After disappointing data in leukemia, France’s Erytech is refocusing its red blood cell-encapsulated drug therapy to solid tumors—and will target triple-negative breast cancer in its next trial.
The Lyon-based biotech says it is preparing for a phase 2 study of Graspa (red-cell encapsulated L-asparaginase or eryaspase) in TNBC, the second solid tumor indication for the therapy after metastatic pancreatic cancer, and it hopes to have the trial underway in the third quarter.
Erytech reported a clinical benefit with the drug in a phase 2b pancreatic cancer trial last year, but also suffered a setback after it failed a test in acute myeloid leukemia (AML), wiping more than a quarter of the value off its share price at a stroke.
It has had earlier success in blood cancers, however, and is currently waiting for a regulatory verdict on a refiled application for Graspa in acute lymphocytic leukemia (ALL) in Europe after withdrawing its first attempt at the end of 2016, while also preparing for a pivotal trial to support a U.S. filing in ALL.
L-asparaginase is already used to treat ALL but is tough to tolerate, and Erytech’s approach of delivering the drug within red blood cells is a way to expand its use. The drug reduces levels of asparaginase within tumor cells, starving them of an essential nutrient that helps to drive cell division.
The pancreatic cancer data showed that adding Graspa to chemotherapy achieved a 40% reduction in death rate compared to chemo alone. Erytech is hopeful it can show a similar benefit in TNBC, which is the most commonly diagnosed cancer in women globally—with nearly 1.8 million new cases diagnosed annually.
It’s another big potential indication that could erase the disappointment of the AML study if all goes according to plan, and it builds on recent data published in the journal Nature which suggested that depriving breast cancer cells of asparagine can reduce metastatic progression.
“TNBC is a heterogenous subgroup of breast cancer associated with poor patient outcome and high risk of recurrence compared to other breast cancer subtypes,” commented Iman El-Hariry, M.D., Ph.D., Erytech’s chief medical officer. “Aside from BRCA1/2 mutation status, treatment options for TNBC remain limited,” he added.