Serina Therapeutics to Present at the 4th LNP Formulation & Process Development Summit
Serina Therapeutics (NYSE: SER) announced that their Chief Development Officer, Dr. Randall Moreadith, will present groundbreaking data at the 4th LNP Formulation & Process Development Summit 2025 in Boston. The presentation, titled 'The PEG Dilemma – A Solution,' will take place on April 15, 2025, at 9:30 AM ET.
The presentation focuses on the company's innovative POZ-lipid technology, developed as an immune-silent alternative to PEG-lipids in mRNA vaccines and therapeutics. Key research findings show that Serina's POZ-lipid component in lipid nanoparticles (LNPs) demonstrated no IgM or IgG antibody response in rat studies with repeat dosing, unlike traditional PEG-lipid standards which triggered strong antibody responses.
This breakthrough is particularly significant as anti-PEG antibodies have been linked to anaphylaxis and serious adverse events in patients receiving PEGylated mRNA vaccines, including those from Pfizer and Moderna. The immune-silent nature of POZ-lipid technology could potentially revolutionize the development of safer LNP formulations for gene therapy and RNA-based medicines.
Serina Therapeutics (NYSE: SER) ha annunciato che il loro Chief Development Officer, il Dr. Randall Moreadith, presenterà dati rivoluzionari al 4° Summit sulla Formulazione e Sviluppo di Processi LNP 2025 a Boston. La presentazione, intitolata 'Il Dilemma del PEG – Una Soluzione,' si terrà il 15 aprile 2025 alle 9:30 ET.
La presentazione si concentra sulla tecnologia innovativa POZ-lipid sviluppata dall'azienda come alternativa immune-silente ai PEG-lipidi nei vaccini e nelle terapie a mRNA. I risultati chiave mostrano che il componente POZ-lipid di Serina nei nanoparticelle lipidiche (LNP) non ha generato risposta anticorpale IgM o IgG negli studi sui ratti con somministrazioni ripetute, a differenza degli standard tradizionali PEG-lipid che hanno invece provocato forti risposte anticorpali.
Questa scoperta è particolarmente importante poiché gli anticorpi anti-PEG sono stati associati ad anafilassi e gravi eventi avversi nei pazienti sottoposti a vaccini mRNA PEGilati, inclusi quelli di Pfizer e Moderna. La natura immune-silente della tecnologia POZ-lipid potrebbe rivoluzionare lo sviluppo di formulazioni LNP più sicure per la terapia genica e i farmaci a base di RNA.
Serina Therapeutics (NYSE: SER) anunció que su Chief Development Officer, el Dr. Randall Moreadith, presentará datos innovadores en la 4ª Cumbre de Formulación y Desarrollo de Procesos de LNP 2025 en Boston. La presentación, titulada 'El Dilema del PEG – Una Solución,' tendrá lugar el 15 de abril de 2025 a las 9:30 AM ET.
La presentación se centra en la innovadora tecnología POZ-lipid de la compañía, desarrollada como una alternativa inmune-silente a los PEG-lípidos en vacunas y terapias de ARNm. Los hallazgos clave muestran que el componente POZ-lipid de Serina en nanopartículas lipídicas (LNP) no generó respuesta de anticuerpos IgM o IgG en estudios con ratas con dosis repetidas, a diferencia de los estándares tradicionales de PEG-lípidos que desencadenaron fuertes respuestas de anticuerpos.
Este avance es especialmente significativo ya que los anticuerpos anti-PEG se han relacionado con anafilaxia y eventos adversos graves en pacientes que reciben vacunas de ARNm PEGiladas, incluidas las de Pfizer y Moderna. La naturaleza inmune-silente de la tecnología POZ-lipid podría revolucionar el desarrollo de formulaciones LNP más seguras para terapia génica y medicamentos basados en ARN.
Serina Therapeutics (NYSE: SER)는 최고개발책임자(Chief Development Officer)인 Dr. Randall Moreadith가 보스턴에서 열리는 제4회 LNP 제형 및 공정 개발 서밋 2025에서 획기적인 데이터를 발표할 예정이라고 발표했습니다. 'PEG 딜레마 – 해결책'이라는 제목의 발표는 2025년 4월 15일 오전 9시 30분(동부시간)에 진행됩니다.
이번 발표는 mRNA 백신 및 치료제에서 PEG-지질의 면역 반응을 억제하는 대안으로 개발된 회사의 혁신적인 POZ-지질 기술에 초점을 맞추고 있습니다. 주요 연구 결과에 따르면, Serina의 POZ-지질 성분이 포함된 지질 나노입자(LNP)는 쥐를 대상으로 한 반복 투여 연구에서 IgM 또는 IgG 항체 반응을 나타내지 않은 반면, 전통적인 PEG-지질은 강한 항체 반응을 유발했습니다.
이 획기적인 발견은 PEG 항체가 화이자 및 모더나의 PEG 처리 mRNA 백신을 접종받은 환자들에게서 아나필락시스 및 심각한 부작용과 연관되어 있다는 점에서 특히 중요합니다. POZ-지질 기술의 면역 무반응성은 유전자 치료 및 RNA 기반 의약품을 위한 더 안전한 LNP 제형 개발에 혁신을 가져올 수 있습니다.
Serina Therapeutics (NYSE : SER) a annoncé que leur Chief Development Officer, le Dr Randall Moreadith, présentera des données révolutionnaires lors du 4e Sommet sur la Formulation et le Développement des Processus LNP 2025 à Boston. La présentation, intitulée « Le Dilemme du PEG – Une Solution », aura lieu le 15 avril 2025 à 9h30 ET.
