Delving into the Latest Updates on Lutetium (177lu) lilotomab satetraxetan with Synapse

Overview

Basic Info

Drug Type

Radiolabeled antibody, Therapeutic radiopharmaceuticals

Synonyms

177Lu-Dota-tetulomab, 177Lu-lilotomab satetraxetan, 177Lu-tetraxetan-tetulomab

+ [8]

Target

CD37

Mechanism

CD37 antagonists(Leukocyte antigen CD37 antagonists), B cells stimulants(B cells stimulants)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases

Active Indication-

Inactive Indication

Diffuse large B-cell lymphoma recurrentDiffuse large B-cell lymphoma refractoryFollicular Lymphoma+ [3]

Originator Organization

Nordic Nanovector ASA

Active Organization-

Inactive Organization

Nordic Nanovector ASA

Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

RegulationOrphan Drug (EU), Orphan Drug (US)

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Gene Sequence

Sequence Code 319372611H

Source: *****

Sequence Code 319372681L

Source: *****

This study is a Phase 1b, open-label, single arm dose escalation study of Betalutin followed by rituximab in patients with previously treated follicular lymphoma. The purpose of this study is to characterise the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumour activity of Betalutin in combination with rituximab.

Start Date04 Oct 2018

Sponsor / Collaborator

Nordic Nanovector ASA

[+1]

NCT02657447 / WithdrawnPhase 1

A Phase 1, Open Label, Randomized Study to Assess Pharmacokinetics, Biodistribution and Radiation Dosimetry of Lutetium (177Lu) Lilotomab Satetraxetan (Betalutin®) Radioimmunotherapy in Patients With Relapsed Non-Hodgkin Lymphoma

This study is a phase I, open label, randomized study to assess pharmacokinetics, biodistribution and radiation dosimetry of lutetium (177Lu) lilotomab satetraxetan (Betalutin®) radioimmunotherapy in patients with relapsed non-Hodgkin lymphoma. The study will also investigate the safety, toxicity and efficacy of Betalutin and pre-dosing.

Start Date19 Dec 2017

Sponsor / Collaborator

Nordic Nanovector ASA

NCT02658968 / CompletedPhase 1

A Phase 1 Dose Finding Study of Lutetium (177Lu)-Lilotomab Satetraxetan (Betalutin®) in Patients With Relapsed/Refractory, Diffuse Large B-cell Lymphoma, Not Eligible for Autologous Stem Cell Transplant

This study is a phase 1, dose finding, open-label study in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). This is a dose escalating study to define the maximum tolerated dose (MTD) of lutetium (177Lu)-lilotomab satetraxetan (Betalutin®) in DLBCL patients who are not eligible for autologous stem cell transplant. The study will also assess safety and tolerability, pharmacokinetics, biodistribution and efficacy.

Start Date02 Mar 2017

Sponsor / Collaborator

Nordic Nanovector ASA

100 Clinical Results associated with Lutetium (177lu) lilotomab satetraxetan

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100 Translational Medicine associated with Lutetium (177lu) lilotomab satetraxetan

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100 Patents (Medical) associated with Lutetium (177lu) lilotomab satetraxetan

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20

Literatures (Medical) associated with Lutetium (177lu) lilotomab satetraxetan

01 Oct 2022·Molecular imaging and biology

FDG PET/CT and Dosimetric Studies of 177Lu-Lilotomab Satetraxetan in a First-in-Human Trial for Relapsed Indolent non-Hodgkin Lymphoma—Are We Hitting the Target?

Article

Author: Kolstad, Arne ; Blakkisrud, Johan ; Dahle, Jostein ; Revheim, Mona-Elisabeth ; Stokke, Caroline ; Løndalen, Ayca

Results:

Significant decreases in tMTV and tTLG were observed at 3 months for patients receiving tTAD ≥ 200 cGy compared to patients receiving tTAD < 200 cGy (p = .03 for both). All non-responders had tTAD < 200 cGy. Large variations in tTAD were observed in responders. Reduction in 177Lu-lilotomab satetraxetan uptake in tumor volume was not observed in patients with higher baseline tumor burden (tTMV).

