ERYTECH Presents TRYbeCA-1 Trial-in-Progress Poster at the 2019 ASCO GI Annual Meeting
- Category: Proteins and Peptides
- Published on Saturday, 19 January 2019 10:50
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LYON, France and CAMBRIDGE, MA, USA I January 18, 2019 I ERYTECH Pharma (Euronext Paris: ERYP - Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating drug substances inside red blood cells, announced that a poster entitled “TRYbeCA-1: A randomized, phase 3 study of eryaspase in combination with chemotherapy versus chemotherapy alone as second-line treatment in patients with pancreatic adenocarcinoma (NCT03665441)” will be presented today at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in San Francisco. The poster (Abstract # TPS471) will be available at www.erytech.com after presentation at the conference.
In September 2018, the TRYbeCA-1 trial was initiated. The Trial-in-Progress poster will provide an update on the study progress with investigators sites that have been initiated in multiple countries and actively recruiting patients. The trial is planned to enroll approximately 500 patients with second line metastatic pancreatic cancer in 120-130 clinical sites in 12 European countries and the United states. Currently the trial is approved for patients participation in eight selected European countries, and enrolling patients in 21 clinical sites.
Patients who meet the eligibility criteria are randomized 1-to-1 to receive eryaspase in combination with standard chemotherapy (gemcitabine/abraxane or irinotecan-based regimen) or chemotherapy alone until disease progression. The primary endpoint is overall survival. An interim analysis is foreseen when approximately two-thirds of events have occurred.
The launch of the Trybeca-1 Phase 3 trial follows the positive Phase 2b results in the same patient population, that were reported in September 20171. This open-label, multi-center, 2-to-1 randomized study in 141 patients demonstrated significant improvement in both overall survival and progression-free survival. Overall, eryaspase was well tolerated and did not appear to increase the toxicity of the chemotherapy.
“Patients with advanced pancreatic cancer need new treatment options. As global co-Principal Investigator, I am delighted with the rapid set-up of the study. The Trial-in-Progress poster demonstrates that we are making excellent progress toward the initiation of over 100 centers for TRYbeCA-1,” commented Dr. Manuel Hidalgo-Medina, medical oncologist at Beth Israel Deaconess Medical Center in Boston and professor of medicine at Harvard Medical School.
“The results from our landmark Phase 2b study are highly promising and underscore the importance of targeting tumor metabolism pathways in pancreatic cancer. We are hopeful to provide a novel treatment modality for this highly unmet medical need. We are very pleased that the Phase 3 study is making excellent progress and patient enrollment continues as planned. Our enrolled patients mark the initiation of the trial in Europe. We expect investigator sites in the United States will begin enrolling this quarter,” commented Iman El-Hariry, Chief Medical Officer.
About pancreatic cancer
Pancreatic cancer is a disease in which malignant (cancer) cells are found in the tissues of the pancreas. Every year, there are approximately 150,000 new cases of pancreatic cancer diagnosed in Europe and the United States. Advanced pancreatic cancer is a particularly aggressive cancer, with a five-year survival rate of less than 10%. It is currently the fourth leading cause of cancer death in Europe and the United States and is projected to rise to the second leading cause by 2030. Limited therapeutic options are currently available for this indication, thereby reinforcing the need to develop new therapeutic strategies and rational drug combinations with the aim of improving overall patient outcomes and quality of life.
About ERYTECH and eryaspase (GRASPA®): www.erytech.com
ERYTECH is a clinical-stage biopharmaceutical company developing innovative red blood cell-based therapeutics for cancer and orphan diseases. Leveraging its proprietary ERYCAPS platform, a novel technology to encapsulate drug substances inside red blood cells, ERYTECH is developing a pipeline of product candidates to address markets 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 preparations to enter Phase 2 clinical development for the treatment of triple-negative breast cancer. ERYTECH’s next product candidate erymethionase, which consists of methionine-gamma-lyase encapsulated in red blood cells to target methionine-dependent cancers, has demonstrated promising preclinical results and is in preparations to enter Phase 1 clinical development.
ERYTECH is also exploring the use of its ERYCAPS platform for developing cancer immunotherapies (ERYMMUNE) and enzyme therapies (ERYZYME).
ERYTECH produces product candidates at its GMP-approved manufacturing site in Lyon, France, and at the American Red Cross in Philadelphia, USA. A large-scale GMP manufacturing facility is under construction in 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.
1 Hammel et al, Annals of Oncology (2017) 28 (suppl_5): v209-v268