---
title: "RNA-LNP delivery of potent bNAb 1-18-LS achieves durable HIV-1 viremia suppression"
id: "biorxiv-22-durable-suppression-of-viremia-by-lipid-nanoparticle-formulated-rna-encoding"
canonical_url: "https://medichelpline.com/clinical-feed/biorxiv-22-durable-suppression-of-viremia-by-lipid-nanoparticle-formulated-rna-encoding"
content_type: "clinical_feed_article"
specialty: "Infectious Disease"
source_name: "bioRxiv (Biomedical Preprints)"
source_url: "https://www.biorxiv.org/content/10.64898/2026.09.17.752120v1?rss=1"
published_at: "2026-09-19T12:00:00.000Z"
evidence_level: "Verified Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# RNA-LNP delivery of potent bNAb 1-18-LS achieves durable HIV-1 viremia suppression
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/biorxiv-22-durable-suppression-of-viremia-by-lipid-nanoparticle-formulated-rna-encoding
- **Specialty:** [Infectious Disease](https://medichelpline.com/clinical-feed/infectious-disease.md)
- **Primary Source:** bioRxiv (Biomedical Preprints)
- **Source URL:** [Original Journal Publication](https://www.biorxiv.org/content/10.64898/2026.09.17.752120v1?rss=1)
- **Published At:** 2026-09-19T12:00:00.000Z
- **Evidence Rating:** Verified Feed
## Executive GIST (TL;DR)
- Researchers encoded the potent broadly neutralizing antibody **1-18-LS** as RNA (termed **1-18-LS RibobNAb**) and delivered it using **lipid nanoparticles (LNPs)** to test an alternative to recombinant antibody manufacturing. - Intravenous administration of a 30 µg RNA-LNP dose produced high in vivo expression, with an average peak serum concentration of 1,061 µg/mL measured in human neonatal Fc receptor-transgenic mice. - Weekly 30 µg RNA-LNP dosing maintained higher trough antibody levels than much larger (500 µg) protein injections, indicating sustained expression from the RNA-LNP platform. - In viremic humanized mice infected with HIV-1 YU2, monotherapy with 1-18-LS RNA-LNP resulted in durable suppression of HIV-1 viremia without detection of viral escape in the reported experiments. - In additional humanized-mouse experiments, 1-18-LS RNA-LNP fully controlled infection after antiretroviral therapy (ART) interruption in mice infected with diverse patient-derived polyclonal HIV-1 isolates, demonstrating activity across multiple viral isolates. - The study provides proof-of-principle that **RNA-mediated bNAb immunotherapy** can achieve effective in vivo antibody expression and durable antiviral activity, potentially addressing manufacturing challenges associated with recombinant bNAbs. - Competing interests were declared: multiple authors are BioNTech employees or inventors on related patents; some authors have financial relationships with institutions and companies. Funding sources included the Deutsche Forschungsgemeinschaft, Else Kröner-Fresenius-Stiftung, the German Center for Infection Research, and BioNTech. - The report is a preprint posted on bioRxiv; the publication status beyond the preprint and additional methodological or long-term safety data were not reported in the source.
## Clinical Analysis & Structured Key Points
Durable suppression of viremia by lipid nanoparticle-formulated RNA encoding for a highly potent HIV-1 neutralizing antibody | bioRxiv Skip to main content New Results Durable suppression of viremia by lipid nanoparticle-formulated RNA encoding for a highly potent HIV-1 neutralizing antibody Sophie Sayettat , Felix Tolksdorf , Robin Johannson , Johannes Nelke , Alexandra Malz , Leyla Fischer , Imke Gerhard , Nathalie Ullrich , Ursula Ellinghaus , Christiane R. Stadler , Jan P. Bogen , Candice Morin , Jacqueline Knüfer , Ricarda Stumpf , Philipp Schommers , Uğur Şahin , Michael S. Seaman , Sven Kratochvil , Florian Klein , View ORCID Profile Valentin Le Douce , View ORCID Profile Henning Gruell doi: https://doi.org/10.64898/2026.09.17.752120 Sophie Sayettat 1 University Hospital Cologne; Find this author on Google Scholar Find this author on PubMed Search for this author on this site Felix Tolksdorf 2 BioNTech SE; Find this author on Google Scholar Find this author on PubMed Search for this author on this site Robin Johannson 2 BioNTech SE; Find this author on Google Scholar Find this author on PubMed Search for this author on this site Johannes Nelke 2 BioNTech SE; Find this author on Google Scholar Find this author on PubMed Search for this author on this site Alexandra Malz 2 BioNTech SE; Find this author on Google Scholar Find this author on PubMed Search for this author on this site Leyla Fischer 2 BioNTech SE; Find