Nano får Fast-Track fra FDA!


Nordic Nanovector's Betalutin® Receives Fast-Track Designation from US FDA for Marginal Zone Lymphoma
Oslo, Norway, 29 June 2020

Nordic Nanovector ASA (OSE: NANO) today announces that the US Food and Drug
Administration (FDA) has granted Fast Track designation for investigating
Betalutin® ([177]Lu lilotomab satetraxetan) for the treatment of adult patients
with relapsed or refractory marginal zone lymphoma (MZL) who have received at
least two prior systemic therapies.

Nordic Nanovector is evaluating the opportunity to develop Betalutin® as a
single-agent treatment for MZL, a rare type of non-Hodgkin's lymphoma (NHL).
Betalutin® has demonstrated a very promising clinical effect in nine MZL
patients in the Phase 1/2a LYMRIT 37-01 trial.

Lars Nieba, Interim Chief Executive Officer, commented: "We are very pleased to
receive Fast-track designation for Betalutin® in MZL, which recognizes the clear
need for new therapeutic options for patients with advanced MZL patients who no
longer respond to the therapies they have been receiving. We are evaluating the
opportunity for investigating Betalutin® in this important and underserved
indication and will provide an update when we have made a decision."

The FDA Fast Track Designation is one of several approaches utilized by the US
FDA to expedite development and review of potential medicines for serious
conditions and that fulfil unmet medical needs. A potential new medicine may
fill an unmet medical need by being the first therapy to address a specific
serious condition, offer clinically significant advantages over available
therapies, act via a different mechanism of action than available therapies, or
have a benefit in patients who are unresponsive to or intolerant of available
therapies. Programs that receive Fast Track Designation are entitled to more
frequent interactions with the FDA review team throughout the development
program. Additionally, products that have been granted Fast Track Designation
may be eligible for rolling review and priority review, if supported by clinical
data.

Betalutin® has received Orphan Drug Designation in the European Union for the
treatment of MZL and has applied for the equivalent designation in the US.

About Marginal Zone Lymphoma (MZL)

Marginal Zone Lymphoma is an incurable and long-term debilitating disease due to
its effects on the spleen, lymph nodes and bone marrow, as well as the increased
risk of infection.

Fast Track Designation is granted to drugs and biologics being developed for the
treatment of serious or life-threatening diseases and nonclinical or clinical
data have demonstrated the potential to address an unmet medical need. The
purpose of the Fast Track Designation provision is to help facilitate
development and expedite the review and potential approval of drugs to treat
serious and life-threatening conditions.

In Nordic Nanovector's LYMRIT 37-01 Phase 1/2a trial, Betalutin® showed a highly
encouraging 78% overall response rate (ORR) and 44% complete response (CR) in
the MZL patient group (n=9) - the highest response rates of any patient sub
-population in this study. This followed a once-only administration of
Betalutin® in this heavily pre-treated group of patients with advanced disease.

[1 ]Source: Food and Drug Administration, "Expedited Programs for Serious
Conditions - Drugs and Biologics":
https://www.fda.gov/files/drugs/published/Expedited-Programs-for-Serious
-Conditions-Drugs-and-Biologics.pdf

For further information, please contact:

IR enquiries

Malene Brondberg, CFO
Cell: +44 7561 431 762
Email: ir@nordicnanovector.com

Media Enquiries

Mark Swallow/Frazer Hall/David Dible (Citigate Dewe Rogerson)
Tel: +44 203 926 8535
Email: nordicnanovector@citigatedewerogerson.com

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

Spørre igjen..kan man nå ta betalt for leveranser til MZL pasienter utenfor original kohort?
SomSa
29.06.2020 kl 21:53 1931

NanoVekter skrev Innlegget er slettet

Macro eller Marco, fyren skulle ha fått sparken for lenge siden, ellers sier du mye bla bla som vanligvis........finn ut hvorfor Nano har fjernet flere webcast kvartalpresentasjoner. Korona er tilbake i full fart og pasientgrunnlaget for Betalutin er eldre og svært syke. Det kommer til å bli mye forsinkelser og Nano trenger mye penger i noen år til. Er du ikke redd for en ny emisjon? Når den skal komme? Når du tenker minst!

Merlin
I 2018 fikk Nano Fast Track og det har ikke skjedd noe og de skal ikke skje noe så lenge de ikke klarer å rekruttere pasienter. MZL er en liten pasientgruppe og vi har diskutert om dette og Marco har sagt.........Som sa jeg trodde at Nano hadde også fast Track for MZL pasienter og disse var en del av hovedstudien.......................

SomSa
29.06.2020 kl 22:00 1900


Nano klarer ikke å rekruttere pasienter, tenkt på hvor mange pasienter kan de rekruttere hvis de krever betalt for et ikke godkjent produkt. Mange legemidler med gode resultater mislykkes i fase 3. PledPharma hadde gode data men pga mistanke om bivirkninger i Fase 3 fikk de ikke lov til å rekruttere flere pasienter......
Redigert 29.06.2020 kl 22:03 Du må logge inn for å svare
Hammers
29.06.2020 kl 22:00 1894

Ser at NANO-aksjen oppfører seg like tullete som tidligere.

