Nordic Nanovector - Småprat 2020 (NANO)

[InVivo]

Det må vel trolig heller kjøres to parallelle studier

Nei, jeg har sett flere andre behandlinger mot FL hvor det og kjøres på med combo fra start, så det bør gå fint.

Ser for meg 2 armer med 30-40 stk i hver arm, mono og combo

[Teejay]

Ja i så fall er jeg helt enig.

Med mindre det vesentlig kompliserer/ forlenger studiet så virker det irrasjonelt å ikke gjøre det.
Det blir spennende å se hvordan de griper det an.

Sannsynligheten er vel at de kjører MZL inn som en singel arm i Paradigme, og at kombo evt gjøres i enkeltstående studie.

[sjerkyll]

Børskommentar: Det er pasienter Nordic Nanovector trenger i ekspressfart

Så får vi bare håpe inklusjonskriteriene blir endret også så får vi “ekspressfart” på begge …

[JHF2]

Dersom ny arm også innebærer vesentlig flere pasienter, så er nok det tryggeste å gjøre ferdig Paradigme med mono-behandling i R/R FL og MZL og heller kjøre kombo-studier senere innenfor begge disse indikasjonene.

Hvis Nano derimot kan parkere en arm og fordele de resterende pasientene utover to armer, mono og kombo - da snakker vi.

[Nano2020]

fullastet med NANO - venter på flere godbiter

[TekBot]

Nordic Nanovector to amend PARADIGME trial protocol to expand eligible patient population

Oslo, Norway, 30 June 2020

Nordic Nanovector ASA (OSE: NANO) announces that it will amend the trial
…

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protocol for its PARADIGME trial to broaden the inclusion criteria and expand
the pool of eligible patients with the aim of increasing the present rate of
enrolment. This decision has been made based on the company’s reviewed
discussions with the US Food and Drug Administration (FDA).

PARADIGME is the company’s ongoing pivotal, global, randomised Phase 2b trial
investigating Betalutin® ([177]Lu-lilotomab satetraxetan) as a single
administration in 3[rd]-line relapsed/refractory follicular lymphoma (3L R/R FL)
patients. The trial aims to enrol 130 patients into two arms to compare
different dosing regimens; 51 patients were enrolled as of 25[th] May 2020 - Q1
report.

One of the measures to improve the recruitment rate into PARADIGME is to allow
for FL patients who have undergone stem cell transplant (SCT) to be included in
the trial. In some countries, for example UK, Italy, Turkey, Israel and Spain,
SCT is frequently used for treating R/R FL and patients who have had a SCT make
up the majority of 3L FL patients. This and other ways to broaden the inclusion
criteria will, when implemented, substantially expand the pool of patients
eligible for recruitment into PARADIGME.

As soon as practicable, Nordic Nanovector will seek approvals for the protocol
amendments from the regulators in each of the 25 countries in which PARADIGME is
active. It is anticipated that it will take 2-3 months to gain approval for
these protocol amendments in all countries. Until the amendments have been
approved, the company will continue to enrol patients under the existing
protocol.

A close collaboration with the company’s Clinical Research Organisation (CRO)
will be prioritised to ensure smooth implementation of the new protocol and
maximise enrolment once the new protocol is approved in each country.

The company expects that expanding the pool of eligible patients will
significantly improve the present enrolment rate. During August, the company
will provide updated timelines for PARADIGME based on more clarity on the impact
of COVID-19 and after the completion of the interim analysis.

In the Phase 1/2 LYMRIT 37-01 study, a single administration of Betalutin®
demonstrated encouraging anti-tumour activity, with a 65%, overall response rate
(ORR) and 28% complete responses (CR) in the subset of FL patients (n=57). The
median duration of response (mDoR) was over one year (13.6 months) for all
responders and nearly three years (32.0 months) for complete responders.

The LYMRIT 37-01 study also showed that Betalutin® was safe and well tolerated
in these fragile patients with advanced stage disease, who have few remaining
options available.

Jean Pierre Bizzari, MD, Chair of Nordic Nanovector’s Clinical Committee, said:
“We are extremely encouraged by the preliminary data we are seeing both in terms
of efficacy and safety profile. This novel ‘one-time’ treatment in this
underserved resistant/refractory patient population is especially important in
these frail elderly patients for whom other treatment options are too toxic. We
are confident that the protocol amendments the company is implementing to expand
the eligible pool of FL patients will significantly increase the rate of
enrolment into PARADIGME.”

Dominic Smethurst, MD, interim Chief Medical Officer, commented: “We are very
happy that we can now start to implement these important protocol amendments to
PARADIGME. As soon as the amendments are made, we will implement a plan with our
CRO to gain approval in all currently active countries as soon as possible. We
intend to provide an updated timeline for PARADIGME once we have more clarity on
the impact of the easing of the COVID-19 restrictions and the completion of the
interim analysis.”

“We are also very pleased to have received Fast Track designation for Betalutin®
in marginal zone lymphoma (MZL), another form of non-Hodgkin’s lymphoma for
which new treatments are urgently needed and against which Betalutin® has
already demonstrated encouraging data. We are evaluating this new opportunity
within the context of PARADIGME and will provide an update when we have made a
decision on our development plans in this indication.”

