tiakis Biotech AG
Clinical-stage biopharmaceutical company based in Kiel, Germany, focused on development of an investigational recombinant human protein therapeutic with anti-inflammatory and tissue-protective properties for indications with high unmet medical need (notably pulmonary arterial hypertension, prevention of postoperative inflammatory complications and acute inflammatory lung disease). The company conducts preclinical research, GLP-compliant testing, clinical development (Phase I to Phase II), and collaborates with CDMOs and academic partners to scale manufacturing and run clinical trials.
Industries
N/A
Nr. of Employees
small (1-50)
tiakis Biotech AG
Products
Investigational recombinant human protease-inhibitor therapeutic (recombinant protein candidate)
Clinical-stage recombinant human protein therapeutic developed as an anti-inflammatory and tissue-protective agent; being developed for pulmonary arterial hypertension, prevention of postoperative inflammatory complications following major surgery, and treatment of severe inflammatory lung disease.
Investigational recombinant human protease-inhibitor therapeutic (recombinant protein candidate)
Clinical-stage recombinant human protein therapeutic developed as an anti-inflammatory and tissue-protective agent; being developed for pulmonary arterial hypertension, prevention of postoperative inflammatory complications following major surgery, and treatment of severe inflammatory lung disease.
Services
Partnering for research collaborations, clinical program internationalization, regulatory support, market preparation, and licensing or co-development arrangements for biopharmaceutical candidates.
Partnering for research collaborations, clinical program internationalization, regulatory support, market preparation, and licensing or co-development arrangements for biopharmaceutical candidates.
Expertise Areas
- Clinical trial management (Phase I–II)
- Biologics process development and scale-up
- Recombinant protein therapeutic development
- Preclinical translational research
Key Technologies
- Recombinant protein production
- Industrial-scale fermentation (stainless-steel bioreactors, up to 3,000 L)
- Rodent disease models (neonatal lung injury, PAH models)
- Pharmacokinetic assays
News & Updates
Academic partner received NIH funding to run a U.S. Phase II trial of the company’s investigational recombinant protein therapeutic in pulmonary arterial hypertension; first patients expected mid-2026.
U.S. regulatory authority provided supportive scientific advice on a planned randomized Phase II trial (ATHENA) including primary and secondary endpoints for pulmonary arterial hypertension.
Randomized, double-blind, placebo-controlled Phase Ib/II trial in hospitalized COVID-19 patients reported safety, tolerability and exploratory efficacy signals; pharmacokinetics showed no plasma accumulation.
Completed technology transfer and manufacturing ramp-up with a CDMO enabling industrial fermentation-scale production of clinical trial material (3,000 L stainless-steel fermenter train).
First participant dosed in a nationwide Phase Ib/II trial evaluating the investigational recombinant protein therapeutic in hospitalized COVID-19 patients.
Competent authority inspection confirmed GLP-compliant archival and test-site procedures supporting in-house development activities.
Academic partner received NIH funding to run a U.S. Phase II trial of the company’s investigational recombinant protein therapeutic in pulmonary arterial hypertension; first patients expected mid-2026.
U.S. regulatory authority provided supportive scientific advice on a planned randomized Phase II trial (ATHENA) including primary and secondary endpoints for pulmonary arterial hypertension.
Randomized, double-blind, placebo-controlled Phase Ib/II trial in hospitalized COVID-19 patients reported safety, tolerability and exploratory efficacy signals; pharmacokinetics showed no plasma accumulation.
Completed technology transfer and manufacturing ramp-up with a CDMO enabling industrial fermentation-scale production of clinical trial material (3,000 L stainless-steel fermenter train).
First participant dosed in a nationwide Phase Ib/II trial evaluating the investigational recombinant protein therapeutic in hospitalized COVID-19 patients.
Competent authority inspection confirmed GLP-compliant archival and test-site procedures supporting in-house development activities.