Ocean Biomedical Advances Malaria Vaccine Research with New NIH Funding and Expedited Development Pathway
Ocean Biomedical (NASDAQ: OCEA) has announced significant advances in its malaria vaccine research program. The company's Scientific Co-founder, Dr. Jonathan Kurtis, has secured additional $3.5 million NIH funding and may benefit from new FDA guidance on lipid-encapsulated vaccines that could expedite development.
The research team has identified a unique protein called GARP on malaria-infected red blood cells, discovered through studies of children who naturally developed resistance to severe malaria. With a $4.6 million non-governmental Foundation grant, the team is currently testing three vaccine candidates in non-human primates.
The company aims to utilize lipid-encapsulated mRNA technology for vaccine delivery and plans to potentially initiate human trials by Q4 2025. The research focuses on blocking the malaria parasite's ability to enter and exit red blood cells, targeting a disease that claims over 500,000 children's lives annually in sub-Saharan Africa.
Ocean Biomedical (NASDAQ: OCEA) ha annunciato significativi progressi nel suo programma di ricerca sui vaccini contro la malaria. Il Co-fondatore Scientifico dell'azienda, il Dr. Jonathan Kurtis, ha ottenuto ulteriori 3,5 milioni di dollari di finanziamenti NIH e potrebbe beneficiare di nuove linee guida della FDA sui vaccini incapsulati in lipidi che potrebbero accelerare lo sviluppo.
Il team di ricerca ha identificato una proteina unica chiamata GARP sulle cellule del sangue rosse infette dalla malaria, scoperta attraverso studi su bambini che hanno sviluppato naturalmente resistenza alla malaria severa. Con un finanziamento di 4,6 milioni di dollari da una Fondazione non governativa, il team sta attualmente testando tre candidati vaccinali su primati non umani.
L'azienda mira a utilizzare la tecnologia mRNA incapsulata in lipidi per la somministrazione dei vaccini e prevede di avviare potenzialmente sperimentazioni umane entro il Q4 2025. La ricerca si concentra sul blocco della capacità del parassita malarico di entrare e uscire dalle cellule del sangue rosse, mirando a una malattia che ogni anno strappa la vita a oltre 500.000 bambini nella parte sub-sahariana dell'Africa.
Ocean Biomedical (NASDAQ: OCEA) ha anunciado avances significativos en su programa de investigación sobre la vacuna contra la malaria. El cofundador científico de la compañía, el Dr. Jonathan Kurtis, ha asegurado financiamiento adicional de 3.5 millones de dólares de los NIH y podría beneficiarse de nuevas directrices de la FDA sobre vacunas encapsuladas en lípidos que podrían acelerar el desarrollo.
El equipo de investigación ha identificado una proteína única llamada GARP en glóbulos rojos infectados por la malaria, descubierta a través de estudios en niños que desarrollaron naturalmente resistencia a la malaria severa. Con una subvención de 4.6 millones de dólares de una fundación no gubernamental, el equipo está actualmente probando tres candidatos a vacunas en primates no humanos.
La empresa tiene como objetivo utilizar la tecnología de mRNA encapsulado en lípidos para la entrega de vacunas y planea iniciar potencialmente ensayos en humanos para el Q4 2025. La investigación se centra en bloquear la capacidad del parásito de la malaria para entrar y salir de los glóbulos rojos, apuntando a una enfermedad que reclama más de 500,000 vidas de niños anualmente en el África subsahariana.
오션 생물의학 (NASDAQ: OCEA)가 말라리아 백신 연구 프로그램의 중대한 발전을 발표했습니다. 회사의 과학 공동 창립자 인 조나단 커티스 박사는 추가 350만 달러의 NIH 자금을 확보했으며, 백신 개발을 가속화할 수 있는 새로운 FDA 지침의 혜택을 받을 수 있습니다.
연구 팀은 말라리아에 감염된 적혈구에서 발견된 독특한 단백질인 GARP를 확인했으며, 이는 심각한 말라리아에 자연적으로 저항력을 발전시킨 아동 연구를 통해 발견되었습니다. 비정부재단으로부터 460만 달러의 보조금을 받고 현재 비인간 영장류에서 3개의 백신 후보를 시험하고 있습니다.
회사는 백신 전달을 위해 지질 캡슐화된 mRNA 기술을 활용하고, 2025년 4분기까지 인체 시험을 시작할 계획입니다. 연구는 말라리아 기생충의 적혈구 출입 능력을 차단하는 데 중점을 두고 있으며, 이는 사하라 이남 아프리카에서 매년 50만 명 이상의 어린이 생명을 앗아가는 질병을 겨냥하고 있습니다.
