Bavarian Nordic Reports Positive Results from Human Challenge Trial of its RSV Vaccine Candidate
- Study achieved the primary endpoint by demonstrating a statistically significant reduction in viral load in vaccinated versus control (placebo) treated volunteers
- Demonstrated up to a 79% efficacy in reducing symptomatic RSV infections
- Management will host a conference call today at 2 pm CET (8 am EST) to review the results
COPENHAGEN, Denmark, September 1, 2021 – Bavarian Nordic A/S (OMX: BAVA) announced today results from a human challenge trial of the RSV vaccine candidate, MVA-BN® RSV. The phase 2 double-blinded, placebo-controlled trial enrolled healthy adult volunteers, 18-50 years of age who were randomized to receive either a single vaccination of MVA-BN RSV or placebo. Volunteers were challenged intranasally with an RSV type A strain 28 days after vaccination. A total of 61 subjects were evaluable.
The study demonstrated a significant reduction in viral load in vaccinated subjects (n=30) versus placebo (n=31), thus meeting the primary endpoint of this pivotal study. At the same time, the vaccinated subjects showed a significant reduction in clinical symptoms typically associated with RSV infections. The MVA-BN RSV vaccine demonstrated a vaccine efficacy of up to 79% in preventing symptomatic RSV infections.
No vaccine-related serious adverse events were observed, and the vaccine was well tolerated, consistent with the safety profile previously reported in phase 1 and phase 2 clinical studies.
Paul Chaplin, President and CEO of Bavarian Nordic, commented: “We are pleased to report these highly encouraging results, that are equivalent to, or even better than those of competitor candidates and which confirm the potential of our RSV vaccine candidate. MVA-BN RSV has been designed to simulate a broad immune response against RSV by incorporating not only one, but five different antigens of the virus, thereby offering the advantage of a broad protection against RSV that will likely be required to prevent hospitalization with severe disease caused by RSV. The COVID-19 pandemic has clearly demonstrated the susceptibility and severity of respiratory viruses in vulnerable populations, and we remain committed to bring this novel vaccine to the market to fulfil the high unmet medical need in the elderly population, which is estimated to be on par with influenza.”
Pending further analysis of the current RSV infection rates, discussions with regulatory authorities about the Phase 3 design, and funding/partnering considerations, the Company will determine the immediate next steps and expects to communicate these during fourth quarter of 2021.
Conference call and webcast
The management of Bavarian Nordic will host a conference call today at 2 pm CET (8 am EST) to review the trial results followed by a Q&A session. A listen-only version of the call can be accessed via https://www.bavarian-nordic.com/investor/events.aspx?event=6392. To join the Q&A session, use one of the following dial-in numbers: Denmark: +45 32 72 04 17, UK: +44 (0) 844 481 9752, USA: +1 646-741-3167. Participant code is 7370558.
About Respiratory Syncytial Virus (RSV)
RSV is a common virus that usually causes mild, cold-like symptoms, but in serious cases can cause severe lung infections, including bronchiolitis and pneumonia. Those at risk are typically young infants and the elderly as well as people with weakened immune systems. RSV-induced infections result in a similar number of hospitalizations and deaths in the elderly population, as influenza. According to the CDC1, approximately 177,000 elderly U.S. citizens are hospitalized annually, due to RSV-induced infections, and about 14,000 of them die. With no approved vaccines, RSV remains a high unmet medical need, particularly in children and the elderly.
About MVA-BN RSV
MVA-BN RSV, Bavarian Nordic's product candidate for the prevention of RSV, is being developed for an elderly population. The vaccine incorporates five different RSV antigens to stimulate a broad immune response against both RSV subtypes (A and B), thus mimicking the immune response observed following a natural response to an RSV infection. The incorporation of five antigens differentiates MVA-BN RSV from any other RSV vaccine candidates in development.
Bavarian Nordic has previously concluded a phase 2 trial of MVA-BN RSV in 421 elderly subjects, demonstrating that the vaccine was well tolerated and induced both broad and durable antibody and T-cell responses against RSV, as well as mucosal immune responses that may be important for protection against RSV. The phase 2 program in elderly included a revaccination of subjects after one year, following which the immune responses were rapidly and significantly increased, notably in subjects with the weakest immunity prior to the booster vaccination.
The vaccine candidate is based on Bavarian Nordic’s proprietary MVA-BN® platform technology, also used in the Company’s approved vaccines for smallpox and Ebola.
