PHAXIAM THERAPEUTICS S.A. ERYTECH Announces Presentation of Results of Expanded Access Program in ALL at 2021 ASH Annual Meeting and Acceptance of Two Abstracts at ASCO GI
- Full results of the Expanded Access Program in ‘Double Allergic’ acute lymphoblastic leukemia (ALL) patients were presented this weekend at ASH 2021, highlighting the feasibility of eryaspase (GRASPA®) to continue the intended course of treatment of ALL patients who developed hypersensitivities to other asparaginases
- Full results from Phase 3 TRYbeCA-1 study of eryaspase in second-line metastatic pancreatic cancer accepted for oral presentation on
January 21 st at ASCO GI as a late-breaking abstract - Interim data from the Phase 1 rESPECT trial of eryaspase plus mFOLFIRINOX in first-line pancreatic cancer patients will be provided in a poster session at ASCO GI on
January 21 st
Poster presentation at ASH 2021
On
Abstract # 1214 Direct Hyperlink
Expanded Access Program: Evaluating Safety of Erythrocytes Encapsulating L-Asparaginase in Combination with Polychemotherapy in Patients Under 55 Years Old with Acute Lymphoblastic Leukemia (ALL) at Risk to Receive Other Formulations of Asparaginase
The eryaspase EAP was conducted at ten clinical sites in
The highlights of the presentation by Prof Bertrand were:
- This study is the first study to demonstrate activity of an asparaginase (ASNase) therapy in a double (and even triple) allergic patient population who received prior E. coli- and Erwinia-derived asparaginase
- The ASNase concentration exceeded the therapeutic target level of 100 U/L for all patients
- ASNase activity was associated with complete asparagine (ASN) reduction (<0.1 µM/L) in 39% of patients, and with at least 50% ASN reduction relative to baseline in an additional 39% of patients
- All except one of the 18 patients in the study achieved complete remission and 14 (77.8%) were still alive at the end of the study
- Eryaspase was well-tolerated when combined with chemotherapy for treatment of patients with ALL
- Eryaspase provides an additional option for patients for whom further ASNase treatment is contraindicated due to toxicity
Hypersensitivity is the most common cause of truncated asparaginase therapy which has been associated with decreased event free survival. The EAP results provide additional support for the feasibility of eryaspase (GRASPA®) to continue the intended course of treatment of ALL patients who developed hypersensitivities to other asparaginases.
In the EAP and consistently across eryaspase ALL studies, eryaspase provides a sustained asparaginase enzyme activity level with few hypersensitivity reactions and is generally well tolerated in combination with chemotherapy. The company is currently preparing a BLA to seek approval for ALL patients who developed hypersensitivity to E. coli-derived asparaginase, based on the results of a Phase 2 clinical trial sponsored by the NOPHO group1. The Company intends to submit the BLA in the first quarter of 2022, subject to completion of remaining data requested by the FDA.
Oral presentations at ASCO GI 2022
Two abstracts have been accepted for presentation at the ASCO GI annual conference in
Abstract # 518 - TRYbeCA-1: A randomized, phase 3 study of eryaspase in combination with chemotherapy versus chemotherapy alone as second-line treatment in patients with advanced pancreatic adenocarcinoma (NCT03665441).
The study findings will be featured as an oral presentation at ASCO GI by Prof.
Abstract # 581 - rESPECT: A phase I dose-escalation study of eryaspase in combination with modified FOLFIRINOX in locally advanced and metastatic pancreatic ductal adenocarcinoma: Interim update (NCT04292743).
An interim analysis will be presented as a poster by Dr
The full abstracts will be made available online via https://meetinglibrary.asco.org at
As reported in late October, the Phase 3 TRYbeCA-1 trial did not meet the primary efficacy endpoint of overall survival (OS), but the prespecified subgroup of patients treated with eryaspase and FOLFIRI, a fluoropyrimidine- and irinotecan-based chemotherapy, demonstrated a nominal increase in median OS of 2.3 months, from 5.7 to 8 months (HR = 0.77; per protocol population), which the Company believes merits further investigation. The rESPECT, Phase 1 IST in first-line pancreatic cancer is evaluating eryaspase in combination with mFOLFIRINOX, also a fluoropyrimidine and irinotecan-based chemotherapy. Based on the full results of TRYbeCA-1 and the available results of the rESPECT trial, the Company will evaluate a potential path forward for eryaspase in pancreatic cancer.
About ERYTECH and eryaspase (GRASPA®)
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 (GRASPA®), which consists of L-asparaginase encapsulated inside donor-derived red blood cells, targets the cancer cells’ altered asparagine and glutamine metabolism. The proof of concept of eryaspase as a cancer metabolism agent was established in different trials in acute lymphoblastic leukemia (ALL) and pancreatic cancer. An investigator sponsored Phase 2 trial (IST) evaluating the use of GRASPA® in ALL patients who developed hypersensitivity reactions to pegylated asparaginase recently reported positive results, based on which the Company intends to request approval in
Eryaspase received Fast Track designation from the
ERYTECH produces its product candidates for treatment of patients in
ERYTECH is listed on the Nasdaq Global Select Market in
For more information, please visit www.erytech.com
CONTACTS
| ERYTECH CFO & COO | Investor relations | NewCap Investor relations Nicolas Merigeau Media relations |
+33 4 78 74 44 38 investors@erytech.com | +1 (212) 915 - 2577 cdavis@lifesciadvisors.com | +33 1 44 71 94 94 erytech@newcap.eu |
Forward-looking Information
This press release contains forward-looking statements including, but not limited to, statements with respect to the clinical development and regulatory plans of eryaspase including the timing of a potential BLA submission to the FDA for the treatment of acute lymphoblastic leukemia, the Company’s ability to obtain regulatory approval for the treatment of patients with acute lymphoblastic leukemia who developed hypersensitivity reactions to E. coli-derived asparaginase, the Company’s ability to extend the indication scope of eryaspase, the Company’s ability for additional funding under the OCABSA financing agreement or other financing attempts, and the Company’s anticipated cash runway. 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. 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 and timeline 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
1 DOI: https://doi.org/10.1182/blood-2020-139373
Attachment
- 211213 ERYTECH_PR_ASCO-GI and ASH_EN_vf
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