ERYTECH Provides Update on the TRYbeCA-1 Phase 3 Clinical Trial of Eryaspase in Second Line Pancreatic Cancer - Seite 2

With more than 75% of the patients enrolled in the trial, the Company believes that the planned interim superiority analysis, to be conducted by an IDMC when two-thirds of the total death events have been reached, will not be significantly affected by the expected delay in enrollment. However, based on recent tracking of the total death events in the trial, the average time to event appears longer than originally anticipated. As a result, the Company now expects to report the interim analysis around year-end 2020 and the final analysis in the second half of 2021.

About TRYbeCA-1

TRYbeCA-1 is a randomized, controlled Phase 3 clinical trial evaluating eryaspase in second-line metastatic pancreatic cancer. The trial is designed to enroll approximately 500 patients at approximately 100 clinical sites in Europe and the United States. Eligible patients are randomized 1-to-1 to receive eryaspase in combination with standard chemotherapy (gemcitabine/nab-paclitaxel or an irinotecan-based regimen) or chemotherapy alone. The primary endpoint of TRYbeCA-1 is overall survival. An interim superiority analysis will be conducted when approximately two-thirds of the events have occurred.

About ERYTECH and eryaspase: www.erytech.com

ERYTECH is a clinical-stage biopharmaceutical company developing innovative red blood cell-based therapeutics for severe forms of cancer and orphan diseases. Leveraging its proprietary ERYCAPS platform, which uses a novel technology to encapsulate drug substances inside red blood cells, ERYTECH is developing a pipeline of product candidates for patients with high unmet medical needs. ERYTECH’s primary focus is on the development of product candidates that target the altered metabolism of cancer cells by depriving them of amino acids necessary for their growth and survival.

The Company’s lead product candidate, eryaspase, which consists of L-asparaginase encapsulated inside donor-derived red blood cells, targets the cancer cell’s altered asparagine and glutamine metabolism. Eryaspase is in Phase 3 clinical development for the treatment of second-line pancreatic cancer and in Phase 2 development for the treatment of first-line triple-negative breast cancer. An investigator-sponsored Phase 2 trial in second-line acute lymphoblastic leukemia is ongoing in the Nordic countries of Europe.