Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
biotechnology scientist using scientific microscope for research in biology medicine laboratory, equipment for chemistry science or microbiology analysis in term of medical technology experiment

Proof of Concept and Clinical Trials

The Innovations area focuses on developing and conducting innovative diagnostic and therapeutic studies, with a particular emphasis on immunomodulated inflammatory diseases. Core expertise includes designing, drafting, organizing, and project-managing clinical studies, as well as analyzing and interpreting the resulting data — as a central interface to the institute’s competencies in medicine, data science, and preclinical research. An established, quality-controlled infrastructure enables conducting clinical studies — particularly investigator-initiated studies under Fraunhofer Society sponsorship — as an independent research organization, funded, but also in collaboration with academic and industrial partners, to realize patient-relevant, quality-assured study and research projects. All studies are developed and implemented in accordance with the highest regulatory and scientific standards.

 

Core Expertise:

  • Broad and deep medical expertise in immunomodulated diseases at site-specific focus areas, plus implementation of innovative endpoints
  • Close network and local access to university clinics with patient access across indications
  • Experience in Investigator-Initiated Trials and sponsor oversight, leveraging in-house expertise in project management, medical writing, statistics, data management, pharmacovigilance, and monitoring
  • Management of clinical infrastructure for all study phases (Phase I–III) based on solid knowledge of ICH-GCP and European and national regulations
  • Interdisciplinary interface competence (preclinical, medical, data science – university clinic partners)

 

Objectives/Services:

  • Conception of clinical studies leveraging medical expertise and innovative endpoints in line with "Quality by Design"
  • Definition and access to suitable study populations through close collaboration with university clinics at the sites, aligned with their focus areas
  • Infrastructure for conducting ICH-GCP compliant single- and multi-center clinical studies (Investigator-Initiated Trials, IIT) in the drug field under Fraunhofer Society sponsorship or with external sponsors in immunomodulated diseases, per medical expertise at the sites, including medical devices – national and multinational
  • Focus on PoC (Proof of Concept) studies with interfaces to preclinical, medical, and data science
  • Infrastructure for early clinical studies (first-in-human / Phase I), and a study clinic for Phases II–III
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SPLENDID-Study

An open label, phase I/II study investigating the safety and efficacy of the bispecific T-cell engaging antibody cizutamig (BCMAxCD3) in patients with immune-mediated inflammatory diseases – the SPLENDID Trial.

Further Informations

RENEWAL-Study

An open label, phase I/II study investigating the safety and efficacy of a CD3/CD20 bispecific T-cell engager therapy in patients with active, treatment refractory, ANCA-IgG-positive associated vasculitis.

Further Informations

DEXAD

Randomized, placebo-controlled clinical trial to investigate the safety and efficacy of two dexamfetamine sulfate formulations in adults with ADHD and moderate to severe depression (DEXAD)

Further Informations

PrevTel

Proof-of-Concept study to evaluate the efficacy and safety of the drug candidate TMP002 for the prevention of chemotherapy-induced neuropathic pain in a high-risk population - PrevTel Partners: Helmholtz Association and Goethe University Frankfurt. This study was conducted under the Proof-of-Concept Initiative.

Further Informations

Clinical Phase-2a-Study

A multicenter, randomized, double-blind, placebo-controlled Phase 2a clinical trial with parallel groups to assess safety, tolerability, and exploratory efficacy of the orthosteric selective muscarinic M1 agonist NSC001 in mild to moderate Alzheimer’s disease.

Further Informations

Koehm M, Rossmanith T, Foldenauer AC, Herrmann E, Brandt-Jürgens J, Burmester GR, Kellner H, Kiltz U, Kofler DM, Rech J, Mojtahed-Poor S, Jonetzko C, Burkhardt H, Behrens F; MUST Investigator Group. Methotrexate plus ustekinumab versus ustekinumab monotherapy in patients with active psoriatic arthritis (MUST): a randomised, multicentre, placebo-controlled, phase 3b, non-inferiority trial.
Lancet Rheumatol. 2023 Jan;5(1):e14-e23.
doi: 10.1016/S2665-9913(22)00329-0.

 

Geladaris A, Torke S, Saberi D, Alankus YB, Streit F, Zechel S, Stadelmann-Nessler C, Fischer A, Boschert U, Häusler D, Weber MS. BTK inhibition limits microglia-perpetuated CNS inflammation and promotes myelin repair.
Acta Neuropathol. 2024 Apr 24;147(1):75
doi: 10.1007/s00401-024-02730-0.

 

Behrens F, Koehm M, Rossmanith T, Alten R, Aringer M, Backhaus M, Burmester GR, Feist E, Herrmann E, Kellner H, Krueger K, Lehn A, Müller-Ladner U, Rubbert-Roth A, Tony HP, Wassenberg S, Burkhardt H. Rituximab plus leflunomide in rheumatoid arthritis: a randomized, placebo-controlled, investigator-initiated clinical trial (AMARA study).
Rheumatology (Oxford). 2021 Nov 3;60(11):5318-5328.
doi: 10.1093/rheumatology/keab153.

 

Häusler D., Häusser-Kinzel S., Feldmann L., Torke S., Lepennetier G., Bernard C.C.A., Zamvil S.S., Brück W., Lehmann-Horn K., Weber M.S. Functional characterization of reappearing B cells after anti-CD20 treatment of CNS autoimmune disease.
Proc Natl Acad Sci U S A. 2018 Sep 25;115(39):9773-9778.
doi: 10.1073/pnas.1810470115

 

Geisen C, Kjaer M, Fleck E, Skogen B, Armstrong R, Behrens F, Bhagwagar Z, Braeuninger S, Mortberg A, Olsen KJ, Gastón Schäfer SM, Walter C, Seifried E, Wikman A, Kjeldsen-Kragh J, Koehm M. An HPA-1a-positive platelet-depleting agent for prevention of fetal and neonatal alloimmune thrombocytopenia: a randomized, single-blind, placebo-controlled, single-center, phase 1/2 proof-of-concept study.
J Thromb Haemost. 2023 Apr;21(4):838-849.
doi: 10.1016/j.jtha.2022.11.041.