29 dec: Aktier/middag: Vestas tager bundplacering trods nye ordrer
29 dec: Skidt år for vindmølleaktier - trods god ordreaktivitet
29-12-2016 13:00:12

Bavarian Nordic Initiates Trial of CV301 in Combination with Nivolumab in Patients with Lung Cancer

Relateret indhold
09:15 - 
Aktier/åbning: Novo, Pandora og Mærsk tager fokus i neg..
06:55 - 
Bavarian/Jefferies: Sænker kursmål til 335 kr. fra 385 ..
25 sep - 
Mandagens aktier: Nets fik opmærksomheden og Mærsk sejl..
Relateret debat
10:06 - 
Tak, det ville glæde os alle
10:05 - 
Og jeg tog imod dit væddemål men har aldrig set nogen g..
09:59 - 
Hvad du endnu ikke har opdaget er at alle griner af dig..

  • Study is exploring potential benefits of combining a cancer vaccine and PD-1 checkpoint inhibitor

COPENHAGEN, Denmark, December 29, 2016 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced the initiation of a clinical trial combining its proprietary cancer immunotherapy candidate, CV301, with the anti-PD-1 drug, OPDIVO® (nivolumab) from Bristol-Myers Squibb. The study is enrolling patients with non-small cell lung cancer (NSCLC) who have failed prior therapy.

 

The trial will begin with a Phase 1 safety component, enrolling up to 40 patients; the Phase 2 portion of the study will enroll 120 patients who will be randomized to receive either nivolumab (monotherapy) or a combination of CV301 and nivolumab. The study will enroll patients from up to 20 clinical sites throughout the United States. Detailed information on the trial can be found at http://clinicaltrials.gov/ct2/show/NCT02840994.

The rationale for this combination approach is for the vaccine to generate a tumor specific T cell response and allow the checkpoint inhibitor to maintain that immune effect by preventing the tumor from turning that response off.

While the primary endpoint of the study is overall survival, numerous secondary endpoints including response rate, progression free survival and duration of response will be evaluated and offer the potential for an early efficacy signal, prior to an overall survival endpoint.

"We are pleased to announce the initiation of this study, which marks the entry for Bavarian Nordic into lung cancer. While CV301 has shown the ability to generate immune responses to tumor-associated antigens in a variety of cancers, this study is the first seeking proof-of-concept for a promising combination approach and we look forward to the results as well as to advance CV301 as combination therapy in additional indications over the next years," said Paul Chaplin, President & CEO of Bavarian Nordic.

About CV301

CV301 is an immunotherapy candidate which is being developed under a CRADA with the National Cancer Institute (NCI).

CV301 targets two tumor-associated antigens, CEA and MUC-1, which are over-expressed in multiple solid tumors, including lung, bladder and colorectal cancer. Similar to PROSTVAC®, CV301 uses a prime/boost dosing schedule. CV301 incorporates a modified version of vaccinia (MVA-BN, a proprietary technology of Bavarian Nordic) as a priming dose, followed by multiple fowlpox boosts, and encodes the TRICOM costimulatory molecules.

A precursor version of CV301 has been tested in six NCI-sponsored clinical trials in various cancers, and a Phase 2 study in bladder cancer is currently ongoing. More than 300 patients have been treated with the product candidate.

About OPDIVO (nivolumab)

Marketed by Bristol-Myers Squibb, OPDIVO is an immune checkpoint inhibitor (anti-PD-1 therapy) approved for treatment of patients with advanced NSCLC in the second line setting, among other indications. OPDIVO has demonstrated superior overall survival across histologies, versus chemotherapy, in two pivotal Phase 3 trials in patients with advanced NSCLC.

