OSLO, Norway--(BUSINESS WIRE)--Nordic Nanovector ASA (OSE:NANO) announces its results for the first quarter 2016. A presentation of the results by the company’s senior management team will take place today at 8:30 a.m. CEST in Oslo - details below.
Nordic Nanovector reports steady operational progress on Betalutin®’s clinical development plan in Follicular Lymphoma (FL), with recruitment of both sites and patients proceeding according to schedule. The Lymrit 37-01 study is on track to define the optimized dose regimen to be used in PARADIGME, the pivotal Phase 2 study planned to start in 2H 2017. Updated data from this ongoing clinical study, presented at the American Association of Cancer Research (AACR) in April, confirm Betalutin®’s efficacy potential, durability of response and favourable safety profile in patients with advanced FL.
The company continues to advance its product pipeline. Having received clearance of the Investigational New Drug (IND) Application from the FDA and acceptance of the protocol design from EU Authorities, Nordic Nanovector is ready to initiate its Phase 1 clinical study for Betalutin® in diffuse large B cell lymphoma (DLBCL). Other progresses include the research and development collaboration with Paul Scherrer Institute, aiming at developing new Antibody-Radionuclide-Conjugates (ARCs) for treatment of single cell leukaemias. During the first quarter, the company received a grant of up to NOK 15 million from the Research Council of Norway’s User-driven Research-based Innovation programme to support the discovery and development of novel targeted therapeutics for leukaemia and NHL.
Luigi Costa, CEO of Nordic Nanovector, comments: “We are pleased to report that our operations are progressing according to plan and on track to meet milestones. The updated results from Betalutin® in FL are promising and reinforce our belief in its promise to become a significant new treatment of NHL. We have also made good progress across all key areas, including the initiation of a clinical study for Betalutin® in a second NHL indication, with a significant unmet medical need, and promising preclinical research highlighting further opportunities for our pipeline.”
• Steady operational progress on Betalutin®’s clinical development plan in number of sites activated and patients enrolled
• Received grant from Research Council of Norway
• Presented updated clinical results at AACR in April, which confirm Betalutin®’s promising efficacy and increasing Duration of Response
• Received clearance of the Investigational New Drug (IND) application, enabling initiation of the study in the US, for a new Phase 1 clinical study of Betalutin® in DLBCL
• Research and development collaboration entered with Paul Scherrer Institute, aiming at developing new Antibody-Radionuclide-Conjugates for treatment of single cell leukaemias
• First good manufacturing process batch of the chimeric HH1 antibody successfully completed
Financial Highlights Q1 2016
(Figures in brackets = same period 2015 unless otherwise stated)
• Revenues amounted to MNOK 0.078 (MNOK 0.076)
• Total operating expenses were MNOK 52.7 (MNOK 35.9)
• Loss for the quarter amounted to MNOK 52.7 (loss of MNOK 35.8)
• Cash and cash equivalents amounted to MNOK 671.9 at 31 March 2016 (MNOK 743.4 at 31 December 2015)
The promising updated results from the ongoing Phase 1/2 study with Betalutin®, the good progress made in advancing this study and strong findings from the research and development pipeline bode well for Nordic Nanovector’s operations going forward. Management will continue to focus its efforts on the efficient execution of its plans and to meet the anticipated clinical milestones. Current cash resources are expected to be sufficient to reach the first regulatory submission for Betalutin® in FL in 1H 2019.
Presentation and web cast details
A presentation by Nordic Nanovector’s senior management team will take place at 8:30 am CEST at:
Thon Hotel Vika Atrium Munkedamsveien 45 0250 Oslo
Meeting Room: NYLAND
The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investor Relations/Webcast.
The results report and the presentation will be available at www.nordicnanovector.com in the section: Investor Relations/Reports and Presentation/Quarterly Reports/2016 from 7:00 am CEST the same day.
About Nordic Nanovector
Nordic Nanovector is a biotech company focusing on the development and commercialisation of novel targeted therapeutics in haematology and oncology. The Company’s lead clinical-stage product opportunity is Betalutin®, the first in a new class of 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 worth over $12 billion by 2018.
Betalutin® comprises a tumour-seeking anti-CD37 antibody (HH1) conjugated to a low intensity radionuclide (lutetium-177). The preliminary data has shown promising efficacy and safety profile in an ongoing Phase 1/2 study in a difficult-to-treat NHL patient population. The Company is aiming at developing Betalutin® for the treatment of major types of NHL with first regulatory submission anticipated in 1H 2019.
Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets, while exploring potential distribution agreements in selected geographies. The Company is committed to developing its ARC pipeline to treat multiple selected 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.
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