Free breaking news alerts from StreetInsider.com!
ERYTECH announced the results of the ALL extended visit program at the 2021 ASH annual meeting and accepted two abstracts on ASCO GI
Cambridge, Massachusetts (USA) and Lyon (France), December 13, 2021-ERYTECH Pharma (NASDAQ and Euronext: ERYP) is a clinical-stage biopharmaceutical company, Drug substances encapsulated in red blood cells to develop innovative therapies, today announced a summary of its poster presentation at the 2021 ASH annual meeting evaluating GRASPA® (eryaspase) in acute lymphoblastic leukemia (ALL) and in the American Society of Clinical Oncology The Gastrointestinal Cancer Symposium (ASCO GI) accepted two abstracts evaluating eryaspase in advanced pancreatic cancer), which will be held in San Francisco, California and a virtual location from January 20-22, 2022.
On Saturday, December 11, 2021, Professor Yves Bertrand, an oncologist at the Institute of Pediatric Hematology and Oncology of the Municipal Hospital of Lyon, France, introduced the results of the Extended Access Program (EAP) of GRASPA® (eryaspase) in ALL. E. coli and Erwinia-derived asparaginase therapy limits patients with hypersensitivity.
Abstract # 1214 Direct Hyperlink Expanded Access Program: To evaluate the safety of using L-asparaginase-encapsulated red blood cells in combination with multiple chemotherapy in acute lymphoblastic leukemia (ALL) patients under 55 who are at risk of receiving other asparaginase preparations
Eryaspase EAP was performed at 10 clinical sites in France and 18 patients were recruited. EAP assesses the tolerability and pharmacological characteristics of ALL patients under 55 years of age, and is unable or at risk to receive any other available asparaginase preparations.
The key points of Professor Bertrand’s speech are:
Hypersensitivity is the most common cause of truncated asparaginase therapy, and it is related to a decrease in event-free survival. The EAP results provide additional support for the feasibility of eryaspase (GASPA®) to continue the anticipated treatment of ALL patients with hypersensitivity to other asparaginases.
In the EAP and consistent eryaspase ALL studies, eryaspase provided a sustained level of asparaginase activity with almost no hypersensitivity reactions, and was generally well tolerated when used in combination with chemotherapy. Based on the results of a phase 2 clinical trial sponsored by NOPHO group1, the company is currently preparing a BLA to seek approval for ALL patients who are allergic to E. coli-derived asparaginase. The company intends to submit the BLA in the first quarter of 2022, but needs to complete the remaining data required by the FDA.
Oral report of ASCO GI 2022
Both abstracts have been accepted for publication at the ASCO GI Annual Meeting in January 2022. The full results of the Phase 3 trial of TRYbeCA-1 eryaspase in second-line metastatic pancreatic cancer were reported orally on ASCO GI on January 21 as the latest abstract (Abstract #518) and ongoing first-line advanced pancreatic cancer (Abstract #581) The update of the first phase investigator-sponsored trial has been accepted for poster presentation.
Abstract #518-TRYbeCA-1: A randomized, phase 3 study using eryaspase combined with chemotherapy and chemotherapy alone as the second-line treatment for patients with advanced pancreatic cancer (NCT03665441).
The results of the study will be presented orally on ASCO GI by Pascal Hammel, MD and PhD at 4:35 PM Eastern Time/22:35 Central European Time on Friday, January 21, 2022.
Abstract# 581-rESPECT: Phase I dose escalation study of eryaspase combined with modified FOLFIRINOX in the treatment of locally advanced and metastatic pancreatic ductal adenocarcinoma: mid-term update (NCT04292743).
Dr. Marcus Noel will present the interim analysis in the form of a poster on Friday, January 21, 2022 at 3:05 pm Eastern Time / 21:05 Central European Time.
The full summary will be available online at https://meetinglibrary.asco.org on January 18, 2022 at 5:00 PM Eastern Time.
As reported in late October, the phase 3 TRYbeCA-1 trial did not reach the primary efficacy endpoint of overall survival (OS), but pre-designated patients receiving eryaspase and FOLFIRI (a fluoropyrimidine and irinotecan-based chemotherapy) treatment The subgroup of patients demonstrated a nominal increase in median OS of 2.3 months, from 5.7 months to 8 months (HR = 0.77; per agreement population), and the company believes it is worthy of further investigation. The first-line pancreatic cancer stage 1 IST is evaluating the combination of eryaspase and mFOLFIRINOX, which is also a fluoropyrimidine and irinotecan-based chemotherapy. Based on the complete results of TRYbeCA-1 and the available results of the rESPECT trial, the company will evaluate the potential development path of eryaspase in pancreatic cancer. About ERYTECH and eryaspase (GASPA®)
ERYTECH is a clinical-stage biopharmaceutical company that develops innovative therapies based on red blood cells for serious cancer and orphan diseases. Using its proprietary ERYCAPS® platform, which uses new technology to encapsulate drug substances in red blood cells, ERYTECH is developing a series of candidate products for patients with unmet medical needs. The main focus of ERYTECH is to develop candidate products that alter the metabolism of cancer cells by depriving them of amino acids needed for growth and survival.
