Products

Date: 2017-10-16

Type of information: Granting of the orphan status in the EU

Product name: SAG-101 - adenoviral vector of serotype 5 modified to contain a chimeric sequence consisting of a minimal urokinase-type plasminogen activator receptor promoter preceded by three Notch-responsive elements, and coated with oligopeptide end-modified poly (beta-amino) esters

Compound: adenoviral vector of serotype 5 modified to contain a chimeric sequence consisting of a minimal urokinase-type plasminogen activator receptor promoter preceded by three Notch-responsive elements, and coated with oligopeptide end-modified poly (beta-amino) esters

Therapeutic area: Cancer - Oncology - Rare diseases

Action mechanism:

• immunotherapy product/oncolytic virus/gene therapy. SAG-101, is a Advanced Therapy Medicinal Product (ATMP) that consists of an oncolytic adenovirus named AdNuPARmEIA, coated with a combination of two propietary oligopeptide end-modified poly(?-amino ester) polymers (VIROSHIELD™ technology) for the treatment of Pancreatic Ductal Adenocarcinoma (PDAC).
• ?

Company: Sagetis Biotech (Spain)

Disease: pancreatic cancer

Latest news:

• • On October 16, 2017, the  European Commission has granted orphan designation for SAG-101, Sagetis Biotech's polymer-coated adenovirus for the treatment of pancreatic cancer.
• • On June 21, 2017, Sagetis Biotech announced that it has been granted Advanced Therapy Medicinal Product (ATMP) designation for SAG-101. The Committee for Advanced Therapies (CAT), following consultation with the European Commission, has adopted at its plenary 17 March 2017 a scientific recommendation of the classification of SAG-101. The EMA/CAT considers that product SAG-101, falls within the definition of gene therapy medicinal product.

   

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA:

Orphan status UE: 2017-10-16

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes