What Topas Therapeutics does

Topas Therapeutics GmbH is a privately held, clinical-stage biotechnology company headquartered in Hamburg, Germany, spun out of Evotec AG in March 2016 around a proprietary nanoparticle platform licensed from University Medical Center Hamburg-Eppendorf (UKE). The company is developing the Topas Particle Conjugates (TPC) platform — polymer-coated iron oxide nanoparticles conjugated with disease-relevant peptide antigens — which are engineered for targeted delivery to liver sinusoidal endothelial cells (LSECs) to induce antigen-specific immune tolerance via regulatory T cells (Tregs). The platform is designed to be antigen-agnostic, with rapid systemic clearance intended to limit off-target immune effects, and has been applied across multiple autoimmune and immune-mediated indications.

The company has advanced two candidates into the clinic. The lead asset, TPM502, targets celiac disease using gluten-derived peptides restricted to HLA-DQ2.5; a 38-patient Phase 2a trial (NCT05660109) reported in October 2024 a significant dose-dependent reduction in IL-2 and IFN-γ release by gluten-specific T cells, an increase in gluten-specific regulatory CD4+ T cells, and a favorable safety profile, supporting progression into a global Phase 2b. The second asset, TPM203, couples a desmoglein-3 peptide for pemphigus vulgaris and completed Phase 1 with good safety and PK data, published in the British Journal of Dermatology in August 2025. Earlier-stage programs extend the platform into multiple sclerosis, rheumatoid arthritis, and Type 1 diabetes.

Topas operates a B2B pharmaceutical partnership model. The company generates value through out-licensing and option-driven co-development agreements — currently with Eli Lilly (multi-year research and option agreement signed August 2017) and Boehringer Ingelheim (multi-year collaboration signed April 2018 focused on anti-drug antibodies) — and through continued academic collaboration with UKE's Collaborative Research Center 841 on liver inflammation. The company has raised EUR 58 million cumulatively across a Series A (EUR 14M in March 2016 led by Epidarex Capital, extended to EUR 18M in November 2017) and a Series B (EUR 22M in October 2020 co-led by Vesalius BioCapital III and BioMedPartners, extended by EUR 18M in July 2021). It has no commercial products and no disclosed revenue, with a 51-100 employee headcount focused on CMC, translational science, and clinical development.

Name

Topas Therapeutics

Legal name

Topas Therapeutics GmbH

Website

https://topas-therapeutics.com

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

51–100 employees

Short description

Topas Therapeutics is a Hamburg-based, clinical-stage biotech developing the Topas Particle Conjugates (TPC) nanoparticle platform to induce antigen-specific immune tolerance in autoimmune diseases, with lead candidate TPM502 in Phase 2a for celiac disease and TPM203 in Phase 1 for pemphigus vulgaris, monetized through Big Pharma licensing and co-development partnerships.

Ownership category

akta.pro rank

Product category

Biopharmaceutical Therapeutics (Immune Tolerance)

NAICS

Pharmaceutical Preparation Manufacturing (325412), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Immunology & Autoimmune Specialty Pharmaceuticals (HLAIACAB)

Keywords

• Autoimmune disease therapeutics
• Nanoparticle drug delivery
• Immune tolerance induction
• Biopharmaceutical drug development
• Clinical-stage biotechnology

Headquarters

HQ city

Hamburg

HQ country

Germany

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Pharmaceutical Licensing and Partnership Deals: Topas Therapeutics generates value through licensing its proprietary TPC platform technology and advancing drug candidates through clinical development for partnership with pharmaceutical companies. The company has existing research and option agreements with Eli Lilly and Boehringer Ingelheim, with partners holding options to in-license candidates produced under collaboration.
2. Co-development Agreements: Strategic collaborations where Topas conducts pre-clinical proof-of-principle studies and clinical development in partnership with pharmaceutical companies, with shared development costs and future royalty arrangements.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels4 records

Core offering

Topas Therapeutics is a clinical-stage biopharmaceutical company developing proprietary antigen-coupled nanoparticles (Topas Particle Conjugates, or TPCs) that target liver sinusoidal endothelial cells to induce antigen-specific immune tolerance. Its lead clinical candidate, TPM502, addresses celiac disease and is preparing for a global Phase 2b trial following positive Phase 2a results, while a second candidate, TPM203, targets pemphigus vulgaris. The company pursues pharmaceutical licensing and co-development partnerships to advance and commercialize its pipeline candidates.

Product overview

Topas Therapeutics is a clinical-stage biotech company advancing a proprietary Topas Particle Conjugates (TPC) platform technology for antigen-specific immune tolerance induction. The platform comprises polymer-coated iron oxide nanoparticles that deliver disease-relevant peptide antigens to liver sinusoidal endothelial cells (LSECs) to drive regulatory T cell responses and suppress autoimmune reactions. The company has two clinical-stage candidates: TPM502 (lead program, Phase 2a complete) for celiac disease and TPM203 (Phase 1 complete) for pemphigus vulgaris. The TPC platform is designed to be versatile and scalable, with potential applications across multiple autoimmune and immune-mediated diseases including Type 1 diabetes, multiple sclerosis, and rheumatoid arthritis.