Ocean Biomedical (NASDAQ: OCEA) a annoncé des avancées significatives dans son programme de recherche sur le vaccin contre le paludisme. Le co-fondateur scientifique de l'entreprise, le Dr. Jonathan Kurtis, a obtenu un financement supplémentaire de 3,5 millions de dollars de l'NIH et pourrait bénéficier de nouvelles directives de la FDA concernant les vaccins encapsulés dans des lipides, ce qui pourrait accélérer le développement.
Le groupe de recherche a identifié une protéine unique appelée GARP sur des globules rouges infectés par le paludisme, découverte grâce à des études sur des enfants ayant développé naturellement une résistance au paludisme sévère. Grâce à une subvention de 4,6 millions de dollars d'une fondation non gouvernementale, l'équipe teste actuellement trois candidats vaccins sur des primates non humains.
L'entreprise vise à utiliser la technologie de l'ARNm encapsulé dans des lipides pour la livraison du vaccin et prévoit de potentiellement initier des essais cliniques humains d'ici le Q4 2025. La recherche se concentre sur le blocage de la capacité du parasite du paludisme à entrer et sortir des globules rouges, visant une maladie qui tue chaque année plus de 500 000 enfants en Afrique subsaharienne.
Ocean Biomedical (NASDAQ: OCEA) hat bedeutende Fortschritte in seinem Forschungsprogramm für einen Malaria-Impfstoff angekündigt. Der wissenschaftliche Mitgründer des Unternehmens, Dr. Jonathan Kurtis, hat zusätzliche 3,5 Millionen Dollar NIH-Finanzierung gesichert und könnte von neuen Leitlinien der FDA zu lipidkapselierten Impfstoffen profitieren, die die Entwicklung beschleunigen könnten.
Das Forschungsteam hat ein einzigartiges Protein namens GARP auf malaria-infizierten roten Blutkörperchen identifiziert, das durch Studien an Kindern entdeckt wurde, die natürlicherweise Widerstand gegen schwere Malaria entwickelt haben. Mit einem 4,6 Millionen Dollar umfassenden Fördergrant einer Nichtregierungsstiftung testet das Team derzeit drei Impfstoffkandidaten an nichtmenschlichen Primaten.
Das Unternehmen beabsichtigt, lipidkapselierte mRNA-Technologie für die Impfstoffverabreichung zu nutzen und plant, möglicherweise im Q4 2025 mit Tests am Menschen zu beginnen. Die Forschung konzentriert sich darauf, die Fähigkeit des Malariaparasiten zu blockieren, in rote Blutkörperchen einzutreten und sie zu verlassen, und zielt auf eine Krankheit ab, die jährlich mehr als 500.000 Kinderleben in Subsahara-Afrika fordert.
- Secured new $3.5 million NIH grant in December 2024
- Existing $4.6 million non-governmental Foundation grant for vaccine development
- FDA guidance may expedite pathway to human trials
- Potential initiation of human trials by Q4 2025
- None.
Insights
The convergence of new NIH funding and FDA guidance marks a pivotal moment for Ocean Biomedical's malaria vaccine program. The $8.1 million in combined funding (
The GARP protein discovery represents a paradigm shift in malaria vaccine development. Unlike traditional approaches that focus on parasite proteins, this strategy targets a protein expressed on infected red blood cells, identified through natural immunity studies. This approach has several advantages: 1) It's based on proven human immunity mechanisms, 2) It targets both entry and exit of the parasite from red blood cells, creating multiple intervention points and 3) The protein's expression on infected cells makes it more accessible to immune responses.
The FDA's new guidance on lipid-encapsulated vaccines could accelerate development by:
- Leveraging extensive safety data from COVID-19 mRNA vaccines
- Streamlining the regulatory process for similar delivery platforms
- Potentially reducing the scope of required safety studies
The market opportunity is substantial, with over 500,000 annual childhood deaths and effective solutions. The current leading malaria vaccine, RTS,S/AS01, shows only
The dual catalyst of NIH funding and expedited regulatory pathway materially strengthens Ocean Biomedical's financial position and development timeline. The
The global malaria vaccines market, projected to reach
- Potential for premium pricing in developed markets and volume-based models in emerging economies
- Significant governmental and NGO funding support
- competition with few effective alternatives
- Multiple revenue streams through potential licensing and partnership opportunities
The expedited regulatory pathway could significantly reduce development costs and time to market, typically estimated at
Providence, RI, Jan. 29, 2025 (GLOBE NEWSWIRE) -- Ocean Biomedical (NASDAQ: OCEA) announced today that its Scientific Co-founder, Dr. Jonathan Kurtis, MD, PhD, and his research team have received additional significant funding from the National Institutes of Health (NIH) to advance their groundbreaking malaria vaccine research. In parallel, recent U.S. Food and Drug Administration (FDA) Guidance on lipid-encapsulated vaccines may offer an expedited development pathway for their innovative approach.
