On February 27, 2018 Nordic Nanovector ASA (OSE: NANO) reported results for the fourth quarter and full year 2017 (Press release, Nordic Nanovector, FEB 27, 2018, View Source [SID1234553510]). A presentation by the company’s team will take place today in Oslo at 08:30 CET, see details below.
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Nordic Nanovector made significant progress during 2017, continuing the strong positive momentum started in 2016. The company has advanced the clinical development programme for Betalutin into its pivotal PARADIGME trial and expanded the knowledge base from which it intends to develop a successful commercialisation strategy for the candidate. The company also advanced its partnered early stage programmes aimed at creating a pipeline of novel targeted therapies for haematological cancers.
Updated clinical data from the Phase 1/2a LYMRIT 37-01 trial presented at ASH (Free ASH Whitepaper) in December continue to highlight Betalutin’s strong clinical profile as a single agent for treating patients with relapsed/refractory follicular lymphoma (R/R FL). Nordic Nanovector initiated its pivotal PARADIGME trial with Betalutin in the fourth quarter as planned and the study is currently open for patient enrolment. PARADIGME is a global randomized Phase 2b study comparing two Betalutin dosing regimens in third line (3L) FL patients who are refractory to standard-of-care anti-CD20-based therapy (including rituximab). Nordic Nanovector is targeting initial data read-outs from the study and subsequent filing in the second half of 2019 for marketing approval.
The final design for ARCHER-1 was completed and the trial will open for enrolment once regulatory approval has been received. The trial will be the first to combine Betalutin with rituximab in second line (2L) FL patients, based on promising preclinical data showing strong synergy between the two agents.
Recruitment into the Phase 1 study in diffuse large B-Cell lymphoma (DLBCL) remains on track, and a Phase 1 trial of Humalutin is ready to start with the first patient expected to be dosed in the second half of 2018.
Luigi Costa, CEO of Nordic Nanovector, comments: "In 2017 we continued with a strong momentum and have delivered on several important milestones. We continue to show strong clinical data that consistently reinforce Betalutin’s potential as one of the most promising new treatments for indolent non-Hodgkin Lymphoma (iNHL). We have transitioned the company to the next phase by starting PARADIGME, the pivotal Phase 2b study with the intent to generate the data for regulatory submission in 3L FL. I am very pleased with the good progress towards the first trial of Betalutin in combination with standard of care anti-CD20 therapy (rituximab) in 2L FL (ARCHER-1). Our focus during 2018 will be to drive recruitment into our leading clinical studies with the objective of taking Betalutin to patients as fast as possible while we progress in development of our commercial strategy."
Operational Highlights Q4’17
• Updated results from LYMRIT 37-01 Phase 1/2a trial presented at ASH (Free ASH Whitepaper) show Betalutin’s strong clinical profile in patients with R/R iNHL
o Significant anti-tumour activity observed: 90% of patients (n=59) had a reduction in tumour size
o ORR of 60% and CR of 24% for all evaluable iNHL patients
o Highly active in target population of FL patients with two or more prior therapies (3L FL) with 66% ORR and 25% CR
o Median duration of response of 13.3 months for FL patients receiving 40 mg lilotomab pre-dosing followed by 15 MBq/kg Betalutin (n=17); median duration of response of 22.9 months for patients with a CR (n=7)
o Promising early data from second dosing regimen (Arm 4 – 100 mg/m2 lilotomab/20 MBq/kg Betalutin)
o Well tolerated with predictable and manageable safety profile
• Phase 1/2a study LYMRIT 37-01 recruitment completed with 74 patients enrolled
• Pivotal Phase 2b PARADIGME trial initiated to investigate Betalutin in patients with 3L R/R FL
o Study opened for patient enrolment
o Two promising dosing regimens to be evaluated (40mg lilotomab/15 MBq/kg Betalutin and 100 mg/m2 lilotomab/20 MBq/kg Betalutin)
• Finalised design for ARCHER-1, trial aims to investigate Betalutin in combination with rituximab in 2L FL
o Trial will open for patient enrolment once regulatory approvals has been received
• Results from extensive research aimed at supporting market strategy for Betalutin demonstrate clear commercial opportunities
• Rosemarie Corrigan appointed to the Executive management team as Chief Quality Officer
Events after Q4’17
• Malene Brondberg appointed as Vice President, IR and Corporate Communications
Financial Highlights Q4 and FY’17
(Figures in brackets = same period 2016 unless otherwise stated)
• Revenues for the fourth quarter amounted to NOK 0.1 million (NOK 0.1 million). Revenues for the full year 2017 were NOK 0.3 million (NOK 0.3 million).
• Total operating expenses for the fourth quarter were NOK 102.0 million (NOK 65.4 million). Total operating expenses for the full year 2017 amounted to NOK 316.8 million (NOK 216.7 million).
• Comprehensive loss for the fourth quarter amounted to NOK 87.6 million (loss of NOK 59.3 million). Comprehensive loss for the full year 2017 was NOK 295.6 million (NOK 235.8 million).
• Cash and cash equivalents amounted to NOK 756.6 million at the end of December 2017 (NOK 1 018.2 million).
Outlook
Nordic Nanovector aspires to become a leader in the field of Precision Therapies for haematological cancers by developing, manufacturing and commercialising innovative therapies to address major unmet medical needs and advance cancer care.
Betalutin, the company’s most advanced product candidate, is developing a well differentiated, competitive, clinical profile for R/R FL, based on the promising preliminary results from the LYMRIT 37-01 Phase 1/2a clinical study. The company’s pivotal Phase 2b PARADIGME trial with Betalutin in 3L R/R FL is underway with the goal to have the initial data read-outs from the study and subsequent filing in the second half of 2019 for marketing approval.
Nordic Nanovector intends to maximize the value of Betalutin across other stages of FL, NHL and other haematological cancer indications. A further element of the company’s strategy is to selectively extend its pipeline of novel targeted biopharmaceutical candidates to support future growth.
Management will continue to focus its efforts on the efficient execution of its plans and to meet clinical and pre-commercialisation milestones. The company is confident that Betalutin could become an attractive and convenient therapeutic option, which, based on detailed market research, has the potential to be commercially successful.
Current cash resources are expected to be sufficient until first regulatory filing of Betalutin in 3L R/R FL and to advance other key programmes
Presentation and webcast – Fourth Quarter and Full Year 2017 results
A presentation by Nordic Nanovector’s senior management team will take place today at 8:30 am 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: Investors & Media
The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2017 from 7:00 am CET today.