OPKO Health’s ModeX Therapeutics Announces Epstein-Barr Virus Vaccine Candidate Enters Phase I Clinical Study in Collaboration with Merck
OPKO Health's subsidiary ModeX Therapeutics has initiated Phase I clinical trials for an Epstein-Barr virus (EBV) vaccine candidate in collaboration with Merck. The first participant has been dosed in the study (NCT06655324), which will evaluate the safety and tolerability of MDX2201 in up to 200 healthy adults. This milestone triggers an undisclosed cash payment from Merck to ModeX.
The vaccine candidate targets multiple viral proteins and aims to stimulate protective immunity against EBV, which causes infectious mononucleosis and is associated with several types of cancer and multiple sclerosis. Currently, there are no approved treatments or vaccines for EBV. The collaboration leverages Merck's clinical development expertise with ModeX's innovative technology platform to address this latent virus that affects a majority of the global population.
La sussidiaria di OPKO Health, ModeX Therapeutics, ha avviato la fase I di studi clinici per un candidato vaccinale contro il virus di Epstein-Barr (EBV) in collaborazione con Merck. Il primo partecipante è stato dosato nello studio (NCT06655324), che valuterà la sicurezza e la tollerabilità di MDX2201 in un massimo di 200 adulti sani. Questo traguardo attiva un pagamento in contante non rivelato da Merck a ModeX.
Il candidato vaccinale mira a colpire più proteine virali e si propone di stimolare un'immunità protettiva contro l'EBV, responsabile della mononucleosi infettiva e associato a diversi tipi di cancro e sclerosi multipla. Attualmente, non esistono trattamenti o vaccini approvati per l'EBV. La collaborazione sfrutta l'expertise di Merck nello sviluppo clinico insieme alla piattaforma tecnologica innovativa di ModeX per affrontare questo virus latente che colpisce la maggior parte della popolazione globale.
La subsidiaria de OPKO Health, ModeX Therapeutics, ha iniciado ensayos clínicos de Fase I para un candidato a vacuna contra el virus Epstein-Barr (EBV) en colaboración con Merck. El primer participante ha sido dosificado en el estudio (NCT06655324), que evaluará la seguridad y tolerabilidad de MDX2201 en hasta 200 adultos sanos. Este hito activa un pago en efectivo no revelado de Merck a ModeX.
El candidato a vacuna apunta a múltiples proteínas virales y tiene como objetivo estimular una inmunidad protectora contra el EBV, que causa mononucleosis infecciosa y se asocia con varios tipos de cáncer y esclerosis múltiple. Actualmente, no hay tratamientos ni vacunas aprobados para el EBV. La colaboración aprovecha la experiencia en desarrollo clínico de Merck con la plataforma tecnológica innovadora de ModeX para abordar este virus latente que afecta a la mayoría de la población mundial.
OPKO Health의 자회사인 ModeX Therapeutics가 Merck와 협력하여 Epstein-Barr 바이러스 (EBV) 백신 후보에 대한 1상 임상 시험을 시작했습니다. 첫 번째 참가자가 연구(NCT06655324)에서 투여되었으며, 이 연구는 최대 200명의 건강한 성인에서 MDX2201의 안전성과 내약성을 평가할 것입니다. 이 이정표는 Merck가 ModeX에 비공식적인 현금 지급을 시작하게 합니다.
이 백신 후보는 다수의 바이러스 단백질을 대상으로 하며 EBV에 대한 보호 면역을 자극하는 것을 목표로 합니다. EBV는 감염성 단핵구증을 유발하며, 여러 유형의 암과 다발성 경화증과 관련이 있습니다. 현재 EBV에 대해 승인된 치료제나 백신은 없습니다. 이 협력은 Merck의 임상 개발 전문성과 ModeX의 혁신적인 기술 플랫폼을 결합하여 전 세계 대다수 인구에 영향을 미치는 이 잠재적 바이러스를 해결하는 데 초점을 맞추고 있습니다.
