Nordic Nanovector: Updated Results From Phase 1/2 Trial of Betalutin® in Non-Hodgkin Lymphoma to be Presented at ASH in December

Wednesday, November 1, 2017 Clinical Trials News
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OSLO, Norway, November 1, 2017 /PRNewswire/ --

Nordic Nanovector ASA (OSE: NANO) announces that updated results

from its ongoing LYMRIT 37-01 Phase 1/2 clinical study of Betalutin® (177Lu-satetraxetan-lilotomab) in patients with recurrent indolent non-Hodgkin lymphoma (iNHL) will be presented in a poster at the 59th Annual American Society of Hematology (ASH)
meeting (9-12 December 2017 in Atlanta, GA, USA).

The dataset (as of 3 July 2017) includes 55 evaluable patients. Data from patients receiving the two most promising dosing regimens in the Phase 2 expansion cohorts – Arm 1 (15 MBq/kg Betalutin® after 40 mg lilotomab pre-dosing) and Arm 4 (20 MBq/kg Betalutin® after 100 mg/m2 lilotomab) – are described and will be updated at the congress.

The data continue to highlight the encouraging clinical profile of single-agent Betalutin® therapy in iNHL patients, particularly in those with follicular lymphoma (FL), the primary NHL population for which Betalutin® is being developed. These data will continue to mature up until presentation in December. Key facts are:

Single-agent Betalutin® is highly active and well tolerated in recurrent iNHL:

• 64% Overall Response Rate (ORR) and 24% Complete Responses (CR) in the 55 evaluable iNHL patients

• 81% ORR (CR 28%) in 21 FL patients in Arm 1 (of 32 iNHL patients evaluated); median duration of response (DoR) of 15 months in FL patients

• No unexpected safety findings, the safety profile is both predictable and manageable

Lisa Rojkjaer, Chief Medical Officer of Nordic Nanovector, commented: "These data are very encouraging for a primarily elderly, heavily pre-treated patient population, especially for those with relapsed FL, where the greatest need exists. The data from Arm 4, while so far evaluable in only six patients (50% ORR, CR 17%) are also very encouraging and we look forward to seeing how these data evolve with a larger patient population. These data from both arms of the study are enabling us to refine the design of the pivotal Phase 2 PARADIGME trial, which we expect to initiate this year."

Luigi Costa, Chief Executive Officer of Nordic Nanovector, added: "We are very excited with these results, which support the strategy course we undertook when we decided to explore alternative dosing regimens. These data strengthen our confidence in the potential of Betalutin® to be an attractive therapeutic option with the convenience of being a one-time treatment. We now have two promising dosing options, and as a result we have further strengthened the development path for Betalutin®.  We are also very encouraged that Betalutin® treatment consistently demonstrates a highly competitive profile when compared to other therapies in development or recently approved for FL."

The ASH annual meeting is the premier event for scientific exchange in the field of haematology, attracting more than 20,000 attendees from all over the world. Typically, more than 5,000 scientific abstracts are submitted each year, and more than 3,000 abstracts are accepted for oral and poster presentations through an extensive peer review process.

The abstract is now available online - click here

Poster details

Abstract 2769 Abstract title:  177Lu-Lilotomab Satetraxetan, a Novel CD37-Targeted Antibody-Radionuclide Conjugate in Relapsed Non-Hodgkin's Lymphoma (NHL): Updated Results of an Ongoing Phase I/II Study (LYMRIT 37-01) Authors: Kolstad, A et al.

Session Name:  623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster II

Date:  Sunday, December 10, 2017

Presentation Time:  6:00 PM - 8:00 PM

Location:   Georgia World Congress Center, Bldg A, Lvl 1, Hall A2, Atlanta, GA, USA

For further information, please contact:

IR enquiries: Tone Kvåle, Chief Financial Officer

Cell: +47-91-51-95-76

Email: [email protected]

Media enquiries: Mark Swallow/David Dible/Marine Perrier (Citigate Dewe Rogerson)

Tel: +44-207-638-9571

Email: [email protected]

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 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.

This information was brought to you by Cision http://news.cision.com

http://news.cision.com/nordic-nanovector/r/nordic-nanovector--updated-results-from-phase-1-2-trial-of-betalutin--in-non-hodgkin-lymphoma-to-be-,c2380409

View original content:http://www.prnewswire.com/news-releases/nordic-nanovector-updated-results-from-phase-12-trial-of-betalutin-in-non-hodgkin-lymphoma-to-be-presented-at-ash-in-december-300547375.html

SOURCE Nordic Nanovector



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