CORDIS
EU research results

CORDIS

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EUROpean consortium for antiCALINs as next generation high-affinity protein therapeutics

Project information

Grant agreement ID: 278408

Status

Closed project

  • Start date

    1 August 2011

  • End date

    30 November 2015

Funded under:

FP7-HEALTH

  • Overall budget:

    € 8 730 394,21

  • EU contribution

    € 5 996 303,50

Coordinated by:

PIERIS PHARMACEUTICALS GMBH

Germany

Objective

The consortium aims to develop and produce an Anticalin, a member of a novel high-affinity scaffold derived from the lipocalin protein family. The Anticalin is specific for hepcidin which is a central regulator of iron homeostasis, and will be used to antagonize hepcidin for the treatment of “anemia of chronic disease” (ACD). Anticalins are genetically modified lipocalins that can target almost any desired molecule. Unlike Immunoglobulins, they can be produced at low cost in microbial expression systems, are expected to be non immunogenic and offer therapeutic advantages where antibody effector functions are not desired. ACD, the most frequent anemia in hospitalized patients, develops in subjects suffering from infections, inflammatory and auto-immune disease, cancer and chronic kidney disease. It is often successfully treated by administering Erythropoiesis-Stimulating Agents. However, a significant number of patients are hypo- or non-responsive to ESA. Anti-hepcidin therapies, alone or together with ESAs, may improve anemia and the patients’ erythropoietic response and enable the use of no or even much lower ESA doses, avoiding the potential detrimental effects of high doses of ESA. The Consortium has already generated proof-of-concept data in an animal model with early candidates. The project aims at identifying, validating, and developing a specific, high affinity drug candidate based on the lipocalin scaffold as promising alternatives to immunoglobulins and a therapeutic approach based on the neutralization of hepcidin. Animal models will be developed and utilized to characterize pharmacokinetic and pharmacodynamic relationships, optimize dosing, to determine safety, biomarker responses and potential synergy with ESA’s. Furthermore, production processes will be optimized leading to a scalable GMP process which provides material for preclinical and clinical studies to establish the safety, tolerability, and PK/PD of an Anticalin hepcidin blocker (Phase Ia/b).

Coordinator

PIERIS PHARMACEUTICALS GMBH

Address

Lise-Meitner-StraSSE 30
85354 Freising

Germany

Activity type

Private for-profit entities (excluding Higher or Secondary Education Establishments)

EU Contribution

€ 2 164 000

Administrative Contact

Rita Fischer (Mrs.)

Participants (10)

TECHNISCHE UNIVERSITAET MUENCHEN

Germany

EU Contribution

€ 261 600

MEDIZINISCHE UNIVERSITAT INNSBRUCK

Austria

EU Contribution

€ 416 200

STICHTING KATHOLIEKE UNIVERSITEIT

Netherlands

EU Contribution

€ 494 340

COVANCE LABORATORIES LTD

United Kingdom

EU Contribution

€ 456 800

ANTITOPE LIMITED

United Kingdom

EU Contribution

€ 263 040

FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED

United Kingdom

EU Contribution

€ 1 109 963,50

CORIOLIS PHARMASERVICE GMBH

Germany

EU Contribution

€ 92 734,16

FGK CLINICAL RESEARCH GMBH

Germany

EU Contribution

€ 271 200

CONSULTECH TECHNOLOGIEBERATUNG GMBH

Germany

EU Contribution

€ 309 800

CORIOLIS PHARMA RESEARCH GMBH*

Germany

EU Contribution

€ 156 625,84

Project information

Grant agreement ID: 278408

Status

Closed project

  • Start date

    1 August 2011

  • End date

    30 November 2015

Funded under:

FP7-HEALTH

  • Overall budget:

    € 8 730 394,21

  • EU contribution

    € 5 996 303,50

Coordinated by:

PIERIS PHARMACEUTICALS GMBH

Germany