La filiale d'OPKO Health, ModeX Therapeutics, a lancé des essais cliniques de phase I pour un candidat vaccin contre le virus d'Epstein-Barr (EBV) en collaboration avec Merck. Le premier participant a été dosé dans l'étude (NCT06655324), qui évaluera la sécurité et la tolérance de MDX2201 chez un maximum de 200 adultes en bonne santé. Cette étape déclenche un paiement en espèces non divulgué de Merck à ModeX.
Le candidat vaccin vise plusieurs protéines virales et a pour objectif de stimuler une immunité protectrice contre l'EBV, qui cause la mononucléose infectieuse et est associé à plusieurs types de cancers et à la sclérose en plaques. Actuellement, il n'existe aucun traitement ou vaccin approuvé contre l'EBV. La collaboration exploite l'expertise de Merck en développement clinique avec la plateforme technologique innovante de ModeX pour s'attaquer à ce virus latent qui affecte une grande partie de la population mondiale.
Die Tochtergesellschaft von OPKO Health, ModeX Therapeutics, hat klinische Studien der Phase I für einen Impfstoffkandidaten gegen das Epstein-Barr-Virus (EBV) in Zusammenarbeit mit Merck gestartet. Der erste Teilnehmer wurde in der Studie (NCT06655324) behandelt, die die Sicherheit und Verträglichkeit von MDX2201 bei bis zu 200 gesunden Erwachsenen bewerten wird. Dieser Meilenstein löst eine nicht offengelegte Barzahlung von Merck an ModeX aus.
Der Impfstoffkandidat zielt auf mehrere virale Proteine ab und soll eine schützende Immunität gegen EBV stimulieren, das infektiöse Mononukleose verursacht und mit mehreren Krebsarten sowie Mult sclerosis in Verbindung gebracht wird. Derzeit gibt es keine zugelassenen Behandlungen oder Impfstoffe für EBV. Die Zusammenarbeit nutzt die klinische Entwicklungsexpertise von Merck und die innovative Technologieplattform von ModeX, um dieses latente Virus anzugehen, das einen Großteil der Weltbevölkerung betrifft.
- First participant dosed in Phase I trial, advancing EBV vaccine development
- Milestone payment received from Merck collaboration
- Targeting an unmet medical need with no existing vaccines or treatments
- None.
Insights
The initiation of Phase I trials for ModeX's EBV vaccine candidate represents a significant milestone in addressing an unmet medical need. The collaboration with Merck, a pharmaceutical giant, adds substantial credibility and resources to the development process. The undisclosed milestone payment strengthens OPKO's financial position and validates the technology.
The vaccine candidate MDX2201 employs an innovative nanoparticle approach targeting multiple viral proteins, which could potentially provide broader protection compared to single-target vaccines. EBV's association with various cancers (including nasopharyngeal carcinoma and certain lymphomas) and multiple sclerosis makes this vaccine's potential market substantial - approximately
The 200-participant Phase I study is appropriately sized for initial safety assessment. Early success could accelerate development timelines, though investors should note that vaccine development typically requires 5-7 years through approval.
This development carries multiple positive financial implications for OPKO Health. First, the milestone payment from Merck provides immediate non-dilutive capital, enhancing OPKO's cash position. Second, the advancement to clinical trials significantly de-risks the asset and increases its potential value.
The collaboration with Merck is particularly strategic, as it offloads substantial development costs while maintaining upside potential through milestone payments and potential future royalties. Given OPKO's current market cap of
The global vaccine market for EBV represents a substantial opportunity, especially considering its widespread prevalence and lack of current treatments. ModeX's technology platform validation through this progress could also increase the value of other pipeline assets using similar technology.