Conclusion:

tTAD of ≥ 200 cGy may prove valuable to ensure clinical response, but further studies are needed to confirm this in a larger patient population. Furthermore, this work indicates that higher baseline tumor burden (up to 585 cm3) did not induce reduction in radioimmunoconjugate accumulation in tumor.

02 Nov 2021·Acta oncologica (Stockholm, Sweden)Q2 · MEDICINE

Myelosuppression in patients treated with¹⁷⁷Lutetium-lilotomab satetraxetan can be predicted with absorbed dose to the red marrow as the only variable

Q2 · MEDICINE

Article

Author: Blakkisrud, Johan ; Kolstad, Arne ; Dahle, Jostein ; Stokke, Caroline ; Martinsen, Anne Catrine ; Løndalen, Ayca

BACKGROUND:

The aim of this study was to investigate dosimetry data and clinical variables to predict hematological toxicity in non-Hodgkin lymphoma (NHL) patients treated with [¹⁷⁷Lutetium]Lu-lilotomab satetraxetan.

MATERIAL AND METHODS:

A total of 17 patients treated with [¹⁷⁷Lu]Lu-lilotomab satetraxetan in a first-in-human phase 1/2a study were included. Absorbed dose to the red marrow was explored using SPECT/CT-imaging of the lumbar vertebrae L2-L4 over multiple time points. Percentage reduction of thrombocytes and neutrophils at nadir compared to baseline (PBN) and time to nadir (TTN) were chosen as indicators of myelosuppression and included as dependent variables. Two models were applied in the analysis, a multivariate linear model and a sigmoidal description of toxicity as a function of absorbed dose. A total of 10 independent patient variables were investigated in the multivariate analysis.

RESULTS:

Absorbed dose to the red marrow ranged from 1 to 4 Gy. Absorbed dose to the red marrow was found to be the only significant variable for PBN for both thrombocytes and neutrophils. The sigmoid function gave similar results in terms of accuracy when compared to the linear model.

CONCLUSION:

Myelosuppression in the form of thrombocytopenia and neutropenia in patients treated with [¹⁷⁷Lu]Lu-lilotomab satetraxetan can be predicted from the SPECT/CT-derived absorbed dose estimate to the red marrow.

08 Sep 2020·Blood advancesQ2 · MEDICINE

Phase 1/2a study of 177Lu-lilotomab satetraxetan in relapsed/refractory indolent non-Hodgkin lymphoma

Q2 · MEDICINE

Article

Author: Rojkjaer, Lisa ; Madsbu, Ulf ; Holte, Harald ; Illidge, Tim ; Beasley, Matthew ; Bayne, Mike ; Jurczak, Wojciech ; O'Rourke, Noelle ; Kaščák, Michal ; Spetalen, Signe ; Blakkisrud, Johan ; Obr, Aleš ; Dahle, Jostein ; Kolstad, Arne ; Løndalen, Ayca ; Bolstad, Nils ; Stokke, Caroline ; Pascal, Veronique ; Fagerli, Unn-Merete

Abstract:

