20-25 pasienter i ARCHER-1. Opprettholder guiding på FPD i år.
Edit: og relativt hyggelig cashburn.
Men dårlig effekt fra DLBCL-studien så langt. Øker dose for å se om de ser sammenheng. Ikke at det sjokkerer.
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Nordic Nanovector ASA: Results for the Second Quarter and First Half 2018
Oslo, Norway, 22 August 2018
Nordic Nanovector ASA (OSE: NANO) announces its second quarter and first half 2018 results today. A presentation by the company’s senior management team will take place today in Oslo at 08:30 CEST, see details below.
Eduardo Bravo, CEO, commented: "I am pleased to report a quarter marked by important progress in the development of lead candidate Betalutin® in follicular lymphoma (FL). The first patients in the PARADIGME trial have now been dosed. Betalutin® was also granted Fast Track designation in June for relapsed or refractory 3L FL, adding to the Orphan drug designation for treating FL it received in 2014. These designations, granted based on the potential of Betalutin® to address an unmet patient need in FL, could support a quicker and smoother regulatory process and path to market, if PARADIGME is successful. We are also pleased that Archer-1 has been approved in Norway and we expect the first patient to be dosed before the end of 2018.
“Betalutin® is an exciting therapeutic candidate for non-Hodgkin’s lymphoma (NHL) and Nordic Nanovector is well positioned to drive its development through clinical trials. I’m excited to join the Company at this important time and look forward to working with the excellent board and management team to realise the significant potential of Betalutin® and to provide a new treatment option to NHL patients who are in need of effective therapies.”
Operational Highlights
· Eduardo Bravo appointed as Chief Executive Officer
o Brings more than 25 years’ experience from the biopharmaceutical industry· First patient dosed in pivotal Phase 2b PARADIGME trial investigating Betalutin® as a potential new treatment for patients with third-line relapsed antiCD20 refractory follicular lymphoma (3L R/R FL)
o Site activations continuing - as of August 21st, 41 (of 80-85) sites in 13 (of 20) countries are open for enrolment
o First data read-out targeted for 1H 2020· Betalutin® granted Fast Track designation in the US for FL
o Based on promising safety and preliminary efficacy data from the LYMRIT 37-01 study· Phase 1b Archer-1 trial of Betalutin® in combination with rituximab in second-line (2L) FL patients approved in Norway
o First patient expected to be dosed in 2H 2018· Phase 1 study with Betalutin® in DLBCL advances to next dosing level
o First dosing levels found to be safe and well-tolerated· Further appointments to strengthen the Management Team and Board of Directors
o Maureen Deehan, PhD, appointed as Head of Corporate Development and Strategy
o Rainer Boehm, MD, elected as a member of the Board of DirectorsFinancial Highlights Q2 and 1H 2018
(Figures in brackets = same period 2017 unless otherwise stated)
· Revenues for the second quarter amounted to NOK 0 (NOK 0.1 million). Revenues for the first half of 2018 were NOK 0 (NOK 0.1 million).
· Total operating expenses for the second quarter were NOK 84.5 million (NOK 76.3 million). Total operating expenses for the first half of 2018 amounted to NOK 166.8 million (NOK 142.1 million)
o Research and development (preclinical, clinical, medical affairs, regulatory and CMC activities) expenses accounted for 72.2 % of total operating expenses (71 %) for the first half of 2018.· Comprehensive loss for the second quarter amounted to NOK 82.9 million (loss of NOK 66.3 million). Comprehensive loss for the first half was NOK 173.6 million (loss of NOK 122.1 million)
· Cash and cash equivalents amounted to NOK 570.1 million at the end of June 2018 (NOK 641.5 million at 31 March 2018 and NOK 756.6 million at 31 December 2017)
Outlook
Nordic Nanovector aspires to become a leader in the field of targeted 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, has a highly differentiated, competitive, clinical profile for R/R FL, based on the promising 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 initial clinical data read-outs targeted for 1H 2020 and subsequent filing in 2020 for marketing approval.
Betalutin® has been granted Fast Track designation in the US for the treatment of patients with R/R FL.
Nordic Nanovector intends to maximize the value of Betalutin® across other stages of FL, NHL and other haematological cancer indications.
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 to reach data read-out from PARADIGME in 1H 2020.
Second Quarter and First Half 2018 Results Presentation and Webcast
A presentation by Nordic Nanovector’s senior management team in English will take place today at 8:30 am CEST at:
Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo
Meeting Room: AKER
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 are available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentations/Interim Reports/2018.
Results presentation in Norwegian
A separate presentation of the results in Norwegian, to be hosted by Nordic Nanovector’s CFO, and its VP IR & Corporate Communications, will take place on Thursday, 23 August 2018 at 8:30 am CEST at:
Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo
Meeting Room: VIPPETANGEN
To attend the meeting please email - [email protected]
The presentation will NOT be recorded as a webcast
For further information, please contact:
IR enquiries
Malene Brondberg, VP Investor Relations and Corporate Communications
Cell: +44 7561 431 762
Email: [email protected]
International Media Enquiries
Mark Swallow/David Dible (Citigate Dewe Rogerson)
Telephone: +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
Ekstern link: http://news.cision.com/nordic-nanovector/r/nordic-nanovector-asa–results-for-the-second-quarter-and-first-half-2018,c2597692
Ekstern link: http://mb.cision.com/Public/9819/2597692/b6d9055b1aa949ae.pdf
Ekstern link: http://mb.cision.com/Public/9819/2597692/8c75dda2525074a1.pdfNyheten er levert av Cision.
http://www.netfonds.no/quotes/release.php?id=20180822.Cision.20180821:BIT:3992:0
Nytt?
