Nordic Nanovector AS

Oslo, Norway

Nordic Nanovector AS

Oslo, Norway
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News Article | May 24, 2017
Site: www.prnewswire.com

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." • 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 • 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). 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. A presentation by Nordic Nanovector's senior management team will take place today at 8:30 a.m. CET at: 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: 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 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-asa---results-for-first-quarter-2017,c2272776 The following files are available for download: To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/nordic-nanovector-asa--results-for-first-quarter-2017-300462975.html


News Article | May 24, 2017
Site: www.prnewswire.co.uk

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." • 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 • 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). 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. A presentation by Nordic Nanovector's senior management team will take place today at 8:30 a.m. CET at: 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: 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 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-asa---results-for-first-quarter-2017,c2272776 The following files are available for download:


News Article | May 24, 2017
Site: www.prnewswire.co.uk

All proposals were resolved by the Annual General Meeting as presented in the notice convening the general meeting distributed on 2 May 2017 except item 13, authorisation to the Board to increase the share capital in connection with the option program. The Board will revert with an amended proposal for a long term share incentive program acceptable for all relevant parties. The complete minutes of the annual general meeting are attached to this release and also available on www.nordicnanovector.com. For further information, please contact: 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 This information is subject to duty of disclosure pursuant to Section 5-12 of the Norwegian Securities Trading Act. This information was brought to you by Cision http://news.cision.com http://news.cision.com/nordic-nanovector/r/nordic-nanovector-asa--annual-general-meeting-held,c2273252 The following files are available for download:


News Article | May 24, 2017
Site: www.prnewswire.co.uk

Nordic Nanovector rapporterer om fortsatt operasjonell fremgang i første kvartal. Den pågående kliniske fase 1/2-studien med Betalutin®i fremskreden, sakte-voksende lymfekreft av typen non-Hodgkins lymfom (iNHL) utviklet seg i tråd med planen. Studiens sikkerhetskomite godkjente fortsettelse av klinisk evaluering av 20 MBq/kg Betalutin®med 100 mg/m2lilotomab, hvilket gir anledning til å bygge en solid base med kliniske data. Ledelsen fastholder planen om oppstart av den endelige Fase 2 PARADIGME studien i andre halvår 2017. Den første pasienten ble behandlet i Fase 1 studien for fremskreden og tilbakevendende diffus storcellet B celle lymfom (DLBCL) med Betalutin®. Selskapet besluttet også å utvide undersøkelsene av sin anti-radionuklide-konjungat (ARC) for Fase 2 kombinasjonsstudien for Betalutin®og rituximab, og en fase 1 studie av Humalutin™, et kimert anti-CD37 ARC. Begge studiene er forventet å starte i løpet av andre halvår 2017. Nordic Nanovectors ledende legemiddelkandidat under klinisk utvikling er Betalutin®, et målrettet CD37 antistoff-radionuklid-konjugat (ARC) utviklet for å forbedre og supplere dagens behandlingsalternativ for pasienter med lymfekreftformen non-Hodgkin's Lymfom (NHL). NHL er en indikasjon med et stort udekket behandlingsbehov og muligheter for såkalt «orphan drugs designation», en incentivordning for få frem nye legemidler til sjeldne sykdommer. NHL representerer er et voksende marked med et antatt markedspotensial på omkring 20 milliarder amerikanske dollar innen 2024. This information was brought to you by Cision http://news.cision.com http://news.cision.com/nordic-nanovector/r/nordic-nanovector-asa---resultater-for-forste-kvartal-2017,c2272787 The following files are available for download:


News Article | May 24, 2017
Site: www.prnewswire.com

All proposals were resolved by the Annual General Meeting as presented in the notice convening the general meeting distributed on 2 May 2017 except item 13, authorisation to the Board to increase the share capital in connection with the option program. The Board will revert with an amended proposal for a long term share incentive program acceptable for all relevant parties. The complete minutes of the annual general meeting are attached to this release and also available on www.nordicnanovector.com. For further information, please contact: 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 This information is subject to duty of disclosure pursuant to Section 5-12 of the Norwegian Securities Trading Act. This information was brought to you by Cision http://news.cision.com http://news.cision.com/nordic-nanovector/r/nordic-nanovector-asa--annual-general-meeting-held,c2273252 The following files are available for download: To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/nordic-nanovector-asa-annual-general-meeting-held-300463083.html


Patent
Nordic Nanovector AS | Date: 2012-12-12

The present invention relates to chimieric or humanized antibodies derived from the mouse monoclonal antibody HH1. The applications of the present invention include therapeutic applications in which pharmaceutical compositions comprising the antibodies of the present invention or radioimmunoconjugates hereof are used for treating B-cell malignancies.


Patent
Nordic Nanovector As | Date: 2014-06-06

The present invention relates to radioimmunoconjugates that are capable of upregulating expression of one or more antigens. The upregulated antigens can be the antigens that are targeted by the radioimmunoconjugates or different antigens expressed on the same cells. The present invention also relates to methods of treating cancer and diseases and disorders of the immune system by utilizing this enhanced expression of antigens.


Patent
Nordic Nanovector As | Date: 2011-01-28

The present invention relates to a radioimmunoconjugate that binds human CD37. Pharmaceutical compositions and uses thereof for the treatment of cancerand in particular B-cell malignanciesare aspects of the present invention.


Patent
Nordic Nanovector AS | Date: 2013-12-09

The present invention relates to a radioimmunoconjugate that binds human CD37. Pharmaceutical compositions and uses thereof for the treatment of cancer and in particular B cell malignancies are aspects of the present invention.


Patent
Nordic Nanovector AS | Date: 2014-03-12

The present invention relates to a radioimmunoconjugate that binds human CD37. Pharmaceutical compositions and uses thereof for the treatment of cancer - and in particular B-cell malignancies - are aspects of the present invention.

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