Vel, det er ikke noe nytt som er journalført på dette tidspunkt. Ved forrige korsvei, dvs vedtakene, fikk vi børsmelding fra Nano før de aktuelle dokumentene havnet i journalen. Tipper det samme skjer nå, mtp REKs brannmur av ferieavvikling og andre sommerrelaterte ting.
Er jo børssenitive ting, disse vedtakene.
Det gjelder kun å omformulere pasientinformasjon og gjøre den lettere tilgjengelig for pasientene. Man burde forvente at Kolstad ved hjelp av Nano har klart å sende inn justert informasjon før 8. juni. Eller i hvert fall at komiteleder ikke velger å vente med tilbakemelding til over fellesferien.
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Synes det er en helt ellevill ting å forsinke et helt studie på.
Hva med å si at de forventer en forbedring, men første fem pasienter må få ekstra veiledning av prosjektleder.
4 Likes
Blir for mye detalj-styring, og mangler en reell kvalitetssikring av forbedring til de andre pasientene.
Dersom teksten er formet slik at det ikke kan forventes en potensiell pasient forstår det, er det mulig brudd på norsk lov om informert samtykke. Det er en bagatell dog, hadde de ledige hender å sette på saken burde det være en ‘quick fix’.
Edit* ser for meg der er et hav av potensielle maler å benytte.
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Jeg tror også at han har gjort det. Men det er ikke journalført, ennå.
Manglende journalføring i div. etater er ikke et uvanlig fenomen. Definitivt ikke etter boka, men likevel utbredt.
Noen saker om manglende dokumentinnsyn og manglende journalføring havner hos sivilombudsmannen. Har ikke sjekket om Rek har havnet der, ennå… En liten kveldsoppgave, kanskje?
Vedlegger et tilfeldig eksempel …
Ja det burde man 
Hvordan Nano håndterer sine søknader og oppfølgninger er mildt sagt uheldig (les: udugelig), som har ført til at når godkjenningene endelig kommer blir det “non-events” ut av det.
Må opp til 59 igjen! Noen som kan hausse litt?
En ANTICd47 + rituximab mot 2L har fått fast track av FDA etter fase 1. NANO har fase 1 resultater med Betalutin og prekliniske data på kombinasjonen. Det behøver ikke være lenge til det samme skjer med Archer-1!
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Kvalitetsikring om medisinsk forskning må være på plass. Konsekvensene av manglende kvalitetssikring kan jo ellers bli ganske stygge, både med tanke på pasienter og ellers. En sti er bedre enn en snarvei. Eller short cuts.
Tålmodighetskrem kan være et bra alternativ nå.
Edit: Selv om man kunne ønske seg litt turbokrem.
Lisa har sagt at så snart REK godkjennelse for Archer foreligger vil Nano gi mer detaljer om studiet. Burde kunne gi et ølige løft, sammen med infor om første pasient dosert i Paradigme og åpning av sentere i USA.
Vi har nå 10 land og 35 sentere. Ventger på de siste 10 land. Spennende hvor mange sentere i USA,
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Nordic Nanovector to present preclinical data demonstrating Betalutin® reverses resistance to anti-CD20 treatment in NHL cell
Poster to be presented at Inaugural AACR International Meeting: Advances in
Malignant Lymphoma
Oslo, Norway, 11 June 2018Nordic Nanovector ASA (OSE: NANO) announces that a poster reporting the ability
of Betalutin® (177Lu-lilotomab satetraxetan) to reverse resistance to anti-CD20
treatment in non-Hodgkin’s lymphoma (NHL) cell lines will be presented at the
inaugural AACR International Meeting: Advances in Malignant Lymphoma (22-26
June, Boston, MA, USA).The preclinical data, described in an abstract published online (link
here (http://www.abstractsonline.com/pp8/#!/5739/presentation/322)), demonstrate
that treatment of rituximab-resistant NHL cells with Betalutin® significantly
elevated the expression of the CD20 receptor on the surface of cells. The
increase in CD20 receptors re-sensitizes the cells to the anti-CD20 NHL
immunotherapies rituximab (Rituxan®) and obinutuzumab (Gazyva®/Gazyvaro®),
causing increased tumour cell death.These results support previous preclinical studies that highlight the
synergistic anti-tumour effects of combining Betalutin® with rituximab
immunotherapy. Nordic Nanovector is planning to investigate this novel
combination therapy in patients with relapsed/refractory follicular lymphoma in
the Archer-1 Phase 1b clinical study. This study is targeting dosing of the
first patient in the second half of 2018.Details for the poster presentation are as follows:
Poster Title: 177Lu-lilotomab satetraxetan has the potential to counteract
resistance to rituximab and obinutuzumab in non-Hodgkin’s lymphoma SessionDate and Time: Saturday 23 June, 11:45 AM to 1:45 PM (Eastern Daylight Time)
Poster Session A: Basic and Translational Science 1
Location: Salon F, 4th floor, Boston Marriot Copley Plaza Permanent
Abstract Number: A28
The poster will be available on the company’s website at the time of the
presentation: www.nordicnanovector.com.For further information, please contact:
IR enquiries Malene Brondberg, VP, Investor Relations and Corporate
CommunicationsTel/Cell: + 44 7561 431 762
Email: [email protected]
International Media Enquiries Mark Swallow/David Dible/Isabelle Andrews
(Citigate Dewe Rogerson)Tel: +44 207 638 9571
Email: [email protected]
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-conjugate 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. Nordic Nanovector intends to retain
marketing rights and to actively participate in the commercialisation of
Betalutin® in core markets. Further information can be found at
www.nordicnanoveEkstern link: http://www.newsweb.no/index.jsp?messageId=453308
Nyheten er levert av OBI.