In the USA, the Food & Drug Administration (FDA) has completed its review of the PARADIGME study and Nordic Nanovector expects US sites to be open for enrolment in the next month.
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Hvor står det dårlig effekt?
At de øker dosen er nå et positivt signal da første dose hadde god toleranse. Høyere dose vil teoretisk gi høyere effekt.
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1 down, 6 to go
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BRAVO.
Etter min mening gir Eduardo Bravo et svært solid inntrykk. Lovende
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Bunnsolid… Bravo, bravo bravissimo! Må også trekke frem Lisa, hun har stålkontroll. Vel blåst!
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Ting går som det skal, 13 land og 41 sites åpen, USA guidet nå til neste måned, det er en måned senere enn forventet i grunn. Men ikke noe som skremmer.
Allerede flere sites enn DNB anslo i sin analyse som endelig antall sites totalt.
Bravo gjorde en god figur, satte pris på at han hentet Renoldi opp også til Q&A.
Archer-1, fase 1B er ikke ment å bare gjøres i Norge, det har vært en misforståelse som har florert og blitt tatt som fakta.
Kombinasjonsstudier for R/R DLBCL med mere er kommet på planstadiet, det tror jeg må regnes som en positiv indikasjon her.
Var vel brukt nær forventning i bullcase, av penger for kvartalet. Mens nærmere 100m var forventet. Så positivt angående cashburn.
Er fornøyd som første inntrykk selv, kanskje noe jeg har mistet?
DLBCL og Archer-1 tar tid enda.
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Lurer på hvordan det blir med doseeskalering i denne studien.Altså, hvor kjedelig det blir å følge.
La oss håpe det blir en annen takt enn man har sett i DLBCL-studien. 
Doseeskaleringen består av å øke fra 10MBq/kg til 15MBq/kg Betalutin.
Jeg tror hastigheten kan sammenlignes forholdsvis godt med begynnelsen av Lymrit 37-01, kanskje litt raskere ettersom Betalutin nå er et velkjent produkt.
Data fra Archer-1 blir ekstremt spennende på ASH 2019.
Hvor ser du effekt fra DLBCL-studien? (Fikk ikke det med meg)
At de øker doser etterhvert i et safety-/doseeskaleringsstudie er jo bare normalt så fremt safety tilsier det.
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Slik som Tyrion skriver så betyr ikke en økning av dose at tidligere doseringer ikke gir effekt. Dette viser bare at DLBCL-pasienter forventes å tåle en økning - altså utelukkende positivt i mine øyne.
Synes ellers at Bravo er flink til å prate foran publikum og virket selvsikker på sin egen rolle i NANO. Er helt enig når han sier at Fast Track fra FDA ikke har fått nok recognition (type aksjekursen).
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For all del helt enig. Safety på luten er ok, at vi kan gå opp på hardere lut er positivt!
Eventuell Dlbcl poster Ash 2018 kan fjernes fra triggerlista
Lisa svarte at Nei på at Dlbcl lymrit 37-05 data er sendt for presentasjon på ash.
Og sa før det at antall pasienter i de 2 første kohortene vil først komme sammen med presentasjon av hele studietdatasettet.
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Kan muligens håpe på Lugano 2019
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Frem til nå har de brukt 1,4år på 2 kohorter. Ja muligens Lugano 2019. Men iom de sier at de «kan starte» med neste kohort (15Mbq) og ikke sier at allerede rekruterer for den. Så antar jeg at omtrent nå er starttidspunktet for rekrutering.
Tar kanskje 3 månder å rekrutere
Vente 3 mnd.
Behandle data 1 mnd.
Få svar av REK 2 mnd.
I mars har de datasetet for 15Mbq dosen og litt senere avgjørelse om de kan gå videre til 20. Det er ganske tett på søknadsfrister for lugano.
Lisa sa idag de ikke skal oppgi antall før de presentere hele datasettet samla. Det høres ut som i praksis å presentere alt samla og bare gi oppdateringer på hvor de er frem til alt er klart.
Så da har vi ca 7 nye mnd fra mai før 20Mbq data er klar. (Nov 2019)
Om de ikke får DLT, går de kanskje videre over 20.
Så er mere bekymret for å ikke nå Ash 2019 enn jeg håper på Lugano 2019.
Archer-01 data Ash 2019 spøker det også tidslinjemessig for.
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Gode betraktninger! Samtidig tenker jeg at et nytt produkt uten en eneste safety review og lav dose (10/100), vil være vanskeligere å rekruttere til enn høyere doser?