For patients with indolent non-Hodgkin lymphoma who fail initial anti-CD20–based immunochemotherapy or develop relapsed or refractory disease, there remains a significant unmet clinical need for new therapeutic approaches to improve outcomes and quality of life. 177Lu-lilotomab satetraxetan is a next-generation single-dose CD37-directed radioimmunotherapy (RIT) which was investigated in a phase 1/2a study in 74 patients with relapsed/refractory indolent non-Hodgkin B-cell lymphoma, including 57 patients with follicular lymphoma (FL). To improve targeting of 177Lu-lilotomab satetraxetan to tumor tissue and decrease hematologic toxicity, its administration was preceded by the anti-CD20 monoclonal antibody rituximab and the “cold” anti-CD37 antibody lilotomab. The most common adverse events (AEs) were reversible grade 3/4 neutropenia (31.6%) and thrombocytopenia (26.3%) with neutrophil and platelet count nadirs 5 to 7 weeks after RIT. The most frequent nonhematologic AE was grade 1/2 nausea (15.8%). With a single administration, the overall response rate was 61% (65% in patients with FL), including 30% complete responses. For FL with ≥2 prior therapies (n = 37), the overall response rate was 70%, including 32% complete responses. For patients with rituximab-refractory FL ≥2 prior therapies (n = 21), the overall response rate was 67%, and the complete response rate was 24%. The overall median duration of response was 13.6 months (32.0 months for patients with a complete response). 177Lu-lilotomab satetraxetan may provide a valuable alternative treatment approach in relapsed/refractory non-Hodgkin lymphoma, particularly in patients with comorbidities unsuitable for more intensive approaches. This trial was registered at www.clinicaltrials.gov as #NCT01796171.

31

News (Medical) associated with Lutetium (177lu) lilotomab satetraxetan

21 Apr 2023

·www.fiercebiotech.com

2 embattled biotechs fight to survive as cash, options run dry

The pressure is rising as cell therapy-focused Idogen faces liquidation and oncology-centered Nordic Nanovector searches for a partner. As difficult market conditions continue, two European biotechs are slashing costs and seeking ways to stay afloat as the end of the road nears. After the failed acquisition of APIM in December, Nordic Nanovector’s entire pipeline has been put on pause as the company searches for a partner to pick up its lead program, according to an April 18 update. The oncology biotech has faced persistent clinical and operational obstacles, winding down its PARADIGM trial in July of last year. The phase 2b study was evaluating the biotech’s lead antibody-radionuclide conjugate betalutin among patients with refractory follicular lymphoma. After enrollment difficulties, the trial failed to hit its main goals and was axed. Layoffs and restructuring quickly followed, whittling down staff to eight full-time workers. The company’s luck had appeared to be turning around when it announced in November that it would acquire fellow clinical-stage, Norway-based oncology company APIM. However, the good fortune was short-lived. Despite backing from both biotech’s boards, shareholders voted down the proposed transaction. To top it all off, Nordic board members resigned en masse at the following meeting and, in wake of the failed deal and in efforts to save cash, Nordic’s interim CEO and CFO Malene Brondberg also departed. Now, the biotech says it still believes there could be a market for betalutin in early lines of therapy given its safety profile. However, new development programs to test betalutin in different patient populations would require significant financial resources—money the company doesn’t have. Instead, Nordic is “exploring all strategic options” including potential partnerships to see if there is a possible path forward for the drug, according to this morning's release. In the same announcement, Nordic said that all of its pipeline projects are currently on hold. This includes Orano Med-partnered Alpha37, a preclinical alpha-emitting radioimmunotherapy that has been on hold since 2021; a preclinical anti-CD37 antibody program for hematological cancer and autoimmune diseases that was put on hold earlier this year; and a CAR-T project for hematological cancer in collaboration with the University of Pennsylvania. Nordic’s board is focused on reducing cash burn until a strategic partner can be found, the biotech added. Idogen is similarly cash-strapped. The Swiss cell therapy biotech's solution is to consider a reverse acquisition in hopes of avoiding liquidation. At the start of April, the biotech said its cash would run out at the end of June. Now, Idogen has said efforts to raise money haven’t been successful, prompting the company to consider a reverse acquisition, which means another company would take over Idogen’s stock listing, among other things. If the company can’t capitalize, the board will propose liquidation at its annual general meeting on June 9, according to acting CEO Christina Herder. Investors didn't appear reassured by Idogen’s honesty, sending the company's stock plummeting 35% to 0.05 Swedish krona (less than 1 cent) over the course of Tuesday. The company’s most advanced development program, dubbed IDO 8, is a tolerogenic cell therapy for patients with severe hemophilia that was set to enter a phase 1/2a clinical trial in 2022, though it’s unclear if the study ever launched. "We work with several financing options. However, time is short and therefore we are evaluating a reverse acquisition in parallel,” Herder said in the release. “If we do not reach the goal with our various capitalization processes, we must liquidate the company before the cash and equity run out.”

