Nordic Nanovector ASA (OSE: NANO) announces that the Safety Review Committee (SRC) for the ongoing LYMRIT 37-05 clinical trial of single-administration Betalutin® (177Lu-satetraxetan-lilotomab) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not eligible for stem cell transplantation (SCT) has now reviewed safety data from the first three cohorts of patients. Based on the data, the SRC approved advancing the trial to the next and final cohort with the dose regimen 20 MBq/kg Betalutin and a lilotomab pre-dose of 100 mg/m2.

The LYMRIT 37-05 study is a Phase 1 open-label, single-arm, dose-escalation study 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 Europe in total. More information on this study can be found at www.clinicaltrials.gov(NCT02658968). Preliminary results are expected in the second half of 2019.

Lisa Rojkjaer, Chief Medical Officer of Nordic Nanovector, commented: “We are pleased to be moving ahead with the final cohort of patients in the study, which will enable the selection of a recommended dose for further evaluation of safety and preliminary efficacy in additional patients.”

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. Approximately 40% of DLBCL patients relapse after first-line combination treatment with rituximab and chemotherapy and only 30-40% of relapsed patients respond with subsequent high-dose chemotherapy followed by SCT (ref. 1). There are currently very few therapeutic options for patients not eligible for SCT, which makes relapsed DLBCL a serious unmet medical need. The number of diagnosed cases of DLBCL in the US and Europe in 2016 was 26,500 and 17,200, respectively. These numbers are expected to reach 31,500 (US) and 19,000 (Europe) by 2024 (ref. 2).

References

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:

IR enquiries

Malene Brondberg, VP Investor Relations and Corporate Communications
Cell: +44-7561-431-762
Email: ir@nordicnanovector.com

International Media Enquiries

Mark Swallow/David Dible (Citigate Dewe Rogerson) 
Tel: +44-207-638-9571 
Email: nordicnanovector@citigatedewerogerson.com

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