ASPAREC

Development of a new recombinant L-asparaginase

ASPAREC est accrédité par Lyonbiopôle

Identity card

Global budget: 3 889 k€

Public funding: 1 704 k€

Public funders: FEDER Rhône-Alpes, Fonds Unique Interministériel (FUI) – DGCIS/Oséo, Grand Lyon, Région Rhône-Alpes

Call for projects: FUI (FUI AAP7)

Year start: 2009

Completed project (2011-12)


Accredited by the French competitiveness cluster Lyonbiopôle


Strategic business area: Human Medicines

Application fields: Oncology, Orphan diseases

Technological approaches / Keywords: Biobank, Biologics, Biomanufacturing, Chemotherapy, Innovative formulation

Stage of development at the beginning of the project: Basic research

Abstract

ASPAREC program aimed at exploring the mechanism of action and initiating the early nonclinical development of Asparec, in order to propose a product for clinical development. Asparec is an innovative PEGylated recombinant Erwinia chrysanthemi L-asparaginase with improved PK/PD properties and reduced immunogenicity as compared to the native enzyme. It is primarily intended for use in the treatment of Acute Lymphoblastic Leukemia. Its therapeutic potential was also evaluated in virus-related leukemia and lymphoma. Based on the results obtained, a Phase I clinical trial has been initiated.


Objectives

Main objectives were as follows: - Perform proof-of-concept studies and pharmacological profiling - Investigate therapeutic of Asparec in the treatment of other hematologic malignancies including virus-related leukemia and lymphoma Specific objectives were as follows: - Scale-up of the manufacturing process - Characterization of the pharmacological and immunogenicity profile - Efficay and safety in experimental models of leukemia - Investigation of the mechanism of action - Physico-chemical and biological characterization of large scale batches


Innovative assets
Highlights
Actual results
Perspectives

Innovative assets

An international PCT patent application was filed in 2010 with the objective of giving Asparec a long patent protection. Orphan Designations have been granted in the US and in the EU which will give an additional protection to Asparec once marketing authorisation is granted and also incentive during the product development.

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