Differentiator

Problem solved

Functional benefit

Products and services

• TPM502 TPM502 is Topas' lead clinical candidate consisting of polymer-coated iron oxide nanoparticles coupled with gluten-specific peptide epitopes for HLA-DQ2.5, designed to induce antigen-specific immune tolerance in celiac disease patients. After positive Phase 2a results demonstrating dose-dependent reduction in IL-2 and IFN-γ release by gluten-specific T cells and durable Treg induction, TPM502 is being prepared for a global Phase 2b trial.
• TPM203 TPM203 is a clinical-stage candidate using desmoglein 3 peptide-coupled tolerizing nanoparticles for the treatment of pemphigus vulgaris, a rare autoimmune skin disease. The Phase 1 trial demonstrated good safety, tolerability, and pharmacokinetics with rapid clearance from circulation, and Phase 1 results were published in the British Journal of Dermatology in August 2025.
• Topas Particle Conjugates (TPC) Platform The TPC Platform is Topas' proprietary, antigen-coupled nanoparticle platform technology: polymer-coated iron oxide nanoparticles conjugated with disease-relevant peptide antigens and engineered for targeted delivery to liver sinusoidal endothelial cells (LSECs) to induce antigen-specific immune tolerance via regulatory T cells. The platform is licensable for use across multiple autoimmune and immune-mediated indications and forms the basis of existing collaborations with Eli Lilly and Boehringer Ingelheim.

Quantifiable outcome

• Significant and dose-dependent reduction in IL-2 and IFN-γ release by gluten-specific T cells observed after TPM502 treatment at highest dose
• +4 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Three partnerships are on record, tiered core.

• Boehringer IngelheimcoreStrategic or Co-development Partner · 24 April 2018Multi-year collaboration and option agreement in immune tolerance to tackle anti-drug antibodies (ADA), with initial focus on next generation vector-based therapeutics. Topas designs, applies and produces tolerizing particles while Boehringer Ingelheim contributes antigen know-how and pharmacology expertise. Boehringer Ingelheim has option to license pre-clinical development candidates for development and commercialization.
• University Medical Center Hamburg-Eppendorf (UKE)coreStrategic or Co-development Partner · 25 January 2018Topas serves as exclusive translational partner for Collaborative Research Center (CRC) 841, 'Liver inflammation: infection, immune regulation and consequences.' The CRC has 25 sub-projects investigating causes and mechanisms of inflammatory liver diseases. Topas will translate research results into clinical development and explore additional applications of immune tolerance approach in various indications.
• Eli Lilly and CompanycoreStrategic or Co-development Partner · 22 August 2017Multi-year research and option agreement focused on antigen-specific tolerance induction with initial focus on external antigens thought to induce inflammation and/or autoimmune disease. Topas responsible for pre-clinical proof-of-principle studies to generate drug candidates. Lilly has option to in-license all candidates produced under collaboration for further development. Topas receives R&D funding and participates in future success of compounds in-licensed by Lilly.

Scale indicators6 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Anokion: Clinical-stage biotech developing antigen-specific immune tolerance therapies for autoimmune diseases (celiac disease, MS, Type 1 diabetes) using a proprietary nanoparticle/liver-targeting platform — directly comparable to Topas' TPC approach and lead celiac indication.
• Cour Pharmaceuticals: Developer of tolerogenic nanoparticle therapies (e.g., CNP-101/TIMP-GLIA for celiac disease, partnered with Takeda) — competes with Topas in antigen-specific tolerance via biodegradable nanoparticles for autoimmune indications.
• Selecta Biosciences (now part of AskBio/AskBio Holdings): Pioneer in ImmTOR tolerogenic nanoparticle platform for autoimmune disease and gene-therapy immune tolerance — directly comparable technology category to Topas' TPC platform.

Emerging players

• Paragon Therapeutics / Paragon Therapeutics: Tolerance-focused spinouts and adjacent emerging biotechs working on antigen-specific immune tolerance mechanisms — emerging players in the same autoimmune-tolerance category as Topas.

Broad incumbents

• Eli Lilly: Global pharmaceutical incumbent with a major autoimmune and immunology franchise (Taltz, Olumiant) and existing Topas research/option partner — overlapping therapeutic focus and potential acquirer/partner for TPM502 and platform assets.
• Boehringer Ingelheim: Large pharma with established autoimmune/immunology presence and existing Topas collaboration in anti-drug antibody immune tolerance — strategic partner and broad incumbent in the same disease space.
• Roche: Global pharmaceutical incumbent with deep autoimmune franchise (Actemra, Ocrevus) and historical relationship via Topas' CMO (ex-Roche tocilizumab lifecycle leader) — overlapping space and potential acquirer of differentiated tolerance assets.
• Sanofi: Major autoimmune player (Dupixent) with deep interest in immune tolerance approaches; Topas' CEO Hugo Fry was previously Sanofi UK/Ireland MD, creating potential partnership/M&A adjacency.
• Novartis: Pharma incumbent with strong autoimmune franchise (Cosentyx) and active in immune-mediated disease R&D — relevant comparable for autoimmune therapeutic commercial dynamics and partnering environment.
• AbbVie: Autoimmune leader (Humira, Skyrizi, Rinvoq) facing biosimilar erosion and aggressively seeking next-generation disease-modifying autoimmune assets — representative comparator for autoimmune partnering and acquisition benchmarks.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Funding overview

Funding rounds4 records

Investors7 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Topas Therapeutics