Malaria remains a devastating global health challenge, claiming the lives of over 500,000 children annually in sub-Saharan Africa. Despite hundreds of vaccine development efforts, few have succeeded, largely due to ineffective target selection strategies. Dr. Kurtis and his team have taken a novel approach by studying naturally occurring immune responses in children who have developed resistance to malaria.
Through longitudinal studies of children frequently exposed to infected mosquitoes, the researchers identified a unique protein—glutamic acid-rich protein (GARP)—on the surface of malaria-infected red blood cells. Notably, children who naturally resisted severe malaria were found to have developed antibodies against GARP. This discovery, supported by multiple NIH and non-governmental grants, has paved the way for vaccine development.
With the support of a
Building on clinical data from millions of individuals who received lipid-encapsulated mRNA vaccines, the FDA has issued new guidance that could facilitate a faster transition to first-in-human trials. Ocean Biomedical intends to leverage this opportunity, with a potential to initiate human trials as early as 4Q 2025.
In December 2024, Dr. Kurtis secured an additional
“We are thrilled to receive this additional funding and are encouraged by the emerging data from our human cohort studies. FDA’s new guidance for lipid-encapsulated vaccines will bring us closer to translating years of research into a potential breakthrough malaria vaccine.”
Dr. Chirinjeev Kathuria, Chairman and Co-founder of Ocean Biomedical, added:
“Dr. Kurtis’ work continues to gain significant validation, reinforcing our confidence in the potential of our patented technology. We look forward to further exploring the GARP pathway to develop a vaccine that could have a transformative impact on global health.”
About Dr. Jonathan Kurtis
Dr. Kurtis is the Chair of the Department of Pathology and Laboratory Medicine at the Warren Alpert Medical School of Brown University, the Director of Laboratories at the Center for International Health Research, and the Executive Director of the MD/PhD Program at Brown University. He is also a co-founder of Ocean Biomedical.
Malaria Mortality in Sub-Saharan Africa:
- Statement: "Malaria remains a devastating global health challenge, claiming the lives of over 500,000 children annually in sub-Saharan Africa."
- Citation: According to UNICEF, in 2022, there were 249 million malaria cases globally, leading to 608,000 deaths, with
76% of these deaths occurring in children under 5 years of age. This translates to over 1,000 child deaths daily, many of which are in sub-Saharan Africa.
UNICEF DATA
About Ocean Biomedical
Ocean Biomedical, Inc. is a Providence, Rhode Island-based biopharma company with an innovative business model that accelerates the development and commercialization of scientifically compelling assets from research universities and medical centers. Ocean Biomedical deploys the funding and expertise to move new therapeutic candidates efficiently from the laboratory to the clinic, to the world. Ocean Biomedical is currently developing five promising discoveries that have the potential to achieve life-changing outcomes in lung cancer, brain cancer, pulmonary fibrosis, and the prevention and treatment of malaria. The Ocean Biomedical team is working on solving some of the world’s toughest problems, for the people who need it most.
To learn more, visit www.oceanbiomedical.com.
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The announced discoveries were based solely on laboratory and animal studies. Ocean Biomedical has not conducted any studies that show similar efficacy or safety in humans. There can be no assurances that this treatment will prove safe or effective in humans, and that any clinical benefits of this treatment is subject to clinical trials and ultimate approval of its use in patients by the FDA. Such approval, if granted, could be years away.
Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside the control of the Company that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. Important factors, among others, that may affect actual results or outcomes include (i) the outcome of any legal proceedings that may be instituted against the Company; (ii) changes in the markets in which the Company competes, including with respect to its competitive landscape, technology evolution, or regulatory changes; (iii) changes in domestic and global general economic conditions; (iv) risk that the Company may not be able to execute its growth strategies; (v) risks related to the ongoing COVID-19 pandemic and response, including supply chain disruptions; (vi) risk that the Company may not be able to develop and maintain effective internal controls; (vii) the risk that the Company may fail to keep pace with rapid technological developments to provide new and innovative products and services or make substantial investments in unsuccessful new products and services; (viii) the ability to develop, license or acquire new therapeutics; (ix) the risk that the Company will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; (x) the risk that the Company experiences difficulties in managing its growth and expanding operations; (xi) the risk of product liability or regulatory lawsuits or proceedings relating to the Company’s business; (xii) the risk of cyber security or foreign exchange losses; (xiii) the risk that the Company is unable to secure or protect its intellectual property.
The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties that are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 and its subsequent Quarterly Reports on Form 10-Qs, and which are described in the “Risk Factors” sections thereof, and other documents to be filed by the Company from time to time with the SEC and which are and will be available at www.sec.gov. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements. These forward-looking statements should not be relied upon as representing the Company’s assessments as of any date subsequent to the date of this filing. Accordingly, undue reliance should not be placed upon the forward-looking statements.
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FAQ
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