For further information, please contact:

IR enquiries

Malene Brondberg, CFO
Cell: +44 7561 431 762
Email: [email protected]

Media Enquiries

Mark Swallow/Frazer Hall/David Dible (Citigate Dewe Rogerson)
Tel: +44 203 926 8535
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 29 billion by 2026. Nordic Nanovector retains global marketing
rights to Betalutin® and intends to actively participate in the
commercialisation of Betalutin® in the US and other major markets.

Further information can be found at www.nordicnanovector.com.

Forward-looking statements

This press release contains certain forward-looking statements. These
statements are based on management’s current expectations and are subject to
uncertainty and changes in circumstances, since they relate to events and depend
on circumstances that will occur in the future and which, by their nature, will
have an impact on Nordic Nanovector’s business, financial condition and results
of operations. 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. These forward-looking statements are not historic
facts. 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, the ability to commercialise Betalutin®,
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. No
assurance can be given that such expectations will prove to have been correct.
Nordic Nanovector disclaims any obligation to update or revise any forward
-looking statements, whether as a result of new information, future events or
otherwise.

This information is subject to a duty of disclosure pursuant to Sections 4-2 and
5-12 of the Securities Trading Act.

Kilde

[TheObserver]

We are confident that the protocol amendments the company is implementing to expand the eligible pool of FL patients will significantly increase the rate of
enrolment into PARADIGME.”

Folkens, nå må dere sitte rolige på aksjene deres, og aller helst akkumulere.

Nå venter komiteen på interim i august, og etter at resultatet av dette foreligger optimaliseres Paradigme. Hensikten er klar; vise at Betalutin kan anvendes bredt og få en stor del av 3L markedet.

[JHF2]

Fikk vi interim allerede nå? Interim er tydeligvis bankers:

Jean Pierre Bizzari, MD, Chair of Nordic Nanovector’s Clinical Committee, said:
“We are extremely encouraged by the preliminary data we are seeing both in terms
of efficacy and safety profile. This novel ‘one-time’ treatment in this
underserved resistant/refractory patient population is especially important in
these frail elderly patients for whom other treatment options are too toxic. We
are confident that the protocol amendments the company is implementing to expand
the eligible pool of FL patients will significantly increase the rate of
enrolment into PARADIGME.”

Kan komme en oppdatering ang MZL i Paradigme any time:

“We are also very pleased to have received Fast Track designation for Betalutin®
in marginal zone lymphoma (MZL), another form of non-Hodgkin’s lymphoma for
which new treatments are urgently needed and against which Betalutin® has
already demonstrated encouraging data. We are evaluating this new opportunity
within the context of PARADIGME and will provide an update when we have made a
decision on our development plans in this indication.”

[sjerkyll]

Håpet nå er at de følgte Einarsson sitt råd og allerede har pasienter linet opp slik at de får en running start. Uansett herlig å få denne servert nå på morgenen!

[JHF2]

Det har de nok. De har uansett 2-3 måneder på seg til å screening.

[TyrionIV]

Den kommentaren gjaldt Lymrit, så ikke interrim…

[amagad]

…og 32 mnd for CR i lymrit…det er vel oppdaterte tall eller?

[JHF2]

Preliminary data? Jeg tror også komiteen får innsikt i dataene. De har vel oppgaven med å bearbeide og tolke disse.

[gautev]

Er dette meldingen vi har ventet på?

[InVivo]

Ja…

[amagad]

Endelig virker det som de har styr på skuta og leverer på guiding😀

[InVivo]

“We are also very pleased to have received Fast Track designation for Betalutin®
in marginal zone lymphoma (MZL), another form of non-Hodgkin’s lymphoma for
which new treatments are urgently needed and against which Betalutin® has
already demonstrated encouraging data. We are evaluating this new opportunity
within the context of PARADIGME and will provide an update when we have made a
decision on our development plans in this indication.”

Veldig mye bra info om godkjente behandlinger mot MZL, og nye studier som pågår

https://www.oatext.com/changing-treatment-landscape-of-marginal-zone-lymphoma.php#gsc.tab=0

Given the approvals of ibrutinib and R2 and recent breakthrough designations to copanlisib and umbralisib, it is important to see how the treatment landscape of MZL will change in Asian countries once these targeted therapies approved for this indication.

[Hirsh]

De kan bruke nye inklusjon kriteria i USA allerede nå, ikke det?

[vegar_beider]

Hadde jeg styrt skuten i Nano nå med ett par meldinger på rad som løfter kursen med 20-30% så hadde det blitt satt en emisjon rett etterpå for å få satt igang hjulene igjen.

Nyhetene er gode de for all del, men om 1 uke er vi allerede inne i en ny lang venteperiode.

[InVivo]

ar meldinger på rad som løfter kursen med 20-30% så hadde det blitt satt en emisjon rett etterpå for å få satt igang hjulene igjen.

Vanskelig å si, burde egentlig vente til interimen med emisjon. Men med tanke på makrobildet så burde den kanskje settes ASAP?

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