◆ DI-101 · IND-Enabling Studies Active · 2026 ◆ 30+ Viral Antigens · Native Conformation ◆ 3 Patents Issued · 10+ Jurisdictions · 2038+ ◆ Phase 1 Target · 2028 · HSCT + SOT ◆ 100× T-Cell Amplification · Preclinical PoC ◆ Unmet Need · ~270,000 Transplants Annually · Global ◆ DNA-Free · Non-Replicating · Preclinical PoC ◆ DI-101 · IND-Enabling Studies Active · 2026 ◆ 30+ Viral Antigens · Native Conformation ◆ 3 Patents Issued · 10+ Jurisdictions · 2038+ ◆ Phase 1 Target · 2028 · HSCT + SOT ◆ 100× T-Cell Amplification · Preclinical PoC ◆ Unmet Need · ~270,000 Transplants Annually · Global ◆ DNA-Free · Non-Replicating · Preclinical PoC
DI-101
DI-101 · IND-Enabling Studies Active
HCMV Prophylactic Vaccine · Transplant Indication
Dense Immune
Frankfurt / Mainz, Germany
Seed Round — 2026

The Dense Body delivers what HCMV demands.

Dense Immune is advancing DI-101, a Dense Body-based HCMV prophylactic vaccine for immunocompromised transplant recipients. Our platform delivers 30+ viral antigens in native conformation, simultaneously activating cellular and humoral immunity — the complete immune architecture that published HCMV biology identifies as necessary for durable protection.

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Patents
Issued
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T-Cell
Amplification
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IP
Runway
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01IND-Enabling Studies Active · 2026
02GMP Manufacturing · Partner Secured
03Phase 1 Clinical Trial · Target 2028
Dense Immune · DI-101
Dense Body Particle · Structural Analysis
Layer 01 / 04
Ø ~200nm · DNA-Free · Non-Replicating
0%
Lipid Bilayer Envelope
gB + Pentamer (PC)
Tegument · pp65 / pp150 / pp28 / pp71 / pUL48+
DNA-Free Core
The Dense Body · Structural Anatomy

One particle.
30+ antigens.
Complete architecture.

Dense Bodies are non-replicating, DNA-free subviral particles produced by HCMV-infected cells. They retain the lipid bilayer envelope, native glycoprotein conformation, and tegument protein cargo that the immune system has co-evolved to recognise. Scroll to dissect each structural layer.

01

Lipid Bilayer Envelope

Host-derived lipid bilayer presenting glycoproteins in their native membrane-embedded conformation — the structural context that determines antibody recognition quality and neutralising breadth.

02

Glycoprotein Envelope — Pentamer-Positive Architecture

The Dense Body envelope displays the complete HCMV glycoprotein repertoire in native membrane-embedded conformation. Neutralisation targets: gB (UL55, trimeric, dominant antibody target), gH/gL (UL75/UL115, scaffold for both trimer and pentamer), gO (UL74, fibroblast tropism trimer), gM/gN (UL100/UL73, most abundant envelope complex). Pentameric complex (PC): gH/gL + UL128/UL130/UL131A — the determinant of epithelial and endothelial cell tropism, congenital transmission, and the primary target for high-potency neutralising antibodies. Additional: gp48 (UL4). In pentamer-positive Dense Bodies, the full breadth of neutralising epitopes — across both fibroblast and epithelial/endothelial entry pathways — is presented simultaneously.

03

Tegument Protein Cargo — Complete Proteome

The Dense Body tegument is the most immunologically dense layer of the particle. Upper tegument: pp65 (pUL83, dominant CD8⁺ antigen, ~80% of total DB protein mass), pp71 (pUL82, IE-gene transactivator, T-cell target), pUL48 (~250kDa, deubiquitinase, inner tegument scaffold). Lower tegument: pp150 (pUL32, nucleocapsid-proximal, CD4⁺/CD8⁺ target), pUL47 (interacts with pUL48), pp28 (pUL99, myristylated, secondary envelopment). Additional: pUL46, pUL26 (NFκB modulator), pUL25, pUL24, pUL17, pUL14, pUL13 — all documented by Varnum et al. proteomics. Together: 14+ tegument proteins presenting the CD8⁺ T-cell targets that are primary correlates of viral control in post-transplant immune reconstitution.

04

DNA-Free · Non-Replicating Core

Dense Bodies contain no viral DNA and no capsid. Replication-incompetent by definition — an intrinsic safety profile confirmed across all preclinical studies, not dependent on chemical inactivation.

01
Scientific Rationale

HCMV biology defines
a precise immunological
brief.

HCMV establishes lifelong latency, deploys extensive immune evasion machinery, and exploits both fibroblast and epithelial cell tropism. Published immunological studies consistently identify concurrent cellular and humoral immunity as the requirement for durable viral control. The Dense Body platform was designed to address this requirement in a single, structurally complete particle.

