PROVIREX Genome Editing Therapies GmbH

What PROVIREX Genome Editing Therapies GmbH does

PROVIREX Genome Editing Therapies GmbH is a Hamburg-based clinical-stage biotech founded in 2019 as a spin-off from the Leibniz Institute of Virology (LIV) and focused on site-specific recombinase-based genome editing therapies for persistent viral infections. Its lead technology is the proprietary Brec1 recombinase platform, designed to precisely excise integrated HIV-1 proviral DNA from infected host cells with nucleotide precision, functioning independently of host DNA repair and producing error-free recombinants; this technology is in clinical testing in the HIVcure first-in-human Phase Ib/IIa trial at University Medical Center Hamburg-Eppendorf (UKE). The company's portfolio is expanding through RecHTLV, a patent-protected designer recombinase targeting HTLV-1, developed under the TheraImmun project with LIV and funded by a €1.7 million PROFI Transfer Plus award from IFB Hamburg and ERDF.

The company operates Europe's only S3** biosafety cleanroom facility for ATMP manufacturing at the tecHHub in Hamburg-Altona, integrated with seven CliniMACS Prodigy devices from Miltenyi Biotec to enable in-house CAR-T cell production — a capability targeted for GMP certification and official authorization in Q3 2026. This infrastructure underpins the S3LTEC sub-brand, through which PROVIREX offers contract manufacturing services to academic institutions, the 44 qualified CAR-T treatment centers in Germany, and pharmaceutical companies developing cell and gene therapies. Supporting delivery technologies include the PTX×LNP lipid-based mRNA platform licensed-in from Pantherna Therapeutics for non-viral delivery of Brec1 to CD4+ lymphocytes, and VHH-AAV targeting systems co-developed with LIV.

PROVIREX is pre-revenue, with planned monetization through one-time licensing or commercialization of approved gene therapies and CMO service fees once GMP authorization is secured. The investor base comprises Ascenion GmbH, IFB Innovationstarter GmbH / Innovationsstarter Fonds Hamburg GmbH, and Bioventure (lead investor from the 2022 Series A). The leadership team combines the scientific founders who pioneered recombinase-based HIV excision at LIV (Prof. Joachim Hauber, Prof. Frank Buchholz, PD Dr. Jan Chemnitz, Dr. Maike Voges, Dr. Niklas Beschorner, Dr. Ilona Hauber, and CFO Oliver Ahnfeld) with newly appointed CEO and Partner Dr. Jan-Uwe Claas, who joined in March 2025 with over 25 years of biotech and pharma experience.

Name

PROVIREX Genome Editing Therapies GmbH

Legal name

PROVIREX Genome Editing Therapies GmbH

Website

https://provirex.de

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

11–50 employees

Short description

PROVIREX is a Hamburg-based clinical-stage biotech developing site-specific recombinase genome-editing therapies, with a proprietary Brec1 platform in first-in-human trials for an HIV functional cure, an HTLV-1 program, and Europe's only S3** cleanroom-based CAR-T cell manufacturing services under the S3LTEC sub-brand.

Ownership category

akta.pro rank

Product category

Gene Therapy & Genome Editing Biotechnology

NAICS

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

SIC

Services-Commercial Physical & Biological Research (8731), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Genome Editing Gene Therapies (CRISPR/TALEN/ZFN; in vivo/ex vivo) (HLAAACAD)

akta.pro secondary industries

Lentiviral Vector Gene Therapy Developers (HLAAACAB), AAV Vector Gene Therapy Developers (HLAAACAA), Cell Therapy Manufacturing Platforms & Automation (closed systems, bioreactors, fill-finish) (HLAAABAG), Gene Therapy Regulatory, Pharmacovigilance & Clinical Operations Services (HLAAACAM)

Keywords

• Gene therapy development
• Genome editing therapeutics
• HIV cure research
• CAR-T cell production
• ATMP manufacturing