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 partner Janssen are developing an Ebola vaccine regimen, which has been fast-tracked, with the backing of worldwide health authorities, and a vaccine for the prevention and treatment of HPV. 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

2016-12-29-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: 2016-12-29-en.pdf

Opret kommentar

Relateret debat

  • 1 uge
  • 1 måned
  • 1 År
21 sep
BAVA
Nogle gange...bare nogle gange ville jeg godt nok vaere glad og taknemmelig hvis vi ikke evig og alt..
25
25 sep
BAVA
Luk computeren ned for i dag Baron. Alt hvad du forudsiger er helt til hest... og det fryder mig!!! ..
8
24 sep
BAVA
Ja Baronen har altid ment, at shorterne havde fat i den lange ende. (Hykleri)   Indlæg af : Baro..
6
22 sep
BAVA
Meget spændende læsning. Bl.a. kan man på s. 109 se Bavarian Nordics portefølje af prækliniske udvik..
6
22 sep
BAVA
Åhhh. Kender i det at man taler til en dør og føler sig dum. At man ikke vil gøre det igen men så ig..
6
25 sep
BAVA
Gør det modsatte af Baronen og bliv rig....
5
22 sep
BAVA
Nøj er det de 4% ned du spåëde i går? Tosse,,
5
22 sep
BAVA
Den betød faktisk lidt og pointen er, at din overskrift hedder "Intet nyt" hvilket er forkert. Din..
5
20 sep
BAVA
Marc har shortet den.:)
5
07:30
BAVA
Hvis vi alle ignorerer ham, slipper vi lettest af med ham.
4

Novo/Exane: Sænker anbefaling til "neutral" fra "outperform"

26-09-2017 06:34:01
Novo Nordisk har fået sænket anbefalingen hos finanshuset Exane til "neutral" fra tidligere "outperform, skriver Bloomberg News.Kursmålet er i samme ombæring justeret til 300 kr. fra 290 kr. Det er 2,8 pct. lavere end mandagens lukkeniveau, hvor Novo-aktien endte i 308,60 kr. efter en stigning på 0,9 pct., mens det er 0,9 pct. under analytikernes konsensusgennemsnit på 302,77 kr.Inden ændringen an..

Pandora: Amerikansk investeringsselskab øger igen short-position

25-09-2017 15:17:33
Endnu engang har det amerikanske investeringsselskab AQR Capital Managment øget sin andel af såkaldte "shortede" aktier i smykkeselskabet Pandora.Det fremgår af en indberetning til Finanstilsynet.AQR Capital Managment har nu en shortposition i Pandora på 2,1 pct., hvor investeringsselskabet tidligere kun ejede 2 pct. af den samlede udstedte aktiekapital i selskabet.Mandag eftermiddag stiger Pandor..

NKT/Jyske: Triton Knoll-ordre vil give god sigtbarhed i Köln i 2019

25-09-2017 14:25:53
NKT er i favoritposition til at løbe med kabelkontrakten til det britiske havvindmølleprojekt Triton Knoll, efter at udviklerne bag, et joint venture mellem Innogy og Statkraft, har valgt den danske leverandør som den foretrukne.Kommer der i løbet af 2018 som ventet en fast og ubetinget aftale ud af det, så vil det sammen med en eventuel ordre på Borssele beta sikre NKT en god kapacitetsudnyttelse..

Mest læste nyheder

  • 24 timer
  • 48 timer
  • 1 uge
1
Bavarian Nordic-aktien slikker sårene efter kæmpe tab - citat
2
Pandora: Amerikansk investeringsselskab øger igen short-position
3
Mærsk/ABM: 4 mia. dollar for Mærsk Drilling er i den lave ende - ny
4
Aktier/middag: Nets rider på købsbølgen i let positivt marked
5
Nye Nets-ejere vil starte massive opkøb

Relaterede aktiekurser

Bavarian Nordic A/S 277,00 -1,1% Fald i aktiekurs

Køb- og salgsanbefalinger

  • Trend
  • Pengemaskinen

Copyright Euroinvestor A/S 2017  Disclaimer Privatlivspolitik
Aktieinformation leveres af Morningstar.
Data er forsinket 15-20 minutter iht. de enkelte børsers regler om videredistribution.
 
26. september 2017 11:00:51
(UTC+01:00) Brussels, Copenhagen, Madrid, Paris
Version: LiveBranchBuild_20170925.1 - EUROWEB4 - 2017-09-26 11:00:51 - 2017-09-26 11:00:51 - 1 - Website: OKAY