Sier det samme som deg, akkurat nå føles det skummelt binært.
Det begynner å anta helt febrile tilstander på HO, nesten så det blir for mye av det gode.
Fin fin dag i dag tenker jeg:
23.09.2016 08:04:05: Safety Review Committee supports dose escalation with Betalutin® in Lymrit 37-01 trial pending safety data from cohort receiving higher pre-dosing
Dose-escalation of Betalutin® accompanied by increase in lilotomab pre-dosing
could further improve efficacy while maintaining a favourable safety profile
Oslo, Norway, 23 September 2016
Nordic Nanovector ASA (OSE: NANO) announces that the independent Safety Review
Committee (SRC) for the ongoing Lymrit 37-01 clinical trial of Betalutin® in
follicular lymphoma (FL) has given its support to the continuation of the trial
potentially at a higher dose of Betalutin® and increased pre-dosing with
lilotomab, as soon as safety data from Arm 4 of the same study become available.
FL is one of the most prevalent forms of non-Hodgkin lymphoma (NHL).
Lymrit 37-01 is a Phase 1/2 open label, single injection dose-ascending study
investigating different dose levels of Betalutin® and different pre-dosing
regimens in patients with relapsed NHL with the aim of identifying an optimal
dose regimen to take into the Phase 2 PARADIGME study.
After a planned review of the interim safety data from the Phase 1 and 2 parts
of Arm 1 of Lymrit 37-01, based on 15 patients with relapsed/refractory FL
treated with 15 MBq/kg Betalutin® and pre-dosed with 40 mg lilotomab*, the SRC
concluded the following:
. The regimen of 15 MBq/kg Betalutin® administered after pre-dosing with 40
mg lilotomab is safe and the safety profile observed to date supports a possible
dose escalation of Betalutin®
. The efficacy profile is promising compared to other candidates in
development, particularly with regard to complete responses
. The limited safety data available to date from the first cohort of three
patients in Arm 4 (receiving 15 MBq/kg Betalutin® and pre-dosed with 100mg/m2
lilotomab**) is encouraging and appears to show that an increase in pre-dosing
with lilotomab improves the safety profile of Betalutin®
. Safety and dosimetry data from Arm 4 should confirm if and to what level
the doses of Betalutin® and lilotomab in Phase 2 can be increased to further
improve the risk/benefit profile seen so far.
The company does not expect any impact to previously communicated timelines,
neither for the dose definition date (Q1 2017) nor the planned pivotal PARADIGME
trial, which is scheduled to start in 2H 2017.
Luigi Costa, Nordic Nanovector CEO, commented: “We are pleased with the
conclusions of the SRC meeting, which provide us with further confidence that we
are closing in on the optimal dose regimen.”
*Lilotomab is a murine anti-CD37 antibody, previously referred to as HH1. The
way the dose of lilotomab is referred to has been changed (from 50 mg/patient to
40mg/patient) following further characterisation of lilotomab, which has
determined the actual absorbance factor of lilotomab reference standard (1.74
vs. the previous estimate of 1.4). The absorbance factor is used to measure the
concentration of lilotomab drug product.
**The change in dose units for lilotomab from mg to mg/m2 is because a more
accurate way of calculating the administered concentration of antibody is now
being applied, as described in previous footnote.
For further information, please contact:
IR enquiries:
Luigi Costa, Chief Executive Officer
Cell: +41 79 124 8601
Tone Kvåle, Chief Financial Officer
Cell: +47 91 51 95 76
Email: ir@nordicnanovector.com
Media enquiries:
Mark Swallow/David Dible (Citigate Dewe Rogerson)
Tel: +44 207 282 2948/+44 207 282 2949
Email: nordicnanovector@citigatedr.co.uk
About Nordic Nanovector:
Nordic Nanovector is a biotech company focusing on the development and
commercialisation of novel targeted therapeutics in haematology and oncology.