Headquarters

HQ city

Hamburg

HQ country

Germany

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Technology or R&D, Personnel, Infrastructure, Operations, Supply Chain

Revenue model

1. Gene Therapy Development: Pre-revenue biotech company developing genome editing therapies. Revenue will be generated through successful clinical development and commercialization of HIV cure therapy and other gene therapies. Currently in clinical development stage with first-in-human trial.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels4 records

Core offering

PROVIREX Genome Editing Therapies GmbH is a clinical-stage biotech company developing site-specific recombinase-based genome editing therapies to functionally cure HIV and treat other persistent viral infections. Its proprietary Brec1 recombinase platform precisely excises integrated HIV-1 proviral DNA from infected host cells, and the RecHTLV designer recombinase targets HTLV-1. The company also operates S3LTEC, a CAR-T cell manufacturing service utilizing Europe's only S3** biosafety cleanrooms for ATMP production.

Product overview

PROVIREX Genome Editing Therapies GmbH is a pioneering biotech company developing genome editing therapies for persistent viral infections. The company's portfolio centers on two proprietary recombinase platforms: the Brec1 platform for HIV cure (under clinical investigation in the HIVcure Phase Ib/IIa trial) and the RecHTLV recombinase for HTLV-1 treatment (in the TheraImmun project). The company operates S3LTEC, its CAR-T cell manufacturing arm with Germany's only S3** cleanroom facility, offering GMP-compliant cell therapy production services. Supporting technologies include PTX×LNP lipid-based mRNA delivery (via Pantherna collaboration) and VHH-AAV targeting systems (via LIV collaboration). The company is spin-off from the Leibniz Institute of Virology, founded in 2019 and based in Hamburg, Germany.

Differentiator

Problem solved

Functional benefit

Brands

• S3LTEC: A CMO (Contract Manufacturing Organization) services brand providing cleanroom facilities for ATMP manufacturing and CAR-T cell production in Hamburg.

Products and services

• Brec1 Recombinase Platform Proprietary site-specific recombinase-based genome editing technology that precisely excises integrated HIV-1 proviruses from the genome of infected host cells with high specificity and nucleotide precision, producing error-free recombinants without relying on host DNA repair mechanisms. Used for functional cure of HIV.
• RecHTLV Designer Recombinase Proprietary and patent-protected designer recombinase that specifically excises integrated HTLV-1 (Human T-lymphotropic virus 1) proviral genomes from infected immune cells, delivered via adeno-associated viral vectors (AAV) engineered with VHH antibody fragments for precise targeting.
• S3LTEC CAR-T Cell Production Services Contract manufacturing organization (CMO) services offering cleanroom-based CAR-T cell manufacturing utilizing S3** biosafety infrastructure unique in Germany, enabling production of personalized cell therapies for hematological malignancies including for people with HIV. Features GMP-compliant facilities with seven CliniMACS Prodigy automated devices.
• HIVcure Phase Ib/IIa Clinical Trial Program First-in-human Phase Ib/IIa clinical trial evaluating Brec1 recombinase therapy for functional cure of HIV, involving gene editing of patient's peripheral blood hematopoietic stem cells at University Medical Center Hamburg-Eppendorf (UKE).
• TheraImmun Modular Gene Therapy Platform Modular gene therapy platform for targeted modification of immune cells using proprietary recombinases and advanced AAV delivery systems, initially focused on HTLV-1 treatment with potential expansion to other retroviral diseases.

Quantifiable outcome

• Plasma viral load declines to levels below detection limits of most sensitive assay systems
• +2 more outcomes

Named customers2 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Six partnerships are on record, tiered core and minor.

