CD4 Therapeutics
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NewsNobel Prize 2025 in Medicine awarded for regulatory T cell research

Unlocking the power of regulatory T cells for autoimmune disease

A game-changer in autoimmune therapeutics

CD4 Therapeutics pioneers first-in-class immunotherapy with Tregalizumab, the only monoclonal antibody designed to selectively activate regulatory T cells (Tregs). With clinical proof-of-concept and high-value indications, we present an exceptional investment opportunity in a rapidly expanding market.

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Tregalizumab · humanized anti-CD4 antibody 700+ subjects dosed · prior clinical development Worldwide rights · exclusive licence · Starnberg, Munich area

Investment snapshot

The case in five points

Every point below is drawn from the program as it stands today. Detail and sources follow further down the page.

  1. 01

    First-in-class Treg activation

    Tregalizumab is the only monoclonal antibody designed to selectively activate regulatory T cells — no approved competitors, and no direct competition in Treg activation.

  2. 02

    Clinical proof-of-concept

    Proof-of-concept achieved in rheumatoid arthritis and psoriasis. De-risked, biomarker-driven development with targeted patient selection.

  3. 03

    €10B+ lead opportunity

    Combined market opportunity across oral lichen planus and acute GvHD; €20B+ total market with expansion into RA, AD and IBD.

  4. 04

    Defensible position

    Strong IP and regulatory moat with orphan designation potential.

  5. 05

    Proven leadership

    80+ years of combined experience across biotech, drug development and investment.

Scientific validation

Nobel Prize in Physiology or Medicine 2025

They understood how the immune system is kept in check.

The body's powerful immune system must be regulated, or it may attack our own organs. Mary E. Brunkow, Fred Ramsdell and Shimon Sakaguchi made groundbreaking discoveries concerning peripheral immune tolerance that prevents the immune system from harming the body. Their discoveries have laid the foundation for a new field of research and spurred the development of new treatments, for example for cancer and autoimmune diseases.

Read more at nobelprize.org
01

Nobel discovery

Peripheral immune tolerance is identified as the mechanism that keeps the immune system in check.

02

15+ years of research

Translational research on Treg activation, with 20+ publications establishing the scientific validity of CD4 modulation.

03

700 subjects dosed

Human validation demonstrated: Tregalizumab has been dosed in 700 subjects across prior clinical development.

04

Tregalizumab therapy

Selective Treg activation is taken into indications with no approved therapy.

The problem

Addressing high unmet medical needs

Millions suffer from immune-driven diseases with no approved treatments or high failure rates of existing biologics. Tregalizumab offers a breakthrough solution where conventional therapies fall short.

>50% failure rates in second-line biologics
3M+ patients living with oral lichen planus worldwide
60,000+ annual progressions from oLP to oral cancer
60% of stem cell transplant patients develop acute GvHD
  • More than 300 million people are affected by over 80 different autoimmune diseases, at an annual healthcare cost above €100 billion.
  • Biologics fail too often. More than half of patients do not respond durably to second-line biologics.
  • Current options carry risk. Severe safety concerns with steroids and systemic immunosuppressants.
  • Whole indications are untreated. No approved therapies for critical indications like immune-driven cancer prevention.
  • Treg loss or dysfunction is a shared hallmark across these diseases — restoring tolerance addresses the underlying disease, not just symptoms.
A researcher examining samples under a microscope

Mechanism of action

A differentiated mechanism, not another suppressant

Unlike traditional biologics that suppress the immune system, Tregalizumab is the first and only monoclonal antibody designed to selectively activate regulatory T cells, restoring immune balance rather than shutting immunity down.

Tregalizumab targets CD4 on T cells and binds to a distinct CD4 epitope. Regulatory T cells are selectively activated; effector T cells are not.

Schematic illustration of the mechanism of action. Not to scale; not structurally representative.

Mechanism of action of Tregalizumab on regulatory and effector T cells Tregalizumab binds domain 2 of the CD4 receptor. In regulatory T cells this triggers selective activation with increased cAMP and TGF-beta signalling. In effector T cells the same binding event does not lead to activation. Treg CD4 D2 Tregalizumab TCR cAMP TGF-β CD137 Selective Treg activation Teff CD4 D2 Tregalizumab TCR STOP No Teff activation
Step 01

Binds CD4 domain 2

Tregalizumab binds the CD4 receptor at domain 2, a binding mode that sets it apart from other molecules in its class.

Step 02

Activates Tregs

Regulatory T cells are selectively activated. cAMP and TGF-β signalling are increased.

Step 03

Restores tolerance

Immune tolerance is re-established, reducing harmful inflammation without broad immunosuppression.

Regulatory T cells — selective activation

Tregalizumab activates Tregs and enhances immune regulation in inflammatory disease.

  • cAMP signalling increased
  • TGF-β signalling increased
  • Immune tolerance restored

Effector T cells — no activation

The same binding event does not activate effector T cells, so harmful immune responses stay controlled.

