DelveInsight’s, “Cytomegalovirus (CMV) Infection Pipeline Insight, 2025” report provides comprehensive insights about 15+ companies and 20+ pipeline drugs in Cytomegalovirus (CMV) Infection pipeline landscape. It covers the Cytomegalovirus Infection pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Cytomegalovirus Infection pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Cytomegalovirus Infection Pipeline Report

• In August 2025, ModernaTX, Inc. announced a study is to evaluate the efficacy of mRNA 1647 vaccine in CMV-seronegative female participants and to evaluate the safety and reactogenicity of mRNA-1647 vaccine in all participants. The purpose of the Phase 3 extension substudy is to extend the observation period of the main study and to assess the longer-term immunogenicity, efficacy, and safety of the mRNA-1647 vaccine against primary CMV infection in healthy females who were CMV-seronegative at Baseline of the mRNA-1647-P301 main study (including participants who remain CMV-seronegative upon entry into the extension substudy and participants who seroconverted during the main study).
• In August 2025, Memorial Sloan Kettering Cancer Center conducted a study is to determine of letermovir (LTC) is effective at preventing Cytomegalovirus (CMV) infection from returning in people who have already had CMV infection after a bone marrow transplant.
• DelveInsight’s Cytomegalovirus Infection pipeline report depicts a robust space with 15+ active players working to develop 20+ pipeline therapies for Cytomegalovirus Infection treatment.
• The leading Cytomegalovirus Infection Companies such as Hoffmann-La Roche, ModernaTX, Inc., Helocyte, VBI Vaccines Inc., SpyBiotech Limited, Vir Biotechnology, Inc., GlaxoSmithKline, and EVAXION BIOTECH A/S and others.
• Promising Cytomegalovirus Infection Pipeline Therapies such as Valganciclovir, V160, Letermovir, MCMV3068A, Maribavir, mRNA-1647, Ganciclovir, Brincidofovir, and others.

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Cytomegalovirus Infection Emerging Drugs Profile

• mRNA-1647: ModernaTX, Inc.

mRNA-1647 comprises six mRNAs encoding two antigens in one vaccine and is designed to protect against CMV infection. Of the six mRNAs, five encode the subunits of the CMV pentamer complex and one mRNA encodes the Glycoprotein B (gB) protein, both of which are highly immunogenic. The pentamer complex is important for CMV entry into a variety of cells, including epithelial cells, while gB is important for entry into all susceptible cells including fibroblasts. A vaccine that produces an immune response against both pentamer and gB has the potential to prevent CMV entry into a range of target cell types and thus prevent primary and congenital infections. Unlike a protein-based vaccine, mRNA-1647 instructs the body’s own cells to manufacture the antigens, resulting in functional antigens that mimic those presented to the immune system by CMV during a natural infection. Preclinical data previously published in Vaccine showed that vaccination with mRNA-1647 in animal models elicited potent and durable neutralizing antibody titers. Currently, the drug is in Phase III stage of its development for the treatment of Cytomegalovirus (CMV) Infection.

• Cytomegalovirus vaccine (Triplex) : Helocyte

The Triplex vaccine by Helocyte is a multi-antigen vaccine designed to induce a robust and durable virus-specific T-cell response against cytomegalovirus (CMV) infections, particularly in recipients of allogeneic hematopoietic stem cell transplants (HSCT) and solid organ transplants (SOT). The vaccine utilizes the Modified Vaccinia Ankara (MVA) vector to express three immunodominant CMV proteins: UL83 (pp65), UL123 (IE1), and UL122 (IE2). By targeting these proteins, Triplex stimulates a host antiviral response, enhancing both CD4+ and CD8+ T-cell responses. This mechanism of action helps control CMV infections by promoting cellular immunity, which is crucial for managing and preventing CMV-related complications in immunocompromised patients.. Currently, the drug is in Phase II stage of its development for the treatment of Cytomegalovirus (CMV) Infection.

• VBI-1501: VBI Vaccines Inc.

VBI-1501 by VBI Vaccines Inc. is a prophylactic cytomegalovirus (CMV) vaccine candidate developed using the company’s proprietary enveloped virus-like particle (eVLP) technology. This vaccine presents a modified form of the glycoprotein B (gB) found on CMV, which plays a crucial role in viral entry into host cells. The mechanism of action (MOA) of VBI-1501 involves inducing protective CMV-neutralizing antibodies that can block infection in multiple cell types, including fibroblasts and epithelial cells. By eliciting these antibodies, VBI-1501 aims to prevent CMV infection by mimicking the natural immune response observed in individuals who have developed immunity through natural infection. Currently, the drug is in Phase I stage of its development for the treatment of Cytomegalovirus (CMV) Infection.

The Cytomegalovirus Infection Pipeline Report Provides Insights into

• The report provides detailed insights about companies that are developing therapies for the treatment of Cytomegalovirus Infection with aggregate therapies developed by each company for the same.
• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Cytomegalovirus Infection Treatment.
• Cytomegalovirus Infection Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Cytomegalovirus Infection Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Cytomegalovirus Infection market

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Cytomegalovirus Infection Companies

Hoffmann-La Roche, ModernaTX, Inc., Helocyte, VBI Vaccines Inc., SpyBiotech Limited, Vir Biotechnology, Inc., GlaxoSmithKline, and EVAXION BIOTECH A/S and others.

Cytomegalovirus (CMV) Infection pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Cytomegalovirus Infection Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

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Scope of the Cytomegalovirus Infection Pipeline Report

• Coverage- Global
• Cytomegalovirus Infection Companies- Hoffmann-La Roche, ModernaTX, Inc., Helocyte, VBI Vaccines Inc., SpyBiotech Limited, Vir Biotechnology, Inc., GlaxoSmithKline, and EVAXION BIOTECH A/S and others.
• Cytomegalovirus Infection Pipeline Therapies- Valganciclovir, V160, Letermovir, MCMV3068A, Maribavir, mRNA-1647, Ganciclovir, Brincidofovir, and others.
• Cytomegalovirus Infection Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• Cytomegalovirus Infection Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Contents

1. Introduction
2. Executive Summary
3. Cytomegalovirus (CMV) Infection: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Cytomegalovirus (CMV) Infection– DelveInsight’s Analytical Perspective
7. Late Stage Products (Phase III)
8. mRNA-1647: ModernaTX, Inc.
9. Mid Stage Products (Phase II)
10. Cytomegalovirus vaccine (Triplex): Helocyte
11. Early Stage Products (Phase I)
12. VBI-1501: VBI Vaccines Inc.
13. Preclinical and Discovery Stage Products
14. Drug Name: Company Name
15. Inactive Products
16. Cytomegalovirus (CMV) Infection Key Companies
17. Cytomegalovirus (CMV) Infection Key Products
18. Cytomegalovirus (CMV) Infection- Unmet Needs
19. Cytomegalovirus (CMV) Infection- Market Drivers and Barriers
20. Cytomegalovirus (CMV) Infection- Future Perspectives and Conclusion
21. Cytomegalovirus (CMV) Infection Analyst Views
22. Cytomegalovirus (CMV) Infection Key Companies
23. Appendix

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