at the greatest risk from COVID-19 infection. As a result, the rate of patient recruitment has been slower than anticipated.
Nordic Nanovector continues to prioritise and commit all necessary resources to the completion of PARADIGME. As part of this prioritisation, Nordic Nanovector has decided to close clinical sites at which enrolment has been particularly challenging and refocus resources on other initiatives; the trial remains open for enrolment at 85 sites. The Company’s current cash position will support its operations into H2 2022.
In addition, the Company confirms it will invest no further funds in its Archer-1 Phase 1b trial investigating Betalutin® in combination with rituximab in 2nd-line FL. The findings from this study, announced on 25 May 2021, will be important to inform the future development strategy for Betalutin® in 2L FL.
The Company is planning to host an R&D Day for analysts, investors and press in Q4 2021. At the event, senior management and selected external speakers will discuss the positioning of Betalutin® as a potential new treatment for R/R FL and outline the strategy for its future development and commercialisation in this indication pending positive results. In addition, the Company will discuss its multiple opportunities to expand the market for Betalutin® and present other projects in its portfolio.
Christine Wilkinson Blanc, Chief Medical Officer of Nordic Nanovector, commented: “The positive changes to the trial protocol and the initiatives we have implemented have increased the rate of recruitment into PARADIGME. However, they have not led to the expected acceleration in enrolment rate due to the spread of the emerging delta variant, which has meant that COVID restrictions have continued to impede the progress of PARADIGME, in common with many other clinical trials. Given this situation, we believe it is prudent to reset the anticipated timeline for completing the study, as we continue to focus on delivering preliminary top line data as soon as possible.”
For further information, please contact:
Malene Brondberg, interim CEO
Cell: +44 7561 431 762
Mark Swallow/Frazer Hall/David Dible (MEDiSTRAVA Consulting)
Tel: +44 203 926 8535
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.
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.