Phase 2Cell TherapyImmunotherapyAcquisition

19 Apr 2023

·www.prnewswire.com

Nordic Nanovector Publishes Data from the PARADIGME Phase 2 Clinical Trials with Betalutin® on European Clinical Trials Database

OSLO, Norway, April 18, 2023 /PRNewswire/ -- Nordic Nanovector ASA (OSE: NANOV) ("Nordic Nanovector" or the "Company") announces that full results from its Phase 2 clinical trials of Betalutin® (177 Lu lilotomab satetraxetan) in resistant/refractory (R/R) indolent non-Hodgkin's lymphoma (NHL) have been published at EudraCT, the European Union Drug Regulating Authorities Clinical Trials Database (the database for all interventional clinical trials on medicinal products submitted to the National Competent Authorities (NCAs) of the European Union). The data from the Phase 1b/2a LYMRIT 37-01 and the Phase 2b PARADIGME studies can be found via this link: EU Clinical Trials Register As previously announced on 5 July 2022, the PARADIGME trial of Betalutin® in 3rd-line follicular lymphoma patients refractory to rituximab/anti-CD20 (3L R/R FL) was discontinued following a comprehensive review and independent data evaluation and a subsequent request for regulatory agency interaction. The data from the 109 patients enrolled in PARADIGME up until its discontinuation show: Overall response rate (ORR) was 38.9% and 32.1%; complete response (CR) rate was 20.8% and 14.3% in participants receiving doses of 40/15 (Betalutin® dose of 15 MBq/kg after a pre-dose of 40 mg lilotomab) and 100/20 (Betalutin® dose of 20 MBq/kg after a pre-dose of 100 mg lilotomab), respectively. Median duration of response (DoR) was approximately 8.5 months for the 40/15 dose and 3.4 months for the 100/20 dose. Median duration of complete response (DoCR) was 8.5 months for 40/15 and 9.2 months for 100/20. DoR and DoCR are difficult to interpret due to the small number of responders. Over half the participants had progressed 6 months following treatment. The median progression-free survival (PFS) was 5.9 months versus 5.8 months with 40/15 and 100/20, respectively. The majority of treatment emergent adverse events (TEAEs) were due to cytopenias, most notably decreases in platelets (thrombocytopenia was observed in 19 [16.8%] and platelet count decreased in 11 [9.7%] participants) and neutrophils (neutropenia in 18 [15.9%] and decreased neutrophil count in six [5.3%] participants). Anaemia and fatigue were also reported in >10% of participants. As previously communicated in the 5 July 2022 announcement, the former Board of Directors of Nordic Nanovector took the decision to wind-down PARADIGME in a structured manner while ensuring that patients received the best possible care during this period, as the observed profile did not fully meet the objectives set out for the study. As a result, the former Board was of the opinion that the demonstrated profile was no longer sufficiently competitive to bring Betalutin® to the market in 3L R/R FL within a timeframe that made financial and commercial sense for the Company. The current board and management concurs with the decision to discontinue PARADIGME and Betalutin® development in the 3L R/R FL indication. The Company still believes there could be a market for Betalutin® in light of its safety profile, promising efficacy in earlier lines of therapy and unique feature of being delivered as a one-time dose. However, a potential new development programme would need to be conducted in a different patient population and line of treatment and would require significant financial resources. The Company is exploring all strategic options including potential partnerships to see if there is a possible way forward for Betalutin® in an alternative setting. Pipeline update: The rest of Nordic Nanovector's pipeline consists of: 1. Humalutin®: a radioimmunotherapy candidate based on a chimeric anti-CD37 antibody and the beta-emitting radionuclide lutetium-177 for NHL. The project has been on hold since 2016 and all preclinical data have been published in the following journals: · The European Journal of Nuclear Medicine and Molecular Imaging · Nature Scientific Reports · PLOS ONE 2. Alpha37: an alpha-emitting radioimmunotherapy candidate based on a chimeric anti-CD37 antibody conjugated to lead-212. The project is a collaboration with partner OranoMed and has been on hold since 2021. All preclinical data has been published in: PLOS ONE 3. Fully humanized anti-CD37 antibodies with potential in haematological cancers and autoimmune diseases. Preclinical data were presented in two posters at ASH, both available on the Nordic Nanovector website: ASH posters The project has been on hold in 2023. 