this author on Google Scholar Find this author on PubMed Search for this author on this site Imke Gerhard 2 BioNTech SE; Find this author on Google Scholar Find this author on PubMed Search for this author on this site Nathalie Ullrich 2 BioNTech SE; Find this author on Google Scholar Find this author on PubMed Search for this author on this site Ursula Ellinghaus 2 BioNTech SE; Find this author on Google Scholar Find this author on PubMed Search for this author on this site Christiane R. Stadler 2 BioNTech SE; Find this author on Google Scholar Find this author on PubMed Search for this author on this site Jan P. Bogen 2 BioNTech SE; Find this author on Google Scholar Find this author on PubMed Search for this author on this site Candice Morin 2 BioNTech SE; Find this author on Google Scholar Find this author on PubMed Search for this author on this site Jacqueline Knüfer 1 University Hospital Cologne; Find this author on Google Scholar Find this author on PubMed Search for this author on this site Ricarda Stumpf 1 University Hospital Cologne; Find this author on Google Scholar Find this author on PubMed Search for this author on this site Philipp Schommers 1 University Hospital Cologne; Find this author on Google Scholar Find this author on PubMed Search for this author on this site Uğur Şahin 2 BioNTech SE; Find this author on Google Scholar Find this author on PubMed Search for this author on this site Michael S. Seaman 3 Beth Israel Deaconess Medical Center Find this author on Google Scholar Find this author on PubMed Search for this author on this site Sven Kratochvil 2 BioNTech SE; Find this author on Google Scholar Find this author on PubMed Search for this author on this site Florian Klein 1 University Hospital Cologne; Find this author on Google Scholar Find this author on PubMed Search for this author on this site Valentin Le Douce 2 BioNTech SE; Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Valentin Le Douce Henning Gruell 1 University Hospital Cologne; Find this author on Google Scholar Find this author on PubMed Search for this author on this site ORCID record for Henning Gruell For correspondence: henning.gruell{at}uk-koeln.de Abstract Info/History Metrics Supplementary material Preview PDF Abstract Recombinant broadly neutralizing antibodies (bNAbs) are promising tools to treat and prevent HIV-1 infection but are associated with manufacturing challenges. To overcome this limitation, we encoded the potent bNAb 1-18-LS on RNA (1-18-LS RibobNAb) for delivery via lipid nanoparticles (LNPs). Indicating high in vivo antibody expression, a 30 ug RNA-LNP intravenous injection resulted in an average peak 1-18-LS RibobNAb serum concentration of 1,061 ug/mL in human neonatal Fc receptor-transgenic mice. Notably, weekly 30 ug RNA-LNP doses maintained higher trough bNAb levels than 500 ug protein injections. Highlighting potent antiviral activity, RNA-LNP-mediated 1-18-LS RibobNAb monotherapy of viremic HIV-1 YU2 -infected humanized mice resulted in durable HIV-1 suppression without emerging viral escape. Importantly, 1-18-LS RNA-LNP treatment also fully controlled infection after interruption of antiretroviral therapy in humanized mice infected with different patient-derived polyclonal HIV-1 isolates. Our findings provide a proof-of-principle for effective RNA-mediated bNAb immunotherapy of HIV-1 infection. Competing Interest Statement F.T., R.J., J.N., A.M., L.F., I.G., N.U., U.E., C.R.S., J.P.B., C.M., S.K., and V.L.D. are employees of BioNTech and may hold stock options. U.Ş. is a management board member and stock owner of BioNTech SE. F.T., J.N., S.K., and V.L.D. are inventors on patents related to RNA-encoded anti-HIV antibodies. S.K. and V.L.D. are inventors on a patent application related to the HIV-1 neutralizing antibody BNT351. U.Ş. and V.L.D. are inventors on a patent related to an RNA vaccine against HIV. P.S., F.K., and H.G. are inventors on patent applications on virus neutralizing antibodies, including on the HIV-1 neutralizing antibody 1-18, and have received compensation from the University of Cologne for licensed patents. F.K. and H.G. hold options in Togontech GmbH. H.G. has received consulting fees from GSK. Funder Information Declared Deutsche Forschungsgemeinschaft, https://ror.org/018mejw64 , Emmy Noether Program - 495793173 Else Kröner-Fresenius-Stiftung, https://ror.org/03zcxha54 German Center for Infection Research BioNTech (Germany), https://ror.org/04fbd2g40 Copyright The copyright holder for this preprint is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . Back