• Miltenyi BioteccoreTechnology or Integration · 24 November 2025Strategic partnership with seven CliniMACS Prodigy devices from Miltenyi Biotec installed for automated CAR-T cell production. Joint development activities planned for pioneering cell and gene therapy solutions.
• Leibniz Institute of Virology (LIV)coreStrategic or Co-development Partner · 29 July 2025Joint project TheraImmun awarded €1.7 million funding through PROFI Transfer Plus program. Combines PROVIREX's patented gene editing technology with LIV's expertise in VHH-AAV delivery systems for developing a modular gene therapy platform targeting HTLV-1. LIV spin-off origin of PROVIREX.
• Pantherna Therapeutics GmbHcoreTechnology or Integration · 1 March 2020Research collaboration to develop and evaluate Pantherna's proprietary PTXxLNP delivery technology based on novel lipid-based mRNA formulations for transfecting CD4+ lymphocytes with PROVIREX's Brec1 genome editing tool for non-viral delivery.
• University Medical Center Hamburg-Eppendorf (UKE)coreStrategic or Co-development PartnerClinical trial partner for HIVCure Phase Ib/IIa first-in-human trial testing Brec1 technology. Collaboration on novel HIV therapy development funded by IFB Hamburg PROFI program for four years.
• TU DresdencoreStrategic or Co-development PartnerResearch collaboration with Prof. Frank Buchholz (co-founder) who serves as professor for medical systems biology and Dean of Research at TU Dresden Medical Faculty. Contributed to HTLV-1 provirus excision research milestone.
• Friedrich Alexander University Erlangen-Nuremberg (FAU)minorStrategic or Co-development PartnerAcademic research partner in HTLV-1 project collaboration with TU Dresden and PROVIREX for therapeutic approach against T-cell leukemia trigger.

Scale indicators5 records

Recent moves6 records

Expansion highlights6 records

Others

• Miltenyi Biotec: Global cell and gene therapy technology provider and PROVIREX's strategic partner, supplying CliniMACS Prodigy devices and co-developing CAR-T workflows. Comparable as an enabling technology and ecosystem participant.
• Pantherna Therapeutics: German biotech developing lipid nanoparticle (LNP) delivery technologies for mRNA therapeutics. PROVIREX's research collaboration partner for non-viral delivery of Brec1 — adjacent infrastructure enabler.

Regional players

• Medigene AG: German-listed clinical-stage immuno-oncology company developing TCR-based therapies and cell therapy platforms. Comparable as a Germany-based clinical-stage cell/gene therapy peer of similar scale and stage.

Emerging players

• Adaptimmune Therapeutics: Clinical-stage cell therapy company developing engineered TCR therapies. Comparable as a clinical-stage cell/gene therapy peer competing for similar partnerships and capital.
• Cellectis: Clinical-stage gene editing company using TALEN and other nucleases for allogeneic CAR-T and gene therapy. Comparable in combining gene editing technology with CAR-T cell manufacturing, mirroring PROVIREX's dual platform approach.
• Beam Therapeutics: Clinical-stage base editing company developing precision genetic medicines. Comparable as a next-generation gene editing platform peer competing for the same therapeutic gene editing capital and partnerships.

Broad incumbents

• CRISPR Therapeutics: Leading commercial-stage CRISPR/Cas9 gene editing company with a broad pipeline across hemoglobinopathies, oncology, and regenerative medicine. Represents the dominant competing modality in genome editing.
• Editas Medicine: Clinical-stage CRISPR and Cas12a gene editing company with oncology and rare disease programs. Comparable as a genome editing platform peer, though not focused on viral cure indications.

Direct peers

• Sangamo Therapeutics: Pioneer in zinc finger nuclease and genome editing, with historical programs in HIV and recombinase-adjacent platforms. Closest mechanistic analog to PROVIREX's site-specific recombinase approach.
• Excision BioTherapeutics: Clinical-stage gene therapy company developing CRISPR-based therapies targeting HIV, the same indication as PROVIREX's lead HIVcure program. Direct competitor in the HIV-cure gene-editing space.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/provirex

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Funding overview

Funding rounds

Investors

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 PROVIREX Genome Editing Therapies GmbH