Globally, more than 58 million people are chronically infected with Hepatitis C virus (HCV) with 1.5 million new infections occurring each year. An effective vaccine for HCV is therefore a major unmet medical and public health need. Since HCV rapidly accumulates mutations, vaccines must elicit the production of broadly neutralising antibodies (bnAbs) in a reproducible fashion. Decades of research have generated a number of HCV vaccine candidates. Based on the available data and research through clinical development, a vaccine antigen based on the E1E2 glycoprotein complex appears to be the best choice, but robust induction of humoral and cellular responses leading to virus neutralisation has not yet been achieved. One issue that has arisen in developing an HCV vaccine (and many other vaccines as well) is the platform used for antigen delivery. The majority of viral vaccine trials have employed subunit vaccines. However, subunit vaccines often have limited immunogenicity, as seen for HCV, and thus multiple formats must be examined in order to elicit a robust anti‐HCV immune response. Nanoparticle vaccines are gaining prominence in the field due to their ability to facilitate a controlled multivalent presentation and trafficking to lymph nodes, where they can interact with both arms of the immune system. This review discusses the potential for development of a nanoparticle‐based HCV E1E2 vaccine, with an emphasis on the potential benefits of such an approach along with the major challenges facing the incorporation of E1E2 into nanoparticulate delivery systems and how those challenges can be addressed.

2013-08-01·Vaccine3区 · 医学

WITHDRAWN: Immunogenicity and safety of HCV E1E2 peptide vaccine in chronically HCV-infected patients who did not respond to interferon based therapy

3区 · 医学

Article

作者: Dawood, Reham M ; El Shenawy, Reem ; Tabll, Ashraf A ; Abdelhafez, Tawfeek H ; El Gendy, Mohamed ; Bader El Din, Noha ; Waked, Imam ; Allam, Aleef ; El Abd, Yasmin ; El-Awady, Mostafa K

This article has been withdrawn at the request of the author(s) and/or editor. The Publisher apologizes for any inconvenience this may cause. The full Elsevier Policy on Article Withdrawal can be found at http://www.elsevier.com.libproxy1.nus.edu.sg/locate/withdrawalpolicy.

2012-06-01·Vaccine3区 · 医学

Superior protection conferred by inactivated whole virus vaccine over subunit and DNA vaccines against salmonid alphavirus infection in Atlantic salmon (Salmo salar L.)

3区 · 医学

Article

作者: Cheng Xu ; Stephen Mutoloki ; Øystein Evensen

Salmonid alphavirus 3 (SAV-3) is an emerging pathogen in Norwegian salmon farming and causes severe annual losses. We studied the immunogenicity and protective ability of subunit and DNA vaccines based on E1 and E2 spike proteins of salmonid alphavirus subtype 3 (SAV-3), and compared these to an experimental inactivated, whole virus (IWV) vaccine in Atlantic salmon. The antigens were delivered as water-in-oil emulsions for the subunit and inactivated vaccines and non-formulated for the DNA vaccines. The IWV and the E2 subunit prime-boost groups had circulating neutralizing antibodies at challenge, correlating with high protection against lethal challenge and 3-log(10) reduction of virus titer in heart for the IWV group. Prime-boost with E1 subunit vaccine also conferred significant protection against mortality, but did not correlate with neutralizing antibody levels. Protection against pathology in internal organs was only seen for the IWV group. Prime-boost with E1 and E2 DNA vaccines showed marginal protection in terms of reduction of viral replication in target organs and protection against mortality was not different from controls. The IWV group showed significant upregulation of IFNγ and IL2 mRNA expression at 4 weeks post challenge possibly indicating that other mechanisms in addition to antibody responses play a role in mediating protection against infection. This is the first report comparing the immunogenicity and protection against mortality for IWV vaccines and spike protein subunit and DNA vaccines against salmonid alphavirus infection in Atlantic salmon. The IWV vaccine has superior immunogenicity over sub-unit and DNA vaccines.

