IMUNON Announces New Immunogenicity Data from Phase 1 Clinical Trial of Its DNA Vaccine in Treatment of COVID-19
IMUNON (NASDAQ: IMNN) has announced new data from its Phase 1 clinical trial of IMNN-101, a DNA plasmid vaccine using their PlaCCine® technology platform. The trial, involving 24 healthy volunteers previously vaccinated against Omicron XBB1.5, demonstrated promising results as a seasonal COVID-19 vaccine.
Key findings include:
- A 2-4 fold increase in neutralizing antibody titers from baseline through Week 4
- Cross-reactivity against XBB1.5 and newer variants
- Safe and well-tolerated profile with no serious adverse effects
- Vaccine stability up to one year at 4°C and one month at 37°C
The vaccine's performance aligns with preclinical results showing over 95% protection in non-human primates, comparable to mRNA vaccines. The company is now seeking potential partners for further development, highlighting IMNN-101's potential as a next-generation vaccine alternative.
IMUNON (NASDAQ: IMNN) ha annunciato nuovi dati dal suo studio clinico di Fase 1 su IMNN-101, un vaccino a plasmide DNA che utilizza la loro piattaforma tecnologica PlaCCine®. Lo studio, che ha coinvolto 24 volontari sani precedentemente vaccinati contro Omicron XBB1.5, ha mostrato risultati promettenti come vaccino stagionale contro il COVID-19.
I risultati chiave includono:
- Aumento di 2-4 volte dei titoli di anticorpi neutralizzanti rispetto al valore iniziale fino alla settimana 4
- Reattività incrociata contro XBB1.5 e varianti più recenti
- Profilo sicuro e ben tollerato senza effetti avversi gravi
- Stabilità del vaccino fino a un anno a 4°C e un mese a 37°C
Le prestazioni del vaccino sono in linea con i risultati preclinici che mostrano oltre il 95% di protezione nei primati non umani, comparabile ai vaccini mRNA. L'azienda sta ora cercando potenziali partner per ulteriori sviluppi, evidenziando il potenziale di IMNN-101 come alternativa vaccinale di nuova generazione.
IMUNON (NASDAQ: IMNN) ha anunciado nuevos datos de su ensayo clínico de Fase 1 sobre IMNN-101, una vacuna de plásmido de ADN que utiliza su plataforma tecnológica PlaCCine®. El ensayo, que involucró a 24 voluntarios sanos previamente vacunados contra Omicron XBB1.5, demostró resultados prometedores como vacuna estacional contra el COVID-19.
Los hallazgos clave incluyen:
- Aumento de 2-4 veces en los títulos de anticuerpos neutralizantes desde la línea base hasta la semana 4
- Reactividad cruzada contra XBB1.5 y variantes más nuevas
- Perfil seguro y bien tolerado sin efectos adversos graves
- Estabilidad de la vacuna hasta un año a 4°C y un mes a 37°C
El rendimiento de la vacuna está en línea con los resultados preclínicos que muestran más del 95% de protección en primates no humanos, comparable a las vacunas de ARNm. La empresa ahora busca socios potenciales para un desarrollo adicional, destacando el potencial de IMNN-101 como una alternativa de vacuna de nueva generación.
IMUNON (NASDAQ: IMNN)은 IMNN-101에 대한 1상 임상 시험의 새로운 데이터를 발표했습니다. IMNN-101은 그들의 PlaCCine® 기술 플랫폼을 사용하는 DNA 플라스미드 백신입니다. 이 시험은 Omicron XBB1.5에 대해 이전에 백신을 접종받은 24명의 건강한 자원자를 대상으로 진행되었으며, 계절성 COVID-19 백신으로서 유망한 결과를 보여주었습니다.
주요 발견 사항은 다음과 같습니다:
- 기준선 대비 4주차까지 중화항체 수치가 2-4배 증가
- XBB1.5 및 최신 변종에 대한 교차 반응성
- 심각한 부작용 없이 안전하고 잘 견딜 수 있는 프로필
- 4°C에서 최대 1년, 37°C에서 1개월까지 백신 안정성
백신의 성능은 비인간 영장류에서 95% 이상의 보호를 보여주는 전임상 결과와 일치하며, mRNA 백신과 비교할 수 있습니다. 회사는 이제 IMNN-101의 차세대 백신 대안으로서의 잠재력을 강조하며 추가 개발을 위한 잠재적 파트너를 찾고 있습니다.
IMUNON (NASDAQ: IMNN) a annoncé de nouvelles données provenant de son essai clinique de Phase 1 sur IMNN-101, un vaccin à plasmide ADN utilisant leur plateforme technologique PlaCCine®. L'essai, impliquant 24 volontaires en bonne santé précédemment vaccinés contre Omicron XBB1.5, a montré des résultats prometteurs en tant que vaccin saisonnier contre le COVID-19.