The Company’s lead clinical-stage product opportunity is Betalutin®, the first
in a new class of Antibody-Radionuclide-Conjugates (ARC) designed to improve
upon and complement current options for the treatment of non-Hodgkin Lymphoma
(NHL). NHL is an indication with substantial unmet medical need and orphan drug
opportunities, representing a growing market worth over $12 billion by 2018.
Betalutin® comprises a tumour-seeking anti-CD37 antibody, lilotomab (previously
referred to as HH1), conjugated to a low intensity radionuclide (lutetium-177).
The preliminary data has shown promising efficacy and safety profile in an
ongoing Phase 1/2 study in a difficult-to-treat NHL patient population. The
Company is aiming at developing Betalutin® for the treatment of major types of
NHL with first regulatory submission anticipated in 1H 2019.
Nordic Nanovector intends to retain marketing rights and to actively participate
in the commercialisation of Betalutin® in core markets, while exploring
potential distribution agreements in selected geographies. The Company is
committed to developing its ARC pipeline to treat multiple selected cancer
indications.
Further information about the Company can be found at www.nordicnanovector.com
This information is subject to the disclose requirements pursuant to section 5
-12 of the Norwegian Securities Trading Act.
4 Likes
Det føles nesten litt sært at man var så heldig å finne den misforståtte aksjen midt på vinteren. Burde aldri falt så lavt iht noen logikk.
3 Likes
At kursen denne uken endte på 53,- kan jeg ikke si meg missfornøyd med! Hvis vi ikke rykker tilbake mot 50 etter helga blir det vel opp mot 58-60,- som blir neste stopp? Eller hva tror dere?
NANO har en travel høst foran seg, blir det flere gode nyheter kommer kan vi fort stå i en kurs på 3 siffer rundt årsskiftet. Blir neste trigger allerede om 2,5 uke på ekstraordinær generalforsamling? Eller blir det kanskje om 3 uker i Barcelona under EANM?
Siden jeg ikke overholdt strategien min om å selge en del av beholdningen på 40-tallet for å redusere risikoen må jeg innrømme jeg er litt ekstra spent for hver uke som går. Eller nervøs er kanskje det riktige ordet? Ha en god helg alle NANOitter!
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Med gårsdagens melding forsvant det mye risiko ut av betalutin og selskapet er egentlig billigere nå enn før meldingen. Jeg har tro på fortsatt stigning.
Skal bli moro å se om den posten på 150k askjer fortsatt ligger der på mandag. Flyttes den oppover, blir det full stopp eller spises den brutalt raskt.
Dagens melding fra Investtech:
Nordic Nanovector ASA (NANO) endte på 53.00 kroner etter en oppgang på 14.47%. Aksjen har ikke steget mer på en dag siden 1. desember 2015, da den var opp 16.67%. Dette var den fjerde dag på rad aksjen steg og den siste måneden har aksjen steget hele 87.28%. Teknisk ser det også bra ut. Aksjen er trendmessig positiv på mellomlang sikt og en videre oppgang indikeres.
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Litt galskap på morgenkvisten, intradag topp på over 60.
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Det får bære eller briste, ligger på rundt 100% avkastning nå, men jeg lar det stå til.
Tar ikke sjansen på å hoppe av. Inngangen var under 10 % av porteføljen, nå er den ca 16 % av porteføljen…
Selvsagt dumt å ikke pantsatt huset når den var nede på rundt 20 kroner for kort tid siden, men jeg er mer enn fornøyd! Foreløpig. 
Edit: Må heller ikke glemme at børsen er rimelig rød i dag…
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RSI er oppe ca 90 nå, begynner og bli glodvarm
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Steget 58% fra IPO kurs i 2015. Eneste grunnen til den vanvittige oppgangen er fordi kursen var gruset da de endret strategi. Hvis man ser på helheten i oppgangen i forhold til hvor langt de har kommet i utviklingen er det forsvarlig. Men vi kan vel regne med en konsolidering snart.
