Clinical Proof-of-Concept Data for DNA-Encoded Monoclonal Antibodies (DMAbs) Published in Nature Medicine
INOVIO (NASDAQ: INO) announced that Phase 1 proof-of-concept DMAb data for COVID-19 were published in Nature Medicine on Oct 21, 2025.
Key findings: all 39 participants maintained biologically relevant DMAb levels through week 72, expressed antibodies bound SARS-CoV-2 Spike and neutralized pseudovirus, and no anti-drug antibodies were detected across ~1,000 blood samples. DMAbs were well tolerated; most adverse events were mild, temporary injection-site reactions and no SAEs were linked to the study drug. Investigators continue exploratory sample analyses.
INOVIO (NASDAQ: INO) ha annunciato che i dati del profilo concettuale di fase 1 DMAb per COVID-19 sono stati pubblicati su Nature Medicine il 21 ottobre 2025.
Scoperte chiave: tutti i 39 partecipanti hanno mantenuto livelli biologicamente rilevanti di DMAb fino alla settimana 72, hanno espresso anticorpi che legano la Spike di SARS-CoV-2 e neutralizzano un pseudovirus, e non sono stati rilevati anticorpi anti-farmaco in circa 1.000 campioni di sangue. I DMAb sono stati ben tollerati; la maggior parte degli eventi avversi è stata lieve, reazioni temporanee nel sito di iniezione e nessun SAE è stato collegato al farmaco in studio. Gli investigatori continuano con analisi campionarie esplorative.
INOVIO (NASDAQ: INO) anunció que los datos de fase 1 de prueba de concepto de DMAb para COVID-19 se publicaron en Nature Medicine el 21 de octubre de 2025.
Principales conclusiones: los 39 participantes mantuvieron niveles de DMAb biológicamente relevantes hasta la semana 72, expresaron anticuerpos que se unen a la espiga SARS-CoV-2 y neutralizan un pseudovirus, y no se detectaron anticuerpos anti-drogas en unas ~1.000 muestras de sangre. Los DMAb se toleraron bien; la mayoría de los eventos adversos fueron leves, reacciones temporales en el sitio de inyección y no se asociaron SAE con el fármaco en estudio. Los investigadores continúan con análisis exploratorios de muestras.
INOVIO (NASDAQ: INO)는 COVID-19에 대한 1상 파일럿 데이터의 DMAb를 Nature Medicine에 2025년 10월 21일 발표했다고 밝혔다.
주요 소견: 모든 39명의 참가자가 주 72까지 생물학적으로 관련된 DMAb 수준을 유지했고, SARS-CoV-2 스파이크에 결합하고 의사 바이러스를 중화하는 항체를 발현했으며, 약물에 대한 항약항체는 약 1,000개의 혈액 샘플에서 검출되지 않았다. DMAb는 잘 견뎌졌으며, 대부분의 이상 반응은 가볍고 주사부위의 일시적인 반응이었고 연구 약물과 관련된 중대한 문제(SAE)는 없었다. 연구자들은 샘플 분석을 탐색적으로 계속하고 있다.
INOVIO (NASDAQ: INO) a annoncé que les données de phase 1 de preuve de concept DMAb pour la COVID-19 ont été publiées dans Nature Medicine le 21 octobre 2025.
Principales conclusions : les 39 participants ont maintenu des niveaux de DMAb biologiquement pertinents jusqu'à la semaine 72, ont exprimé des anticorps qui se lient à la Spike du SARS-CoV-2 et neutralisent un pseudovirus, et aucun anticorps anti-médicament n'a été détecté sur environ ~1 000 échantillons sanguins. Les DMAb ont été bien tolérés; la plupart des événements indésirables étaient légers, des réactions temporaires au site d'injection et aucun SAE n'était lié au médicament à l'étude. Les Investigateurs poursuivent des analyses exploratoires des échantillons.
INOVIO (NASDAQ: INO) gab bekannt, dass die Phase-1-Proof-of-Concept-DMAb-Daten für COVID-19 in Nature Medicine am 21. Oktober 2025 veröffentlicht wurden.
