21 sep: DSV/Jyske: Sænker anbefaling til "reducer" efter kursridt
21 sep: Danmark/Økonomer: Beskæftigelsesnedgang giver ingen grund til pan..
21-09-2017 10:13:32

Bavarian Nordic Provides Update on its Universal RSV Vaccine

Relateret indhold
13 jun - 
Aktier/middag: WDH og GN trækker indekset frem inden re..
12 jun - 
C25-selskaber/Jyske: Dropper dækning af flere selskaber
06 jun - 
Onsdagens aktier: Analysenyt løftede William op i toppe..
Relateret debat
20 jun - 
Dobbeltskat? Det må du forklare. Du ved noget, jeg ikke..
20 jun - 
P/E på 1266 ?
20 jun - 
@Enkommentar: Point taken. Og som sagt, havde overset d..

  • Preliminary 6 Month Phase 2 Data continue to Demonstrate a Broad and Durable Immune Response against RSV 

  • Updated Clinical Plans to Develop and Initiate a Human Challenge Study in 2018

COPENHAGEN, Denmark, September 21, 2017 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced initial 6 month follow-up data from the Phase 2 trial of MVA-BN® RSV, a universal vaccine candidate designed to induce protective immune responses against both subtypes (A & B) of the respiratory syncytial virus (RSV). The randomized, placebo-controlled trial, evaluated the safety, tolerability and immunogenicity of the recombinant vaccine in 421 healthy adults aged 55 and older.

The subjects were enrolled into four active arms of the study, which examined the effects of both a high (5x108) and low (1x108) dose, administered as either one or two vaccinations (day 0, 28) and compared to a placebo arm. At 6 month follow up, a persistent antibody response against multiple RSV targets can still be observed. 

Also announced today are the Company's updated clinical plans for the RSV vaccine, which will now include a human challenge study. Anticipated to initiate recruitment in the second half of 2018 the placebo-controlled study will explore the protective effects of MVA-BN RSV. Bavarian Nordic intends to use evidence from the challenge study to assist in the planning and design of late phase RSV studies as well as demonstrating early evidence regarding efficacy of MVA-BN RSV in preventing disease in healthy volunteers subsequently exposed to live RSV.

Bavarian Nordic will partner with a global CRO to develop a novel and differentiated approach to the RSV challenge model. Previous attempts at RSV challenge studies have historically been seen as lacking in sufficient measurable outcomes, which may be associated with the relatively low virulence of the virus administered to volunteers. The CRO has developed a new primary isolate of RSV which, in infectivity assays, has demonstrated  a degree of virulence and pathogenicity more commonly associated with circulating, wild-type strains. This new model will potentially allow Bavarian Nordic to more accurately assess the protective benefits of its vaccine when confronted with a virulent RSV infection.

"We are very happy to report this data, once again demonstrating the durability of our vaccine for up to 6 months," said Paul Chaplin, President and CEO of Bavarian Nordic, "Announcing the development of a more virulent RSV human challenge model creates the potential to gain efficacy data of our RSV vaccine prior to initiating the pivotal Phase 3. The global CRO is an ideal partner and a leader in the field having previously been successful in developing a virulent influenza challenge model."

About Bavarian Nordic

Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of cancer immunotherapies and vaccines for infectious diseases, based on the Company's live virus vaccine platform. Through long-standing collaborations, including a collaboration with the U.S. government, Bavarian Nordic has developed a portfolio of vaccines for infectious diseases, including the non-replicating smallpox vaccine, IMVAMUNE®, which is stockpiled for emergency use by the United States and other governments. The vaccine is approved in the European Union (under the trade name IMVANEX®) and in Canada. Bavarian Nordic and its strategic partner Janssen are developing an Ebola vaccine regimen, and therapeutic vaccines for HPV, HBV and HIV. Additionally, in collaboration with the National Cancer Institute, Bavarian Nordic has developed a portfolio of active cancer immunotherapies, including PROSTVAC®, which is currently in Phase 3 clinical development for the treatment of advanced prostate cancer. The company has partnered with Bristol-Myers Squibb for the potential commercialization of PROSTVAC. For more information visit www.bavarian-nordic.com or follow us on Twitter @bavariannordic.

Forward-looking statements

This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.

Contacts

Rolf Sass Sørensen

Vice President Investor Relations (EU)

Tel: +45 61 77 47 43

Seth Lewis

Vice President Investor Relations (US)

Tel: +1 978 341 5271

Company Announcement no. 27 / 2017

2017-27-en


This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.

