Nordic Nanovector announces first patient dosed in Phase 1 study of Betalutin® in diffuse large B-cell lymphoma (DLBCL), an aggressive form of NHL
Oslo, Norway, 17 March 2017
Nordic Nanovector ASA (OSE: NANO) announces that the first patient has been dosed in its Phase 1 study evaluating Betalutin® (177Lu-satetraxetan-lilotomab), a novel CD37 targeting antibody-radionuclide conjugate, in patients with relapsed diffuse large B-cell lymphoma (DLBCL) – the “LYMRIT 37-05” trial.
Commenting on the start of the trial, Dr. Lisa Rojkjaer, Nordic Nanovector’s CMO, said: “We are excited to begin this study to evaluate Betalutin® in patients with relapsed DLBCL who are ineligible for stem cell transplantation. This is an area of significant medical need with no approved treatment options. The encouraging data seen in the Phase 1/2 study in relapsed indolent NHL, presented at ASH in December 2016, provide a strong foundation to advance our development of Betalutin® into this second indication”.
DLBCL is an aggressive form of non-Hodgkin’s Lymphoma (NHL) that accounts for up to 43% of all NHL cases, making it the most common form of the disease. After first line combination treatment with rituximab-chemotherapy (R-CHOP) approximately 40% of DLBCL patients relapse and only 30-40% of relapsed patients respond with subsequent high-dose chemotherapy followed by stem cell transplant (SCT) (ref. 1). There are currently very few therapeutic options for patients not eligible for SCT, which make this disease a serious unmet medical need, with a population of over 14 000 patients in the US, EU-5 and Japan. The market for treatment of DLBCL is estimated to be worth more than USD 4.5 billion by 2024 (ref. 2).
The open-label, single-arm, dose-escalation study is designed to assess the safety, tolerability, pharmacokinetic profile and preliminary anti-tumour activity of Betalutin®. Up to 24 patients are planned to be enrolled in the US and EU. Prof. Timothy Illidge at the Manchester Cancer Research Centre, University of Manchester, is the Principal Investigator for the study. More information on this study as well as other Nordic Nanovector studies can be found at www.clinicaltrials.gov (search “Betalutin”).
1. L.S. Raut and P. P. Chakrabarti: Management of relapsed-refractory diffuse large B cell lymphoma (2014) South Asian J. Cancer 3(1): 66–70
2. Non-Hodgkin’s Lymphoma (2015) Decision Resources
For further information, please contact:
Luigi Costa, Chief Executive Officer
Cell: +41 79 124 8601
Tone Kvåle, Chief Financial Officer
Cell: +47 91 51 95 76
Mark Swallow/David Dible (Citigate Dewe Rogerson)
Tel: +44 207 282 2948/+44 207 282 2949
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 improve upon and complement current options for the treatment of non-Hodgkin Lymphoma (NHL). NHL is an indication with substantial unmet medical need and orphan drug opportunities, representing a growing market forecast to be worth nearly USD 20 billion by 2024.
The Company aims to rapidly develop Betalutin®, alone and in combination with other cancer therapies, for the treatment of major types of NHL, targeting first regulatory submission in relapsed/refractory follicular lymphoma in 1H 2019. 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 may contain 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”, “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 a forward-looking statement or affect the extent to which a particular projection is realised. Factors that could cause these differences include, but are not limited to, implementation of Nordic Nanovector’s strategy and its ability to further grow, risks associated with the development and/or approval of Nordic Nanovector’s products candidates, ongoing clinical trials and expected trial results, the ability to commercialise Betalutin®, technology changes and new products in Nordic Nanovector’s potential market and industry, 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.