4. CD37 DOTA CAR-T cell opportunity in haematological cancers is a research collaboration with the University of Pennsylvania. Data from preliminary investigations were inconclusive and the project has been put on hold. 5. Solid tumour radioimmunotherapy: a project directed at radioimmunotherapy for solid tumours, where target identification has been concluded and several interesting molecular targets for solid tumour indications have been identified. Validation of targets and testing of minimal viable products are being evaluated. The Board continues to focus on reducing costs where necessary to enable the Company to minimise cash burn until a strategic partner can be found. No assurances can be given as to the outcome or timing of the ongoing strategic review process. The Company will put forward any recommended proposals for resolution by shareholders in due course. IR enquiries Ludvik Sandnes, Interim CEO & CFO [email protected] +4790743017 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. Further information can be found at Forward-looking statements This press release contains certain forward-looking statements relating to inter alia to the business and strategies, financial performance and results of the Company. Forward-looking statements concern future circumstances and results and other statements that are not historical facts. These statements are based on Nordic Nanovector's current expectations and are subject to uncertainty and changes in circumstances. Any forward-looking statements contained in this release, including assumptions, opinions and views of Nordic Nanovector or cited from third party sources, are subject to risks, uncertainties and other factors that may cause actual results and events to be materially different from those expected or implied by the forward-looking statements. Nordic Nanovector cannot provide any assurance that the assumptions underlying such forward-looking statements are free from errors nor accept any responsibility for the future accuracy of opinions expressed in this release or the actual occurrence of any forecasted developments. Nordic Nanovector disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. The terms "anticipates", "assumes", "believes", "can", "could", "estimates", "expects", "forecasts", "intends", "may", "might", "plans", "should", "projects", "targets", "will", "would" or, in each case, their negative, or other variations or comparable terminology are used to identify forward-looking statements. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied in the forward-looking statements. Factors that could cause these differences include, but are not limited to, risks associated with implementation of Nordic Nanovector's strategy, risks and uncertainties associated with the development and/or approval of Nordic Nanovector's product candidates, ongoing and future clinical trials and expected trial results technology changes and new products in Nordic Nanovector's potential market and industry, Nordic Nanovector's freedom to operate (competitors patents) in respect of the products it develops, 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. This information is subject to a duty of disclosure pursuant to Sections 4-2 and 5-12 of the Securities Trading Act. The following files are available for download: SOURCE Nordic Nanovector

Phase 2ImmunotherapyClinical Result

19 Apr 2023

·www.prnewswire.com

Nordic Nanovector Publishes Data from the PARADIGME Phase 2 Clinical Trials with Betalutin® on European Clinical Trials Database

