AIM announces Paul Goepfert, MD, as the principal investigator for the planned clinical study of Ampligen and FluMist as a vaccine for avian influenza
AIM ImmunoTech has announced that Dr. Paul Goepfert from the University of Alabama-Birmingham will lead a planned clinical study combining Ampligen and AstraZeneca's FluMist as an intranasal vaccine for influenza, including avian influenza. This follows a previous UAB trial where Ampligen, used as a vaccine adjuvant, increased immune response to seasonal variants by over 4-fold and induced cross-reactive protection against highly pathogenic avian influenza strains H5N1, H7N9, and H7N3.
The company has engaged Amarex Clinical Research to prepare an Investigational New Drug application and manage the clinical study. AIM is seeking industry or governmental grants for study funding, with CEO Thomas K. Equels highlighting the potential cost-effectiveness of this approach at approximately $10 million in development costs compared to potentially billions for new mRNA vaccine development.
AIM ImmunoTech ha annunciato che il Dr. Paul Goepfert dell'Università dell'Alabama-Birmingham guiderà uno studio clinico pianificato che combina Ampligen e FluMist di AstraZeneca come vaccino intranasale per l'influenza, compresa l'influenza aviaria. Questo segue un precedente studio della UAB in cui l'Ampligen, utilizzato come adiuvante vaccinale, ha aumentato la risposta immunitaria alle varianti stagionali di oltre 4 volte e ha indotto una protezione cross-reattiva contro ceppi altamente patogeni di influenza aviaria H5N1, H7N9 e H7N3.
L'azienda ha ingaggiato Amarex Clinical Research per preparare una domanda di Nuovo Farmaco Investigativo e gestire lo studio clinico. AIM sta cercando finanziamenti da industrie o enti governativi per finanziare lo studio, con il CEO Thomas K. Equels che sottolinea il potenziale costo-efficacia di questo approccio, con costi di sviluppo di circa 10 milioni di dollari rispetto a potenzialmente miliardi per lo sviluppo di nuovi vaccini mRNA.
AIM ImmunoTech ha anunciado que el Dr. Paul Goepfert de la Universidad de Alabama-Birmingham liderará un estudio clínico planificado que combina Ampligen y FluMist de AstraZeneca como una vacuna intranasal para la influenza, incluida la influenza aviar. Esto sigue a un ensayo previo de UAB donde el Ampligen, utilizado como adyuvante de vacuna, incrementó la respuesta inmune a variantes estacionales en más de 4 veces e indujo protección cruzada contra cepas altamente patógenas de influenza aviar H5N1, H7N9 y H7N3.
La empresa ha contratado a Amarex Clinical Research para preparar una solicitud de Nuevo Medicamento en Investigación y gestionar el estudio clínico. AIM está buscando subvenciones de la industria o del gobierno para financiar el estudio, con el CEO Thomas K. Equels destacando el potencial costo-efectividad de este enfoque, con costos de desarrollo de aproximadamente 10 millones de dólares en comparación con potencialmente miles de millones para el desarrollo de nuevas vacunas de ARNm.
AIM ImmunoTech는 앨라배마 대학교 버밍햄 캠퍼스의 Paul Goepfert 박사가 Ampligen과 아스트라제네카의 FluMist를 결합한 임상 연구를 주도할 것이라고 발표했습니다. 이는 조류 인플루엔자를 포함한 인플루엔자에 대한 비강 투여 백신입니다. 이 연구는 UAB의 이전 시험에 이어지는 것으로, 그 시험에서는 백신 보조제로 사용된 Ampligen이 계절성 변종에 대한 면역 반응을 4배 이상 증가시켰고, H5N1, H7N9, H7N3와 같은 고병원성 조류 인플루엔자 균주에 대한 교차 반응성 보호를 유도했습니다.
회사는 임상 연구를 관리하고 조사 신약 신청서를 준비하기 위해 Amarex Clinical Research를 고용했습니다. AIM은 연구 자금을 위해 산업 또는 정부 보조금을 찾고 있으며, CEO Thomas K. Equels는 이 접근 방식의 잠재적인 비용 효율성을 강조하고 있습니다. 개발 비용이 약 1천만 달러인 반면, 새로운 mRNA 백신 개발에는 수십억 달러가 소요될 수 있습니다.
AIM ImmunoTech a annoncé que le Dr. Paul Goepfert de l'Université de l'Alabama-Birmingham dirigera une étude clinique prévue combinant Ampligen et FluMist d'AstraZeneca en tant que vaccin intranasal contre la grippe, y compris la grippe aviaire. Cela fait suite à un précédent essai de l'UAB où l'Ampligen, utilisé comme adjuvant vaccinal, a augmenté la réponse immunitaire aux variants saisonniers de plus de 4 fois et a induit une protection croisée contre des souches hautement pathogènes de grippe aviaire H5N1, H7N9 et H7N3.
L'entreprise a engagé Amarex Clinical Research pour préparer une demande de médicament nouveau en recherche et gérer l'étude clinique. AIM recherche des subventions de l'industrie ou du gouvernement pour financer l'étude, le PDG Thomas K. Equels soulignant le potentiel de rentabilité de cette approche, avec des coûts de développement d'environ 10 millions de dollars par rapport à potentiellement des milliards pour le développement de nouveaux vaccins à ARNm.