Les résultats clés incluent:
- Une augmentation de 2 à 4 fois des titres d'anticorps neutralisants par rapport à la ligne de base jusqu'à la semaine 4
- Réactivité croisée contre XBB1.5 et de nouvelles variantes
- Profil sûr et bien toléré sans effets indésirables graves
- Stabilité du vaccin jusqu'à un an à 4°C et un mois à 37°C
La performance du vaccin est en accord avec les résultats précliniques montrant plus de 95% de protection chez les primates non humains, comparable aux vaccins à ARNm. L'entreprise recherche maintenant des partenaires potentiels pour un développement supplémentaire, soulignant le potentiel d'IMNN-101 en tant qu'alternative vaccinale de nouvelle génération.
IMUNON (NASDAQ: IMNN) hat neue Daten aus seiner Phase-1-Studie zu IMNN-101, einem DNA-Plasmid-Impfstoff, der die PlaCCine®-Technologieplattform nutzt, bekannt gegeben. Die Studie, an der 24 gesunde Freiwillige teilnahmen, die zuvor gegen Omicron XBB1.5 geimpft wurden, zeigte vielversprechende Ergebnisse als saisonaler COVID-19-Impfstoff.
Wichtige Ergebnisse umfassen:
- Eine 2-4-fache Erhöhung der neutralisierenden Antikörperwerte vom Ausgangswert bis zur Woche 4
- Kreuzreaktivität gegen XBB1.5 und neuere Varianten
- Sicheres und gut verträgliches Profil ohne schwerwiegende Nebenwirkungen
- Stabilität des Impfstoffs bis zu einem Jahr bei 4°C und einem Monat bei 37°C
Die Leistung des Impfstoffs steht im Einklang mit präklinischen Ergebnissen, die über 95% Schutz bei nicht-menschlichen Primaten zeigen, vergleichbar mit mRNA-Impfstoffen. Das Unternehmen sucht nun potenzielle Partner für die weitere Entwicklung und hebt das Potenzial von IMNN-101 als Impfstoffalternative der nächsten Generation hervor.
- 2-4x increase in neutralizing antibody titers
- Cross-reactivity against multiple variants
- 95% protection in preclinical studies
- Superior stability compared to mRNA vaccines
- Clean safety profile with no serious adverse effects
- Only modest increases in T cell responses
- Single-dose study without booster evaluation
- Small trial size of 24 participants
- Requires partnership for further development
Insights
IMUNON's Phase 1 data for IMNN-101 represents a meaningful advancement in DNA-based vaccine technology, showing both safety and immunogenicity in humans. The 2-4 fold increase in neutralizing antibodies through Week 4 is significant as these antibodies directly prevent viral entry into cells, effectively blocking infection. Importantly, these antibodies demonstrated cross-reactivity against variants beyond the target XBB1.5 strain, suggesting broader protection against evolving SARS-CoV-2 mutations.
The PlaCCine platform's temperature stability (one year at 4°C, one month at 37°C) addresses a critical limitation of current mRNA vaccines, which require ultra-cold storage. This characteristic could substantially reduce distribution costs and expand access in regions with cold-chain infrastructure, potentially opening markets inaccessible to mRNA platforms.
While T-cell responses were modest, this is likely attributable to the trial population's prior COVID-19 exposures rather than a limitation of the technology. The non-human primate data showing >95% protection supports the platform's potential efficacy.
For IMUNON as a
The data provides proof-of-concept validation that could attract strategic partners interested in next-generation vaccine technology with improved stability characteristics. However, investors should recognize that partnership negotiations can be protracted, and the company will face competition from established players with alternative non-mRNA platforms also addressing cold-chain limitations.
Results of IMNN-101 Proof-of-Concept study demonstrate persistent immunogenicity in trial participants and further validate PlaCCine® technology
IMNN-101 induced 2- to 4-fold increase in neutralizing antibody (NAb) titers from baseline through Week 4
IMNN-101 continues to show an acceptable safety profile
LAWRENCEVILLE, N.J., Feb. 26, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company focused on developing non-viral DNA-mediated immunotherapy and evaluating an adaptation of the platform’s potential as a next-generation vaccine, today announced new safety and immunogenicity data from ongoing analyses of results from the Company’s first Phase 1 proof-of-concept clinical trial of IMNN-101, its investigational DNA plasmid vaccine based on the Company’s proprietary PlaCCine® technology platform. The Phase 1 study was conducted in 24 healthy volunteers as a seasonal COVID-19 vaccine, targeting the SARS-CoV-2 Omicron XBB1.5 spike antigen. IMNN-101 was administered as a single dose vaccine without a booster dose in study participants who were previously vaccinated against the Omicron XBB1.5 variant. Results demonstrated that IMNN-101 is safe and well-tolerated with no serious adverse effects. IMNN-101 induced a persistent 2- to 4-fold increase in serum neutralizing antibody (NAb) titers from baseline through Week 4, further increasing NAb titers between Week 2 and Week 4. The immune response was observed against the XBB1.5 variant and many newer variants following treatment, demonstrating the IMNN-101 vaccine’s cross-reactivity.
