These forward-looking statements may include, but may not be limited to: the collaboration and license agreement with the University of Pennsylvania; the investigational program candidate BNT163; the timing, for any data readouts of the BNT163 phase 1 trial; the registrational potential of BNT163; ability of BioNTech to further develop and commercialize a vaccine for the Herpes Simplex Virus (HSV); the ability of BioNTechs mRNA technology to demonstrate clinical efficacy outside of BioNTechs infectious disease platform; the potential safety and efficacy of our other product candidates; and BioNTechs anticipated market opportunity and size for its product candidates, the rate and degree of market acceptance of BioNTechs investigational medicines, if approved. government site. According to the World Health Organization, approximately 500 million people globally are estimated to be affected. The study consists of a first dose escalation part that will focus on safety evaluations and assess the optimal dose-response in various dose levels. Disclaimer. Any forward-looking statements in this press release are based on BioNTechs current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Licensed live attenuated vaccines (e.g., influenza vaccines) are allowed at least 28 days before or 28 days after any IMP administration. Reporting by Tristan Chabba in Gdansk Editing by Miranda Murray, https://www.pharmalive.com/wp-content/uploads/2021/04/BioNTech-expects-vaccine-trial-results-for-babies-by-September-Reuters-4-29-21.jpg, https://www.pharmalive.com/wp-content/uploads/2020/01/Pharmalive_4c-300x37.png, Copyright - PharmaLive and Outcomes LLC |, BioSpaces top clinical advancements of 2022. We aim to induce a broad immune response which is directed against multiple antigens of the virus and mobilizes various immune effectors to support virus neutralization and clearance," said BioNTech Co-Founder and Chief Medical Officer zlem Treci. After completion of all IND-enabling studies, BNT163 is the first candidate from this collaboration to enter the clinic. mRNA Unable to load your collection due to an error, Unable to load your delegates due to an error. News Corp is a global, diversified media and information services company focused on creating and distributing authoritative and engaging content and other products and services. 2023 Predictions: the next chapter of the digital-first, artificial intelligence U.S. Centers for Disease Control and Prevention (CDC). The trial will evaluate the safety, tolerability and immunogenicity of the prophylactic mRNA candidate in preventing genital lesions caused by the viruses. View this study on Beta.ClinicalTrials.gov, U.S. Department of Health and Human Services. Bookshelf Epub 2019 Oct 11. Keywords: The four-year-olds two neat braids of dark hair wave behind him as he runs among the dust, dogs, and sheep near his familys ranch on their Navajo reservation in Arizona. NCI CPTC Antibody Characterization Program. Volunteers with oral herpes or herpetic whitlow will not be excluded. Choosing to participate in a study is an important personal decision. For more than a month, Shane Anthony, a 57-year-old auto mechanic, hasnt been able to get his diabetes medication. The novel platforms of vaccines were developed to replace the time-consuming traditional vaccine manufacturing process, but this worldwide campaign raises new safety issues. Part B of the trial will expand the safety characterization for a BNT163 dose selected based on Part A data and enable a more comprehensive assessment of the impact of pre-existing immunity to Herpes Simplex Virus (HSV)-1 and -2 on the safety and BNT163-induced immune responses after one selected (higher) dose of BNT163 than could be done during the dose escalation performed in Part A. Anti-viral ribonucleic acid (RNA) vaccine for active immunization against HSV-2 administered as intramuscular injection. Up to 95% of the global population are estimated to be infected by herpes with most of the infections remaining asymptomatic, but symptoms of herpes include painful blisters or ulcers that can recur over time.3 HSV-1 is mainly transmitted by oral contact and causes lesions around the mouth but in some cases can also lead to genital infections and respective lesions. Up to 95% of the global population are estimated to be infected by herpes with most of the infections remaining asymptomatic, but symptoms of herpes include painful blisters or ulcers that can recur over time. Price Action:BNTX shares are up 1.68% at $175.60 on the last check Wednesday. Dec 21 (Reuters) - BioNtech (22UAy.DE) has dosed the first patient with its BNT163 herpes vaccine candidate designed to prevent genital lesions as part of a first-in-human Phase 1 clinical. This program is part of our strategy to help address diseases with a high unmet medical need and of global health relevance by combining our new