AIM ImmunoTech hat angekündigt, dass Dr. Paul Goepfert von der Universität Alabama-Birmingham eine geplante klinische Studie leiten wird, die Ampligen und FluMist von AstraZeneca als intranasalen Impfstoff gegen Influenza, einschließlich der Vogelgrippe, kombiniert. Dies folgt auf eine frühere UAB-Studie, in der Ampligen, das als Impfstoffadjuvans verwendet wurde, die Immunantwort auf saisonale Varianten um mehr als das 4-Fache erhöhte und einen kreuzreaktiven Schutz gegen hochpathogene Vogelgrippe-Stämme H5N1, H7N9 und H7N3 induzierte.
Das Unternehmen hat Amarex Clinical Research beauftragt, einen Antrag auf ein neues Prüfmedikament vorzubereiten und die klinische Studie zu leiten. AIM sucht nach Fördermitteln aus der Industrie oder von Regierungsstellen zur Finanzierung der Studie, wobei CEO Thomas K. Equels die potenzielle Kosten-Effektivität dieses Ansatzes hervorhebt, mit Entwicklungskosten von etwa 10 Millionen Dollar im Vergleich zu potenziell Milliarden für die Entwicklung neuer mRNA-Impfstoffe.
- Previous trial showed 4x increase in immune response
- Cross-reactive protection against multiple avian flu strains
- Lower development costs ($10M) compared to mRNA vaccines
- Existing positive human and non-human primate data
- Funding not yet secured for the clinical study
- Requires government or industry grant approval
- Timeline for study initiation uncertain
Insights
AIM ImmunoTech's announcement about Dr. Paul Goepfert leading a planned clinical study for Ampligen as a vaccine adjuvant represents a notable advancement in their influenza vaccine development program. The study builds on promising previous clinical results where Ampligen, when combined with FluMist, showed a four-fold increase in immune response against seasonal variants and induced cross-reactive protection against highly pathogenic avian influenza strains.
The company has taken concrete steps by engaging Amarex Clinical Research to prepare an Investigational New Drug application, though funding remains unsecured. Management's strategy positions their approach as significantly more cost-effective than mRNA vaccine development, citing potential development costs of under
This development matters because avian influenza preparedness has become a government priority, potentially opening funding pathways. AIM's strategic messaging emphasizes both speed and cost advantages, referencing existing human and non-human primate data. For a microcap company with a
The scientific foundation for AIM's planned study merits attention, as it builds on immunologically significant findings. The previous UAB trial demonstrated not just enhanced immune response to vaccine-targeted strains but, crucially, the induction of cross-reactive secretory Immunoglobulin A against multiple highly pathogenic avian influenza virus strains (H5N1, H7N9, H7N3).
Cross-reactivity represents a critical advantage in influenza vaccine development, addressing the persistent challenge of viral mutation. The intranasal delivery method also offers immunological benefits over traditional injections by stimulating mucosal immunity at respiratory entry points. This approach targets the virus's primary infection route and potentially provides a more robust protective barrier.
The enlistment of Dr. Goepfert, Director of the Alabama Vaccine Research Clinic, adds scientific credibility given his previous experience with this specific combination. While many adjuvanted vaccine candidates exist in development pipelines globally, the existing human data for this specific combination gives AIM a potential time advantage if avian influenza concerns accelerate. However, without secured funding, translating these immunological advantages into a marketable product remains speculative despite the scientific rationale behind the approach.
Proposed study of Ampligen as a vaccine adjuvant to increase cross-reactivity to influenza strains
OCALA, Fla., Feb. 28, 2025 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that Paul Goepfert, MD, of the University of Alabama-Birmingham (“UAB”), has agreed to act as the Principal Investigator for the company’s planned clinical study in the combination of Ampligen and AstraZeneca’s FluMist as an intranasal vaccine for influenza, including avian influenza. Ampligen would serve as a vaccine adjuvant.
This will be a follow-up study to a previous clinical trial at UAB, which indicated that intranasal delivery of Ampligen after the intranasal delivery of the FluMist seasonal influenza vaccine not only increased the immune response to seasonal variants in the vaccine by greater than four-fold, but most importantly induced cross-reactive secretory Immunoglobulin A against highly pathogenic avian influenza virus strains H5N1, H7N9 and H7N3.
Paul Goepfert, MD, Director for the Alabama Vaccine Research Clinic, stated: “I’m excited for the opportunity to follow-up on my previous work regarding the combination of Ampligen and FluMist, especially with the rising threat of avian influenza.”
AIM has engaged Amarex Clinical Research, its Clinical Research Organization, with the preparation of an Investigational New Drug application and the eventual management of the planned clinical study. A key next step will be to identify study funding through industry or governmental grants.
AIM CEO Thomas K. Equels states: “Our strong belief in the potential of a second Ampligen and FluMist study in humans stems directly from the pre-clinical and clinical work performed with Ampligen and multiple influenza variants, including in the original UAB study. We believe that the U.S. government — which has made the growing threat of avian influenza a top priority — should take a long and close look at this data when deciding how best to prepare for a potential epidemic. Rather than spend perhaps billions of dollars on the lengthy development of a new mRNA vaccine, the government should instead consider the combination of Ampligen and FluMist, which would be no more than
Read more about the Ampligen-involved avian influenza pre-clinical and clinical work here.
About AIM ImmunoTech Inc.
AIM ImmunoTech Inc., an Ocala, Florida-based company, is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The Company’s lead product is a first-in-class investigational drug called Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system.
For more information, please visit aimimmuno.com and connect with the Company on X, LinkedIn, and Facebook.
Cautionary Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “continue,” “believe,” “potential,” “upcoming” and other variations thereon and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Data, pre-clinical success and clinical success seen to date do not guarantee that Ampligen will be approved as a therapy or vaccine adjuvant for any variant of influenza. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Among other things, for those statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the PSLRA. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/afb103f2-0128-42af-ba4b-5a3c720118aa
FAQ
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