1 Like
Lurer på om Nano går opp i dag:
Oslo, Norway, 10 October 2016
Nordic Nanovector ASA (OSE: NANO), is pleased to announce it has entered into a
collaboration with LegoChem Biosciences, Inc. (“LegoChem” ; KOSDAQ: 141080), a
South Korea-based biopharmaceutical company, to develop novel CD37-targeting
antibody-drug conjugates (ADCs) for the treatment of leukaemias. Leukemias are
orphan diseases with a significant unmet medical need, representing a growing
market estimated to be worth over USD 5 billion by 2024.
This collaboration supports Nordic Nanovector’s strategy to expand its pipeline
of targeted therapies to include CD37-targeting antibody products conjugated to
anti-cancer compounds that are not radionuclides. Such conjugates are commonly
referred to as antibody-drug conjugates or ADCs.
Jostein Dahle, Nordic Nanovector’s Chief Scientific Officer, commented: “We are
delighted to expand our R&D activities into the ADC area, a strategic and
natural progression for us given our expertise in antibodies and the prevalence
of the CD37 antigen on many tumour cell types. We believe that anti-CD37 ADCs
will have clinical characteristics that are beneficial for treating a range of
haematological malignancies. Our strategy to build a pipeline of innovative
antibody-radionuclide conjugates (ARCs) and ADCs based on our expertise and
platform, and in collaboration with expert partners such as LegoChem, is aimed
at creating multiple new product opportunities bringing new targeted treatments
to patients.”
“We are very excited to enter into this collaboration agreement to develop CD37
-targeting ADCs with Nordic Nanovector, which has expertise with anti-CD37
antibodies and experience of advancing candidates into clinical research,” said
Jeiwook Chae, Chief Business Development Officer of LegoChem. “We strongly
believe that our proprietary conjugation platform addresses significant unmet
needs of current ADC technologies. With Nordic Nanovector’s deep expertise in
antibodies and commitment to develop novel therapeutics, we are confident that
we will further enrich the pipeline of next-generation ADCs and achieve our
goals of advancing the landscape of cancer treatment and providing new clinical
options for cancer patients.”
For further information, please contact:
For Nordic Nanovector
IR enquiries:
Luigi Costa, Chief Executive Officer
Cell: +41 79 124 8601
Tone Kvåle, Chief Financial Officer
Cell: +47 91 51 95 76
Email: ir@nordicnanovector.com
Media enquiries:
Mark Swallow/David Dible (Citigate Dewe Rogerson)
Tel: +44 207 282 2948/+44 207 282 2949
Email: nordicnanovector@citigatedr.co.uk
For LegoChem Biosciences
BD enquiries
Jeiwook Chae, Chief Business Development Officer
Tel: +82 42 861 0688
Email: bd@legochembio.com
IR enquiries
Wooshik Kim, Investor Relations Manager
Tel: +82 70 4811 3260
Email: ir@legochembio.com
About Nordic Nanovector:
Nordic Nanovector is a biotech company focusing on the development and
commercialisation of novel targeted therapeutics in haematology and oncology.
The Company’s lead clinical-stage product opportunity is Betalutin®, the first
in a new class of Antibody-Radionuclide-Conjugates (ARC) designed to improve
upon and complement current options for the treatment of non-Hodgkin Lymphoma
(NHL). NHL is an indication with substantial unmet medical need and orphan drug
opportunities, representing a growing market worth over $12 billion by 2018.
Betalutin® comprises a tumour-seeking anti-CD37 antibody, lilotomab (previously
referred to as HH1), conjugated to a low intensity radionuclide (lutetium-177).
The preliminary data has shown promising efficacy and safety profile in an
ongoing Phase 1/2 study in a difficult-to-treat NHL patient population. The
Company is aiming at developing Betalutin® for the treatment of major types of
NHL with first regulatory submission anticipated in 1H 2019.