Zentrale Ergebnisse: Alle 39 Teilnehmer behielten bis Woche 72 biologisch relevante DMAb-Spiegel bei, exprimierten Antikörper, die das SARS-CoV-2 Spike-Protein binden und Pseudovirus neutralisieren, und keine Anti-Drug-Antikörper wurden in ca. 1.000 Blutproben nachgewiesen. DMAbs wurden gut toleriert; die meisten unerwünschten Ereignisse waren mild, vorübergehende Reaktionen an der Injektionsstelle, und keine schweren unerwünschten Ereignisse standen in Zusammenhang mit dem Studienmedikament. Die Forscher setzen explorative Probenanalysen fort.
INOVIO (NASDAQ: INO) أعلنت أن بيانات المرحلة 1 لإثبات المفاهيم DMAb ل COVID-19 قد نُشرت في Nature Medicine في 21 أكتوبر 2025.
الاكتشافات الرئيسية: جميع المشاركين الـ 39 احتفظوا بمستويات DMAb ذات صلة بيولوجياً حتى الأسبوع 72، وأظهروا أجساماً مضادة مرتبطة بتاج SARS-CoV-2 وتحيّد فيروس وهمي، ولم تُكشف أجسام مضادة مضادة للدواء عبر نحو 1,000 عينة دم. تم تحمل DMAb بشكل جيد؛ كانت معظم حوادث الخلل خفيفة، وتجاوب موضعي مؤقت في موقع الحقن، ولم ترتبط أي حالات طارئة خطيرة بالعلاج الدوائي قيد الدراسة. يواصل الباحثون تحليل العينات الاستكشافية.
INOVIO (NASDAQ: INO) 宣布，针对 COVID-19 的第一阶段概念验证 DMAb 数据已于 Nature Medicine 于 2025 年 10 月 21 日发表。
关键发现：全部 39 名受试者在 第 72 周前维持了生物学相关的 DMAb 水平，表达的抗体能够结合 SARS-CoV-2 的刺突蛋白并中和假病毒，且未在约 1,000 份血样中检测到 抗药物抗体。DMAb 耐受性良好；大多数不良事件为轻度、注射部位的暂时性反应，与研究药物相关的严重不良事件（SAEs）均未发生。研究人员将继续进行样本的探索性分析。
- Durable expression: 39/39 participants maintained DMAb levels through week 72
- No ADA detected across ~1,000 blood samples
- Functional activity: expressed DMAbs bound Spike and neutralized pseudovirus in all tested participants
- Safety: no serious adverse events related to study drug reported
- Small trial size: Phase 1 with n=39 limits statistical generalizability
- Early-stage data: Phase 1 results require larger trials for clinical validation
- Ongoing analyses: exploratory sample work indicates additional data pending
Insights
Phase 1 data show durable, functional in vivo DMAb expression to
INOVIO and collaborators report that all trial participants (39/39) maintained biologically relevant DMAb levels through
The core business mechanism is direct in vivo expression of monoclonal antibodies via DNA delivery, demonstrated here as durable antibody production and confirmed functional activity. Key dependencies and risks remain limited to the facts provided: ongoing exploratory analyses by investigators and the role of collaborators The Wistar Institute, AstraZeneca, and the Perelman School of Medicine at the University of Pennsylvania. Concrete short‑term items to watch are the results of those exploratory analyses and any subsequent trial updates or partnership disclosures referenced after
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Publication includes complete data for all participants (n=39) up to week 72, further demonstrating durable and tolerable expression of DMAbs
- Effective target binding and confirmed functional activity through week 72
- No immune rejection of the DMAbs detected across ~1,000 blood samples
- Most common side effects were mild, temporary injection site reactions such as pain and redness; no serious adverse events (SAEs) related to study drug
"We believe the data from all participants, now published in a premiere scientific journal, demonstrates the breakthrough potential of DMAbs as a long-acting, scalable and tolerable alternative to traditional delivery of monoclonal antibodies," said INOVIO's Chief Scientific Officer, Laurent Humeau, Ph.D. "With promise in a broad range of diseases, we're excited to advance this novel technology with our current collaborators and through potential future partnerships."
