Greater than 50% enrollment achieved in ongoing Phase 3 trial of eryaspase in pancreatic cancer
Trial in Progress Poster selected for inclusion in Poster Walk
LYON, France and CAMBRIDGE, Mass., Jan. 24, 2020 (GLOBE NEWSWIRE) -- ERYTECH Pharma (Euronext: ERYP - Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating drug substances inside red blood cells, today announced the presentation of a Trial in Progress Poster for the ongoing Phase 3 TRYbeCA1 trial evaluating eryaspase in second-line pancreatic cancer at the American Society of Clinical Oncology (ASCO) 2020 Gastrointestinal Cancers Symposium in San Francisco.
TRYbeCA1 is planned to enroll approximately 500 patients in approximately 100 clinical sites in Europe and the U.S. In this trial, 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. To date, more than 50% of the patients for TRYbeCA1 have been enrolled. The primary endpoint of TRYbeCA1 is overall survival with an interim efficacy analysis planned for when approximately two-thirds of events have occurred.
Along with the U.S., clinical trial authorizations have been obtained for TRYbeCA1 in eleven European countries with the trial actively enrolling patients in more than 50 clinical sites.
“TRYbeCA1 continues to remain on track with well over half of the planned number of patients having been enrolled in the trial. We are encouraged by the level of enthusiasm from both European and US investigators and growing interest in TRYbeCA1 as highlighted by the inclusion of our poster in the Poster Walk at this meeting,” stated Iman El-Hariry, Chief Medical Officer of ERYTECH. “With the enrollment trajectory in Europe and additional enrollment from U.S. trial sites, we expect that an interim superiority analysis of TRYbeCA1 will take place in the third quarter of 2020, as planned”.
“There remains a high unmet need for advances in the treatment of advanced pancreatic cancer,” stated Dr. Manuel Hidalgo, Chief of the Division of Hematology and Medical Oncology and Senior Member of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center, and co-Prinicipal Investigator of the TRYbeCA1 trial. “The TRYbeCA1 trial represents an important clinical trial option for metastatic pancreatic cancer patients in both the US and Europe who have progressed on first-line chemotherapy.”
Details of the poster presentation:
TRYbeCA1: A randomized, phase III study of eryaspase in combination with chemotherapy versus chemotherapy alone as second-line treatment in patients with pancreatic adenocarcinoma (NCT03665441).
Friday January 24, 2020, 12:00pm-1:30pm, 4:30pm-5:30pm; Poster Walk 4:45pm-5:30pm
Level 1 West Hall, Moscone West Building
About ERYTECH: 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 for the treatment of first-line triple-negative breast cancer. An investigator-sponsored Phase 2 study in second-line acute lymphoblastic leukemia is ongoing in the Nordic countries of Europe.
ERYTECH produces its product candidates for treatment of patients in Europe at its GMP-approved manufacturing site in Lyon, France, and for patients in the United States at its recently opened GMP manufacturing site in Princeton, New Jersey, USA.
ERYTECH is listed on the Nasdaq Global Select Market in the United States (ticker: ERYP) and on the Euronext regulated market in Paris (ISIN code: FR0011471135, ticker: ERYP). ERYTECH is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes.
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This press release contains forward-looking statements, forecasts and estimates with respect to the clinical results from and the development plans of eryaspase, business and regulatory strategy, expansion of manufacturing capacity and anticipated future performance of ERYTECH and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. All statements contained in this press release other than statements of historical facts are forward-looking statements, including, without limitation, statements regarding the ERYTECH’s business strategy including its clinical development of eryaspase; the status of the TRYbeCA1 trial including the timeline for patient enrollment, expansion of trial into the United States and intended activities with respect to the interim analysis; the potential of ERYTECH’s product pipeline; the timing of ERYTECH’s preclinical studies and clinical trials and announcements of data from those studies and trials; ERYTECH’s anticipated manufacturing capacity and ability to meet future demand and ERYTECH’s anticipated cash runway and sufficiency of cash resources. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond ERYTECH's control. There can be no guarantees with respect to pipeline product candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Further description of these risks, uncertainties and other risks can be found in the Company’s regulatory filings with the French Autorité des Marchés Financiers (AMF), the Company’s Securities and Exchange Commission (SEC) filings and reports, including in the Company’s 2018 Document de Référence filed with the AMF in March 2019 and in the Company’s Annual Report on Form 20-F filed with the SEC on March 29, 2019 and future filings and reports by the Company. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements. ERYTECH disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in ERYTECH’s expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by law.