“We have strong evidence of vaccine immunogenicity based on the neutralizing antibody response against the Omicron XBB.1.5 strain in this trial, and expect partnering interest in our proof-of-concept data from the PlaCCine platform,” said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. “These data demonstrate that our first-in-human vaccine based on our PlaCCine platform is safe and immunogenic and is well-suited to developing vaccine candidates for protecting the population against a potential future exposure to a pathogen or controlling a rising pathogen. Given proof of immunogenicity, early indications of durability of protection, and competitive advantages in the stability of our vaccine at workable temperatures compared with available mRNA vaccines, we believe that IMNN-101 has significant potential as a superior next-generation vaccine and will seek potential partners for further development.”
The participants in the Phase 1 trial had high baseline immune characteristics presumably from prior infection and multiple previous vaccinations against COVID-19 and ongoing infection as evidenced by the rise in viral nucleocapsid antigen during the study period. Modest increases in T cell responses were observed in this setting of trial participants having received multiple immunizations prior to the study.
“Data from this trial is of high quality and show that IMUNON’s DNA vaccine is immunogenic in humans. Following immunization, participants’ NAb titers increased through Week 4 with a 2- to 4-fold increase from baseline, a clear and convincing response to the vaccination,” said Ai-ris Collier, M.D., Co-Director of the Clinical Trials Unit, Center for Virology and Vaccine Research Center, Beth Israel Deaconess Medical Center.
The Phase 1 clinical data of IMNN-101 is consistent with strong evidence of immunogenicity and protection for the PlaCCine platform in rodents and non-human primates, with prior preclinical results showing that protection exceeded
About PlaCCine® and IMNN-101
IMNN-101 utilizes the company’s PlaCCine® technology platform, a proprietary composition of a DNA plasmid that regulates the expression of key pathogen antigens and a novel synthetic DNA delivery system. The plasmid-based expression vector accommodates single or multiple antigens through its flexible vector design, offers manufacturing flexibility compared to with viral or other DNA or protein vaccines, and the synthetic delivery system protects DNA from degradation and facilitates DNA uptake after injection with acceptable safety.
About the Phase 1 PoC Clinical Trial
This U.S. Phase 1 proof-of-concept (PoC) study inoculated 24 participants to evaluate three escalating doses of IMNN-101 with eight participants at each dose. All participants were treated at DM Clinical Research in Philadelphia. For this study, IMNN-101 has been designed to protect against the SARS-CoV-2 Omicron XBB1.5 variant, in accordance with the FDA’s Vaccines and Related Biological Products Advisory Committee’s June 2023 announcement of the framework for updated COVID-19 doses. The primary objectives of the study are to evaluate safety and tolerability in healthy adults. Secondary objectives include evaluating IMNN-101’s ability to elicit neutralizing antibody responses, cellular responses and their associated durability.
About IMUNON
IMUNON is a clinical-stage biotechnology company focused on advancing a portfolio of innovative treatments that harness the body’s natural mechanisms to generate safe, effective and durable responses across a broad array of human diseases, constituting a differentiating approach from conventional therapies. IMUNON is developing its non-viral DNA technology across its modalities. The first modality, TheraPlas®, is developed for the coding of cytokines and other therapeutic proteins in the treatment of solid tumors where an immunological approach is deemed promising. The second modality, PlaCCine®, is developed for the delivery of DNA-coded viral antigens that can elicit a strong immunological response. This technology may represent a promising platform for the development of vaccines in infectious diseases.
The Company’s lead clinical program, IMNN-001, is a DNA-based immunotherapy for the localized treatment of advanced ovarian cancer currently in Phase 2 development. IMNN-001 works by instructing the body to produce safe and durable levels of powerful cancer-fighting molecules, such as interleukin-12 and interferon gamma, at the tumor site. Additionally, the Company has entered a first-in-human study of its COVID-19 booster vaccine (IMNN-101). We will continue to leverage these modalities and to advance the technological frontier of plasmid DNA to better serve patients with difficult-to-treat conditions. For more information on IMUNON, visit www.imunon.com.
Forward-Looking Statements
IMUNON wishes to inform readers that forward-looking statements in this news release are made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, but not limited to, statements regarding the timing for commencement and potential outcome of a Phase 3 trial of IMNN-001, the timing and enrollment of the Company’s clinical trials, the potential of any therapies developed by the Company to fulfill unmet medical needs, the market potential for the Company’s products, if approved, the potential efficacy and safety profile of our product candidates, the potential partnering opportunities, and the Company’s plans and expectations with respect to its development programs more generally, are forward-looking statements. We generally identify forward-looking statements by using words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances). Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, uncertainties relating to unforeseen changes in the course of research and development activities and in clinical trials, including the fact that interim results are not necessarily indicative of final results; the uncertainties of and difficulties in analyzing interim clinical data; the significant expense, time and risk of failure of conducting clinical trials; the need for IMUNON to evaluate its future development plans; possible actions by customers, suppliers, competitors or regulatory authorities; and other risks detailed from time to time in IMUNON’s filings with the Securities and Exchange Commission. IMUNON assumes no obligation, except to the extent required by law, to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.
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