+++ BioVaria 2027, 3 - 4 May +++ Save the date! +++

C1

Dense Immune

Dr Zahra Ghodratian, Universitätsmedizin Mainz; Dr Azelarab Terkemani, Universitätsmedizin Mainz; Prof. Bodo Plachter, Universitätsmedizin Mainz; Prof. Niels Lemmermann, Universitätsmedizin Mainz

Innovectis


Challenge

Human cytomegalovirus (HCMV) causes severe complications in immunocompromised patients, especially after hematopoietic stem cell transplantation (HSCT) or solid organ transplantation (SOT), where viral reactivation leads to high morbidity and healthcare costs. Current antivirals suppress replication but do not restore protective immunity and reactivation rates remain high after prophylaxis discontinuation. Beyond transplantation, HCMV poses a major public health burden in the congenital setting, where it represents the leading cause of non-genetic hearing loss worldwide and remains without an approved vaccine.
 


Technology

Dense Immune develops a vaccine platform based on non-infectious HCMV Dense Bodies (DBs). These subviral particles present the full native viral antigen architecture without viral DNA, inducing strong CD4⁺ and CD8⁺ T-cell responses and neutralizing antibodies without adjuvants. The platform uniquely restores functional antiviral immunity rather than relying on transient viral suppression. Commercial opportunity*: The initial target market is HSCT patients, a highly defined, high-value segment with urgent unmet need and strong reimbursement dynamics. Expansion into solid organ transplantation and congenital HCMV significantly increases market potential. The platform enables premium pricing while reducing downstream healthcare costs from hospitalizations, antiviral therapy and complications. 
 


Commercial Opportunity

The initial target market is HSCT patients, a highly defined, high-value segment with urgent unmet need and strong reimbursement dynamics. Expansion into solid organ transplantation and congenital HCMV significantly increases market potential. The platform enables premium pricing while reducing downstream healthcare costs from hospitalizations, antiviral therapy and complications.
 


Development Status

The platform has completed extensive preclinical validation demonstrating strong cellular and humoral immunity. Manufacturing feasibility and scalability have been demonstrated with an industrial partner. Regulatory scientific advice has been obtained. The program is currently at TRL 4, with the goal to reach TRL 5 and initiate Phase 1 clinical trials following GLP toxicology and GMP CTM production.
 


Patent Situation

The technology is protected by an international patent family. Letters of Intents for exclusive licensing are already in place with the patent holders, enabling transfer to the spin-out.
 


Further Reading

Peer-reviewed publications demonstrating immunogenicity and mechanism of action are available. A detailed pitch deck and preclinical data package can be provided upon request.
 


 

Dense Immune