Nordic Nanovector ASA
| Allmennaksjeselskap | |
| Traded as | OSE: NANO |
| ISIN | 🆔NO0010597883 |
| Industry | |
| Founded 📆 | July 2, 2009 |
| Founders 👔 | Roy Hartvig Larsen, Øyvind Sverre Bruland and Jostein Dahle..[1] |
| Headquarters 🏙️ | Oslo, Norway |
Area served 🗺️ | |
Key people | Eduardo Bravo (CEO) |
| Members | |
Number of employees | |
| 🌐 Website | [Lua error in Module:WikidataIB at line 665: attempt to index field 'wikibase' (a nil value). ] |
| 📇 Address | |
| 📞 telephone | |
Nordic Nanovector ASA is a clinical stage biotech company based in Oslo, Norway, with subsidiaries in the UK and Switzerland. The company is listed on the Oslo Stock Exchange.[2]
Technology and products[edit]
The technological foundation for Nordic Nanovector is radioimmunotherapy, internally targeted radiopharmaceutical medicine that aims to kill cancer cells by targeting specific antigens found on the surface of cancerous cells, paired with a nuclear payload that releases radiation. The scientic rationale is that targeting the radiation in this way will significantly reduce the radiation damage to healthy cells.[3]
Betalutin[edit]
Betalutin (Lutetium (177Lu)-Lilotomab Satetraxetan) is the lead product of Nordic Nanovector, specifically designed for treating patients with Non-Hodgkin lymphomas[4].
Mechanism of action[edit]
Betalutin is a Antibody Radionuclide Conjugate that consists of two main parts:
- The Lilotomab monoclonal antibody which targets the CD37 antigen, which is abundantly present on such cancers[5][6]. The Lilotomab (HH1) antibody was originally created by researchers on the Norwegian Radium Hospital in 1985[7]
- A Lutetium 177Lu radionuclide payload, which emits Beta particles that can kill cancerous cells.[8]
Clinical trials[edit]
There are currently three ongoing clinical studies for Betalutin, in different Non-Hodkins lymphoma indications.
- LYMRIT-37-01 PARADIGME, pivotal phase 2b study in 3rd line Follicular Lymphoma - NCT01796171 on Clinicaltrials.gov
- LYMRIT-37-07 ARCHER-1, phase 1b study combining Rituximab and Betalutin in 2nd line Follicular Lymphoma - NCT03806179 on clinicaltrials.gov
- LYMRIT 37-05, phase 1 study in DLBCL - NCT02658968 on clinicaltrials.gov
Adverse effects[edit]
During the early dose escalation phase of the LYMRIT-37-01 clinical study, one cohort of patients was treated with 20/40 dosage. Dose Limiting Toxicity, DLT, was reported.
Key findings reported by Nordic Nanovector from studies about Betalutin[edit]
The company has reported key findings from the LYMRIT-37-01 clinical study at medical scientific conferences and in scientific publications: [10].
The company is also investigating a possible synergistic effect between Rituximab and Betalutin, forming the scientific basis for the ARCHER-1 clinical study. [11][12].
Regulatory history[edit]
In June 2014, Betalutin was granted orphan drug designation for treatment of follicular lymphoma in Europe by the European Medicines Agency (EMA) and the European Commission (EC)[13].
In June 2018, Nordic Nanovector reported that Betalutin had gained the American FDA Fast Track designation for Betalutin for the treatment of patients with relapsed or refractory follicular lymphoma (FL) after at least 2 prior systemic therapies[14].
In October 2018, Betalutin was granted the Promising Innovative Medicine (PIM) designation by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of patients with advanced relapsed/refractory follicular lymphoma (R/R FL)[15].
Humalutin[edit]
Humalutin (177Lu-NNV003) is the second investigational drug from the company, which differentiates from Betalutin in that it is using a chimeric antibody called NNV003 instead of Lilotomab[16]. The theoretical basis for this drug is among other that a chimeric antibody will be feasible for repeat use[17].
Notable collaborations with external companies[edit]
Partners in R&D[edit]
As of 2019, Nordic Nanovector has several ongoing preclinical research collaborations ongoing with other companies. Among these, the first to publish a scientific paper about research findings is a product candidate by Orano Med US, a subsidiary of Orano using the NNV003 chimeric antibody paired with a 212Pb (Lead isotope) payload.[18]
Operational partners[edit]
Nordic Nanovector has signed a manufacturing agreement for Betalutin with Diatec Monoclonals AS, a Norwegian company operating in the field of antibody production and conjugation[19].