http://www.netfonds.no/quotes/release.php?id=20180611.OBI.20180611S4
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Vel. Den overskriften elsker jeg.
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Presenter/Authors
Marion M. Malenge1, Sebastian Patzke1, Anne Hansen Ree2, Trond Stokke3, Jostein Dahle1, Ada Repetto-Llamazares1. 1Nordic Nanovector ASA, Oslo, Norway; 2Institute of Clinical Medicine, University of Oslo, Oslo, Norway; 3Institute of Cancer Research, Oslo University Hospital, Oslo, Norway
Disclosures
M.M. Malenge: ; Nordic Nanovector ASA. ; Norwegian Research Council. S. Patzke: ; Nordic Nanovector ASA. A. Hansen Ree: None. T. Stokke: ; Nordic Nanovector ASA. J. Dahle: ; Nordic Nanovector ASA. A. Repetto-Llamazares: ; Nordic Nanovector ASA.
Abstract
Objectives: Sensitivity of non-Hodgkin’s lymphoma (NHL) cells to rituximab or obinutuzumab is dependent on their surface expression of CD20. We have recently shown that pretreatment with the anti-CD37 radioimmunoconjugate 177Lu-lilotomab satetraxetan increases CD20 expression in NHL cell lines in vitro. We have also shown that the combination of 177Lu-lilotomab satetraxetan with rituximab synergistically increases the antitumor effect in vivo. These results have led to a planned phase 1b clinical study (Archer-1) where 177Lu-lilotomab will be given in combination with rituximab to patients with relapsed refractory follicular lymphoma. In the present study, we tested if using 177Lu-lilotomab could counteract anti-CD20 resistance in an in vitro model.
Methods: Rituximab-resistant Raji2R cells and the rituximab-sensitive parental cell line Raji (supplied by Roswell Park Cancer Institute) were incubated for 18 hours with either 177Lu-lilotomab satetraxetan, unlabeled lilotomab, or vehicle, then washed and resuspended in fresh medium. CD20 expression was measured by flow cytometry using fluorescently labeled rituximab, 3 and 6 days after washing. CD20-specific induction of antibody-dependent cell cytotoxicity (ADCC) by rituximab or obinutuzumab was analyzed 6 days after washing by measuring the luciferase activity of FcRγIIIa receptor expressing Jurkat cells (the ADCC reporter bioassay kit, Promega). The data were analyzed by paired two tailed t-test and presented as mean ± SEM.
Results: Vehicle-treated Raji2R cells had a CD20 expression corresponding to 42% relative to the parental Raji cells. However, treatment with 177Lu-lilotomab satetraxetan increased the relative CD20 expression to 71 ± 3.0% (P < 0.0001, total increase of 29%). Moreover, relative ADCC induction by rituximab increased from 13 ± 5.6% without 177Lu-lilotomab treatment to 28 ± 3.7% in the treated counterparts (P < 0.05, total increase of 15%). As expected, obinutuzumab caused higher ADCC induction than rituximab in both cell lines, but with a lower induction in Raji2R cells (31 ± 6.6% relative to Raji cells). Treatment with 177Lu-lilotomab satetraxetan increased ADCC induction by obinutuzumab in Raji2R cells to 40% relative to Raji cells (P < 0.0001, increase of 9%). Treatment with unlabeled lilotomab had no significant effect on CD20 expression nor on ADCC induction by rituximab or obinutuzumab.
Conclusions: We demonstrated that treatment of rituximab-resistant Raji2R cells with 177Lu-lilotomab satetraxetan significantly elevated CD20 surface expression and resensitized the cells to ADCC induction by rituximab and obinutuzumab. If similar effects are confirmed in the Archer-1 study, this could change the way radioimmunotherapy and anti-CD20 immunotherapy will be used in the future.
2 Likes
Kanskje noen av dere som har noen studiepoeng i medisin/forskning kan forklare hvordan en slik in vitro studie faktisk gjennomføres?