The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Bavarian Nordic A/S via Globenewswire

Vedhæftet fil: 817341.pdf

Opret kommentar

Relateret debat

  • 1 uge
  • 1 måned
  • 1 År
18 jun
BAVA
Dvs de bør være der indenfor 9 børsdage... Hvis disse data gentager det som er kommet frem indtil nu..
12
18 jun
BAVA
Jeg har læst vanvittigt mange indlæg du har skrevet om Bavarian, og du bringer mange spændende ting ..
6
20 jun
BAVA
For pokker hvor jeg syntes der er meget tom snak omkring Bavarian pt. Det bær tydelig præg af at de ..
3
20 jun
BAVA
Præsentation fra igår for dem der er i tvivl om der er sket noget... http://www.bavarian-nordic.com/..
3
20 jun
BAVA
Kopper - accepteret i EU og Canada, godkendes i USA i 2019 Stor kontrakt på ebola Rsv - langt henn..
2
20 jun
BAVA
Den burde falde -  siger geniet, hvorhen? i et hul eller hvad, se lidt mere realistist på aktien.  
2
18 jun
BAVA
Aaah sådan noget vrøvl - hvis rsv lykkes, så lykkes den uanset hvad jeg skriver - du er vist overtro..
2
18 jun
BAVA
Bava meddelte på forleden på investordag i Århus, at data fra RSV kommer inden for 14 dage   så rigt..
2
18 jun
BAVA
Disse data er lovet så sent som ifm præsentation for Dansk Aktionærforening den 12/6 - kik her...   ..
2
20 jun
BAVA
Der skulle komme nye data inden for Maks et par uger?!
1

Jyske Bank/CEO: Vi satser meget, meget hårdt på it - citat

20-06-2018 13:38:15
Jyske Bank vil i løbet af 2018 blive en forandret bank, hvilket vil været drevet af store investeringer i optimeringer. Det skal ske gennem hvad bankens ordførende direktør, Anders Dam, i et interview med Finanswatch kalder "robotisering". For nylig fik banken sine kapitalforhold på plads efter salget af sin 38,5 pct. ejerandel i Nordjyske Bank.- Nu er det endt der, hvor vi har fået løst vores kap..

Ambu: Udenlandske investorer sender aktien mod rekord

20-06-2018 11:18:25
Der er rift om Ambu onsdag formiddag, hvor aktien har sat kursen mod rekord efter en gevinst, der bare har vokset sig større og større i løbet af formiddagen.En rundringning til et par handlere og analytikere har umiddelbart ikke kastet en forklaring af sig.- Der er ingen nyheder ude om Ambu, og vi sidder umiddelbart også og undrer os lidt, siger chefhandler i Danske Bank Mads Zink til Ritzau Fina..

Aktier/tendens: Comeback i sigte - salgstal kan løfte Genmab

20-06-2018 08:30:13
En løftet anbefaling og lovende salgstal fra USA kan løfte Genmab fra åbningen onsdag, hvor udsigterne er noget lysere, end da handlerne slukkede for deres skærme tirsdag eftermiddag.De amerikanske aktier faldt godt nok tirsdag, efter at USA og Kina havde udvekslet nye toldafgifter, men markedet rettede sig noget efter dansk børslukketid, og onsdag morgen peger S&P 500-futuren på en positiv åbning..

Mest læste nyheder

  • 24 timer
  • 48 timer
  • 1 uge
1
Aktier/tendens: Comeback i sigte - salgstal kan løfte Genmab
2
Aktier/åbning: Udlandet løfter Ambu i rekord - Genmab går til tops
3
Onsdagens aktier: Rekord-Ambu satte C25 til vægs
4
Aktier/middag: Ambu sætter fart på med uforklaret stigning
5
MHI Vestas/CEO: Skal udvikle os uden at "disrupte" værdikæden

Relaterede aktiekurser

Bavarian Nordic A/S 196,35 -1,1% Fald i aktiekurs
Bavarian Nordic Ord Shs 194,50 -2,0% Fald i aktiekurs

Køb- og salgsanbefalinger

  • Trend
  • Pengemaskinen

Copyright Euroinvestor A/S 2018  Disclaimer  |  Cookie- og privatlivspolitik  |  Persondatapolitik
Aktieinformation leveres af Morningstar.
Data er forsinket 15-20 minutter iht. de enkelte børsers regler om videredistribution.
 
21. juni 2018 06:52:45
(UTC+01:00) Brussels, Copenhagen, Madrid, Paris
Version: LiveBranchBuild_20180619.1 - EUROWEB7 - 2018-06-21 06:52:45 - 2018-06-21 06:52:45 - 1 - Website: OKAY