Nordic Nanovector provides update on the PARADIGME clinical trial
Oslo, Norway, 4 April 2018
Nordic Nanovector ASA (OSE: NANO) today provides an update on its clinical development programme, including updated guidance on expected milestones for the pivotal PARADIGME trial, and its financial outlook. A presentation by the company’s management team will take place tomorrow in Oslo at 10 am CEST, see details below.
• A re-assessment of expected recruitment rates has led the company to revise its timelines for the pivotal PARADIGME Phase 2b trial with Betalutin® in third line (3L) follicular lymphoma (FL) patients. Results from PARADIGME are targeted for 1H 2020 (previously 2H 2019) and first regulatory filing in 2020. The first patient is expected to be dosed in 1H 2018.
• The company will focus its resources towards PARADIGME and other Betalutin® clinical programmes, which has led to the decision to postpone the start of the first-in-human clinical trial with Humalutin® for the foreseeable future; this study was being prepared to start in 2H 2018.
• Guidance is unchanged for previously reported milestones for ARCHER-1 (Betalutin® plus rituximab in second line FL; first patient dosed) and LYMRIT 37-05 (Betalutin® in R/R diffuse large B cell lymphoma, DLBCL; preliminary data read-out), both anticipated in 2H 2018.
• Financial resources are expected to be sufficient to reach data read-out from PARADIGME
Lisa Rojkjaer MD, Nordic Nanovector CMO, said: “While we are encouraged with the progress being made to the start-up of the pivotal PARADIGME study, a re-analysis of the patient enrolment rate and the fact that it has taken longer than expected to enrol the first patient have led us to adjust the timelines we previously communicated. We now expect to deliver data from PARADIGME in the first half of 2020.
“The PARADIGME study reflects our conviction in the significant potential of Betalutin® based on the promising clinical data generated to-date. We therefore remain committed to completing this robust study, which is designed to select the best dosing regimen to support Betalutin® as an important new treatment option for 3L FL patients.”
PARADIGME – clear focus for company
PARADIGME is a global randomised Phase 2b study comparing two Betalutin® dosing regimens in 3L R/R FL patients, which have shown a promising clinical profile in the LYMRIT 37-01 Phase 1/2a trial. The pivotal PARADIGME study was initiated at the end of 2017 in Europe and the first patient is expected to be dosed during the first half of 2018. The trial is aiming to enrol 130 patients in 20 countries.
To date, PARADIGME is open for enrolment at 13 sites and in six countries.
In Norway, PARADIGME is pending approval and the company is working closely with the Norwegian regulators to address its questions.
In the USA, the Food & Drug Administration (FDA) has completed its review of the PARADIGME study and Nordic Nanovector expects US sites to be open for enrolment during mid-2018.
Humalutin® – first human trials postponed
Nordic Nanovector was preparing a Phase 1 study of Humalutin®, a novel 177Lu-conjugated chimeric anti-CD37 antibody, in NHL patients. The company previously guided that it expected to start this study in the second half of 2018. As a consequence of the revised timelines for PARADIGME and the need to conserve cash until data read-out, Nordic Nanovector has decided to put the Humalutin® study on hold for the foreseeable future.
ARCHER-1 and LYMRIT 37-05 – on track
ARCHER-1 is a planned clinical study designed to evaluate the safety and efficacy of combining Betalutin® with rituximab in second line (2L) FL patients. The company expects the first patient to be dosed in the second half of 2018 as previously guided.
LYMRIT 37-05 is an on-going Phase 1 study evaluating Betalutin® in patients with R/R DLBCL. As previously guided, the company expects preliminary data read-out from this study in the second half of 2018.
Presentation and webcast
A presentation by Nordic Nanovector’s management team will take place tomorrow at 10 am CEST at:
Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo
Meeting Room: Aker
The presentation will be recorded as a webcast and will be available, with the presentation, at www.nordicnanovector.com in the section: Investors & Media.
For further information, please contact:
IR enquiries Malene Brondberg, VP Investor Relations and Corporate Communications
Cell: +44 7561 431 762
International Media Enquiries
Mark Swallow/David Dible/Isabelle Andrews (Citigate Dewe Rogerson)
Tel: +44 207 638 9571
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-Conjugates (ARC) 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 20 billion by 2024.
Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets.
The Company is also advancing a pipeline of ARCs and other immunotherapies for multiple cancer indications.
Further information about the Company can be found at www.nordicnanovector.com
This announcement contains certain forward-looking statements and forecasts based on uncertainty, 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 statement. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied in these 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 products 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 Securities Trading Act.