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Scaffolds for alternative delivery

Objective

The SME-based SADEL consortium intends to develop the first generation of oral bio-therapeutics tackling disease targets in the digestive tract, by making optimal use of the Nanofitin (Nf) protein scaffold. Nf based drugs will progress through routes not travelled by antibodies while interacting with targets not modulated by chemical compounds.

Existing Nf hits against validated targets will progress to the preparation of Phase I Clinical trials in Ulcerative Colitis (UC). To achieve this, SADEL assembles a virtual biopharmaceutical company with SMEs (70%), academics, clinicians and pharma industry with all cutting-edge skills: production (including GMP), analytics, formulation, preclinical and clinical development, up to licensing.

Nfs are small (optimal tissue penetration), exhibit strong resistance to pH and human intestinal fluids (long half-life in digestive track) and their high affinity implies low effective concentration. They also demonstrate strong potential for optimizing pharmacological properties, including reducing immunogenicity.

The Nf based drugs will be administered orally, reducing the systemic exposure and avoiding the safety issues reported with systemic administration of antibodies. This requires large quantities of proteins for frequent administration. Nfs are produced in bacterial systems for which GMP-compliant processes are broadly adopted in the industry, with a low cost of goods. The resulting proteins will be formulated for optimal release at the sites of action.

The project is designed to address unmet technical challenges while avoiding external risks beyond those related to the scaffold behaviour itself. All additional elements are chosen for documented validation, from targets to evaluation protocols.

Achieving SADEL aims will solve unmet patient needs by providing affordable, safe, efficient products in a format raising comfort and compliance to treatment. It will also assess the therapeutic potential of the Nanofitin platform.

Field of science

  • /natural sciences/biological sciences/biochemistry/biomolecules/proteins
  • /medical and health sciences/clinical medicine/gastroenterology/inflammatory bowel disease

Call for proposal

FP7-HEALTH-2011-two-stage
See other projects for this call

Funding Scheme

CP-FP - Small or medium-scale focused research project

Coordinator

INNOVHUB - STAZIONI SPERIMENTALI PER L'INDUSTRIA SRL
Address
Via Meravigli 9 B
20123 Milano
Italy
Activity type
Research Organisations
EU contribution
€ 283 613
Administrative Contact
Ilaria Bonetti (Ms.)

Participants (9)

ELAN PHARMA INTERNATIONAL LIMITED

Participation ended

Ireland
Address
Treasury Building, Lower Grand Canal Street
Dublin 2
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
William Daniel (Dr.)
AFFILOGIC
France
EU contribution
€ 995 951,74
Address
Bio Ouest 21 Rue La Noue Bras De Fer
44200 Nantes
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Olivier Kitten (Mr.)
BIOMEDICAL SCIENCES RESEARCH CENTER ALEXANDER FLEMING
Greece
EU contribution
€ 292 320
Address
Fleming Street 34
16672 Vari-athens
Activity type
Research Organisations
Administrative Contact
George Kollias (Dr.)
INTESTINAL BIOTECH DEVELOPMENT
France
EU contribution
€ 1 055 016,26
Address
Boulevard Du Prof Jules Leclercq, Faculte De Medecine Pole Recherche Amphi J&k
59045 Lille
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Nghiep Truong Tan (Dr.)
EUROPEAN CROHN'S AND COLITIS ORGANISATION
Austria
EU contribution
€ 74 896
Address
Ungargasse 6/13
1030 Wien
Activity type
Research Organisations
Administrative Contact
Nicole Eichinger (Mrs.)
UNIVERSITE DE GENEVE
Switzerland
EU contribution
€ 723 544
Address
Rue Du General Dufour 24
1211 Geneve
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Leonardo Scapozza (Dr.)
GENIBET - BIOPHARMACEUTICALS SA
Portugal
EU contribution
€ 468 796
Address
Avenida Da Republica Quinta Do
2781 901 Oeiras
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Teresa Alves (Dr.)
INSTITUTO DE BIOLOGIA EXPERIMENTAL E TECNOLOGICA
Portugal
EU contribution
€ 921 110,40
Address
Avenida Da Republica Quinta Do Marques
2781-901 Oeiras
Activity type
Research Organisations
Administrative Contact
Manuel Carrondo (Prof.)
FERRING PHARMACEUTICALS AS
Denmark
EU contribution
€ 136 545
Address
Kay Fiskers Plads 11
2300 Kobenhavn
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Gregoire Schwach (Dr.)