Nordic Nanovector intends to retain marketing rights and to actively participate
in the commercialisation of Betalutin® in core markets, while exploring
potential distribution agreements in selected geographies. The Company is
committed to developing its ARC pipeline to treat multiple selected cancer
indications.
Further information about the Company can be found at www.nordicnanovector.com
This information is subject to the disclose requirements pursuant to section 5
-12 of the Norwegian Securities Trading Act.
About LegoChem Biosciences, Inc.
LegoChem Biosciences is a biopharmaceutical company focusing on the development
of next generation cancer therapeutics utilizing its proprietary ADC platform
technology ‘ConjuAllT’.
ConjuAllT is a 2nd generation ADC platform technology utilizing novel linker
chemistry combined with site-specific enzymatic conjugation. Our platform
provides solutions for Site-specific conjugation, Linker stability and Efficient
payload release, which are three major unmet needs in ADC development.
LegoChem has been successfully building ADC pipelines through rigorous
partnership activities. In August 2015, LegoChem Biosciences signed a license
and commercialization agreement with Fosun Pharma regarding Her2 targeting ADC
for the Greater China market and in 2012, LegoChem licensed out its ADC platform
technology to Green Cross, one of the leading biopharmaceutical companies in
Korea for a Mesothelin-targeted ADC.
2 Likes
Dette er vel den tredje slike avtalen etter PSI og Areva, så markedet har nok kanskje oppfattet at dette er langsiktige samarbeid uten umiddelbar payoff. Så kanskje ikke det største utslaget i dag?
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Ser man på alle suppehuene på HO,)(ikke rettet mot deg Boven), så blir det sikkert opp mange prosent rett etter åpning, litt som Funcom, ikke mye som skal til
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Det er absolutt bra de inngår samarbeidsavtale med andre, men ja det vil ikke gi noe store utslag på kursen (foruten det faktumet at for hver melding som kommer er det færre som vil selge posten sin).
Nå er Barcelona rett rundt hjørnet også, så har ikke blitt overrasket om vi havner mot 60 tallet iløpet av denne uka. HO har jeg sluttet å lese på… Tidligere kunne en luke ut baissinga og haussinga, men nå er det fryktelig mange uvesentlige kommentarer og meninger der. Jeg er sikker på at enkelte dedikerer hele dagen sin på å sitte på HO!
2 Likes
Det er ekstremt mange som har tatt det binære gambelet og sitter long i Nano, hvilket medfører at det ikke er så veldig stor andel av aksjene som er i omløp. Det er nok med og bidrar til at aksjen kan gjøre ganske store byks i ene og andre retningen.
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DnB oppdaterer kursmålet til 80kr.
We believe the company is moving in the right direction and that the Likelihood of Approval (LOA) has improved in recent months. As a result, we have upgraded our LOA from 20% to 30%, which has had a significant impact on our target price, increasing it to NOK80 (NOK40). We reiterate our BUY recommendation.
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Niiiiiiiiiiice! 
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Nå bør en ikke legge for mye i kursmålet, en bør ihvertfall ikke la det avgjøre hvilket selskap en skal investere i, men det er jo hyggelig da 
Jeg har vært inn og ut av Nano, først rundt 18-19kr, nå 28kr.
Nå skal jeg sitte, lenge.
Men hadde jeg hørt på holmes og solgt nærmere topp (rundt60) hadde jeg selvsagt kunne gjort litt penger, men det blir fort å løpe etter…
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Ja, det salgsrådet var bare ment som at man kunne selge en mindre del og hente igjen lavere (ville sikkert ha kjøpt det tilbake nå), det er ikke noe dypere analyse.
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Når LOA øker så øker også kursmålet og ofte kursen. Hyggelig analyse. LOA øker for hver gang man skifter fase vanligvis. DNB hadde kursmål på Algeta som lå skyhøyt over kursen, men DNB fikk rett til slutt.
2 Likes