to top Previous Next Posted September 19, 2026. Download PDF Supplementary Material Email Thank you for your interest in spreading the word about bioRxiv. NOTE: Your email address is requested solely to identify you as the sender of this article. Your Email * Your Name * Send To * Enter multiple addresses on separate lines or separate them with commas. You are going to email the following Durable suppression of viremia by lipid nanoparticle-formulated RNA encoding for a highly potent HIV-1 neutralizing antibody Message Subject (Your Name) has forwarded a page to you from bioRxiv Message Body (Your Name) thought you would like to see this page from the bioRxiv website. Your Personal Message CAPTCHA This question is for testing whether or not you are a human visitor and to prevent automated spam submissions. Share Durable suppression of viremia by lipid nanoparticle-formulated RNA encoding for a highly potent HIV-1 neutralizing antibody Sophie Sayettat , Felix Tolksdorf , Robin Johannson , Johannes Nelke , Alexandra Malz , Leyla Fischer , Imke Gerhard , Nathalie Ullrich , Ursula Ellinghaus , Christiane R. Stadler , Jan P. Bogen , Candice Morin , Jacqueline Knüfer , Ricarda Stumpf , Philipp Schommers , Uğur Şahin , Michael S. Seaman , Sven Kratochvil , Florian Klein , Valentin Le Douce , Henning Gruell bioRxiv 2026.09.17.752120; doi: https://doi.org/10.64898/2026.09.17.752120 Share This Article: Copy Citation Tools Durable suppression of viremia by lipid nanoparticle-formulated RNA encoding for a highly potent HIV-1 neutralizing antibody Sophie Sayettat , Felix Tolksdorf , Robin Johannson , Johannes Nelke , Alexandra Malz , Leyla Fischer , Imke Gerhard , Nathalie Ullrich , Ursula Ellinghaus , Christiane R. Stadler , Jan P. Bogen , Candice Morin , Jacqueline Knüfer , Ricarda Stumpf , Philipp Schommers , Uğur Şahin , Michael S. Seaman , Sven Kratochvil , Florian Klein , Valentin Le Douce , Henning Gruell bioRxiv 2026.09.17.752120; doi: https://doi.org/10.64898/2026.09.17.752120 Citation Manager Formats BibTeX Bookends EasyBib EndNote (tagged) EndNote 8 (xml) Medlars Mendeley Papers RefWorks Tagged Ref Manager RIS Zotero Tweet Widget Facebook Like Google Plus One Subject Areas All Articles Animal Behavior and Cognition (8013) Biochemistry (18737) Bioengineering (14888) Bioinformatics (44415) Biophysics (22597) Cancer Biology (19722) Cell Biology (26899) Clinical Trials (138) Developmental Biology (13964) Ecology (21005) Epidemiology (2067) Evolutionary Biology (25454) Genetics (16165) Genomics (23505) Immunology (18703) Microbiology (42483) Molecular Biology (18058) Neuroscience (93440) Paleontology (700) Pathology (2977) Pharmacology and Toxicology (5094) Physiology (8114) Plant Biology (15999) Scientific Communication and Education (2095) Synthetic Biology (4560) Systems Biology (10235) Zoology (2391)
## Related Clinical Research

- [COVID-19 mortality among people with HIV in Florida before and after COVID-19 vaccine availability](https://medichelpline.com/clinical-feed/plos-one-13-covid-19-mortality-risk-among-people-with-hiv-in-florida-before-and-after-the.md)
- [Understanding Parasitic Identification in Delusional Parasitosis](https://medichelpline.com/clinical-feed/plos-one-21-bridging-perception-and-reality-parasitic-identification-in-delusional.md)
- [Member States advance negotiations on pathogen access and benefit-sharing ahead of UN General Asse](https://medichelpline.com/clinical-feed/who-0-1-member-states-advance-negotiations-on-pathogen-access-and-benefit-sharing-ahead.md)
- [WHO launches new primary health care course to strengthen health systems globally](https://medichelpline.com/clinical-feed/who-0-0-who-launches-new-primary-health-care-course-to-strengthen-health-systems.md)
- [Multidrug-Resistant Organisms in Combat Injuries: Evidence from Iraq, Afghanistan, and Ukraine](https://medichelpline.com/clinical-feed/pubmed-42763423.md) (DOI: 10.1093/milmed/usag428)

## Navigation
- [← Back to Infectious Disease Feed](https://medichelpline.com/clinical-feed/infectious-disease.md)
- [← All Clinical Specialties](https://medichelpline.com/clinical-feed.md)
## Medical & Regulatory Disclaimer

> [!CAUTION]
> MedicHelpline content is structured for research, educational, and professional discovery purposes. It does not constitute individual medical advice, clinical diagnosis, or treatment recommendations.
> Always verify dosing, contraindications, and regulatory alerts against official product labeling and primary regulatory sources before clinical decision-making.