项与 Hepatitis C vaccine(Fujirebio, Inc.) 相关的新闻（医药）

2022-07-12

·GlobeNewswire-Health Care

Bioventus Completes CartiHeal Acquisition

DURHAM, N.C., July 12, 2022 (GLOBE NEWSWIRE) -- Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, announced today that it has completed its acquisition of CartiHeal. “We are excited to add CartiHeal to our diverse portfolio of active healing solutions,” commented Ken Reali, Bioventus’ chief executive officer. “CartiHeal represents an important breakthrough for the treatment of osteoarthritis and osteochondral defects of the knee with significant medium- and long-term potential as evidenced by the robust data generated from its pivotal clinical trial showing superiority to current treatments. We believe that the addition of CartiHeal will complement our joint preservation technologies and specifically our HA business, further supporting our short- and mid-term growth drivers and helping us to deliver on our goal of sustained double-digit revenue growth. We welcome the CartiHeal team to Bioventus and look forward to bringing this life-improving technology to as many patients as possible.” CartiHeal is an attractive alternative for the approximately 650,000 U.S. patients that receive microfracture or debridement annually and can potentially delay the need for a total knee replacement in patients with joint surface lesions of the knee. The acquisition of CartiHeal is directly aligned with Bioventus’ sports medicine and total joint reconstruction call point and extends the Company's leadership position in joint preservation technologies. In a randomized controlled clinical trial, CartiHeal’s Agili-C implant demonstrated superiority to either microfracture or debridement. On March 29, 2022, CartiHeal received premarket approval (PMA) of its Agili-CTM implant from the U.S. Food and Drug Administration. Agili-C was granted Breakthrough Device Designation by the FDA in 2020 and is indicated for the treatment of International Cartilage Repair Society (ICRS) grade III or above knee–joint surface lesions, with a total treatable area of 1-7 cm2 for patients without severe osteoarthritis (Kellgren-Lawrence grade 0-3). The Company will provide adjusted earnings per share guidance reflecting the acquisition of CartiHeal on its upcoming second quarter earnings call. About BioventusBioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for Pain Treatment, Restorative Therapies and Surgical Solutions. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC. Forward-Looking Statements This press release contains forward-looking statements within the meaning of federal securities laws. Any statements contained herein that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, the Company’s future financial results, the benefits of the CartiHeal acquisition and the potential for the Company’s current portfolio to deliver sustained double-digit growth. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results to differ materially from those contemplated herein include, but are not limited to, the ability to obtain financing for and to make the deferred payments in connection with the CartiHeal acquisition on expected timelines or at all; our ability to recognize the benefits of the investment in CartiHeal; the adverse impacts on our business as a result of the COVID-19 pandemic; our dependence on a limited number of products; our ability to develop, acquire and commercialize new products, line extensions or expanded indications; the continued and future acceptance of our existing portfolio of products and any new products, line extensions or expanded indications by physicians, patients, third-party payers and others in the medical community; our ability to achieve and maintain adequate levels of coverage and/or reimbursement for our products, the procedures using our products, or any future products we may seek to commercialize; our ability to complete acquisitions or successfully integrate new businesses, products or technologies in a cost-effective and non-disruptive manner, including the CartiHeal acquisition; risk related to the Company’s debt and payment obligations relating to the CartiHeal acquisition; competition against other companies; and the other risks identified in the Risk Factors section of the Company’s public filings with the Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 as updated by the Company’s Quarterly Report on Form 10-Q for the quarter ended April 2, 2022 and as such factors may be further updated from time to time in the Company’s other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. Except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Actual results may differ materially from those set forth in the forward-looking statements. Media Contact: Jamica Whitaker919-474-6715jamica.whitaker@bioventus.com Investor Inquiries:Dave Crawford919-474-6787dave.crawford@bioventus.com

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2021-08-31

·NS Medical Devices

Bioventus exercises $50m option to buy CartiHeal

The decision is based on a statistical analysis report of Agili-C implant pivotal clinical trial, as well as the reimbursement coding analysis and significant market diligence, including surgeon interviews with respect to Agili-C’s commercialisation opportunity Bioventus decides to make a $50m escrow payment for the acquisition. (Credit: Gerd Altmann/Pixabay) Active healings solutions provider Bioventus has announced that it is exercising its option to acquire Israel medical device firm CartiHeal. The company has decided to make a $50m escrow payment to proceed with its option and equity purchase agreement for the acquisition of CartiHeal. The acquisition decision is based on the assessment of a statistical analysis report of Agili-C implant pivotal clinical trial, as well as the reimbursement coding analysis and significant market diligence. It also included surgeon interviews with respect to Agili-C’s commercialisation opportunity and ultimate market potential. Bioventus stated: “The Company’s obligation to consummate the Potential Transaction is subject to the exercise by the Company of the call option provided under the Option Agreement, or the exercise by CartiHeal of its put option provided under the Option Agreement.” The put option is expected to be exercised following premarket approval (PMA) by the Food and Drug Administration (FDA) of the Agili-C implant and the satisfaction of certain other conditions pursuant to the option agreement. Agili-C is designated to treat cartilage and osteochondral defects in the knee joint in patients without severe osteoarthritis. CartiHeal intends to submit the clinical module of its PMA by the end of this year. The closing of the potential transaction is subject to certain customers following the exercise of such option rights. Bioventus senior vice president and chief science officer Alessandra Pavesio said: “The robust data generated from the pivotal clinical trial, a randomized controlled trial with Agili-C, demonstrated superiority over surgical standard of care, microfracture and debridement, in KOOS overall compared to baseline. “We believe this product could be a strong alternative for the approximately 650,000 US patients annually receiving microfracture or debridement along with other cartilage treatment options.” In July this year, Bioventus agreed to acquire ultrasonic medical devices provider Misonix in a cash-and-stock transaction valued at around $518m.

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2021-08-30

·Mass Device

Bioventus triggers $50M option to acquire CartiHeal

Bioventus (NSDQ:BVS) announced today that it chose to make a $50 million escrow payment to acquire CartiHeal and its Agili-C implant. Durham, N.C.-based Bioventus elected to make its escrow payment pursuant to its option and equity purchase agreement with CartiHeal to signal its intent to move forward with an acquisition of the company. According to a news release, the decision came on the back of a review of a statistical analysis report of the pivotal clinical trial of Agili-C, reimbursement coding analysis and significant market diligence, including surgeon interviews, with respect to Agili-C and its commercialization opportunity and market potential. Bioventus’ obligation to consummate the transaction is subject to the exercise of the call option under the agreement or the exercise by CartiHeal of its put option, which may only be exercised following FDA premarket approval for Agili-C, which won FDA breakthrough device designation last year. CartiHeal plans to submit the clinical module of their PMA later this year. CartiHeal designed the Agili-C implant to treat cartilage and osteochondral defects in patients with severe osteoarthritis. “The robust data generated from the pivotal clinical trial, a randomized controlled trial with Agili C, demonstrated superiority over surgical standard of care, microfracture and debridement, in KOOS overall compared to baseline. We believe this product could be a strong alternative for the approximately 650,000 U.S. patients annually receiving microfracture or debridement along with other cartilage treatment options,” Bioventus SVP & CSO Alessandra Pavesio said in the release. “In combination with our HA products, Agili-C represents an exciting potential new offering for our portfolio designed to address the spectrum of osteoarthritis disease.”

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100 项与 Hepatitis C vaccine(Fujirebio, Inc.) 相关的药物交易

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