The Biological Challenge

HCMV Demands Concurrent Immune Activation

Robust CD8⁺ T-cell responses targeting tegument antigens — led by pp65 (pUL83), pp150 (pUL32), pp71 (pUL82), and pUL48 — are the primary documented correlates of viral control in seropositive individuals and post-transplant immune reconstitution. Simultaneously, neutralising antibodies against gB, the pentameric complex (PC: gH/gL/UL128/UL130/UL131A), and the gH/gL/gO trimer are the established mechanism for preventing cell-free virus spread and maternal-foetal transmission. No single subunit antigen addresses both arms.

The Dense Body Solution

A Single Particle for the Complete Requirement

Dense Bodies simultaneously present 30+ viral antigens in native conformation, engaging both MHC I and MHC II antigen-processing pathways. This architecture addresses the concurrent cellular and humoral immune activation that the accumulated HCMV immunology literature identifies as the necessary condition for durable protection.

Antigen Breadth Rationale

30+ Antigens · 14+ Tegument Proteins · Full Glycoprotein Repertoire

Dense Body proteomics (Varnum et al., J Virol) document 14+ tegument proteins including pp65, pp150, pp71, pp28, pUL48, pUL47, pUL46, pUL26, pUL25, pUL24, and pUL17 — covering 6/15 top CD8⁺ T-cell epitopes in published HLA-antigen mapping. The glycoprotein envelope simultaneously presents gB, gH/gL, gO, gM/gN, and the pentameric complex (UL128/130/131A), covering 5/6 top CD4⁺ targets. Projected HLA diversity coverage exceeds 90% of global ethnogeographical populations.

Market Opportunity

Two Large Indications · One Shared Platform

The transplant programme (HSCT + SOT) provides a defined regulatory pathway and near-term clinical milestone. Congenital HCMV — the most common congenital infection worldwide, affecting ~1 in 200 live births globally and a leading non-genetic cause of childhood sensorineural hearing loss and disability — represents the primary long-term expansion opportunity, addressable with the same Dense Body platform infrastructure.

02
Clinical Pipeline

Two indications.
One shared platform.

Lead Program
DI-101
HSCT & SOT
IND-Enabling Active

Prophylactic Dense Body vaccine targeting post-transplant CMV in hematopoietic stem cell and solid organ transplant recipients. IND-enabling studies underway with a leading GMP-qualified CDMO partner. Phase 1 initiation targeted for 2028.

Discovery
Complete
Preclinical
PoC
IND-Enabling
Active ◆
Phase 1a/b
→ 2028
Phase 2
→ 2030
Approval
TBD
IndicationHSCT + Solid Organ Transplant
StudiesGLP Toxicology · GMP CTM manufacturing
ProtocolPhase 1a/b + Phase 2 fully defined
IP3 Patents Issued · Coverage to 2038+
Expansion · Primary Value Driver
DI-201
Congenital CMV
From 2028

Maternal prophylactic vaccine leveraging the shared Dense Body platform to reduce congenital HCMV transmission risk. Congenital HCMV is the world's most common congenital infection and a leading non-genetic cause of childhood sensorineural disability. Platform infrastructure shared with DI-101, substantially reducing marginal development cost.

Discovery
Complete
Preclinical
PoC
IND-Enabling
From 2028
Phase 1+2
→ 2030
Approval
TBD
Shared InfraDI-101 GMP + TOX platform reused
Global burden~1 in 200 live births · Leading congenital infection
IndicationMaternal prophylaxis · cCMV transmission prevention
03
Platform Advantages

Four structural
properties.
One particle.

01
Dual Immune Activation

Concurrent Cellular & Humoral Activation

Dense Bodies are designed to engage both MHC I and MHC II antigen-processing pathways simultaneously, driving concurrent CD4⁺ and CD8⁺ T-cell responses alongside high-avidity antibody production. This dual-arm activation profile — observed in preclinical models across species — addresses the full immunological brief that published HCMV literature identifies as necessary for durable viral control.

02
Native Conformation

Glycoproteins in Native Membrane Architecture

Glycoprotein B and the pentameric complex are presented within the native Dense Body lipid bilayer in their authentic trimeric and pentameric configurations. Native glycoprotein conformation is a critical determinant of neutralising antibody quality, epitope access, and breadth — structural fidelity inherent to Dense Bodies as intact viral particles.

03
Antigen Breadth

30+ Antigens · Complete Viral Proteome Delivery

Pentamer-positive Dense Bodies carry the complete HCMV structural proteome: 14+ tegument proteins (pp65/pUL83, pp150/pUL32, pp71/pUL82, pp28/pUL99, pUL48, pUL47, pUL46, pUL26, pUL25, pUL24, pUL17, pUL14, pUL13) alongside the full glycoprotein repertoire (gB, gH, gL, gO, gM, gN, UL128, UL130, UL131A, gp48/UL4). This breadth is a direct consequence of the particle's biology. Projected HLA diversity coverage exceeds 90% of global ethnogeographical populations, supporting deployment across the heterogeneous transplant patient base without the need for adjuvant optimisation by antigen subtype.

04
Immunocompromised Validation

100× T-Cell Amplification Under Immunosuppressive Conditions

In the preclinical mCMV hematopoietic cell transplant model — the directly relevant biological context for the primary indication — Dense Bodies demonstrated 100× functional T-cell amplification, CD8⁺-dependent and lung-protective, maintained under immunosuppressive conditions. Robust humoral responses were observed in parallel, validating the concurrent dual-arm profile in the target patient setting.