About Bavarian Nordic
Bavarian Nordic is a fully integrated vaccines company focused on the development, manufacturing and commercialization of life-saving vaccines. We are a global leader in smallpox vaccines and have been a long-term supplier to the U.S. Government of a non-replicating smallpox vaccine, which has been approved by the FDA under the trade name JYNNEOS®, also for the protection against monkeypox. The vaccine is approved as a smallpox vaccine in Europe under the trade name IMVANEX® and in Canada under the trade name IMVAMUNE®. Our commercial product portfolio furthermore contains the market-leading vaccine Rabipur®/RabAvert® against rabies and Encepur® against tick-borne encephalitis. Using our live virus vaccine platform technology, MVA-BN®, we have created a diverse portfolio of proprietary and partnered product candidates designed to save and improve lives by unlocking the power of the immune system, including an Ebola vaccine, MVABEA®, which is licensed to the Janssen Pharmaceutical Companies of Johnson & Johnson. We are also committed to the development of a next generation COVID-19 vaccine based on an in-licensed capsid virus-like particle technology. The vaccine candidate, ABNCoV2, is currently being investigated in clinical trials. For more information visit www.bavarian-nordic.com.
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.
Europe: Rolf Sass Sørensen, Vice President Investor Relations, Tel: +45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors, firstname.lastname@example.org, Tel: +1 781 686 9600
Company Announcement no. 29 / 2021
AttachmentTo view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire
Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire
Exterro Adds e-Discovery Industry Veteran Clay Cocalis to Spearhead Rapidly Growing Business Unit Responsible for Document Review22.9.2021 14:00:00 CEST | Press release
Latest Version of Revamped Exterro Review Platform Optimized for Entire Legal Ecosystem Including use by Legal Service Providers, and Law Firms and Corporate Legal Departments PORTLAND, Ore., Sept. 22, 2021 (GLOBE NEWSWIRE) -- Exterro Inc. – the preferred provider of Legal GRC software specifically designed for in-house legal, privacy, and IT teams at Global 2000 and AmLaw 200 organizations – today announced it has expanded its business unit in charge of Exterro Review, with the addition of Clay Cocalis as Senior Vice President, Review Software. Mr. Cocalis’ newly minted position at the company represents the significant investment Exterro is placing in Exterro Review. In conjunction with the strategic hire, the company is announcing that it has revamped and optimized Exterro Review to make it more scalable and affordable for the entire legal ecosystem, including legal service providers, law firms and corporate clients. “I’m incredibly excited to welcome Clay to Exterro. He is a distin
Benjamin Hill Releases Inaugural Drill Program Targeting Most Prospective Locations on the Sonora Gold Property22.9.2021 13:30:00 CEST | Press release
VANCOUVER, British Columbia, Sept. 22, 2021 (GLOBE NEWSWIRE) -- Benjamin Hill Mining Corp. (CSE: BNN) (OTCBB: BNNHF) (“BHM” or the “Company”) is pleased to announce their inaugural drill program for their never before drilled Sonora Gold property in the Caborca Gold belt of Sonora Mexico. The program consists of 80 strategic drill holes targeting the main mineralized structures in the Caracahui, Caracahui North, Sonora Copper, La Salada and Antenas exploration areas. The 80 sites were selected based on detailed mapping of mineralized structures and very encouraging surface sample assay results. Drill targets have been prioritized to assess areas where surface samples revealed the highest gold values and in locations that are accessible with minimal road building and ground disturbance (Figure 1). Benjamin Hill plans a phased approach to the drill program to maximize the value of the data collected. The exploration areas containing the best assays from surface sampling will be the focus
Millicom Announces Early Participation Results of and Increases the Maximum Acceptance Amount for the Exchange Offer22.9.2021 13:05:00 CEST | Press release
Millicom Announces Early ParticipationResults of and Increases the Maximum Acceptance Amount for the Exchange Offer Luxembourg, September 22, 2021 – In connection with its previously-announced offer to exchange (the “Exchange Offer”) its outstanding 6.625% Senior Notes due 20261 (the “2026 Existing Notes” or “Old Notes”) for 4.500% Senior Notes due 2031 (the “New Notes”), Millicom International Cellular S.A. (the “Company”) (NASDAQ U.S.: TIGO, Nasdaq Stockholm: TIGO_SDB) announces the results as of the Early Participation Date (as defined below) and increases the Maximum Acceptance Amount (as defined below) for the Exchange Offer to accept all 2026 Existing Notes that were validly tendered and not validly withdrawn by the Early Participation Date (as defined below). Early Participation Date Results The Early Participation Date with respect to the Exchange Offer occurred at 5:00 PM, New York City time, on September 21, 2021 (such time and date, the “Early Participation Date”). According