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Conclusions: We demonstrated that treatment of rituximab-resistant Raji2R cells with 177Lu-lilotomab satetraxetan significantly elevated CD20 surface expression and resensitized the cells to ADCC induction by rituximab and obinutuzumab. If similar effects are confirmed in the Archer-1 study, this could change the way radioimmunotherapy and anti-CD20 immunotherapy will be used in the future.
1 Like
“If similar effects are confirmed in the Archer-1 study, this could change the way radioimmunotherapy and anti-CD20 immunotherapy will be used in the future.”
Liker den siste setningen her. Kan ikke se at NANO ble en mindre attraktiv partner eller oppkjøpsobjekt etter denne studien akkurat.
8 Likes
Nordic Nanovector to present preclinical data demonstrating Betalutin® reverses resistance to anti-CD20 treatment in NHL cells
Poster to be presented at Inaugural AACR International Meeting: Advances in Malignant Lymphoma
Oslo, Norway, 11 June 2018
Nordic Nanovector ASA (OSE: NANO) announces that a poster reporting the ability of Betalutin® (177Lu-lilotomab satetraxetan) to reverse resistance to anti-CD20 treatment in non-Hodgkin’s lymphoma (NHL) cell lines will be presented at the inaugural AACR International Meeting: Advances in Malignant Lymphoma (22-26 June, Boston, MA, USA).
The preclinical data, described in an abstract published online (link here (http://www.abstractsonline.com/pp8/#!/5739/presentation/322)), demonstrate that treatment of rituximab-resistant NHL cells with Betalutin® significantly elevated the expression of the CD20 receptor on the surface of cells. The increase in CD20 receptors re-sensitizes the cells to the anti-CD20 NHL immunotherapies rituximab (Rituxan®) and obinutuzumab (Gazyva®/Gazyvaro®), causing increased tumour cell death.
These results support previous preclinical studies that highlight the synergistic anti-tumour effects of combining Betalutin® with rituximab immunotherapy. Nordic Nanovector is planning to investigate this novel combination therapy in patients with relapsed/refractory follicular lymphoma in the Archer-1 Phase 1b clinical study. This study is targeting dosing of the first patient in the second half of 2018.
Details for the poster presentation are as follows:
Poster Title: 177Lu-lilotomab satetraxetan has the potential to counteract resistance to rituximab and obinutuzumab in non-Hodgkin’s lymphoma Session
Date and Time: Saturday 23 June, 11:45 AM to 1:45 PM (Eastern Daylight Time)
Poster Session A: Basic and Translational Science 1
Location: Salon F, 4th floor, Boston Marriot Copley Plaza Permanent
Abstract Number: A28
The poster will be available on the company’s website at the time of the presentation: www.nordicnanovector.com.
For further information, please contact:
IR enquiries Malene Brondberg, VP, Investor Relations and Corporate Communications
Tel/Cell: + 44 7561 431 762
Email: [email protected]
International Media Enquiries Mark Swallow/David Dible/Isabelle Andrews (Citigate Dewe Rogerson)
Tel: +44 207 638 9571
Email: [email protected]
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-conjugate 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. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets. Further information can be found at www.nordicnanovector.com
Nyheten er levert av Cision.
http://www.netfonds.no/quotes/release.php?id=20180611.Cision.20180610:BIT:9914:0
At de har fått samme resultat på obinutuzumabresistens er veldig bra. Det er Roche sin Rituximab version 2.
Vehicle-treated Raji2R cells had a CD20 expression corresponding to 42% relative to the parental Raji cells. However, treatment with 177Lu-lilotomab satetraxetan increased the relative CD20 expression to 71 ± 3.0% (P < 0.0001, total increase of 29%)
Legg merke til hva de egentlig sier her. 71 / 42 = 69%. Betalutin øker altså uttrykk av CD20 på rituximabresistente celler med nesten 70%
Moreover, relative ADCC induction by rituximab increased from 13 ± 5.6% without 177Lu-lilotomab treatment to 28 ± 3.7% in the treated counterparts (P < 0.05, total increase of 15%)
ADCC = antibody-dependent cell-mediated cytotoxicity - SELVE EFFEKTEN AV RITUXIMAB øker med 28 / 13 = 115% etter behandling av Betalutin
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Er dette abstraktet basert på behandling av mennesker? I så fall, har noen funnet ut hvor mange som deltok i undersøkelsen.
Dette er pre-kliniske data. ARCHER-1 skal teste dette på mennesker.
Men For å spekulerer litt:
Husk at NANO har behandlet mange pasienter allerede, i LYMRIT 37-01 studien. Mitt tips er derfor at de faktisk sitter på kliniske data som viser hvordan Betalutin påvirker CD-20 expression. Noe annet ville overraske meg stort. Det er vel også rimelig å anta at de har behandlet pasienter som ikke responderer på CD-20 behandling i LYMRIT…
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