technologies such as mRNA and our expertise in immune engineering, saidProf. zlem Treci, M.D., Chief Medical Officer and Co-Founder of BioNTech. WHO Supports 1-Dose HPV Vaccine Strategy, Bloomberg: Herpes simplex viruses (HSV) types 1 and 2 are ubiquitous. Print 2017 May 1. They also metabolize cholesterol and synthesize hormones and neurotransmitters. BNT163 is based on three non-infectious mRNA-encoded HSV-2 glycoproteins. J Clin Invest. Vaccines As neurotropic and neuroinvasive viruses, HSV-1 and -2 persist in the body by hiding from the immune system in the cell bodies of neurons where they reside lifelong, and thus cannot be eradicated with current treatments (Currently available HSV therapies only reduce the severity and frequency of symptoms.). 2020 Jan 3;38(1):79-89. doi: 10.1016/j.vaccine.2019.09.090. Is this happening to you frequently? For a discussion of these and other risks and uncertainties, see BioNTechs Quarterly Report as Form 6-K for the quarter ended September 30, 2022, filed with the SEC on November 7, 2022, which is available on the SECs website at www.sec.gov. The second part of the trial is designed to expand the safety characterization for the selected dosing of BNT163 for a more comprehensive assessment of the impact of pre-existing immunity to HSV-1 and -2 on the safety and BNT163-induced immune responses. BioNTech doses first patient in herpes vaccine candidate clinical trial. 50% off + free delivery on $20 orders with DoorDash promo code, 60% off running shoes and apparel at Nike without a promo code, Get up to 60% off best selling video game titles - GameStop coupon code, Hotel Promo: Up to 40% off + Extra 10% off with Barcelo coupon code. Given a decrease in the quantitative SARS-CoV-2 spike 1-2 IgG antibody titers three months following the second BNT162b2 dose, healthcare workers got a third booster dose after six months of completing the original scheme. The vaccine candidate is meant to prevent HSV-2, the herpes simplex virus that causes genital herpes, and potentially HSV-1, which causes oral herpes and can lead to genital herpes. Print 2019 May 1. 2006 Summer;19(2):220-36. doi: 10.1089/vim.2006.19.220. HSV-2 is a sexually transmitted disease that causes genital herpes. Both viruses are highly contagious and can also be transmitted during childbirth. eCollection 2019. Trump tax audits required by IRS were delayed: panel 1 hour ago History of psychiatric illness, including alcohol abuse or drug addiction within 1 year before Visit 0, or a history (within the past 5 years) of substance abuse or known medical, psychological, or social conditions which, in the opinion of the investigator, could compromise their wellbeing if they participate as participants in the trial, or that could prevent, limit, or confound the protocol-specified assessments. Federal government websites often end in .gov or .mil. Front Cell Infect Microbiol. Please. The mRNA vaccine candidate encodes three HSV-2 glycoproteins with the aim of helping to prevent HSV cellular entry and spread, as well as counteract the immunosuppressive properties of HSVs. The second part of the trial is designed to expand the safety characterization for the selected dosing of BNT163 for a more comprehensive assessment of the impact of pre-existing immunity to HSV-1 and -2 on the safety and BNT163-induced immune responses. Are willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (e.g., to practice social distancing and to follow good practices to reduce their chances of being infected or spreading COVID-19), and other requirements of the trial. This copy is for your personal, non-commercial use only. Dow Jones Reprints at 1-800-843-0008 or visit www.djreprints.com. fourth dose of the BNT162b2 vaccine (30 microgram) adminstered IM. The Wall Street Journal news department was not involved in the creation of this content. HSV-2 neutralizing antibody titers. 1 min read (Reuters) - BioNtech has dosed the first patient with its BNT163 herpes vaccine candidate designed to prevent genital lesions as part of a first-in-human. PMC As inventors of certain intellectual property related to the BNT163 vaccine candidate, some of the scientists involved in the preclinical development of the candidate along with Penn, may receive additional financial benefits under the BioNTech license in the future. Here's How Much Marjorie Taylor Greene Has Lost On Her Trump SPAC Investment - Digital World Acq (NASDAQ: Don't miss real-time alerts on your stocks - join Benzinga Pro for free! BNT163 is based on three non-infectious mRNA-encoded HSV-2 glycoproteins. Negative anti-Hepatitis C virus antibodies (anti-HCV), or undetectable hepatitis C virus (HCV) viral load if the anti-HCV is positive at Visit 0. Cuando utilizas nuestros sitios y aplicaciones, usamos. Hes smiley, silly, and definitely trying to make you laugh. BNT163 BioNTech's HSV-2 vaccine (BNT163) seems to be further along in the process. HHS Vulnerability Disclosure, Help (Under the terms of the agreement, BioNTech can obtain an exclusive worldwide license to further develop and commercialize product candidates arising from the research collaboration.) RVx-201 RVx-201 is a treatment vaccine developed by Rational Vaccines. