ERYTECH Pharma, a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating drug substances inside red blood cells, announced the opening of its new Princeton GMP manufacturing facility.
The facility will support production capacity needs for eryaspase, the company’s lead product candidate for patients in the United States. Eryaspase is in Phase 3 clinical development for the treatment of second-line pancreatic cancer. The Phase 3 clinical trial, which is referred to as the Trybeca-1 trial is expected to enroll approximately 500 patients with second-line metastatic pancreatic cancer at approximately 120 clinical sites in Europe and the United States. The trial started enrolling patients in Europe in September 2018 and is now actively enrolling patients in several European countries. The Princeton facility is targeted to begin manufacturing eryaspase in the fourth quarter of this year to ensure supply for US participants in the Trybeca-1 trial.
The Princeton facility is equipped with multiple clean rooms, with flexibility designed into its configuration and staffing for further scale-up, in view of supplying eryaspase for this Phase 3 and other clinical trials, as well as for the initial expected commercial demand in the United States, if approved.
“The official inauguration of the Princeton facility last week represents our strong commitment to the United States and the technologic transferability of our ERYCAPS platform”, said Gil Beyen, CEO of Erytech. “The investment we see coming to fruition today signals the company’s growth and ushers in hope for the numerous cancer patients we are dedicated to serve.”
Speakers at the site inauguration included Pancreatic Cancer Expert Physician Marcus Noel, MD, and Kerry McKean Kelly, founder of Kelly’s Heroes patient advocacy group. Comments were also shared by the local Mayor, Hemant Marathe, ERYTECH’s Facility Project Leader, Siera Talbott, and CFO/COO, Eric Soyer.
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