Cette présentation met en lumière la technologie innovante POZ-lipid de l'entreprise, développée comme une alternative immunologiquement silencieuse aux PEG-lipides dans les vaccins et traitements à ARN messager. Les résultats clés montrent que le composant POZ-lipid de Serina dans les nanoparticules lipidiques (LNP) n'a déclenché aucune réponse anticorps IgM ou IgG lors d'études sur des rats avec des doses répétées, contrairement aux standards PEG-lipides traditionnels qui ont provoqué de fortes réponses anticorps.
Cette avancée est particulièrement importante car les anticorps anti-PEG ont été liés à des réactions anaphylactiques et à des effets indésirables graves chez les patients recevant des vaccins ARNm PEGylés, notamment ceux de Pfizer et Moderna. La nature immunologiquement silencieuse de la technologie POZ-lipid pourrait révolutionner le développement de formulations LNP plus sûres pour la thérapie génique et les médicaments à base d'ARN.
Serina Therapeutics (NYSE: SER) gab bekannt, dass ihr Chief Development Officer, Dr. Randall Moreadith, bahnbrechende Daten auf dem 4. LNP Formulierungs- & Prozessentwicklungs-Gipfel 2025 in Boston präsentieren wird. Die Präsentation mit dem Titel 'Das PEG-Dilemma – Eine Lösung' findet am 15. April 2025 um 9:30 Uhr ET statt.
Die Präsentation konzentriert sich auf die innovative POZ-Lipid-Technologie des Unternehmens, die als immunstille Alternative zu PEG-Lipiden in mRNA-Impfstoffen und Therapeutika entwickelt wurde. Wichtige Forschungsergebnisse zeigen, dass die POZ-Lipid-Komponente von Serina in Lipid-Nanopartikeln (LNPs) bei Rattenstudien mit wiederholter Dosierung keine IgM- oder IgG-Antikörperreaktion hervorrief, im Gegensatz zu herkömmlichen PEG-Lipid-Standards, die starke Antikörperreaktionen auslösten.
Dieser Durchbruch ist besonders bedeutsam, da Anti-PEG-Antikörper mit Anaphylaxie und schweren Nebenwirkungen bei Patienten, die PEGylierte mRNA-Impfstoffe erhalten, darunter von Pfizer und Moderna, in Verbindung gebracht wurden. Die immunstille Natur der POZ-Lipid-Technologie könnte die Entwicklung sichererer LNP-Formulierungen für Gentherapie und RNA-basierte Medikamente revolutionieren.
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HUNTSVILLE, AL, April 15, 2025 (GLOBE NEWSWIRE) -- Serina Therapeutics, Inc. (“Serina”) (NYSE American: SER), a clinical-stage biotechnology company developing its proprietary POZ Platform™ drug optimization technology, announced that Randall Moreadith, M.D., Ph.D., Chief Development Officer, will present new data at the 4th LNP Formulation & Process Development Summit 2025 in Boston, MA. The presentation, titled "The PEG Dilemma – A Solution," will take place on Tuesday, April 15, at 9:30 AM ET. The session will focus on addressing challenges related to anti-PEG antibodies in mRNA vaccines and therapeutics and introduces Serina's POZ-lipid technology as an immune-silent alternative to PEG-lipids.
Dr. Moreadith will share data demonstrating that Serina’s POZ-lipid, a key component of lipid nanoparticles (LNPs), did not trigger an IgM or IgG antibody response following repeat dosing in rats in a vaccine format. In contrast, polyethylene glycol (PEG)-lipid standards, commonly used in current LNP formulations, elicited a strong and boosted antibody response.
Anti-PEG antibodies have been implicated as a potential cause of anaphylaxis and other serious adverse events observed in humans receiving PEGylated mRNA vaccines, such as those from Pfizer and Moderna. The absence of an immune response to Serina’s POZ-lipid represents a novel discovery that could enable the development of safer and more effective LNP formulations for gene therapy and RNA-based medicines.
About Serina Therapeutics
Serina is a clinical-stage biotechnology company developing a pipeline of wholly owned drug product candidates to treat neurological diseases and other indications. Serina’s POZ Platform™ provides the potential to improve the integrated efficacy and safety profile of multiple modalities including small molecules, RNA-based therapeutics and antibody-based drug conjugates (ADCs). Serina is headquartered in Huntsville, Alabama on the campus of the HudsonAlpha Institute of Biotechnology.
For more information, please visit https://serinatherapeutics.com.
Cautionary Statement Regarding Forward-Looking Statement
This release contains forward-looking statements within the meaning of federal securities laws. These statements are based on management’s current expectations, plans, beliefs or forecasts for the future, and are subject to uncertainty and changes in circumstances. Any express or implied statements in this press release that are not statements of historical fact, including statements about the potential of Serina’s POZ polymer technology, are forward-looking statements that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any applications may be filed for any drug or vaccine candidates in any jurisdictions; whether and when regulatory authorities may approve any potential applications that may be filed for any drug or vaccine candidates in any jurisdictions, which will depend on a myriad of factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether any such drug or vaccine candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of any drug or vaccine candidates; and competitive developments. These risks as well as other risks are more fully discussed in Serina’s Annual Report on Form 10-K, and Serina’s other periodic reports and documents filed from time to time with the SEC. The information contained in this release is as of the date hereof, and Serina assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
For inquiries, please contact:
Stefan Riley
sriley@serinatherapeutics.com
(256) 327-9630
FAQ
What breakthrough will Serina Therapeutics (SER) present at the LNP Summit 2025?
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