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Vaccine. Front Immunol. WHO Supports 1-Dose HPV Vaccine Strategy The vaccine candidate is meant to prevent HSV-2, the herpes simplex virus that causes genital herpes, and potentially HSV-1, which causes oral herpes and can lead to genital herpes. | Source: vOut += aTags[i].trim().replace(reg, '-').substring(0,40); Editors Note: The University of Pennsylvania has licensed some intellectual property related to the BNT163 vaccine candidate to BioNTech. VOCBP who agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during trial, starting at Visit 0 and continuously until 60 days after receiving the last trial treatment. The incorporation of adjuvants of the vaccine candidates in the past, may account for their partial efficacy. 21 Dec 2022 23:45:09 Benzinga does not provide investment advice. J Virol. As neurotropic and neuroinvasive viruses, HSV-1 and -2 persist in the body by hiding from the immune system in the cell bodies of neurons where they reside lifelong, and thus cannot be eradicated with current treatments. December 21, 2022 06:45 ET This program is part of our strategy to help address diseases with a high unmet medical need and of global health relevance by combining our new technologies such as mRNA and our expertise in immune engineering, said Prof. zlem Treci, M.D., Chief Medical Officer and Co-Founder of BioNTech. Received blood/plasma products or immunoglobulin within 120 days before Visit 1 or planned administration starting at Visit 0 until completion of Visit 12. Distribution and use of this material are governed by Media RelationsJasmina Alatovic+49 (0)6131 9084 1513Media@biontech.de, Investor RelationsSylke Maas, Ph.D.+49 (0)6131 9084 1074Investors@biontech.de. Meanwhile, Cohen and his team are working on developing herpes vaccines, and numerous studies have looked at different herpes vaccine candidates. var reg = new RegExp('\\W+', "g"); Under the terms of the agreement, BioNTech can obtain an exclusive worldwide license to further develop and commercialize product candidates arising from the research collaboration. A new panel of adverse events was recently reported at nation-wide registry levels.1 However, the information is very limited in . return vOut; (Silverman, 12/21), Stat: BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. (Reuters) - BioNtech has dosed the first patient with its BNT163 herpes vaccine candidate designed to prevent genital lesions as part of a first-in-human Phase 1 clinical research study, the . Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech expects to enroll 100 people between ages 18 and 55 for its Phase 1 trial of the drug, the firm added. We also review what is known of the natural immune control of herpes lesions, via interacting innate immunity and CD4 and CD8 T cells and the lessons they provide for development of new, more effective vaccines. Despite more than 60 years of research, there is no licensed prophylactic HSV vaccine and some doubt as to whether this can be achieved. Meet Hemp-Derived Delta-9 THC. ! Infections with HSV-2 further increase the risk of acquiring and transmitting HIV infections. Talk with your doctor and family members or friends about deciding to join a study. doi: 10.1128/JVI.02309-18. Bettahi I, Zhang X, Afifi RE, BenMohamed L. Viral Immunol. Furthermore, HSV-2 infection increases the risk of acquiring HIV infections by approximately three-fold, and co-infections with both HIV and HSV-2 increase the likelihood of transmitting HIV to others, according to the WHO. A placebo-controlled, observer blinded, dose-escalation Phase 1 trial is expected to enroll around 100 healthy volunteers aged 18 to 55 years without current or history of symptomatic genital herpes infections in the US. (Court, 12/21), Stat: All rights reserved. Received chronic suppressive antiviral therapy for treatment of recurrent HSV-1 and/or HSV-2 genital herpes infections (i.e., oral acyclovir, oral valacyclovir, oral famciclovir, and/or intravenous ganciclovir) from 1 year prior to Visit 0 until completion of Visit 12. if (i!=(aTags.length-1)) Any existing condition which may affect vaccine injection and/or assessment of local reactions assessment at the injection site, e.g., tattoos, severe scars, etc. Our Standards:The Thomson Reuters Trust Principles. The trial (NCT05432583) will evaluate the safety, tolerability, and immunogenicity of BNT163. After completion of all IND-enabling studies, BNT163 is the first candidate from this collaboration to enter the clinic. 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