Nordic Nanovector’s Betalutin® Receives Fast-Track Designation from US FDA for Marginal Zone Lymphoma
Oslo, Norway, 29 June 2020
Nordic Nanovector ASA (OSE: NANO) today announces that the US Food and Drug Administration (FDA) has granted Fast Track designation for investigating Betalutin® (177Lu lilotomab satetraxetan) for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior systemic therapies.
Nordic Nanovector is evaluating the opportunity to develop Betalutin® as a single-agent treatment for MZL, a rare type of non-Hodgkin’s lymphoma (NHL). Betalutin® has demonstrated a very promising clinical effect in nine MZL patients in the Phase 1/2a LYMRIT 37-01 trial.
Lars Nieba, Interim Chief Executive Officer, commented: “We are very pleased to receive Fast-track designation for Betalutin® in MZL, which recognizes the clear need for new therapeutic options for patients with advanced MZL patients who no longer respond to the therapies they have been receiving. We are evaluating the opportunity for investigating Betalutin® in this important and underserved indication and will provide an update when we have made a decision.”
The FDA Fast Track Designation is one of several approaches utilized by the US FDA to expedite development and review of potential medicines for serious conditions and that fulfil unmet medical needs. A potential new medicine may fill an unmet medical need by being the first therapy to address a specific serious condition, offer clinically significant advantages over available therapies, act via a different mechanism of action than available therapies, or have a benefit in patients who are unresponsive to or intolerant of available therapies. Programs that receive Fast Track Designation are entitled to more frequent interactions with the FDA review team throughout the development program. Additionally, products that have been granted Fast Track Designation may be eligible for rolling review and priority review, if supported by clinical data.
Betalutin® has received Orphan Drug Designation in the European Union for the treatment of MZL and has applied for the equivalent designation in the US.
About Marginal Zone Lymphoma (MZL)
Marginal Zone Lymphoma is an incurable and long-term debilitating disease due to its effects on the spleen, lymph nodes and bone marrow, as well as the increased risk of infection.
Fast Track Designation is granted to drugs and biologics being developed for the treatment of serious or life-threatening diseases and nonclinical or clinical data have demonstrated the potential to address an unmet medical need. The purpose of the Fast Track Designation provision is to help facilitate development and expedite the review and potential approval of drugs to treat serious and life-threatening conditions.
In Nordic Nanovector’s LYMRIT 37-01 Phase 1/2a trial, Betalutin® showed a highly encouraging 78% overall response rate (ORR) and 44% complete response (CR) in the MZL patient group (n=9) – the highest response rates of any patient sub-population in this study. This followed a once-only administration of Betalutin® in this heavily pre-treated group of patients with advanced disease.
1 Source: Food and Drug Administration, “Expedited Programs for Serious Conditions – Drugs and Biologics”: https://www.fda.gov/files/drugs/published/Expedited-Programs-for-Serious-Conditions-Drugs-and-Biologics.pdf
For further information, please contact:
Malene Brondberg, CFO
Cell: +44 7561 431 762
Mark Swallow/Frazer Hall/David Dible (Citigate Dewe Rogerson)
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 29 billion by 2026. 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.