04
Execution Milestones

Regulatory-grade
progress.

Complete
3 Patents Issued — Global IP Coverage
Patent protection until 2038 with SPC potential. Coverage across 10+ jurisdictions: US, EU, AU, JP, KOR, CA, MX, CN, BR, IN. Dense Body production process and immunogenicity platform protected.
2023
Complete
Preclinical Proof of Concept — Cross-Species Validation
100× functional T-cell amplification demonstrated in mCMV HCT model. CD8⁺-dependent lung protection maintained under immunocompromised conditions. Robust cellular and humoral responses confirmed across species.
2023
Complete
Phase 1a/b + Phase 2 Protocol Architecture
Full clinical development plan across HSCT and SOT indications finalised with integrated CRO and KOL consultation. Regulatory-submission ready.
2025
Complete
Regulatory Interactions — Phase 1 Pathway Defined
Regulatory pathway for Phase 1 formally defined through established channels with the competent authority for the EU/Germany jurisdiction. Scientific and procedural alignment confirmed.
2024
Complete
GMP CDMO Partnership — Agreement Signed
Partnership established with an experienced CDMO holding GMP certification and validated viral vaccine manufacturing capabilities. Toxicology batch production, GLP tox support, and Phase 1 CTM manufacturing covered under agreement.
2025
Active
GLP Toxicology + GMP CTM Manufacturing — 2026–2028
IND-enabling GLP toxicology studies ongoing with CDMO partner. GMP Clinical Trial Material manufacturing scheduled in parallel sequence. Phase 1 clinical trial initiation in transplant recipients targeted for 2028.
2026–2028
05
Financial Model

Enormous unmet need.
No approved prophylactic vaccine.

Lead Indication · HSCT + Solid Organ Transplant
~270K
HSCT + Solid Organ Transplants Annually · Global
HCMV Seroprevalence (Global)40–100% · population-dependent
Post-transplant CMV diseaseLeading infectious complication
HSCT annually (global)~90,000 · WBMT 2023
Current prophylactic optionsNo approved prophylactic vaccine
Regulatory pathwayDefined · EU/Germany jurisdiction
Expansion · Congenital HCMV
~1/200
Live Births Affected · Most Common Congenital Infection Worldwide
Annual congenital cases (US)~40,000 · leading non-genetic cause disability
Primary sequelaeSensorineural hearing loss · neurodevelopmental delay
Approved maternal vaccineNone · significant unmet need
Platform leverageShared infrastructure with DI-101
Immune requirementConcurrent cellular + humoral activation
06
Leadership

Science that executes.
Execution that
understands the science.

Zahra Ghodratian
Zahra Ghodratian
CEO & Co-Founder

VMD, Virologist. Leads CMC strategy, manufacturing partnerships, and Phase 1 preparation. Goethe University Frankfurt / Universität Mainz.

VirologyCMCStrategy
Azelarab Terkemani
Azelarab Terkemani, MD
CMO & Co-Founder

MD with extensive clinical trial experience across immunology and infectious disease. Leads clinical development strategy, regulatory submissions, and pharmacovigilance architecture. UCLouvain / UMC Mainz.

Clinical TrialsRegulatoryImmunology
Prof. Bodo Plachter
Prof. Bodo Plachter
CTO & Co-Founder

MD, Deputy Director Institute for Virology (UMC Mainz). Architect of the DNA-free Dense Body production process. Three decades of HCMV virology.

VirologyCMCIP
Prof. Niels Lemmermann
Prof. Niels Lemmermann
CSO & Co-Founder

Professor of Virology, University Hospital Bonn. Expert in preclinical CMV animal models, transplantation immunology, and antigen-specific T-cell biology. Co-inventor on Dense Body patents.

PreclinicalTransplant ImmunologyPatents
Supported by EXIST Women Else Kröner-Fresenius-Stiftung Wilhelm Sander-Stiftung Universitätsmedizin Mainz
07
Investor Relations

Seed financing
round currently
open.

Dense Immune is seeking institutional investment to fund GLP toxicology, GMP Clinical Trial Material manufacturing, and Phase 1 clinical trial initiation in transplant recipients (target: 2028). This round is structured to reach the Phase 1a primary data readout — the clinical value inflection point and foundation for the next financing stage.

The Dense Body platform is grounded in three decades of HCMV virology, a preclinical data package demonstrating the concurrent dual immune activation that published HCMV biology identifies as necessary for durable protection, and active IND-enabling studies with a contracted GMP-certified CDMO partner.

Indicative Use of Proceeds — ~€10M Seed Round
GLP Toxicology + GMP CTM Manufacturing (~€4M)~38%
Phase 1 Clinical Trial — Transplant Recipients (~€5.5M)~52%
Operational Runway (24 months)~10%
→ Request Investor Data Room
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Directed at qualified institutional investors only. This page does not constitute an offer of securities. Full NDA required prior to data room access. Contact: zahra.ghodratian@denseimmune.com