History[edit]
The company was founded in 2009 by Roy Larsen and Øyvind Bruland after they left their previous company Algeta which at that time was going into the commercialization of their lead drug Alpharadin (Xofigo). The founders also included Jostein Dahle [20].
In April 2015, the company was listed on the Oslo Stock Exchange[21]
In December 2016, the company made a private offering of company stock to fund further clinical studies.[22]
In April 2018, Luigi Costa stepped down as CEO of Nordic Nanovector, and Eduardo Bravo assumed the role in June[23]
References[edit]
- ↑ "Nordic Nanovector ASA company profile". BusinessInsider.
- ↑ https://www.oslobors.no/ob_eng/markedsaktivitet/#/details/NANO.OSE/overview
- ↑ "Targeted agent shows early promise for NHL". www.mdedge.com.
- ↑ "Lutetium (177lu) lilotomab satetraxetan - Nordic Nanovector - AdisInsight". adisinsight.springer.com.
- ↑ Stathis, Anastasios; Bertoni, Francesco (2016-12-29). "Staining the target: CD37 expression in lymphomas". Blood. 128 (26): 3022–3023. doi:10.1182/blood-2016-11-748137. PMID 28034866.
- ↑ Hsi, Eric; Chao, Debra; Starling, Gary; Algate, Paul; Gordon, Brian; Kumar, Neeraj; Sho, Mien; Durkin, Lisa; Ybarra, Suzanne; Zhao, Xiaoxian (2010-11-19). "CD37 is a Potential Therapeutic Target for B-Cell Non-Hodgkin Lymphoma". Blood. 116 (21): 3098. doi:10.1182/blood.V116.21.3098.3098.
- ↑ "Characterization of Two Murine Monoclonal Antibodies Reactive with Human B Cells.: Their Use in a High-Yield, High-Purity Method for Isolation of B Cells and Utilization of Such Cells in an Assay for B-Cell Stimulating Factor | Request PDF". ResearchGate.
- ↑ "Betalutin".
- ↑ https://www.researchgate.net/profile/Jostein_Dahle/publication/305984771_Pre-dosing_With_unlabelled_antibody_significantly_increases_the_pharmacokinetic_exposure_and_reduces_haematological_toxicity_of_177Lu-lilotomab_in_non-Hodgkin_lymphoma_patients/links/57a837ff08ae3f452939499f/Pre-dosing-With-unlabelled-antibody-significantly-increases-the-pharmacokinetic-exposure-and-reduces-haematological-toxicity-of-177Lu-lilotomab-in-non-Hodgkin-lymphoma-patients.pdf
- ↑ "Webprogram Unavailable".
- ↑ https://www.researchgate.net/publication/286861748_A_treatment_with_177Lu-HH1_increases_CD20_expression_in_non-Hodgkin_lymphoma_cells_in_vitro_and_in_vivo
- ↑ https://www.researchgate.net/publication/326330884_Combination_of_177_Lu-lilotomab_with_rituximab_significantly_improves_the_therapeutic_outcome_in_pre-clinical_models_of_non-Hodgkin's_lymphoma
- ↑ "Nordic Nanovector: Betalutin™ granted Orphan Designation in Europe". 2014-06-11.
- ↑ "Fast Track status for Nordic Nanovector's follicular lymphoma treatment | Pharma Business International".
- ↑ "Nordic Nanovector's Betalutin® Receives Promising Innovative Medicine (PIM) Designation in the UK for the Treatment of Follicular Lymphoma".
- ↑ "Program Planner". www.abstractsonline.com.
- ↑ "Comparison of murine and chimeric version of the anti-CD37 antibody HH1 used for antibody-radionuclide-conjugate (ARC) therapy of Non-Hodgkin Lymphoma". ResearchGate.
- ↑ "Targeted Alpha Therapy with 212Pb-NNV003 for the Treatment of CD37 Positive B-Cell Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin Lymphoma (NHL)". ASH. Dec 3, 2018 – via ash.confex.com.
- ↑ "Ny behandling knuser lymfekreftceller innenifra - Apollon". www.apollon.uio.no.
- ↑ "Jostein Dahle | PhD | Nordic Nanovector AS, Oslo | Research and Development". ResearchGate.
- ↑ "BRIEF-Nordic Nanovector: Total gross proceeds from IPO increase to..." Reuters. Apr 22, 2015 – via www.reuters.com.
- ↑ "Nordic Nanovector – Private placement successfully completed". News Powered by Cision.
- ↑ "Nordic Nanovector appoints Eduardo Bravo as CEO". www.thepharmaletter.com.
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