The company's main product candidate, eryaspase (GASPA®), consists of L-asparaginase encapsulated in donor-derived red blood cells to target the altered asparagine and glutamine metabolism of cancer cells. In different trials of acute lymphoblastic leukemia (ALL) and pancreatic cancer, the concept of eryaspase as a cancer metabolizer was proved. A researcher-sponsored Phase 2 trial (IST) evaluating the use of GRASPA ® in ALL patients with hypersensitivity to pegylated asparaginase recently reported positive results, and the company intends to apply on this basis Approval in the United States and potentially other regions. The company is also conducting a first-line pancreatic cancer clinical trial sponsored by researchers.
Eryaspase received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of advanced pancreatic cancer and acute lymphocytic leukemia (ALL) hypersensitivity to E. coli-derived PEGylated asparaginase patient. The FDA and the European Medicines Agency have granted eryaspase orphan drug status for the treatment of pancreatic cancer and ALL.
ERYTECH produces candidate products for the treatment of patients in Europe at its GMP-approved production facility in Lyon, France, and produces candidate products for the treatment of patients in the United States at its GMP production facility in Princeton, New Jersey, USA. Eryaspase is not an approved drug.
ERYTECH is listed on the NASDAQ Global Select Market (stock code: ERYP) and the Paris Euronext regulatory market (ISIN code: FR0011471135, stock code: ERYP). ERYTECH is part of CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech Index.
For more information, please visit www.erytech.com
This press release contains forward-looking statements, including but not limited to statements regarding the clinical development and regulatory plan of eryaspase, including the timing of the submission of potential BLA to the FDA for the treatment of acute lymphoblastic leukemia, the company’s ability to obtain regulatory approval for the treatment of Asparaginase derived from Escherichia coli produces hypersensitivity to acute lymphoblastic leukemia patients, the company has the ability to expand the scope of indications for eryaspase, the company has the ability to obtain additional funds under the OCBSA financing agreement or other financing attempts, and the company's expected cash runway . Some of these statements, forecasts, and estimates can be used such as but not limited to "believe", "anticipate", "anticipate", "intend", "plan", "seek", "estimate", "may", " "Will" and "continue" and similar expressions. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors. These assumptions and assessments are considered reasonable at the time they are made, but may or may not be Proved to be correct. Actual events are difficult to predict and may depend on factors beyond ERYTECH's control. For pipeline product candidates, there is no guarantee that the candidates will obtain the necessary regulatory approvals or prove that they will be commercially successful. Therefore, actual results and timetables may differ materially from the expected future results, performance or achievements expressed or implied by such statements, forecasts and estimates. For further descriptions of these risks, uncertainties and other risks, please refer to the company's regulatory documents submitted to the French Financial Market Financial Institution (AMF), the company's Securities and Exchange Commission (SEC) documents and reports, including the company's 2020 documents d' Enregistrement Universel submitted its annual report on Form 20-F to the US Securities and Exchange Commission on March 8, 2021, to AMF and the company on March 8, 2021, as well as the company’s future documents and reports. In light of these uncertainties, we do not make any statements regarding the accuracy or fairness of such forward-looking statements, forecasts and estimates. In addition, forward-looking statements, forecasts and estimates are only issued on the date of this press release. Readers are cautioned not to rely too much on any of these forward-looking statements. ERYTECH assumes no obligation to update any such forward-looking statements, forecasts, or estimates to reflect any changes in ERYTECH’s expectations, or any changes in the events, conditions or circumstances on which any such statements, forecasts, or estimates are based, unless legally The scope of the request. In addition, the COVID-19 pandemic and related containment efforts have had a serious adverse effect on the economy, the severity and duration of which are uncertain. The government's stabilization efforts can only partially mitigate the consequences. The extent and duration of the impact on the company’s business and operations is highly uncertain, including the impact on its clinical trial operations and supply chain. Factors affecting the company’s business and operations include the duration and extent of the pandemic, the extent of mandatory or recommended containment and mitigation measures, and the general economic consequences of the pandemic. The pandemic may have a major adverse impact on the company's business, operations and financial performance over a long period of time.
1 DOI: https://doi.org/10.1182/blood-2020-139373
Get full access to all new and archived articles, unlimited portfolio tracking, email alerts, custom news lines and RSS feeds-and more!