  • Effector T cell activity reduced
  • No broad immunosuppression
  • Graft-versus-leukemia effect preserved

Competitive advantage. Unlike current therapies that block inflammatory cytokines such as TNF, IL-6 and IL-23, Tregalizumab rebalances the immune system, creating a first-in-class solution with high commercial defensibility.

Lead programs

Two lead indications, one mechanism

Both programs follow the same structure: the program, the disease and its data, then the market. Directly comparable, side by side.

Immune-Dermatology · Phase 2b

Oral Lichen Planus (oLP)

A game-changer with curative intent

3M+ patients with chronic, pre-malignant inflammation
60,000+ progress to oral cancer annually
€5B+ market potential
  • No approved therapies. Existing treatments fail to control inflammation, therefore do not prevent malignancy potential.
  • Program type: CD4 Therapeutics sponsored PoCC program.

Why Tregalizumab?

Tregalizumab targets and controls chronic inflammation, offering the first curative therapy for oLP.

Oncology · Phase 2b

Acute Graft-versus-Host Disease (aGvHD)

A life-saving breakthrough

60% of patients develop aGvHD post stem cell transplant
>50% failure rate with first-line steroids
€3B+ market potential
  • Severe complications, long hospitalizations, high costs.
  • U.S. Orphan Drug Designation granted for aGvHD.
  • Lead program: EIC Accelerator-funded, target Phase 2b.

Why Tregalizumab?

Unlike existing treatments, Tregalizumab prevents aGvHD at its source by activating Tregs, while preserving the graft-versus-leukemia (GvL) effect.

„Tregalizumab directly addresses the core pathophysiology of aGvHD, setting it apart from current treatments."

Prof. Dr. Robert Zeiser, GvHD Expert
See the full pipeline Research & Development

Market opportunity

A multi-billion-euro opportunity

Tregalizumab is positioned to lead in high-need markets with clinical validation and a clear commercialization path.

  • First-mover advantage in key indications
  • High medical need with 50% failure rates in biologics
  • Fast-track regulatory potential in orphan and high-urgency diseases
  • No competing Treg-targeting therapies in these high-unmet-need areas
€5B+ Oral Lichen Planus (oLP)
€3B+ Acute Graft-versus-Host Disease
€10B+ Combined lead opportunity
€20B+ Expansion into RA, AD, IBD

Development strategy

Lean, high-impact development

01

Focused initial indications

oLP and aGvHD first — a de-risked, biomarker-driven approach.

02

Expansion on strong data

Into major autoimmune markets: RA, AD and IBD.

03

Defensible position

No direct competitors in Treg activation, creating a defensible market position.

04

Partnerships and exit

Strategic partnerships and exit potential: pharma licensing, M&A, IPO.

Competitive edge

Why CD4 stands apart

First-in-class Treg activator

No approved competitors. The only monoclonal antibody designed to selectively activate regulatory T cells. Unlike current therapies that block inflammatory cytokines such as TNF, IL-6 and IL-23, Tregalizumab rebalances the immune system — a first-in-class solution with high commercial defensibility and no direct competitors in Treg activation.

Strong IP and regulatory moat

Orphan designation potential and biomarker-driven patient selection.

Proven leadership

80+ years of combined experience across biotech, drug development and investment.

The deal

Worldwide exclusive licence

In July 2024, T-Balance Therapeutics GmbH and CD4 Therapeutics GmbH, a biotech company based in the Munich area, signed an exclusive binding term sheet granting CD4 Therapeutics worldwide rights to develop and commercialize Tregalizumab.

Investors & partners

Why invest in CD4?

  • First-in-class science — the only Treg-activating monoclonal antibody
  • €10B+ market potential — autoimmune and oncology focus
  • De-risked clinical strategy — proven PoC, targeted success
  • Fast-track regulatory pathways — orphan drug designation potential
  • Clear exit strategies — licensing, M&A, IPO

Team

A world-class team driving breakthrough immunotherapy

CD4 Therapeutics is led by a powerhouse team with a track record of success in drug development, company building, and biotech investment.

Management and founders

  • Dr. Markus A. LangCo-Founder, Chief Executive Officer
  • Stephan WehselauCo-Founder, Chief Financial Officer
  • Dr. Andreas KerstanCo-Founder, Chief Scientific Officer
  • Dr. Thomas BogenriederCo-Founder, Chief Medical Advisor
  • Dr. Anders B. SørensenFunding Investor and Executive Advisor

Scientific and strategic advisors

  • Dr. Cathrin SchleussnerCo-Founder
  • Prof. Dr. med. Robert ZeiserKey Opinion Leader GvHD
  • Prof. Dr. med. Ilona FunkeStrategic Medical Advisor
  • Dr. Tara HeitnerStrategic Business Advisor
  • Prof. Thierry Passeron, MD, PhDStrategic Scientific Advisor, Dermatology and Immunology

Join the next breakthrough in immunotherapy

Let's discuss how you can be part of this high-impact investment. Contact us today and meet the team.

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