- Epstein-Barr virus (EBV) causes infectious mononucleosis and is associated with several types of cancer and multiple sclerosis
- There are no current treatments or vaccines for EBV
- First participant dosed with novel investigational EBV vaccine targeting multiple viral proteins in Phase I study
WESTON, Mass., Jan. 07, 2025 (GLOBE NEWSWIRE) -- ModeX Therapeutics Inc., an OPKO Health company (NASDAQ: OPK), announces dosing of the first participant in the Phase I study (NCT06655324) of an EBV vaccine candidate being developed in collaboration with Merck, known as MSD outside the United States and Canada. This development triggers an undisclosed cash milestone payment from Merck to ModeX.
“EBV infection can cause serious illness and pose long-term risks of cancer and autoimmunity. Through our collaborators at Merck, human trials to advance a novel vaccine candidate have now begun. Our nanoparticle vaccine aims to stimulate protective immunity in patients and prevent these diseases,” said Gary Nabel, M.D., Ph.D., President and Chief Executive Officer of ModeX and Chief Innovation Officer of OPKO.
The investigational vaccine based on MDX2201 is being evaluated for safety and tolerability in up to 200 healthy adults against EBV.
“We are grateful to the participants and physicians who are actively engaged with Merck in our joint efforts to explore the potential of MDX2201 as a novel vaccine against EBV,” said Elias Zerhouni, M.D., President and Vice Chairman of OPKO. “Our Merck collaboration combines their discovery and clinical development expertise with our innovative and unique technology platform against this latent virus where an approved vaccine could have significant implications for the majority of people around the world.”
About MDX2201
MDX2201 is based on ModeX’s ferritin nanoparticle vaccine platform, which can express as many as 24 copies of a recombinant antigen on its surface to enhance the presentation of key components of the virus and stimulate durable protective immunity. MDX2201 presents antigens from four viral proteins involved in viral entry into host cells. These include a recombinant antigen designed from the proteins gH, gL and gp42, as well as an antigen derived from gp350. By using ModeX’s multi-targeted approach, this combination inhibits infection in two cell types, B cells and epithelial cells, which contrasts from efforts that previously focused on gp350 alone. This EBV vaccine technology was the subject of preclinical data published in May 2022 in Science Translational Medicine.
About Epstein-Barr Virus
Epstein-Barr virus (EBV), a member of the herpes virus family, is one of the most common human viruses. Most people are infected with EBV at some point during their lives. EBV can cause infectious mononucleosis, also called mono, and is associated with other illnesses, including some specific types of cancer and multiple sclerosis. There are currently no FDA approved vaccines or treatments for EBV infection.
About ModeX Therapeutics
ModeX Therapeutics is a clinical-stage biopharmaceutical company developing innovative multispecific biologics for cancer and infectious disease. Its platforms unite the power of multiple biologics in a single molecule to create multispecific antibodies and vaccines with unprecedented versatility and potency in fighting complex disease. The ModeX pipeline includes candidates against both solid and hematologic tumors, as well as several of the world’s most pressing viral threats. Its founding team includes globally recognized medical innovators with proven track records of delivering breakthroughs for patients. ModeX, an OPKO Health company, is based in Weston, Massachusetts. For more information, please visit www.modextx.com.
About OPKO Health, Inc.
OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, please visit www.opko.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," “could,” "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including whether and when the Phase I study will be completed, and whether final study data will be positive and support marketing approval, the ability to develop and commercialize MDX2201, whether MDX2201 is capable of effectively protecting patients against EBV and related disease, whether MDX2201 will be safe, or have any impact on the severity of disease, expectations regarding the product, its efficacy and safety as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in our other filings with the Securities and Exchange Commission, as well as liquidity issues and the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, the success of our relationship with our commercial partners, that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results, and that currently available over-the-counter and prescription products, as well as products under development by others, may prove to be as or more effective than our products for the indications being studied. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.
Contacts:
Investors
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Yvonne Briggs, 310-691-7100
ybriggs@allianceadvisors.com
or
Bruce Voss, 310-691-7100
bvoss@allianceadvisors.com
Media
ModeX Media Relations
media@modextx.com
- Dowd, et al. Seroprevalence of Epstein-Barr Virus Infection in US Children Ages 6-19, 2003-2010. doi: 10.1371/journal.pone.0064921
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