Nordic Nanovector - Småprat 2020 (NANO)

[Autolock]

Unsexy var 2019 det. 2020 skulle være knallår for nano. He he gikk ikke slik.

[Pk2k]

Er det nyttår allerede? Skål!

[Autolock]

Har ikke gått slik hittil, er mer riktig ja kanskje.

[Nano2020]

Ikke noe news denne uken heller …

[Hallakis]

Nano guider vel late q2 eller q3, så fda review kan like gjerne skje i august vel?

[TheObserver]

Late Q2 (juni) / early Q3 (juli).

Ja, kan bli i august, men grunn til å tro rundt disse dager ref guidingen. (Aug er mid Q3, ikke early Q3)

Interim er også forventet i august, og ref hypotesen og mailen fra Malene om mulig ny arm i Paradigme hvis de går videre med kun høyeste dose i Paradigme for mono Betalutin for 3L blir spennende. Vi har vel alle skjønt at man også legger til MZL i Paradigme ved godkjennelse hos FDA, så at farten på rekrutteringen skal opp ved å utvide til MZL + evt Archer-populasjonen (2L)er det liten tvil om.

Vi sitter her på en potensiell bombe som jeg ikke tror så veldig mange andre utenforstående investorer har spekulert i vil komme. Blir det thumbs up fra FDA på MZL, en arm på kun høyeste dose Betalutin og inkludering av Archer i Paradigme tror jeg aksjen går bananas

[hybrid]

"Jan Hendrik Egberts, Nordic Nanovector ASA - Independent Chairman of the Board [7]

---

Yes. As mentioned, we have submitted the briefing book to the FDA. And we have asked for a written feedback, but as you know, the process currently is a bit unpredictable as the FDA is also partly locked down under the COVID-19. So we hope and expect to receive the answers from the FDA in June and then from all of the other – subsequently from all of the other health authorities in Q3 this year."

Det finnes kilder.

[Hallakis]

Et annet aspekt er jo at fda gir go, men så er det 24 regulatoriske myndigheter man også skal få go fra. Og vi husker vel alle REK-fadesen? Misforstå meg rett, jeg har tatt noen lodd på at fda gir tommel opp, men er mer usikker på veien videre…

[Nano2020]

I overkant spennende

[hybrid]

Hvis FDA gir go så er det vel svimlende lite sannsynlig for at andre organer skal ha grunnlag for å avvise søknad.

[Hallakis]

Ref REK så er det jo tydeligvis ikke det?

[GCantona]

Ja REK ja, det var vel en episode man kunne vært spart for. Hang ikke de seg opp i at de ville ha noe pasientinformasjon forenklet. Om jeg husker dette riktig kunne REK ha gitt godkjennelse med forbehold om å forenkle informasjonen.

Det sørget vel for en forsinkelse på to kvartaler?

[Deltoid]

Har ikke vært her inne på lenge, noen som hadde giddet å gitt meg et kort sammendrag på hvordan NANO ligger an i løypa for øyeblikket?

Samme opplegg som for et år siden, eller er det noe lys å se her?

[TekBot]

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
…

Vis børsmeldingen

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.

Kilde

[Biotecinvestor]

Det er lys i tunnelen, ref dagens børsmelding…

[Mani]

Er det denne meldingen vi har ventet på som ble annonsert 1 april 2020?

[sparkonge]

Nei.

Ingen/veldig få så denne komme. Fast Track på 9 pasienter sier jo sitt.

FDA har tro på Betalutin!

[Pk2k]

Nei, vi venter på utfallet av FDA C møtet.

[Fornybar]

Veldig bra utvikling for Betalutin.

[TheObserver]

Ekspressbehandler Nordic Nanovector-legemiddel - E24 Aksjelive