Kursen stiger mer enn 10% pga av at en "hurtigutredning" skal iverksettes.
Dessverre blir det ikke noe mere penger i kassa av slikt. Ikke mer enn det gjorde for 1, 2, 3, 4 eller 5 år siden.
NULL inntekter - og STORE underskudd! Det er hverdagen der i gården!

Hilsen Hammers


Du nevner at MZL er en liten pasientgruppe som nærmest er ubetydelig...

Markedet i EU og NA har en verdi på 9 milliarder kroner i året. Og Både EU og NA har nå favorisert Betalutin. Nøkternt mål, la oss si kun 4 milliarder i året. Det betyr at over halvparten av pasientene velger en medisin som er langt dårligere (ref copanlisib på 15% CR)

Da kan Nano alene hjelpe nok pasienter til å omsette 1 milliard kroner i kvartalet. Eller godt over 300 millioner NOK i måneden.

Spør du meg så bør hele markedet velge Betalutin med sin overlegne profil.

Men det er vel bare marginale tall eller hva SomLa
Hammers
30.06.2020 kl 00:04 1585

Slik har dere snakket så lenge JEG kan huske.
Betalutin ditt og Betalutin datt. Ikke måte på hvor stort dette er - og hvor rike dere skal bli!

Fakta er; Etter FLERE ÅR med ulike pasienter har ikke NANO kommet noen vei.
Fortsatt NULL inntekter - massevis av kostnader - og nå er det en NY RUNDE!
At dere gidder! Gidder å sitte der og vente på neste emisjon!

Hilsen Hammers
Redigert 30.06.2020 kl 00:06 Du må logge inn for å svare
Korsar
30.06.2020 kl 00:09 1564

Uavhengig av alt som diskuteres her, det være seg baissing eller haussing - så skal NANO rent teknisk ned 4-5% ganske raskt.
Så dette vil nok begynne å korrigere tilbake allerede i morra.
Fundamentalt kan aksjen forsvare en kurs på 20-21, så noe alvorlig setback er det ikke snakk om i første omgang.


Hvordan gikk det med BGBIO i går?

en ordentlig teknisk automatisk analyse fra korsar...........

det samme gjorde han også i Bergenbio.......ladies and gentlemen

Korsar = BergenBio 72kr
Realiteten = 37 kr

30.6.2020, 07:00 · Cision
Nordic Nanovector to amend PARADIGME trial protocol to expand eligible patient population
Nordic Nanovector+12,13%22,74 NOK
Oslo, Norway, 30 June 2020
Nordic Nanovector ASA (OSE: NANO) announces that it will amend the trial 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: ir@nordicnanovector.com

Media Enquiries

Mark Swallow/Frazer Hall/David Dible (Citigate Dewe Rogerson)

Tel: +44 203 926 8535

Email: nordicnanovector@citigatedewerogerson.com

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
sjerkyll
30.06.2020 kl 07:41 1134

Lykke til med TA og Hammers tankegangen i dag. Håper ingen ble lurt til å selge, da må dere løpe etter slik som Korsar.

Oppdatering: Jeg skal faktisk ta meg en bolle, vi er i rødt. #bliraldriklokpåNANO
Redigert 30.06.2020 kl 09:36 Du må logge inn for å svare
Korsar
30.06.2020 kl 12:49 678

Tja,
nattens analyse slo til som forventet: Akkurat nå er NANO ned drøyt 4,3%.
Markedet ser selvsagt at selskapet prøver å snu rekrutteringsproblemene med å foreslå et amendment (en endring) i protokollkravene.
Men at dette må først dras gjennom og godkjennes i 25 land i månedene framover.
Som både jeg og markedet forlengst hadde forventet fikk man derfor ikke mange minuttene oppgang på dagens melding om at man vil prøve å rigge en måte å løse rekrutteringsproblemene på.

Redigert 30.06.2020 kl 12:50 Du må logge inn for å svare

tulling...........akkurat som forventet
Korsar
30.06.2020 kl 14:07 500

sjerkyll,
hva mener du med å "løpe etter slik som Korsar"?
Jeg kan ikke se annet enn at min analyse kl 00.09 i natt (ned 4-5% i dag) er den eneste her som har fanget opp dagens faktiske utvikling?
Til og med eksakt på prosenten.
Forklaringen er veldig enkelt: Jeg driver ikke og luller meg inn i "private" fortolkninger av hvilke "fantastiske" ting det kan tenkes å bli meldt om, jeg tenker tvert i mot sånn som tyngden i markedet, og da treffer jeg vanligvis ganske bra.



Skal gindeg den Korsar, Nano er ned. Når denne meldingen ikke var nok er jeg enig med deg, stor sjans for at NANO siger nedover frem til Interim eller andre antatt positive meldinger kommer.