In the trial, all participants (39/39) maintained biologically relevant levels of DMAbs through week 72 follow up, confirming the durability of in vivo antibody production, and the expressed DMAbs successfully bound to the SARS-CoV-2 Spike protein and neutralized the SARS-CoV-2 pseudovirus target in all tested participants, confirming functional activity. Notably, no participant developed anti-drug antibodies (ADA) across ~1,000 blood samples. ADA is a common challenge observed in other gene-based delivery platforms, such as adeno-associated virus (AAV) mediated antibody expression. Additionally, the DMAbs were well tolerated, with the most common side effects being mild, temporary injection site reactions, such as pain and redness. Investigators are continuing exploratory analysis of clinical samples for additional insights into the in vivo expression of DMAbs.
About the Phase 1 Trial
The Phase 1 trial reports using synthetic DNA technology to enable in vivo production of monoclonal antibodies (mAbs) directly from muscle cells. Participants received an intramuscular (IM) injection of synthetic DNA plasmids encoding AZD5396 and AZD8076 (derived from AstraZeneca's cilgavimab and tixagevimab) delivered via INOVIO's proprietary CELLECTRA 2000 electroporation (EP) device. This delivery method temporarily increases cell permeability, which is intended to facilitate efficient DNA uptake and enable sustained antibody production.
The study is an open-label, single center, dose-escalation trial. Enrollment began in May 2022 and was completed in March 2024. The primary endpoints were safety and pharmacokinetics. DMAbs were detected in
About INOVIO's DNA Medicines Platform
INOVIO's DNA medicines platform has two innovative components: precisely designed DNA plasmids, delivered by INOVIO's proprietary investigational medical device, CELLECTRA®. INOVIO uses proprietary technology to design its DNA plasmids, which are small circular DNA molecules that work like software that the body's cells can download to produce specific proteins to target and fight disease. INOVIO's proprietary CELLECTRA delivery devices are designed to optimally deliver its DNA medicines to the body's cells without requiring chemical adjuvants or lipid nanoparticles and without the risk of the anti-vector response historically seen with viral vector platforms.
About INOVIO
INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO's technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease-fighting tools. For more information, visit www.inovio.com.
Forward-Looking Statements
This press release contains certain forward-looking statements relating to INOVIO's business, including the potential benefits of INOVIO's DMAb technology platform. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials, product development programs and commercialization activities and outcomes, the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA medicines, our ability to support our pipeline of DNA medicine products, the ability of our collaborators to attain development and commercial milestones for products we license and product sales that will enable us to receive future payments and royalties, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by us or collaborators, including alternatives that may be more efficacious or cost effective than any therapy or treatment that we and our collaborators hope to develop, issues involving product liability, issues involving patents and whether they or licenses to them will provide us with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether we can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2024, our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, and other filings we make from time to time with the Securities and Exchange Commission. There can be no assurance that any product candidate in our pipeline will be successfully developed, manufactured, or commercialized, that the results of clinical trials will be supportive of regulatory approvals required to market products, or that any of the forward-looking information provided herein will be proven accurate. Forward-looking statements speak only as of the date of this release, and we undertake no obligation to update or revise these statements, except as may be required by law.
The views expressed in this press release reflect the views of the authors and do not necessarily reflect the position of the Department of the Army, Department of War, nor the United States Government. References to non-federal entities do not constitute or imply Department of War or Army endorsement of any company or organization.
This work was funded by the Defense Advanced Research Projects Agency and the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense's (JPEO-CBRND) Joint Project Lead for CBRND Enabling Biotechnologies (JPL CBRND EB) in collaboration with the Defense Health Agency (DHA). (Award HR0011-21-9-0001 to D.B.W.)
Penn and Dr. Weiner have either received, or may receive in the future, financial consideration related to the licensing of certain Penn intellectual property to INOVIO. Dr. Weiner is a member of the Scientific Advisory Board and Board of Directors for INOVIO.
Contacts
Media: Jennie Willson, (267) 429-8567, communications@inovio.com
Investors: Peter Vozzo - ICR Healthcare, (443) 213-0505, investor.relations@inovio.com
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SOURCE INOVIO Pharmaceuticals, Inc.
FAQ
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