ERYTECH Pharma S.A. (ERYP), a clinical-stage biopharmaceutical company developing red blood-cell based cancer therapeutics, has been granted Fast Track designation for its lead drug candidate, Eryaspase, for the treatment of hypersensitive acute lymphocytic leukemia.
Acute lymphoblastic leukemia (ALL) is a cancer of the blood and bone marrow that is the most common type of cancer in children in the US and Europe. Asparaginase has been an integral component of ALL treatment for several years but is associated with treatment limiting hypersensitivity in up to 30% of patients. Discontinuation of asparaginase therapy in ALL patients has been associated with poorer disease-free survival.
Last December, the company reported positive results from a phase II trial of Eryaspase in primarily pediatric acute lymphoblastic leukemia patients who developed hypersensitivity reactions to pegylated asparaginase. The data demonstrated that Eryaspase, in combination with chemotherapy, administered every two weeks, provided a sustained asparaginase enzyme activity level, and was generally well tolerated with few hypersensitivity reactions.
ERYTECH has plans to submit a BLA to the FDA for Eryaspase in hypersensitive acute lymphoblastic leukemia (ALL) patients in the fourth quarter of this year.
Eryaspase is also being evaluated in a phase III trial for the treatment of second-line pancreatic cancer, dubbed TRYbeCA-1.
An interim efficacy and safety analysis of TRYbeCA-1 performed by an independent data monitoring committee (IDMC) in February of this year, found no safety issues. The final results from this trial are expected in the fourth quarter of 2021.
A phase II clinical trial of Eryaspase in combination with gemcitabine and carboplatin compared to chemotherapy alone in triple-negative breast cancer, dubbed TRYbeCA-2, is ongoing, with initial data expected to be reported in the fourth quarter of 2021.
Eryaspase is also being evaluated in a phase I investigator-sponsored trial in first-line pancreatic cancer, dubbed rESPECT. The maximum tolerable dose (*MTD) is expected to be determined in the second half of this year. (*The highest dose of a drug or treatment that does not cause unacceptable side effects is known as MTD – Source: National Cancer Institute).
Cash position:
The company’s cash and cash equivalents were €37.4 million ($43.9 million) at the end of March 2021.
ERYP closed Wednesday’s trading at $4.11, down 4.42%. In after-hours, the stock was up over 140% at $10.20.
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