Continued progress in clinical development programmes with Betalutin®
OSLO, Norway, 24 May 2017 /PRNewswire/ --Nordic Nanovector ASA (OSE: NANO) announces results for the first quarter of 2017. A presentation by the company’s senior management team will take place today at 8:30 a.m. CET in Oslo - details below.
Nordic Nanovector reported continued operational progress during the first quarter. The Phase 1/2 clinical trial with Betalutin® in relapsed indolent non-Hodgkin’s Lymphoma (iNHL) advanced according to schedule. Safety Review Committee (SRC)'s approval of continued clinical evaluation of 20 MBq/kg Betalutin® with 100 mg/m2 lilotomab enables the company to build a robust database of clinical data. Management is confident on plans to initiate the pivotal Phase 2 PARADIGME study in the second half of 2017. The first patient was dosed in a Phase 1 dose-escalation study of Betalutin® in relapsed refractory DLBCL. The company also made the decision to expand investigations of its ARC therapeutics with initial preparations underway for a Phase 2 combination study of Betalutin® and rituximab, and a Phase 1 study of Humalutin™, a chimeric anti-CD37 Antibody Radionuclide Conjugate (ARC). Both studies are expected to start during the second half of 2017.
Luigi Costa, CEO of Nordic Nanovector, comments: “In the first quarter of 2017 we continued the positive momentum of 2016. I am pleased to report the excellent progress Nordic Nanovector is making to advance its clinical development programmes with Betalutin® in FL and now in DLBCL. We are also excited at the prospect of starting new clinical trials later in the year, which potentially could significantly expand the market opportunities for our novel ARCs.”
Operational Highlights Q1 2017
• Progress continues towards start of Phase 2 PARADIGME trial in 2H 2017 as planned, with Betalutin® in patients with iNHL (FL and other subtypes)
• First patient dosed with Betalutin® in Phase 1 dose-escalation study in DLBCL
o The study is open for enrolment in the US and Europe
• Decision made to initiate Phase 2 clinical studies to investigate the potential of Betalutin® combined with rituximab in 2nd line FL
o Phase 2 trial expected to begin in 2H 2017
• Decision made to initiate Phase 1 clinical study to investigate the potential of Humalutin™ in NHL
o Preclinical studies complete, Phase 1 trial expected to begin in 2H 2017
Post Period Events
• Safety Review Committee approved continued evaluation of 20 MBq/kg Betalutin® with 100 mg/m2 lilotomab in a Phase 2 expansion cohort in Arm 4
• Updated results from LYMRIT 37-01 have been accepted for presentation at ICML in June
o Safety and preliminary efficacy data from all evaluable NHL patients
Financial Highlights First Quarter 2017
(Figures in brackets = same period 2016 unless otherwise stated)
• Revenues in the first quarter 2017 amounted to NOK 0.078 million (NOK 0.078 million)
• Total operating expenses for the first quarter were NOK 65.8 million (NOK 52.7 million)
• Comprehensive loss for the first quarter amounted to NOK 55.8 million (loss of NOK 64.1 million)
• Cash and cash equivalents amounted to NOK 933.3 million at the end of March 2017
(NOK 1 018.2 million at the end of December 2016).
Outlook
Building on the progress made in 2016, Nordic Nanovector’s operations remain on track. With a strengthened financial position, the company is now expanding and extending its strategy towards achieving its broader long-term ambitions beyond Betalutin® in NHL. These are centred on maximising the value of its novel targeted biopharmaceutical candidates across all stages of NHL and other major haematological cancer indications; to prepare for the commercialisation of Betalutin®; and to selectively extend its pipeline.
The profile of Betalutin® is well differentiated within the competitive landscape. Encouraging preliminary results and good progress in the LYMRIT 37-01 clinical study give the company confidence that it is on track to initiate the pivotal Phase 2 PARADIGME trial during the second half of 2017. Management will continue to focus its efforts on the efficient execution of its plans and to meet clinical milestones.
Current cash resources are expected to be sufficient to take the company beyond a first regulatory submission for Betalutin® in FL in the first half of 2019 and to meet value-generating clinical milestones in its other programmes.
Presentation and webcast details
A presentation by Nordic Nanovector’s senior management team will take place today at 8:30 a.m. CET 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/2017 from 7:00 am CET today.
For further information, please contact:
IR enquiries:
Luigi Costa, Chief Executive Officer
Cell: +41-79-124-8601
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-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
