Benzinga | Dec 13, 2021 04:13PM EST

ERYTECH Highlights Presentation Of Results Of Expanded Access Program In Acute Lymphoblastic Leukemia At American Society Of Hematology, Acceptance Of 2 Abstracts At American Society Of Clinical Oncology

ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced a summary of its poster presentation at the 2021 ASH Annual Meeting evaluating GRASPA(r) (eryaspase) in acute lymphoblastic leukemia (ALL) as well as the acceptance of two abstracts evaluating eryaspase in advanced pancreatic cancer at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI), which will be held January 20-22, 2022, both in San Francisco, CA and virtually.

Poster presentation at ASH 2021

On Saturday, December 11, 2021, Prof Dr. Yves Bertrand, Oncologist at the Institute of Pediatric Hematology and Oncology, Civil Hospital of Lyon, France, presented the results of the Expanded Access Program (EAP) with GRASPA(r) (eryaspase) in ALL patients who had developed treatment limiting hypersensitivities to both E. coli- and Erwinia-derived asparaginase therapies.

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 France and enrolled 18 patients. The EAP evaluated tolerability and pharmacological profile in patients under 55 years of age with ALL and unable or at risk to receive any other available asparaginase formulation.

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 ?M/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(r)) 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 January 2022. The full results from the TRYbeCA-1 Phase 3 trial of eryaspase in second-line metastatic pancreatic cancer have been accepted for oral presentation on January 21st at ASCO GI as a late-breaking abstract (abstract #518), and an update on the ongoing Phase 1 investigator sponsored trial in first-line advanced pancreatic cancer (abstract #581) has been accepted for a poster presentation.

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. Pascal Hammel, MD, PhD, on Friday January 21st 2022 at 4:35pm EST / 22:35 CET.

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 Marcus Noel, on Friday January 21st 2022 at 3:05pm EST / 21:05 CET.

The full abstracts will be made available online via https://meetinglibrary.asco.org at 5:00pm EST on January 18th 2022.

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.