Originally published Feb. 16.
By Turna Ray
Erytech Pharma is embarking on a research collaboration with MD Anderson Cancer Center to validate a biomarker associated with response to an investigational drug, called Graspa, in solid tumor cancers.
Graspa, Erytech's flagship product, has completed Phase II studies in acute lymphoblastic leukemia. The company claims Graspa is a new enzyme formulation of L-asparaginase that has shown promise in clinical studies for increased efficacy and fewer side effects in ALL patients compared to other asparaginase formulations.
Researchers at MD Anderson have identified a biomarker, asparagine synthetase, that they believe may predict the activity of L-ASP against solid tumors.
The aim of the collaboration with MD Anderson "is to have a companion test for Graspa and to stratify [patients] according to the level of asparagine synthetase in their tumor cells," Yann Godfrin, CEO of Erytech Pharma, told Pharmacogenomics Reporter this week.
In January, the US Food and Drug Administration granted Graspa an orphan drug designation in ALL. "Discussions are ongoing with US key opinion leaders to initiate new clinical trials with Graspa. This orphan drug designation is the first achievement of our US strategy in 2010," Godfrin said in a statement. "As such, Erytech Pharma is now positioned to continue its expansion in the US."
One part of this expansion strategy includes research to broaden Graspa's indication as a treatment for solid tumor cancers. John Weinstein, chair of the department of bioinformatics and computational biology at MD Anderson and the principal investigator of the project, noted in a statement that although L-ASP is a standard component of leukemia chemotherapy regimens, it has shown inconsistent efficacy when used in the treatment of solid tumors.
However, with the identification of the potential response biomarker, MD Anderson researchers think L-ASP treatments such as Graspa may be efficacious in solid tumors.
Philip Lorenzi, supervisor of laboratory and research at MD Anderson's department of bioinformatics and computational biology and another project leader, added that researchers are interested in studying Graspa's reduction of L-ASP side effects.
L-asparaginase formulations has been used as part of combination chemotherapy regimens in ALL for more than three decades. The enzyme diminishes the plasmatic amino acid asparagine, which leukemia cells need for malignant growth.
Although Godfrin did not detail the design of the biomarker study to be conducted with MD Anderson, he noted that the study will use "a large number" of patient samples in multiple tumor types.