Nordic Nanovector provides update on LYMRIT 37-05 Phase 1 DLBCL trial
Oslo, Norway, 12 December 2019
Nordic Nanovector ASA (OSE: NANO) reports an update on its LYMRIT 37-05 Phase 1 trial of Betalutin® in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) who are not eligible for autologous stem cell transplantation (SCT). DLBCL is an aggressive form of non-Hodgkin's lymphoma (NHL) and accounts for up to 43% of all cases, making it the most common type of NHL.
This open-label, dose-escalation safety trial is designed to assess the safety, tolerability, pharmacokinetic profile and preliminary anti-tumour activity of Betalutin® in up to 24 patients. The primary goal of the trial is to identify the maximally tolerated dose of Betalutin® which will then be further evaluated for safety and anti-tumour activity in an expansion cohort in order to select the recommended dose for phase 2. Three additional patients are currently being enrolled for further evaluation of the final dose cohort as one patient has experienced a reversible DLT (dose limiting toxicity).
On the three completed cohorts, no safety issues were identified. Evidence of disease control has been noted in some of the enrolled patients. We expect to complete the data read-out for the dose-escalation phase and submit the data to an international congress in 1H 2020.
Eduardo Bravo, Nordic Nanovector’s Chief Executive Officer, commented: “Patients with relapsed/refractory DLBCL who are not eligible for stem cell transplantation have very limited treatment options and a poor prognosis. As the safety profile of Betalutin® will guide its potential for combination regimens as well as single agent consolidation therapy, we look forward to completing this part of the trial and proceeding with the expansion cohort.”
For further information, please contact:
Malene Brondberg, VP Investor Relations and Corporate Communications
Cell: +44 7561 431 762
Mark Swallow/David Dible (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 radioimmunotherapy 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 29 billion by 2026. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core 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.