OSLO, Norway, April 18, 2023 /PRNewswire/ -- Nordic Nanovector ASA (OSE: NANOV) ("Nordic Nanovector" or the "Company") announces that full results from its Phase 2 clinical trials of Betalutin® (177 Lu lilotomab satetraxetan) in resistant/refractory (R/R) indolent non-Hodgkin's lymphoma (NHL) have been published at EudraCT, the European Union Drug Regulating Authorities Clinical Trials Database (the database for all interventional clinical trials on medicinal products submitted to the National Competent Authorities (NCAs) of the European Union). The data from the Phase 1b/2a LYMRIT 37-01 and the Phase 2b PARADIGME studies can be found via this link: EU Clinical Trials Register As previously announced on 5 July 2022, the PARADIGME trial of Betalutin® in 3rd-line follicular lymphoma patients refractory to rituximab/anti-CD20 (3L R/R FL) was discontinued following a comprehensive review and independent data evaluation and a subsequent request for regulatory agency interaction. The data from the 109 patients enrolled in PARADIGME up until its discontinuation show: Overall response rate (ORR) was 38.9% and 32.1%; complete response (CR) rate was 20.8% and 14.3% in participants receiving doses of 40/15 (Betalutin® dose of 15 MBq/kg after a pre-dose of 40 mg lilotomab) and 100/20 (Betalutin® dose of 20 MBq/kg after a pre-dose of 100 mg lilotomab), respectively. Median duration of response (DoR) was approximately 8.5 months for the 40/15 dose and 3.4 months for the 100/20 dose. Median duration of complete response (DoCR) was 8.5 months for 40/15 and 9.2 months for 100/20. DoR and DoCR are difficult to interpret due to the small number of responders. Over half the participants had progressed 6 months following treatment. The median progression-free survival (PFS) was 5.9 months versus 5.8 months with 40/15 and 100/20, respectively. The majority of treatment emergent adverse events (TEAEs) were due to cytopenias, most notably decreases in platelets (thrombocytopenia was observed in 19 [16.8%] and platelet count decreased in 11 [9.7%] participants) and neutrophils (neutropenia in 18 [15.9%] and decreased neutrophil count in six [5.3%] participants). Anaemia and fatigue were also reported in >10% of participants. As previously communicated in the 5 July 2022 announcement, the former Board of Directors of Nordic Nanovector took the decision to wind-down PARADIGME in a structured manner while ensuring that patients received the best possible care during this period, as the observed profile did not fully meet the objectives set out for the study. As a result, the former Board was of the opinion that the demonstrated profile was no longer sufficiently competitive to bring Betalutin® to the market in 3L R/R FL within a timeframe that made financial and commercial sense for the Company. The current board and management concurs with the decision to discontinue PARADIGME and Betalutin® development in the 3L R/R FL indication. The Company still believes there could be a market for Betalutin® in light of its safety profile, promising efficacy in earlier lines of therapy and unique feature of being delivered as a one-time dose. However, a potential new development programme would need to be conducted in a different patient population and line of treatment and would require significant financial resources. The Company is exploring all strategic options including potential partnerships to see if there is a possible way forward for Betalutin® in an alternative setting. Pipeline update: The rest of Nordic Nanovector's pipeline consists of: 1. Humalutin®: a radioimmunotherapy candidate based on a chimeric anti-CD37 antibody and the beta-emitting radionuclide lutetium-177 for NHL. The project has been on hold since 2016 and all preclinical data have been published in the following journals: · The European Journal of Nuclear Medicine and Molecular Imaging · Nature Scientific Reports · PLOS ONE 2. Alpha37: an alpha-emitting radioimmunotherapy candidate based on a chimeric anti-CD37 antibody conjugated to lead-212. The project is a collaboration with partner OranoMed and has been on hold since 2021. All preclinical data has been published in: PLOS ONE 3. Fully humanized anti-CD37 antibodies with potential in haematological cancers and autoimmune diseases. Preclinical data were presented in two posters at ASH, both available on the Nordic Nanovector website: ASH posters The project has been on hold in 2023. 