Single dose Betalutin® continues to show promising efficacy and safety in recurrent indolent NHL patients

Updated results reported at the International Conference on Malignant Lymphoma (ICML)

Oslo, Norway, 14 June 2017

Nordic Nanovector ASA (OSE: NANO) announces that updated results from its ongoing LYMRIT 37-01 Phase 1/2 clinical trial of Betalutin® (177Lu-satetraxetan-lilotomab) in patients with recurrent indolent non-Hodgkin’s lymphoma (iNHL) are being presented at the International Conference on Malignant Lymphoma (ICML) on June 14-17 in Lugano, Switzerland.

The LYMRIT 37-01 study is a Phase 1/2 open label, dose escalation study investigating the optimal treatment regimen of single dose Betalutin® with lilotomab pre-dosing in patients with recurrent iNHL.

The updated data confirm Betalutin®’s promising efficacy and safety profile as a single agent in recurrent iNHL patients, who have failed multiple prior treatments, and who are eligible for assessment. The results, based on the data cut-off date of 6 May 2017, were presented by the study’s Principal Investigator Dr. Arne Kolstad from the Department of Oncology at the Oslo University Hospital, Radiumhospitalet.

Key conclusions:

• Single dose Betalutin® is highly active in recurrent iNHL:

  • 64% Overall Response Rate (ORR) and 28% Complete Responses (CR) in the 47 evaluable patients
  • Significant activity was seen in 33 patients with recurrent follicular lymphoma (FL) with 70% ORR and 27% CR
  • 87% of patients showed a reduction in tumour size

• Betalutin® was well-tolerated with no unexpected safety findings in the 59 patients evaluated for safety, with a predictable and manageable safety profile:

  • The most common grade 3/4 adverse events were thrombocytopenia and neutropenia, transient and reversible 
  • No grade 4 neutropenia/thrombocytopenia observed for patients receiving higher lilotomab pre-dosing

Dr. Arne Kolstad, MD commented: “Betalutin® continues to demonstrate a very promising clinical profile in relapsed NHL patients who have received numerous prior therapies, including those who have failed standard CD20-targeted chemo immunotherapy. The dataset in FL patients is particularly encouraging given this is the primary NHL population for which Betalutin® is being developed.”

Dr. Lisa Rojkjaer, MD, Nordic Nanovector’s Chief Medical Officer, added: “These updated results are very encouraging, underlining the potential of a single administration of Betalutin® for treatment of relapsed NHL. We look forward to following these patients and to reporting on longer term outcomes. Data continue to support the company’s strategy in Betalutin®’s development and the intent to initiate our pivotal Phase 2 PARADIGME study, in the second half of 2017.”

The poster is available at: http://www.nordicnanovector.com/product-info/scientific-posters.

Nordic Nanovector ASA will host a conference call today at 1 pm CEST (Oslo time) to present the updated results.

Conference call details:

Please make sure to dial in 5-10 minutes prior to scheduled conference call start time using the number and confirmation code below:

Location Phone Number
Norway +47 2100 2610
Switzerland +41 (0)44 580 7206
Sweden +46 (0)8 5033 6574
United Kingdom +44 (0)330 336 9105
United States and International +1 719-457-1036

Conference ID: 5732602

The conference call presentation will be available at www.nordicnanovector.com in the section: Investor Relations/Reports and Presentation/Presentation/2017 from 1 pm CEST (13:00 Oslo time) today.

For further information, please contact:

IR enquiries:
Tone Kvåle, Chief Financial Officer
Cell: +47 91 51 95 76
Email: ir@nordicnanovector.com

Media enquiries:
Mark Swallow/David Dible (Citigate Dewe Rogerson)
Tel: +44 207 282 2948/+44 207 282 2949
Email: nordicnanovector@citigatedr.co.uk

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 (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.

The Company aims to rapidly develop Betalutin®, alone and in combination with other 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

Forward-looking statements
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.

Press Release 23/2017.