Van Lanschot Kempen: EGM agrees to Brigitte Boone’s appointment as a member of the Supervisory Board and takes note of the intention to appoint Maarten Edixhoven as a member and Chair of the Management Board22.9.2021 13:00:00 CEST | Press release
’s-Hertogenbosch/Amsterdam, the Netherlands, 22 September 2021 On 22 September 2021, Van Lanschot Kempen’s extraordinary general meeting (EGM) approved the appointment of Brigitte Boone as a member of its Supervisory Board. It was also officially advised of the intention to appoint Maarten Edixhoven as a member and Chair of the Management Board effective 1 October 2021. Frans Blom, Chair of the Supervisory Board, said: “We’re delighted with Brigitte’s appointment and wish her lots of success as a member of our Supervisory Board. On 1 October 2021, we’ll welcome Maarten as the company’s new CEO, which is also when we’ll bid farewell to our current Chair, Karl Guha. “Van Lanschot Kempen’s results and growth in the years under Karl’s leadership tell their own story, but our people’s engagement, entrepreneurialism and sheer drive are unparalleled. We’ll miss Karl as a director and manager, as a colleague, and most of all as a highly inspiring leader. And we are so grateful to him for headi
Solarisbank selects Feedzai as Risk Management Partner22.9.2021 12:53:53 CEST | Press release
Two fintech Unicorns join forces to shape the future of financial services and democratize access to banking in Europe AMSTERDAM, Sept. 22, 2021 (GLOBE NEWSWIRE) -- Feedzai, the world’s leading cloud-based financial risk management platform, and Solarisbank AG, Europe's leading Banking-as-a-Service platform, announced today at Money20/20 Europe a multi-year partnership. The pioneering companies have joined forces to reshape banking, combining the trailblazing transformation that comes with Banking-as-a-Service with the risk management and security that is expected from financial institutions - all while preserving the customer experience. Importantly, the flexibility of Feedzai’s risk management solution means they can scale as Solarisbank grows, helping the company to keep up with a regulatory and geo-political landscape that is in a constant state of flux as well as more comprehensively protect customers from threats. Solarisbank enables any company to offer financial services via AP
Fobi Data Exchange Launches With First Partner, In-Touch Group, A Leading UK Platform Managing Data From 6,000 Independent Convenience Stores22.9.2021 12:00:00 CEST | Press release
In-Touch group will optimize Data With Fobi AI Driven Analytics And Monetize Through Global CPG Brands. Fobi Data Exchange (FDX) Delivers Analytics For Both Convenience Stores and CPG Brands Previously Thought Unattainable VANCOUVER, British Columbia, Sept. 22, 2021 (GLOBE NEWSWIRE) -- Fobi AI Inc. (FOBI: TSXV FOBIF: OTCQB) (the “Company” or “FOBI”), a global leader in providing real-time data analytics through artificial intelligence to drive operational efficiencies and profitability, is pleased to announce the launch of the Fobi Data Exchange (“FDX”) with its first data monetization agreement and partner, In-Touch Group, a provider of consumer insights and digital marketing to retailers and consumers. In-Touch currently manages a data lake of point-of-sale transactions for approximately 6,000 convenience stores, which is projected to increase to approximately 10,000 stores by the end of 2021. Through FDX, Fobi will optimize and monetize this data by providing Global CPG brands with
RESULT OF RIKSBANK REVERSED AUCTIONS TREASURY BILLS22.9.2021 11:07:00 CEST | Press release
Auction date2021-09-22 LoanDEC 2021IsinSE0015244405Coupon, %0.00Maturity2021-12-15 Tendered volume, SEK mln1,000 +/- 500Offered volume, SEK mln2,800 Volume bought, SEK mln1,000 Number of bids11 Number of accepted bids10 Average yield, %-0.238 %Lowest accepted yield, %-0.288 %Highest yield, %-0.205 %Accepted at lowest yield, %20.00 Auction date2021-09-22 LoanJUN 2022IsinSE0016102057Coupon, %0.00Maturity2022-06-15Tendered volume, SEK mln1,000 +/- 500Offered volume, SEK mln2,000 Volume bought, SEK mln1,000 Number of bids6 Number of accepted bids1 Average yield, %-0.288 %Lowest accepted yield, %-0.288 %Highest yield, %-0.288 %Accepted at lowest yield, %100.00 Auction date2021-09-22 LoanSEP 2022IsinSE0016787204Coupon, %0.00Maturity2022-09-21Tendered volume, SEK mln500 +/- 250Offered volume, SEK mln1,000 Volume bought, SEK mln500 Number of bids3 Number of accepted bids1 Average yield, %-0.311 %Lowest accepted yield, %-0.311 %Highest yield, %-0.311 %Accepted at lowest yield, %100.00