Betalutin® shows strong clinical profile in relapsed/refractory indolent NHL and follicular lymphoma

Updated data reported at the 59th Annual American Society of Hematology (ASH) meeting 

Oslo, Norway, 11 December 2017

Nordic Nanovector ASA (OSE: NANO) has presented updated results from its LYMRIT 37-01 Phase 1/2 clinical study of Betalutin® (177Lu-satetraxetan-lilotomab) in patients with relapsed/refractory (R/R) indolent NHL (iNHL) at the 59th Annual ASH meeting (9-12 December 2017 in Atlanta, GA, USA). A conference call and audio cast to present the results will take place today at 08:00 CET – details below.

The updated data continue to highlight Betalutin®’s strong clinical profile as a single agent for treatment of R/R iNHL, and particularly of third-line R/R follicular lymphoma (3L FL), the primary patient population for which Betalutin® is initially being developed.

Single-agent Betalutin® is effective and well-tolerated in patients with R/R iNHL:

· 90% of all patients (n=59) had a reduction in tumour size

· Overall response rate (ORR) of 60% and complete response (CR) of 24% for all evaluable iNHL patients

· Highly active in patients with 2 or more prior therapies (3L FL) with 66% ORR and 25% CR

· Encouraging results in FL patients:

                     o Arm 1 40/15: 68% ORR and 28% CR

                     o Arm 4 100/20: 50% ORR and 25% CR

· Durable responses, especially for patients with a CR

                    o 13.3 months for all iNHL patients

                         ▪ 20.5 months for patients with CR

                    o 13.3 months for FL patients treated with 40 mg lilotomab/15 MBq/kg Betalutin®

                        ▪ 22.9 months for patients with CR

As reported previously, Betalutin® treatment was well-tolerated with a safety profile characterized by reversible transient neutropenia and thrombocytopenia and a low incidence of infections.

Dr Arne Kolstad, MD, Principal Investigator of the study, commented: “The data presented at ASH are very exciting. The combination of efficacy, tolerability and the convenience of a single administration highlight Betalutin®’s potential in this primarily elderly, heavily pre-treated patient population. Notably, the CRs seen in both Arm 1 and Arm 4 in FL patients and the duration of responses are very promising, and we look forward to treating more patients in the upcoming PARADIGME study. 

Dr Lisa Rojkjaer, Chief Medical Officer of Nordic Nanovector, added: “We are very pleased about these data, which continue to demonstrate a strong clinical profile for Betalutin®, particularly in 3L FL patients. The CR rates are especially encouraging. This is a population of high unmet medical need for whom safe effective therapies are needed, and the Phase 2b PARADIGME trial will focus on these patients. The results obtained provide a strong foundation for this trial.”

The poster has been published on Nordic Nanovector’s website (www.nordicnanovector.com) in the section: /what-we-do/scientific-background/scientific-posters.

Conference call and audio cast details:

Please join the conference 5-10 minutes prior to the start time. You will be asked to provide the confirmation code or the title of the conference.

Event Conference Title:  Nordic Nanovector – ASH update

Date and time:   Monday 11 December 2017 at 08:00 CET

Confirmation Code:  2436440

Location Phone Number
Norway +47 2350 0296
Switzerland +41 44 580 1022
Sweden +46 8 5065 3942
United   Kingdom and International +44 330 336 9411
United States +1 720-452-9217

The conference call presentation will be available at www.nordicnanovector.com in the section: Investor Relations/Reports and Presentation/Presentation/2017 from 08:00 CET on 11 December 2017. If you want to follow the presentation via audio cast with sound and slides, please use the following link:  http://webtv.hegnar.no/presentation.php?webcastId=75022840

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/Marine Perrier (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 Antibody-Radionuclide-Conjugates (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 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.

  

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About Us

About Nordic Nanovector ASA 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 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

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