4. CD37 DOTA CAR-T cell opportunity in haematological cancers is a research collaboration with the University of Pennsylvania. Data from preliminary investigations were inconclusive and the project has been put on hold. 5. Solid tumour radioimmunotherapy: a project directed at radioimmunotherapy for solid tumours, where target identification has been concluded and several interesting molecular targets for solid tumour indications have been identified. Validation of targets and testing of minimal viable products are being evaluated. The Board continues to focus on reducing costs where necessary to enable the Company to minimise cash burn until a strategic partner can be found. No assurances can be given as to the outcome or timing of the ongoing strategic review process. The Company will put forward any recommended proposals for resolution by shareholders in due course. IR enquiries Ludvik Sandnes, Interim CEO & CFO [email protected] +4790743017 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. Further information can be found at Forward-looking statements This press release contains certain forward-looking statements relating to inter alia to the business and strategies, financial performance and results of the Company. Forward-looking statements concern future circumstances and results and other statements that are not historical facts. These statements are based on Nordic Nanovector's current expectations and are subject to uncertainty and changes in circumstances. Any forward-looking statements contained in this release, including assumptions, opinions and views of Nordic Nanovector or cited from third party sources, are subject to risks, uncertainties and other factors that may cause actual results and events to be materially different from those expected or implied by the forward-looking statements. Nordic Nanovector cannot provide any assurance that the assumptions underlying such forward-looking statements are free from errors nor accept any responsibility for the future accuracy of opinions expressed in this release or the actual occurrence of any forecasted developments. Nordic Nanovector disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. The terms "anticipates", "assumes", "believes", "can", "could", "estimates", "expects", "forecasts", "intends", "may", "might", "plans", "should", "projects", "targets", "will", "would" or, in each case, their negative, or other variations or comparable terminology are used to identify forward-looking statements. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied in the forward-looking statements. Factors that could cause these differences include, but are not limited to, risks associated with implementation of Nordic Nanovector's strategy, risks and uncertainties associated with the development and/or approval of Nordic Nanovector's product candidates, ongoing and future clinical trials and expected trial results technology changes and new products in Nordic Nanovector's potential market and industry, Nordic Nanovector's freedom to operate (competitors patents) in respect of the products it develops, 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. This information is subject to a duty of disclosure pursuant to Sections 4-2 and 5-12 of the Securities Trading Act. The following files are available for download: SOURCE Nordic Nanovector

