French Erytech Pharma has announced positive results from its Phase IIb study for its lead candidate GRASPA to treat patients with pancreatic cancer.
Erytech Pharma is developing an innovative cancer treatment, which uses red blood cells to deliver drugs that target the tumor metabolism and cause starvation of tumor cells. The company has now reported positive results of its Phase IIb study, evaluating GRASPA (eryaspase) in combination with standard of care chemotherapy in patients with metastatic pancreatic cancer. The treatment met its primary endpoints of primary progression-free survival and overall survival in patients with low asparagine synthetase (ASNS).
GRASPA is made up of red blood cells, which carry the encapsulated enzyme L-asparaginase. This enzyme depletes the important amino acid asparagine from the bloodstream and thereby leads to starvation of the cancer cells. Unlike normal cells, cancer cells are often not able to produce this amino acid themselves and therefore depend on the blood supply of this nutrient.
At the same time, encapsulation within the red blood cells protects the drug from degradation and reduces adverse effects of the enzyme such as toxicity and allergic reactions.
Erytech recently experienced a setback, when EU marketing approval of GRASPA for the treatment of acute lymphoblastic leukemia (ALL) was delayed due to missing data, but the company is planning on re-submitting its application in mid-2017.
After the candidate already proved effective in a Phase II/III study for the treatment of ALL, the current 140-patient Phase IIb study could show that GRASPA is also effective in patients with pancreatic cancer. The drug has demonstrated a 43% reduction in risk of death in this very difficult-to-treat patient population and was generally well tolerated.
Pancreatic cancer remains one of the most deadliest cancers and current treatment options are limited. Erytech seems to be in a good position to augment treatment possibilities and the company has already been granted orphan drug designation for GRASPA from both FDA and EMA.
Companies such as Rubius Therapeutics in the US have already joined Erytech on their new drug delivery approach, but with the current clinical progress, Erytech seems to be pioneering the field. The company is also exploring the use of its platform for developing cancer vaccines and enzyme replacement therapies.
We will now explore the path forward with clinicians and regulators to bring eryaspase to patients with metastatic pancreatic cancer as soon as possible. The results of this study not only reinforce the role of eryaspase in the treatment of this disease, they also provide further rationale for its evaluation in other tumor types,” commented Gil Beyen, CEO of Erytech.
Images via Tatiana Shepeleva / shutterstock.com and Erytech.com