Phase 2ImmunotherapyClinical Result

100 Deals associated with Lutetium (177lu) lilotomab satetraxetan

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Follicular Lymphoma	Phase 2	US	Nordic Nanovector ASA	01 Dec 2012
Follicular Lymphoma	Phase 2	AT	Nordic Nanovector ASA	01 Dec 2012
Follicular Lymphoma	Phase 2	BE	Nordic Nanovector ASA	01 Dec 2012
Follicular Lymphoma	Phase 2	CA	Nordic Nanovector ASA	01 Dec 2012
Follicular Lymphoma	Phase 2	CZ	Nordic Nanovector ASA	01 Dec 2012
Follicular Lymphoma	Phase 2	FR	Nordic Nanovector ASA	01 Dec 2012
Follicular Lymphoma	Phase 2	HU	Nordic Nanovector ASA	01 Dec 2012
Follicular Lymphoma	Phase 2	IL	Nordic Nanovector ASA	01 Dec 2012
Follicular Lymphoma	Phase 2	IT	Nordic Nanovector ASA	01 Dec 2012
Follicular Lymphoma	Phase 2	NL	Nordic Nanovector ASA	01 Dec 2012

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02658968 (LYMRIT 37-05, CTgov)	Phase 1	Non-Hodgkin's lymphoma refractory \| Diffuse large B-cell lymphoma refractory \| Recurrent Non-Hodgkin Lymphoma ... View more	18	lilotomab+Betalutin (60/10)	lgdozfojqg(ejkdeaegdw) = nvmmkwroiu jmcgtolflb (plaesxpwrw, ftvvlszxwa - jbegqapoge) View more	-	16 Jan 2024
NCT02658968 (LYMRIT 37-05, CTgov)	Phase 1		18	lilotomab+Betalutin (100/10)	lgdozfojqg(ejkdeaegdw) = dyuldoifhb jmcgtolflb (plaesxpwrw, qrkwgxmkre - ljvnzogloi) View more	-	16 Jan 2024
NCT03806179 (Archer-1 \| LYMRIT-37-07, CTgov)	Phase 1	Recurrent Follicular Lymphoma	7	10 MBq/kg Betalutin (10 MBq/kg Betalutin With Rituximab Treatment)	bgadjyhvcv(ojwsuhchkz) = qrltqzpgoz knbcnjdqkw (uggpxxgusb, wjowsjkaye - wvlgaumfoj) View more	-	22 Dec 2023
NCT03806179 (Archer-1 \| LYMRIT-37-07, CTgov)	Phase 1	Recurrent Follicular Lymphoma	7	15 MBq/kg Betalutin (15 MBq/kg Betalutin With Rituximab Treatment)	bgadjyhvcv(ojwsuhchkz) = hgldflgaqi knbcnjdqkw (uggpxxgusb, kuagljdvzk - dogtwjvxox) View more	-	22 Dec 2023
NCT01796171 (PARADIGM, PRNewswire) Manual	Phase 2	Follicular Lymphoma Third line	109	[177]-Lilotomab Satetraxetan	hifgqklbul(wyqeawoyja) = Only one out of three patients responded to the treatment with the average duration of the response of approximately six months. fpjuwjckjw (viavlzvfif )	Negative	05 Jul 2022
NCT02658968 (LYMRIT 37-05, EHA2022) Manual	Phase 1	Diffuse large B-cell lymphoma recurrent	16	rituximab+lilotomab+BETALUTIN	jreryhfzbj(lwdrqzhttt) = bhliyqzzmu duaupqbhes (oavwnfdhrd ) View more	Positive	12 May 2022
NCT03806179 (Archer-1, PRNewswire) Manual	Phase 1	Follicular Lymphoma	7	rituximab+Betalutin	deztfuqbbm(oyowkrnjvz) = yweispihio avwrzhabmf (glblcvqabz )	Positive	25 May 2021
NCT01796171 (Pubmed \| Blood Adv) Manual	Phase 1/2	Indolent Non-Hodgkin Lymphoma	74	177Lu-lilotomab satetraxetan	obwdrszftq(vobswcxivs) = jgzkqqhiqs jiubifwvhc (pvwkqyfclm ) View more	Positive	08 Sep 2020
LYMRIT 37-01 (ICML2017)	Phase 1/2	Recurrent Non-Hodgkin Lymphoma CD37	56	Lilotomab 40 mg pre-dose	qtvnunkpqw(xmbimczmrr) = thrombocytopenia (n = 2) and atrial fibrillation (n = 2) vlrnyefrfn (iveytdatfx ) View more	Positive	07 Jun 2017
LYMRIT 37-01 (ICML2017)	Phase 1/2	Recurrent Non-Hodgkin Lymphoma CD37	56	Lilotomab 100 mg/m2 pre-dose		Positive	07 Jun 2017
AACR2016	Phase 1/2	B-Cell Lymphoma	18	Betalutin	tgseoycibb(wscezuswnm) = Platelet transfusions were given to 2 pts. At 15 MBq/kg (n = 6), 2 DLTs were observed: one G 3 thrombocytopenia lasting >14 days and one G 4 neutropenia/ thrombocytopenia lasting >7 days. Both DLTs recovered without intervention. In Arm 2 with 15 MBq/kg (n = 2) G4 thrombocytopenia was observed in both pts and one patient also had G4 neutropenia lasting >7 days. This pt was hospitalised due to sepsis. No DLTs have been reported at 10 MBq/kg in either arm. guokjvarko (qsawyrnzia ) View more	Positive	15 Jul 2016